OverweightPhase 3SELECTNCT03574597
Semaglutide Effects on Heart Disease and Stroke in Patients With Overweight or Obesity
A Phase 3 study testing Semaglutide in people with Overweight and Obesity, run by Novo Nordisk A/S at 833 sites in 42 countries.
Trial summary
The researchers are doing the study to see if semaglutide may reduce the risk of having cardiovascular events in patients with overweight or obesity and with prior cardiovascular disease. The participant will either get semaglutide (active medicine) or placebo ("dummy" medicine). Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Overweight, Obesity
- What is being tested?
- Semaglutide
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 17,604 participants
- Where
- 833 sitesin 42 countries
- Study dates
- 24 Oct 2018to 29 Jun 2023
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial
- Male or female, age greater than or equal to 45 years at the time of signing informed consent
- Body mass index (BMI) greater than or equal to 27 kg/m^2
- Have established cardiovascular (CV) disease as evidenced by at least one of the following: prior myocardial infarction; prior stroke (ischemic or haemorrhagic stroke); or symptomatic peripheral arterial disease (PAD), as evidenced by intermittent claudication with ankle-brachial index (ABI) less than 0.85 (at rest), or peripheral arterial revascularization procedure, or amputation due to atherosclerotic disease
Who cannot join
- Cardiovascular-related:
- Any of the following: myocardial infarction, stroke, hospitalisation for unstable angina pectoris or transient ischaemic attack within the past 60 days prior to the day of screening
- Planned coronary, carotid or peripheral artery revascularisation known on the day of screening
- Presently classified as being in New York Heart Association (NYHA) Class IV heart failure
- Glycaemia-related:
- HbA1c greater than or equal to 48 mmol/mol (6.5 %) as measured by the central laboratory at screening
Show all 21Show fewer
- History of type 1 or type 2 diabetes (history of gestational diabetes is allowed)
- Treatment with glucose-lowering agents within 90 days before screening
- Treatment with any glucagon-like-peptide-1 receptor agonist (GLP-1 RA) within 90 days before screening
- General safety:
- History or presence of chronic pancreatitis
- Presence of acute pancreatitis within the past 180 days prior to the day of screening
- Personal or first degree relative(s) history of multiple endocrine neoplasia type 2 or medullary thyroid carcinoma
- End stage renal disease or chronic or intermittent haemodialysis or peritoneal dialysis
- Presence or history of malignant neoplasms within the past 5 years prior to the day of screening. Basal and squamous cell skin cancer and any carcinoma in-situ are allowed
- Severe psychiatric disorder which in the investigator's opinion could compromise compliance with the protocol
- Known or suspected hypersensitivity to trial products or related products
- Previous participation in this trial. Participation is defined as randomisation
- Receipt of any investigational medicinal product within 30 days before screening
- Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using a highly effective contraceptive method
- Any disorder, unwillingness or inability, which in the investigator's opinion, might jeopardise the participant's safety or compliance with the protocol
Trial locations and contacts
833 sites in 42 countries.
833 sites in 42 countries
United States205 sites
Albany Medical College - Endo
Albany, New York, 12203
Cambridge Medical Trials
Alexandria, Louisiana, 71301
Inova Cardiology - Mt. Vernon
Alexandria, Virginia, 23306
Ellipsis Group
Alpharetta, Georgia, 30022
Amarillo Med Spec LLP
Amarillo, Texas, 79106
Community Clinical Research_Anderson
Anderson, Indiana, 46011
Internal Medicine Associates of Anderson
Anderson, South Carolina, 29621
Synexus Clin Res US-Anderson
Anderson, South Carolina, 29621
Michigan Medicine
Ann Arbor, Michigan, 48109
Anne Arundel Medical Center
Annapolis, Maryland, 21401
Arlington Family Res. Ctr Inc
Arlington, Texas, 76012-4637
Northwest Heart Clinical Research, LLC
Arlington Heights, Illinois, 60005
University of Colorado Hospital
Aurora, Colorado, 80045
Texas Diab & Endo, P.A.
Austin, Texas, 78749
American Health Network of Indiana, LLC_Avon_0
Avon, Indiana, 46123
University Of Maryland School of Medicine
Baltimore, Maryland, 21201
Ascension Saint Agnes Heart Ca
Baltimore, Maryland, 21229
MedStar Good Samaritan Hosp
Baltimore, Maryland, 21239
UT Health University of Texas
Bellaire, Texas, 77401
Belzoni Clinical Research
Belzoni, Mississippi, 39038
National Heart Institute Cal
Beverly Hills, California, 90211
Central Alabama Research
Birmingham, Alabama, 35209
Univ of Alabama Birmingham
Birmingham, Alabama, 35294
Excel Med Ctr Clinical Trials
Boca Raton, Florida, 33434
Brigham & Women's Hospital
Boston, Massachusetts, 02115-5804
Wade Family Medicine
Bountiful, Utah, 84010
Bradenton Research Center
Bradenton, Florida, 34205
Bridgeport Hospital
Bridgeport, Connecticut, 06610
Holston Medical Group Pc
Bristol, Tennessee, 37620-7352
Dr. Alexander Perkelvald
Brooklyn, New York, 11229
Mercury Street Medical Group, PLLC_Butte
Butte, Montana, 59701
ClinSite LLC.
Canton, Michigan, 48187
UNC Eastowne Clinical Trials Unit
Chapel Hill, North Carolina, 27514
Medical Uni of SC Charleston
Charleston, South Carolina, 29425
OnSite Clinical Solutions, LLC
Charlotte, North Carolina, 28226
Apex Medical Research Inc
Chicago, Illinois, 60607
Mercy Hospital and Medical Center
Chicago, Illinois, 60616
The Carl & Edyth Lindner Center
Cincinnati, Ohio, 45219
Clearwater Cardiovascular Consultants
Clearwater, Florida, 33756
Cleveland Clinic_Cleveland
Cleveland, Ohio, 44195
Optumcare Colorado Springs, LLC
Colorado Springs, Colorado, 80906
Optumcare Colorado Springs
Colorado Springs, Colorado, 80906
Johns Hopkins University
Columbia, Maryland, 21044
Corvallis Clinic PC Clinical Research Department
Corvallis, Oregon, 97330-3737
FDRC
Costa Mesa, California, 92627
Valley Clinical Trials
Covina, California, 91723
Nature Coast Clin Rsrch_Crystal River
Crystal River, Florida, 34429
Thyroid, Endocrinology, and Diabetes, PA
Dallas, Texas, 75208
Texas Health Physicians Group_Dallas
Dallas, Texas, 75231
UT Southwestern Med Cntr
Dallas, Texas, 75390-9302
Geisinger Clinic
Danville, Pennsylvania, 17822-2111
Cardiology Consultants of Danville Inc.
Danville, Virginia, 24541
Providence Health Partners Ctr
Dayton, Ohio, 45439
Florida Premier Cardiology
Delray Beach, Florida, 33445
Henry Ford Health System
Detroit, Michigan, 48202
Doylestown Hospital Pharmacy
Doylestown, Pennsylvania, 18901
Duke University_Durham
Durham, North Carolina, 27705
Durham VA Medical Center - Duke University
Durham, North Carolina, 27705
UniMed Center
East Brunswick, New Jersey, 08816
Centennial Medical Group
Elkridge, Maryland, 21075-6437
MediSphere Medical Research Center, LLC
Evansville, Indiana, 47714
Inova Cardiology-Fairfax
Fairfax, Virginia, 22031
Fleming Island Center for Clinical Research
Fleming Island, Florida, 32003
Northeast Research Institute
Fleming Island, Florida, 32003
Aa Mrc Llc
Flint, Michigan, 48504
Integrative Research Assoc Inc
Fort Lauderdale, Florida, 33312
American Health Network of IN LLC_Franklin
Franklin, Indiana, 46131
WakeMed Garner Hlthplx
Garner, North Carolina, 27529
The Stern Cardiovascular Group
Germantown, Tennessee, 38138
Macoupin Research Group
Gillespie, Illinois, 62033
Synexus Clinical Research US, Inc./Tatum
Glendale, Arizona, 85306
Synexus Clinical Research
Glendale, Arizona, 85308
New West Physicians,Inc.
Golden, Colorado, 80401
St. Vincent Hosp-Prevea Health
Green Bay, Wisconsin, 54303
American Health Network of Indiana, LLC_Greenfield
Greenfield, Indiana, 46140
Physician's East Endocrinology
Greenville, North Carolina, 27834
Palmetto Clinical Research
Greenville, South Carolina, 29615
Louisiana Heart Center
Hammond, Louisiana, 70403
Harleysville Medical Associates
Harleysville, Pennsylvania, 19438
Chicago Medical Research LLC
Hazel Crest, Illinois, 60429
Synexus Clinical Research US
Henderson, Nevada, 89052
Clinical Research of Hollywood_Hollywood
Hollywood, Florida, 33024
Northwest Houston Cardiology, P.A.
Houston, Texas, 77070
PlanIt Research, PLLC
Houston, Texas, 77079
University of Iowa Prev Inter Ctr
Iowa City, Iowa, 52242
Est Cst Inst for Rsrch,Jksnvil
Jacksonville, Florida, 32216
Jacksonville Ctr For Clin Res
Jacksonville, Florida, 32216
Clinical Neuroscience Solutions, Inc.
Jacksonville, Florida, 32256
Baptist Heart Specialists_Jacksonville
Jacksonville, Florida, 32258
Baptist Heart Specialists_Jacksonville Beach
Jacksonville Beach, Florida, 32250
NSC Research, Inc
Johns Creek, Georgia, 30024
Richard M Kastelic MD Assoc
Johnstown, Pennsylvania, 15905
The University Of Kansas Medical Center - Cray Dia
Kansas City, Kansas, 66160
Clinical Inv Spec, Inc.Kenosha
Kenosha, Wisconsin, 53144
Holston Medical Group
Kingsport, Tennessee, 37660
Scripps Whittier Diabetes Inst
La Jolla, California, 92037
Long Island Cardiovascular Consultants PC
Lake Success, New York, 11042
First Valley Medical Group
Lancaster, California, 93534
Palm Research Center Inc-Vegas
Las Vegas, Nevada, 89128
Torrance Clin Res Inst, Inc.
Lomita, California, 90717
Long Beach VA healthcare System
Long Beach, California, 90822
DCOL Ctr for Clin Res
Longview, Texas, 75605
Angel City Research, Inc.
Los Angeles, California, 90010
VAGLAHS Clinical Research Center (CRC)
Los Angeles, California, 90073
Robley Rex VA Medical Center
Louisville, Kentucky, 40206
L-MARC Research Center
Louisville, Kentucky, 40213
Norton Clinical Research Group
Louisville, Kentucky, 40213
Duke University - S.E Cardio
Lumberton, North Carolina, 28358
Advanced Med Res Maumee
Maumee, Ohio, 43537
Clinical Neuroscience Solutions
Memphis, Tennessee, 38119
Reyes Clinical Research, Inc
Miami, Florida, 33175
International Research Associates, LLC_Miami
Miami, Florida, 33183
Franciscan Health Michigan City
Michigan City, Indiana, 46360
Virginia Research Center
Midlothian, Virginia, 23114
Healthscan Clinical Trials,LLC.
Montgomery, Alabama, 36106
Optumcare Colorado Springs, LLC_Monument
Monument, Colorado, 80132
Riverside University Health System Medical Center
Moreno Valley, California, 92555
Burke Primary Care
Morganton, North Carolina, 28655
Accellacare US Inc._SC
Mt. Pleasant, South Carolina, 29464
American Health Network of IN LLC
Muncie, Indiana, 47304
Southern NH Diabetes and Endo_Nashua
Nashua, New Hampshire, 03060
InvestiClin Research
Nashville, Tennessee, 37203
MidState Endocrine Associates
Nashville, Tennessee, 37203
Barnum Medical Research, Inc.
Natchitoches, Louisiana, 71457-5881
American Health Network of Indiana, LLC
New Albany, Indiana, 47150
Yale University School Of Medicine
New Haven, Connecticut, 06510
NYU Grossman School of Med
New York, New York, 10016
NYU School of Medicine
New York, New York, 10016
Comprehensive Weight Ctrl Prog
New York, New York, 10021
York Clinical Research LLC
Norfolk, Virginia, 23504
Strelitz Diabetes Of Eastern V.
Norfolk, Virginia, 23510
Valley Clinical Trials, Inc.
Northridge, California, 91325
Lemah Creek Clinical Research
Oakbrook Terrace, Illinois, 60181
Capital Clin Res Ctr,LLC
Olympia, Washington, 98502
VA NEB - Western IA Health Stm
Omaha, Nebraska, 68105
University of NE Med Ctr
Omaha, Nebraska, 68198
AdventHealth Diab Inst
Orlando, Florida, 32804
Midwest Heart & Vasc Spec
Overland Park, Kansas, 66211
Oviedo Medical Research, LLC
Oviedo, Florida, 32765
MD Medical Research
Oxon Hill, Maryland, 20745
Desert Oasis Hlthcr Med Group
Palm Springs, California, 92262
Hospital of the Univ PA
Philadelphia, Pennsylvania, 19104-4206
Tristar Clin Investigations, PC
Philadelphia, Pennsylvania, 19114
Parkside Family Medicine
Philadelphia, Pennsylvania, 19144
Synexus Rsch /Cnt Phnx Med C
Phoenix, Arizona, 85050
Preferred Primary Care Physicians Inc.
Pittsburgh, Pennsylvania, 15243
Research Institute Of Dallas
Plano, Texas, 75093
Western University of Health Sciences
Pomona, California, 91766
Oregon Health & Science Uni
Portland, Oregon, 97239
Quartz Hill Walk-in Medical Group, inc.
Quartz Hill, California, 93536
Dominion Medical Associates
Richmond, Virginia, 23219
Clinical Research Partners, LLC
Richmond, Virginia, 23226
National Clin Res Inc.
Richmond, Virginia, 23294
Endo And Metab Cons
Rockville, Maryland, 20852
Endocrine Research Solutions
Roswell, Georgia, 30076
East Coast Institute for Research LLC
Saint Augustine, Florida, 32086
VA Medical Center_Salem
Salem, Virginia, 24153-6404
Quality Research Inc
San Antonio, Texas, 78209
Sun Research Institute
San Antonio, Texas, 78215
San Antonio Prem Int Med
San Antonio, Texas, 78220
Physician PrimeCare Research Institute, PLLC dba
San Antonio, Texas, 78228-6205
Audie L. Murphy Va Hospital, Stvhcs
San Antonio, Texas, 78229
VIP Trials
San Antonio, Texas, 78230
TriWest Research Associates
San Diego, California, 92108
San Diego Family Care
San Diego, California, 92111
Mills-Peninsula Medical Center
San Mateo, California, 94401
NorCal Endocrinology and Internal Medicine
San Ramon, California, 94583
Intercoastal Medical Group
Sarasota, Florida, 34239
Saratoga Clinical Research
Saratoga Springs, New York, 12866
Evanston Premier Hlthcr Res
Skokie, Illinois, 60077
NorthShore Univ Hlth Sys
Skokie, Illinois, 60077
Louisiana Heart Center_Slidell
Slidell, Louisiana, 70458
U. of Vermont Med Ctr Burlington
South Burlington, Vermont, 05403-7205
Encompass Clinical Research_Spring Valley
Spring Valley, California, 91978
Central Illinois Diabetes and Clinical Research
Springfield, Illinois, 62711
Amicis Centers of Clinical Research
St Louis, Missouri, 63128
St Louis Heart & Vascular, P.C.
St Louis, Missouri, 63136
Family Health Care Center
Statesboro, Georgia, 30461
Simcare Medical Research, LLC
Sugar Land, Texas, 77478
Houston Center for Clinical Research LLC
Sugar Land, Texas, 77479
Herman Clinical Research LLC
Suwanee, Georgia, 30024
Holy Name Medical Center
Teaneck, New Jersey, 07666
Cotton O'Neil Clin Research Ctr
Topeka, Kansas, 66606
Lundquist Inst-Biomed Innovtn
Torrance, California, 90502
Atlanta Heart Specialists, LLC
Tucker, Georgia, 30084
Trinity Clinical Research LLC
Tullahoma, Tennessee, 37388
Christus Heart and Vascular Institute
Tyler, Texas, 75701
Velocity Clinical_Valparaiso
Valparaiso, Indiana, 46383
Bayview Physician Services
Virginia Beach, Virginia, 23454
Sentara Medical Group_Norfolk
Virginia Beach, Virginia, 23454
Synexus Clinical Research US, Inc._Horsham
Vista, California, 92083
Hillcrest Family Health Center
Waco, Texas, 76708
New Venture Medical Research
Wadsworth, Ohio, 44281
Chase Medical Research LLC
Waterbury, Connecticut, 06708
Aspirus Research Institute
Wausau, Wisconsin, 54401
Cardio Partners Clin Res Inst
Wellington, Florida, 33449
Confluence Health Hospital
Wenatchee, Washington, 98801
Southgate Medical Group, LLP
West Seneca, New York, 14224
Kalo Clinical Research
West Valley City, Utah, 84120
Great Lakes Medical Research
Westfield, New York, 14787
Accellacare
Wilmington, North Carolina, 28401
Selma Medical Associates
Winchester, Virginia, 22601-3834
Amherst Family Practice P.C.
Winchester, Virginia, 22601
PMG Research of Winston-Salem
Winston-Salem, North Carolina, 27103
Trinity Health Michigan Heart
Ypsilanti, Michigan, 48197
Japan49 sites
Seiwa Clinic
Adachi-ku, Tokyo, 123-0845
Toyooka Chuo Hospital
Asahikawa, Hokkaido, 078-8237
The Univ. of Tokyo Hp., Dept. of Cardiovascular Medicine
Bunkyo-ku, Tokyo, 113-8655
New Tokyo Heart Clinic_Matsudo-shi, Chiba,
Chiba, 271-0077
Fukuokaken Saiseikai Futsukaichi Hospital_Cardiovascular Medicine
Chikushino-shi, Fukuoka, 818-8516
Ehime Prefectural Central Hospital
Ehime, 790-0024
Chiba Tokushukai Hospital
Funabashi-shi, Chiba, 274-8503
Gifu Heart Center
Gifu-city, Gifu, 500-8384
Hirakata Kohsai Hospital
Hirakata-shi, Osaka, 573-0153
Medical Corporation JR Hiroshima Hospital
Hiroshima-shi, Hiroshima, 732-0057
Hiroshi Yamaguchi Clinic
Kagoshima-shi, Kagoshima, 892-0828
H.E.C Science Clinic
Kanagawa, 235-0045
Kasugai Municipal Hospital
Kasugai-shi, Aichi, 486-8510
Sugiura Clinic
Kawaguchi-shi, Saitama, 332-0012
Steel Memorial Yawata Hospital
Kitakyushu-shi, Fukuoka, 805-8508
Chikamori Hospital
Kochi-shi, Kochi, 780-8522
Saiseikai Kumamoto Hospital
Kumamoto-shi, Kumamoto, 861-4193
Uji Tokushukai Medical Center
Kyoto, 611-0041
Koseikai Takeda Hospital
Kyoto-shi, Kyoto, 600-8558
Ijinkai Takeda General Hospital, Cardiovascular Medicine
Kyoto-shi,Kyoto, 601-1495
Ijinkai Takeda General Hospital, Neurosurgery
Kyoto-shi,Kyoto, 601-1495
Medical Corporation Matsuyama-heartcenter Yotsuba Circulatio
Matsuyama-shi, Ehime, 790-0062
Shinden Higashi Clinic_Miyagi
Miyagi, 983-0039
Shiga General Hospital
Moriyama-shi, Shiga, 524-8524
Nagoya Ekisaikai Hospital
Nagoya-shi, Aichi, 454-8502
Naha City Hospital
Naha-shi, Okinawa, 902-8511
Takagi hospital, Internal Medicine
Okawa-shi, Fukuoka, 831-0016
Okayama Medical Center
Okayama-shi, Okayama, 701-1192
Takatsuki Red Cross Hospital
Osaka, 569-1045
Sakurabashi Watanabe Advanced Healthcare Hospital
Osaka-city, Osaka, 530-0005
Saga University Hospital, Department of Cardiology
Saga-shi, Saga, 849-8501
Shinsapporo Seiryou Hospital, Intenal Medicine
Sapporo-shi, Hokkaido, 004-0004
Hanaoka Seishu Memorial Hospital
Sapporo-shi, Hokkaido, 062-0003
Medical corporation Sanseikai Miyanomori Memorial Hospital
Sapporo-shi, Hokkaido, 064-8570
Sendai Kousei Hospital_Sendai-shi, Miyagi
Sendai-shi, Miyagi, 980-0873
National Center for Global Health and Medicine
Shinjuku-ku, Tokyo, 162-8655
Japan Community Health care Organization Ritsurin Hospital
Takamatsu-shi, Kagawa, 760-0073
Kagawa Prefectural Central Hospital, Cardiovascular Medicine
Takamatsu-shi, Kagawa, 760-8557
Kagawa Prefectural Central Hospital
Takamatsu-shi, Kagawa, 760-8557
Kan-etsu chu-oh Hospital
Takasaki-shi, Gunma, 370-3513
Tokorozawa Heart Center
Tokorozawa-shi, Saitama, 356-1142
Saino Clinic
Tokorozawa-shi,Saitama, 359-1141
Tokyo-Eki Center-building Clinic
Tokyo, 103-0027
Fukuwa Clinic
Tokyo, 104-0031
Tokyo Shinagawa Hospital Social Medical Corporation Association Tokyokyojuno-kai
Tokyo, 140-8522
Minamino Cardiovascular Hospital
Tokyo, 192-0918
National Hospital Organization Saitama National Hospital
Wako-city, Saitama, 351-0102
Nagata Hospital
Yanagawa-shi, Fukuoka, 832-0059
Yokosuka General Hospital Uwamachi, Cardiology
Yokosuka-shi, Kanagawa, 238-856
Russia49 sites
Volosevich First City Clinical Hospital
Arkhangelsk, 163001
Reg. State Budget Healthc. Inst. Regional Clinical Hospital
Barnaul, 656024
City Hospital #5
Barnaul, 656045
RBSHI "Altay Regional Cardiology Dispensary"
Barnaul, 656055
Belgorod regional clinical hospital of the St. Ioasaph
Belgorod, 308007
Cardiological dispensary
Ivanovo, 153012
KSFMU, Inrereginal Clinical Diagnostic center
Kazan', 420010
Institute of Complex Problems of Cardio-Vascular Diseases
Kemerovo, 650002
Medical Center CAPITAL-HEALTH
Moscow, 109369
Moscow City Clinical Hospital #15
Moscow, 111539
Friendship University of Russia
Moscow, 117292
Moscow State University n.a. M.V. Lomonosov
Moscow, 119991
National Medical Research Center of Cardiology
Moscow, 121552
City Clinical Hospital №52
Moscow, 123182
Federal Bureau for Medical and Social Expertise
Moscow, 127486
PHI "Central Clinical Hospital RZD- Medicine"
Moscow, 129128
Moscow City Clinical Hospital n.a. A.K. Eramishantseva
Moscow, 129327
LLC RC Medical
Novosibirsk, 630005
Limited Law Company "Healthy Family" Medicine Center"
Novosibirsk, 630099
LLC Reafan
Novosibirsk, 630099
Scientific Research Institute of neuroscience and Medicine
Novosibirsk, 630117
Orenburg Regional Clinical Hospital
Orenburg, 460018
Penza Regional Clinical Hospital named after N.N. Burdenko
Penza, 440052
Rostov State Medical University_Rostov-on-Don
Rostov-on-Don, 344068
City policlinic #28
Saint Petersburg, 190013
Joint Stock Company "Modern Medical Technologies"
Saint Petersburg, 190121
SPb SBHI City Outpatient clinic #37
Saint Petersburg, 191119
SPb SBHI City Outpatient clinic #109
Saint Petersburg, 192283
Limited Liability Company "Energiya Zdoroviya"
Saint Petersburg, 194156
SPb SBHI City Multifield Hospital #2
Saint Petersburg, 194354
SPb SBHI City polyclinic #117
Saint Petersburg, 194358
FSPbSMU n.a. Academic I.P. Pavlov
Saint Petersburg, 197022
Consultative & Diagnostic Center with a Outpatient Hospital
Saint Petersburg, 197110
Saint-Petersburg "City Policlinic # 74"
Saint Petersburg, 197762
Astarta Clinic LLC
Saint Petersburg, 199226
SPb SBHI City Hospital #38 n.a. N.A. Semashko
Saint-Petersburg, Pushkin, 196601
Regional Clinical cardiological dispensary n.a. Polyakov
Samara, 443070
City Hospital #4, Sochi
Sochi, 354057
SAHI of Komi Republic "Consultative Diagnostic Center"
Syktyvkar, 167981
Tomsk National Research Medical Center of the RAS
Tomsk, 634012
Tomsk Regional Clinical Hospital
Tomsk, 634041
Siberian State Medical University_Tomsk
Tomsk, 634050
Regional Clinical Hospital of Tver
Tver', 170036
Tumen State Medical University
Tyumen, Russia, 625023
Tumen State Medical University - RIMBB
Tyumen, 625023
Ulianovsk Regional Clinical Hospital
Ulyanovsk, 432063
Voronezh Regional Clinical Consultive-diagnostic Centre
Voronezh, 394018
Solovyov Clinical Emergency Hospital
Yaroslavl, 150003
Urals State Medical University
Yekaterinburg, 620026
United Kingdom42 sites
Crouch Oak Family Practice
Addlestone, KT15 2BH
Stroke Trials Office
Airdrie, ML6 0JS
Antrim Area Hospital
Antrim, BT42 2RL
Axbridge & Wedmore Medical Practice
Axbridge, BS26 2BJ
Bermuda Practice
Basingstoke, RG24 9GT
Sea Road Surgery
Bexhill-on-Sea, TN40 1JJ
Birmingham Heartlands Hospital
Birmingham, B9 5SS
Layton Medical Centre
Blackpool, FY3 7EN
Bollington Medical Centre
Bollington, SK10 5JH
The Health Centre
Bradford on Avon, BA15 1DQ
Southmead Hospital
Bristol, BS10 5NB
Ely Bridge Surgery
Cardiff, CF5 4AD
St Peters Hospital, Chertsey
Chertsey, KT16 0PZ
Countess Of Chester NHS Foundation Trust
Chester, CH2 1UL
St. Richards Hospital
Chichester, West Sussex, PO19 6SE
WISDEM Centre
Coventry, CV2 2DX
Ninewells Hospital
Dundee, DD1 9SY
Royal Devon University Healthcare NHS Foundation Trust
Exeter, EX2 5DW
Harrogate District Hospital
Harrogate, North Yorkshire, HG2 7SX
Department Of Cardiac Research
Harrow, HA1 3UJ
Wycombe General Hospital
High Wycombe, HP11 2TT
Hull Royal Infirmary
Hull, HU3 2JZ
Cardiology
Leicester, LE3 9QP
Lincoln County Hospital
Lincoln, LN2 5QY
University Hospital Aintree
Liverpool, L9 7AL
Guys Hospital
London, SE1 9RT
Kings College Hospital
London, SE5 9RS
Imperial College London
London, W12 0HS
Diabetes Centre North Manchester General Hospital
Manchester, M8 5RB
Cardio Research
Middlesbrough, TS4 3BW
University Dept of Medicine, Derriford Hospital, Plymouth
Plymouth, PL6 8DH
Clarence Medical Centre
Rhyl, LL18 1DA
Clifton Medical Centre
Rotherham, South Yorkshire, S65 1DA
Ashfields Primary Care Centre
Sandbach, CW11 1EQ
Clinical Research Unit
Somerset, BA21 4AT
Moorgreen Hospital
Southampton, SO30 3JB
Lister Hospital
Stevenage, SG1 4AB
Sunderland Royal Hospital
Sunderland, SR4 7TP
Musgrove Park Hospital
Taunton, TA1 5DA
Cardiology Department
Torquay, TQ2 7AA
Royal Cornwall Hospital (Treliske)
Truro, TR1 3LJ
University Hospital Wishaw
Wishaw, ML2 0DP
India34 sites
Apex Heart Institute
Ahmedabad, Gujarat, 380054
CIMS- Care Institute of Medical Sciences
Ahmedabad, Gujarat, 380060
Sri Jayadeva Institute of Cardiovascular Sciences & Research
Bangalore, Karnataka, 560069
Narayana Hrudayalya Institute of Cardiac Sciences
Bangalore, 560 099
St John's Medical College and Hospital
Bangalore, 560034
St John's Medical College Hospital
Bengaluru, Karnataka, 560034
SP Medical College
Bikaner, Rajasthan, 334003
The Madras Medical Mission
Chennai, Tamil Nadu, 600037
Kamalnayan Bajaj Hospital
Chhatrapati Sambhajinagar, Maharashtra, 431010
G Kuppuswamy Naidu Memorial Hospital
Coimbatore, Tamil Nadu, 641037
Maulana Azad Medical College
Delhi, New Delhi, 110002
Medanta - The Medicity Multi-Speciality Hospital, Gurugram
Gurgaon, Haryana, 122001
Osmania General Hospital
Hyderabad, Telangana, 500 012
Guru Nanak CARE Hospitals
Hyderabad, Telangana, 500020
B M Birla Heart Research Centre
Kolkata, West Bengal, 700027
Gandhi Memorial Hospital- King George's Medical University
Lucknow, Uttar Pradesh, 226003
Dayanand Medical College & Hospital
Ludhiana, Punjab, 141001
Seth GS medical college and KEM Hospital
Mumbai, Maharashtra, 400012
Lokmanya Tilak Municipal Medical College & General Hospital
Mumbai, Maharashtra, 400022
Holy Family Hospital and Medical Research Centre
Mumbai, Maharashtra, 400050
Arneja Heart & Multispeciality Hospital
Nagpur, Maharashtra, 440010
Shri Krishna Hrudayalaya & Critical Care Centre
Nagpur, Maharashtra, 440012
Vijan Hospital & Research Centre
Nashik, Maharashtra, 422005
All India Institute of Medical Sciences
New Dehli, New Delhi, 110029
VMMC & Safdarjung Hospital
New Dehli, New Delhi, 110029
Batra Hospital and Medical Research Center
New Delhi, National Capital Territory of Delhi, 110062
Dr. BL Kapur Memorial Hospital
New Delhi, 110005
Sir Ganga Ram Hospital
New Delhi, 110060
Grant Medical Foundation
Pune, Maharashtra, 411001
Shri B. D. Mehta Mahavir Heart Institute
Surat, Gujarat, 395001
Unicare heart institute and research centre
Surat, Gujarat, 395001
Nirmal Hospital Pvt. Ltd.
Surat, Gujarat, 395002
Christian Medical College Hospital, Vellore
Vellore, Tamil Nadu, 632004
Ramesh Hospitals
Vijayawada, Andhra Pradesh, 520008
Germany31 sites
Universitaetsklinikum Aachen AöR
Aachen, 52074
Kardiologische Praxis
Bad Homburg, 61348
Klinische Forschung Berlin (kfgn)
Berlin, 10117
Emovis GmbH
Berlin, 10629
Synexus Berlin
Berlin, 12627
Synexus Bochum
Bochum, 44787
Klinische Forschung Dresden
Dresden, 01069
Hausaerztlich-Kardiologisches MVZ Am Felsenkeller GmbH
Dresden, 01277
Zentrum fuer klinische Studien Suedbrandenburg GmbH
Elsterwerda, 04910
InnoDiab Forschung GmbH
Essen, 45136
Synexus Frankfurt
Frankfurt, 60313
MVZ CCB Frankfurt Und Main-Taunus GbR
Frankfurt, 60389
Denger, Friedrichsthal
Friedrichsthal, 66299
Klinische Forschung Hamburg
Hamburg, 20253
Wendisch/Dahl Hamburg
Hamburg, 22607
Klinische Forschung Hannover
Hanover, 30159
Chevts
Karlsruhe, 76137
Appel
Kassel, 34121
Universitätsklinikum Leipzig, Endokrinologie und Nephrologie
Leipzig, 04103
AmBeNet GmbH
Leipzig, 04107
Universitätsklinikum Schleswig-Holstein
Lübeck, 23562
Die Praxis am Ludwigsplatz
Ludwigshafen, 67059
RED-Institut für medizinische Forschung und Fortbildung GmbH
Oldenburg in Holstein, 23758
Dr. Axthelm Christoph, Pirna
Pirna, 01796
Zentrum für klinische Studien Alexander Segner
Saint Ingbert-Oberwürzbach, 66386
Steindorf, Schkeuditz
Schkeuditz, 04435
Klinische Forschung Schwerin
Schwerin, 19055
Jacob, Villingen-Schwenningen
Villingen-Schwenningen, 78048
Zentrum für klinische Studien Allgäu Oberschwaben
Wangen, 88239
Al-Zoebi
Wermsdorf, 04779
Forschungszentrum Ruhr KliFoCenter GmbH, Dr. med. Kahrmann
Witten, 58455
Canada28 sites
ViaCar Recherche Clinique Inc
Brossard, Quebec, J4Z 2K9
Manna Research Inc. (Burlington N)
Burlington, Ontario, L7M 4Y1
University of Calgary
Calgary, Alberta, T2T 5C7
C-endo Diab Endo Clin Calgery
Calgary, Alberta, T2V 4J2
Cambridge Cardiac Care Centre
Cambridge, Ontario, N1R 6V6
Manna Research Quebec
Lévis, Quebec, G6W 0M5
St. Joseph's Health Care
London, Ontario, N6A 4V2
Manna Research Mirabel
Mirabel, Quebec, J7J 2K8
G.A. Research Associates Ltd.
Moncton, New Brunswick, E1G 1A7
Clinique Sante Cardio MC
Montreal, Quebec, H1T 3Y7
IRCM
Montreal, Quebec, H2W 1R7
Applied Med Inf Res
Montreal, Quebec, H4A 3T2
Manna Research Ottawa
Nepean, Ontario, K2J 4A7
North York Diagn & Cardiac Ctr
North York, Ontario, M6B 3H7
Dr. James Cha
Oshawa, Ontario, L1J 2K1
Kawartha Cardiology Clinical Trials
Peterborough, Ontario, K9J 0B2
Centricity Res Pointe-Claire
Pointe-Claire, Quebec, H9R 4S5
Medical Associates of Port Perry
Port Perry, Ontario, L9L 1L9
Clin des Mal Lipid de Quebec
Québec, Quebec, G1V 4W2
Institut universitaire de cardiologie
Québec, G1V 4G5
Ctr Méd. et pro d l'Ost d port
Saint-Marc-des-Carrieres, Quebec, G0A 4B0
HHI Research Inc.
Scarborough Village, Ontario, M1B 4Z8
Centre de recherché du CHUS
Sherbrooke, Quebec, J1H 5N4
Synergy Wellness Clinic
Sherwood Park, Alberta, T8H 0N2
Manna Research Stoney Creek
Stoney Creek, Ontario, L8J 3W2
Centre de santé et de services
Terrebonne, Quebec, J6V 2H2
The Port Arthur Clinic Research Program
Thunder Bay, Ontario, P7A 4V7
Manna Research Inc._Toronto
Toronto, Ontario, M9W 4L6
Romania26 sites
Minimed S.R.L.
Bacau, 600238
CMI Dr Pop Lavinia
Baia Mare, Maramureş, 430222
Centrul Medical de Diagnostic si Tratament Ambulatoriu Neomed
Brasov, 500283
Sc Nicodiab Srl
Bucharest, 010507
"Carol Davila" Military Emergency Hospital
Bucharest, 010825
Sana Monitoring SRL
Bucharest, 011025
Institutul National de Endocrinologie C.I. Parhon
Bucharest, 011863
SC Eco-Diagnosis SRL
Bucharest, 031818
S.C. Medcon S.R.L
Buzău, 120203
SC Ames Research Center SRL
Clarasi, Calaras, 910103
S.C. Centrul Medical Unirea S.R.L.
Cluj-Napoca, Cluj, 400349
S.C. Top Diabet Srl
Craiova, Dolj, 200515
County Hospital Deva
Deva, Hunedoara County, 330084
S.C Milena Sante SRL
Galati, 800001
SC Diamed Obesity SRL
Galati, 800291
SC Consultmed SRL
Iași, 700547
SC Cardiomed SRL
Iași, 700687
SC Grand Med SRL
Oradea, Bihor County, 410025
S.C. Endodigest S.R.L.
Oradea, Bihor County, 410151
Centrul Medical Bella Praxis
Paşcani, 700502
Bella Praxis S.R.L.
Paşcani, 705200
S.C. Dianutrilife Medica S.R.L.
Ploieşti, 100561
County Emergency Hospital Satu Mare
Satu Mare, 440055
SC Gensan SRL, Policlinica ASTRA
Sibiu, 550371
Sc Mediab Srl
Târgu Mureş, Mureș County, 540142
3rd Clinic for Nutrition-Spitalulul Județean de Urgenta
Timișoara, Timiș County, 300736
South Africa25 sites
Cardiology Clinical Research
Alberton, Gauteng, 1450
Cardiology Research_Bloemfontein
Bloemfontein, Free State, 9301
IATROS International
Bloemfontein, Free State, 9301
Josha Research
Bloemfontein, Free State, 9301
Dr S Dawood
Cape Town, Western Cape, 7405
Dr Corbett
Cape Town, Western Cape, 7500
Tread Research (Pty)Ltd
Cape Town, Western Cape, 7500
UCT Lung institute
Cape Town, Western Cape, 7700
Dr Iftikhar Osman Ebrahim
Centurion, Gauteng, 0157
Dr Jugnundan's Rooms
Durban, KwaZulu-Natal, 4091
CRISMO
Germiston, Gauteng, 1401
Wits Bara Clinical Trial Site
Johannesburg, Gauteng, 2013
Tickerdoc Research (Pty) LTD
Johannesburg, Gauteng, 2157
WITS Clinical Research
Johannesburg, Gauteng, 2193
Cape Town Medical Research Centre
Kuilsriver, Western Cape, 7580
Dr Moosa's Rooms
Lenasia, Gauteng, 1827
Lenasia Clinical Trial Centre
Lenasia, Gauteng, 1827
Paarl Research Centre
Paarl, Western Cape, 7646
Phoenix Pharma
Port Elizabeth, Eastern Cape, 6001
Jongaie Research
Pretoria, Gauteng, 0183
Synexus Watermeyer Clinical Research Centre
Pretoria, Gauteng, 0184
Clinical Trial Systems (CTC)
Pretoria, Gauteng, 0186
Roodepoort Medicross Clinical Research Centre
Roodepoort, Gauteng, 1724
Synexus Helderberg Clinical Research Centre
Somerset West, Western Cape, 7130
Clinical Projects Research
Worcester, Western Cape, 6850
Italy24 sites
AO Papa Giovanni XXIII USS Dietologia Clinica
Bergamo, 24127
A. O. Universitaria S.ORSOLA-MALPIGHI - U. O. Endocrinologia
Bologna, 40138
ARNAS Ospedale Garibaldi
Catania, 95122
Università degli studi G. D'Annunzio Chieti Pescara - CAST
Chieti Scalo, 66100
Ospedale di San Fermo della Battaglia
Como, 22042
Azienda Osp-Univ Ferrara-Dip Scienze Mediche-Endocrinologia
Cona - Ferrara, 44124
AOU Careggi Dipartimento Medico Geriatrico SOD Diabetologia
Florence, 50134
U.O.D. Dietetica e Nutrizione Clinica
Genova, 16132
Ospedale Santa Maria Goretti - UOD Diabetologia
Latina, LT, 04100
Azienda Ospedaliera Universitaria Federico II di Napoli
Naples, 80131
Azienda Ospedaliera di Padova Clin.Med.3
Padova, 35128
Unità Funzionale di nutrizione clinica cod 58.01.3
Palermo, 90127
IRCCS Fondazione "S. Maugeri" U.O. Medicina Interna ed Endo
Pavia, 27100
Azienda Ospedaliero Universitaria Pisana Ospedale Cisanello
Pisa, 56124
Pol. Uni. Campus Biomedico UOC Endocrinologia e Diabetologia
Roma, RM, 00128
UOC di Medicina Interna - Centro Medico dell'Obesità
Roma, 00133
Policlinico Universitario AGemelli DH Patologie dell'Obesità
Rome, 00168
Ist.Clinico Humanitas Endocrinologia e Malattie del ricambio
Rozzano (MI), 20089
Centro di Alta Spec. Diet., Educ. Alim. e Prev. Cardio Metab
San Donato Milanese (MI), MI, 20097
Centro di Alta Spec. Diet., Educ. Alim. e Prev. Cardio Metab
San Donato Milanese (MI), 20097
Osp. Santissima Annunziata ASL CN1 Endocrinol. Diabetol.
Savigliano (CN), 12038
IRCCS Multimedica
Sesto San Giovanni (MI), 20099
A.O.U. Senese Policlinico "Le Scotte" , U.O.C. Diabetologia
Siena, 53100
A.O.U. Città della Salute e della Scienza di Torino
Torino, 10126
Poland22 sites
Gabinet Leczenia Otylosci i Chorob Dietozaleznych
Bialystok, Podlaskie Voivodeship, 15-281
Kresmed Sp. z o. o.
Bialystok, Podlaskie Voivodeship, 15-481
Poradnia Kardiologiczna Jaroslaw Jurowiecki
Gdansk, 80-286
Centrum Badan Klinicznych PI-House
Gdansk, 80-546
Centrum Medyczne Pratia Gdynia
Gdynia, Pomeranian Voivodeship, 81-338
PRATIA Centrum Medyczne
Gdynia, Pomeranian Voivodeship, 81-338
Grazyna Pulka Specjalistyczny Osrodek "All-Med"
Krakow, 30-033
UniCardia & UniMedica & UniEstetica
Krakow, 31-271
Centrum Terapii Wspolczesnej
Lodz, 90-338
Klimed Lomza
Łomża, 18-404
ETG Lowicz
Lowicz, 99-400
NZOZ "CenterMed Lublin" Sp. z o.o.
Lublin, Lublin Voivodeship, 20-044
Centrum Zdrowia Metabolicznego
Poznan, Wielkopolskie Voivodeship, 60-589
Centrum Medyczne HCP Sp. z o.o.
Poznan, 61-485
Velocity Nova Sp. z o.o.
Puławy, 24-100
ETG Siedlce
Siedlce, Masovian Voivodeship, 08-110
Clinmedica Research sp. z o.o.
Skierniewice, Łódź Voivodeship, 96-100
Gabinety Lekarskie LabMed
Szczecin, 71-531
ETG Warszawa
Warsaw, Masovian Voivodeship, 02-677
Przychodnia Lekarzy Specjalistow Serce
Warsaw, 00-416
Panstwowy Instytut Medyczny Ministerstwa Spraw Wewnetrznych I Administracji
Warsaw, 02-507
Velocity Zamość
Zamość, 22-400
Turkey (Türkiye)21 sites
Baskent Universitesi Adana
Adana, 01250
Cukurova University School of Medicine Balcali Hospital
Adana, 01330
Gulhane Egitim Arastirma Hastanesi
Ankara, 06010
Hacettepe Universitesi Tip Fakultesi Hastanesi
Ankara, 06100
Akdeniz University Tip Fakultesi Hastanesi
Antalya, 07058
Adnan Menderes Universitesi Uygulama ve Arastirma Hastanesi
Aydin, 09010
Eskisehir Osmangazi University-Cardio
Eskişehir, 26040
Gaziantep Universitesi Tip Fakultesi Hastanesi
Gaziantep, 27070
Koc University Hospital
Istanbul, 34010
Seyrantepe Hamidiye Etfal Egitim ve Arastirma Hastanesi
Istanbul, 34371
Istanbul Universitesi Istanbul Tip Fakultesi - Endokrinoloji
Istanbul, 34390
TC SB Ist.İl Sag.Müd.Prof.Dr.Cemil Tascioglu Sehir Hastanesi
Istanbul, 34400
Fatih Sultan Mehmet Hastanesi
Istanbul, 34752
Umraniye Egitim ve Arastirma Hastanesi
Istanbul, 34760
T.C. Saglik Bakanligi Pendik Egitim ve Arastirma Hastanesi
Istanbul, 34899
Ege University School of Medicine, Cardiology Department
Izmir, 35100
Izmir Tepecik Training and Research Hospital
Izmir, 35180
Dokuz Eylul University School of Medicine, Cardiology
Izmir, 35340
Erciyes University Cardiology
Kayseri, 38039
Mersin University Cardiology
Mersin, 33343
Cumhuriyet University School of Medicine-Cardiology
Sivas, 58140
France17 sites
CHRU Besançon
Besançon, 25030
Hôpital Jean Verdier
Bondy, 93143
Centre Hospitalier Sud Francilien
Corbeil-Essonnes, 91106
Centre Hospitalier Universitaire de Dijon-Hopital Le Bocage
Dijon, 21079
Chu Du Bocage
Dijon, 21079
Centre Hospitalier Universitaire Grenoble Alpes-Site Nord Michallon-1
La Tronche, 38700
Les Hopitaux de Chartres-Hopital Louis Pasteur
Le Coudray, 28630
Centre Hospitalier de Narbonne
Narbonne, 11100
CHU de Nice
Nice, 06000
Aphp-Hopital La Pitie Salpetriere-2
Paris, 75013
Ap-Hp-Hopital Europeen Georges Pompidou
Paris, 75015
Hôpital Européen Georges Pompidou
Paris, 75015
Ap-Hp-Hopital Bichat-Claude Bernard-2
Paris, 75877
Centre Hospitalier Universitaire de Bordeaux-Hopital Haut Leveque-2
Pessac, 33600
Centre Hospitalier Universitaire de Nantes-Hopital Nord Laennec-1
Saint-Herblain, 44800
Les Hopitaux Universitaires de Strasbourg-Hopital Civil-2
Strasbourg, 67091
Centre de Recherche Clinique Portes Du Sud
Vénissieux, 69200
Ukraine17 sites
CMI City Clinical Hospital #3
Chernivtsi, 58000
CNPI "Kharkiv City Clinical Hospital #27"
Kharkiv, 61002
NI of Therapy na LT Malaya of NAMSU - Chr. Non-Communicable
Kharkiv, 61039
Oleksandrivska Clinical Hospital - cardio rehabilitation dep
Kyiv, 01023
Medical Center of LLC 'Harmoniya Krasy'
Kyiv, 01135
Medical Center 'Ok!Clinic+' of II of Clinical Studies LLC
Kyiv, 02091
Kyiv City Clinical Hospital of Emergency Care - Infarction
Kyiv, 02660
Clinical Hosp on the railway line №2 branch PHC JSC Ukrzaliz
Kyiv, 03049
MD Strazheska Institute of Cardiology of NAMSU - Resuscitati
Kyiv, 03151
Kyiv Regional Hospital
Kyiv, 04053
City Clinical Emergency Hospital - Cardiology department
Lviv, 79059
Odesa Regional Clinical Hospital
Odesa, 65025
Odessa Clinical Railway Hospital - Outpatient department
Odesa, 65059
City Clinical Hospital #1 - Therapy department
Vinnytsia, 21000
Vinnytsia Regional Clinical Hospital - Cardiology department
Vinnytsia, 21018
Central City Hospital #1 - Scientific-Research center
Zhytomyr, 10002
Zhytomir Regional Clinical Hospital - Cardio-Arrhytm. centre
Zhytomyr, 10002
Bulgaria16 sites
Medical Centre Diamedical-2013
Dimitrovgrad, 6400
MHAT Lukovit, Department of Internal Diseases
Lukovit, 5770
"MHAT - Pazardzhik" AD, Second Department of Internal Diseas
Pazardzhik, 4400
"UMBAL-Dr. Georgi Stranski" EAD, First Clinic of cardiology
Pleven, 5800
"UMHAT "Sveti Georgi" EAD
Plovdiv, 4002
Medical centre Razgrad OOD
Razgrad, 7200
"MHAT "NCH" EAD, Cardiology clinic, Noninvasive diag. dep.
Sofia, 1309
"MHAT "NCH" EAD, Clinic of Cardiology, Depart. of Cardiology
Sofia, 1309
"Acibadem City Clinic MHAT Tokuda" EAD,Cardiology department
Sofia, 1407
"Acibadem City Clinic UMHAT" EOOD, Sofia, Cardiology clinic
Sofia, 1407
"Diagnostic - Consulting Center Aleksandrovska" EOOD
Sofia, 1431
"UMHAT "Aleksandrovska" EAD, Cardiology clinic
Sofia, 1431
"UMHAT "Tsaritsa Yoanna-ISUL"" EAD, Clinic of Cardiology
Sofia, 1527
"UMHATEM N.I. Pirogov" EAD
Sofia, 1606
"UMHAT "Sveta Anna" Sofia" AD, Clinic of Cardiology
Sofia, 1750
"Diagnostic - Consulting Center "Ekvita"" EOOD
Varna, 9002
Brazil15 sites
AngioCor Blumenau
Blumenau, Santa Catarina, 89020-430
Hospital do Coração do Brasil
Brasília, Federal District, 70390-700
Instituto de Pesquisa Clínica de Campinas
Campinas, São Paulo, 13060-080
Cline Research Center
Curitiba, Paraná, 80030-480
Núcleo de Pesquisa Clínica S/S
Curitiba, Paraná, 80730-150
Hospital São Vicente de Paulo
Passo Fundo, Rio Grande do Sul, 99010-080
Instituto Brasil de Pesquisa Clinica
Rio de Janeiro, 20241-180
Cárdio Pulmonar da Bahia
Salvador, Estado de Bahia, 40170130
CIP Centro Integrado de Pesquisas do Hospital de Base
São José do Rio Preto, São Paulo, 15090-000
CPQuali Pesquisa Clínica Ltda
São Paulo, São Paulo, 01228-000
CPCLIN - Centro de Pesquisas Clínicas
São Paulo, São Paulo, 01228-200
Instituto Dante Pazzanese de Cardiologia
São Paulo, São Paulo, 04012-909
Departamento de Gastroenterologia - HCFMUSP
São Paulo, São Paulo, 05403-000
Instituto do Coração - HCFMUSP
São Paulo, São Paulo, 05403-000
Eurolatino Medical Research Center
Uberlândia, Minas Gerais, 38400-500
Greece14 sites
Onassis Cardiac Surgery Center
Athens, 17674
"Laiko" General Hospital of Athens
Athens, GR-11527
Hippokration Hospital
Athens, GR-11527
Alexandra General Hospital, Therapeutic Clinic
Athens, GR-11528
Konstantopouleio G.H. of Athens, "Agia Olga"
Athens, GR-14233
"Hygeia" General Hospital of Athens
Athens, GR-15123
Iatriko Athinon (Athens Medical Canter)
Athens, GR-15125
General Hospital of Chios "Skilitsio"
Chios, GR82100
University Hospital of Athens ATTIKON
Haidari-Athens, Attica, GR-12462
University General Hospital of Ioannina,Internal Medicine
Ioannina, 45500
General Hospital of Lamia
Lamia, GR35100
Univ Gen Hospital Larisa, Cardiology Medicine Clinic
Larissa, GR-41110
AHEPA General University Hospital
Thessaloniki, GR-54636
"Thermi" Private Hosital
Thessaloniki, GR-57001
Australia13 sites
Royal Adelaide Hospital Cardiovascular Clinical Trials
Adelaide, South Australia, 5000
Monash Cardiovascular Research Centre
Clayton, Victoria, 3168
Lyell McEwin Hospital
Elizabeth Vale, South Australia, 5112
The Canberra Hospital_Garran
Garran, Australian Capital Territory, 2605
Geelong Cardiology Research Unit
Geelong, Victoria, 3220
Gosford Hospital
Gosford, New South Wales, 2250
Austin Health, Metabolic Disorders Centre
Heidelberg Heights, Victoria, 3081
HeartCare WA (Joondalup)
Joondalup, Western Australia, 6027
Liverpool Hospital
Liverpool, New South Wales, 2170
Hunter Diabetes Centre
Merewether, New South Wales, 2291
Advara HeartCare
Milton, Queensland, 4064
Core Research Centre
Milton, Queensland, 4064
Cholesterol Care Australia
Wollongabba, Queensland, 4102
Malaysia13 sites
Klinik Kesihatan Masjid Tanah
Alor Gajah, 78300
Hospital Sultanah Bahiyah
Alor Star, 05460
Hospital Universiti Sains Malaysia
Kota Bharu, Kelantan, 16150
Sarawak Heart Centre
Kota Samarahan, Sarawak, 94300
Sarawak Heart Centre
Kota Samarahan, 94300
National Heart Institute
Kuala Lumpur, 50400
University Malaya Medical Centre
Kuala Lumpur, 59100
Hospital Tengku Ampuan Afzan
Kuantan, Pahang, 25100
Hospital Tengku Ampuan Afzan
Kuantan, 25100
Hospital Putrajaya
Putrajaya, 62250
Hospital Queen Elizabeth II
Sabak Bernam, 88300
Hospital Seri Manjung
Seri Manjung, Perak, 32040
University Technology MARA (UiTM) - Puncak Alam
Sungai Buloh, Selangor, 47000
Czechia12 sites
Edumed Broumov
Broumov, 550 01
Ordinace pro choroby srdce
Chomutov, 430 02
Fakultni nemocnice Hradec Kralove_Hradec Kralove_0
Hradec Králové, 500 05
Nemocnice Jihlava Kardiologie
Jihlava, 586 33
Kardiologické centrum
Liberec, 460 63
Policska nemocnice
Polička, 572 01
Fakultni poliklinika
Prague, Czech Republic, 128 08
Endocare
Prague, 140 00
ResTrial
Prague, 181 00
Nemocnice Slany Kardiologie
Slaný, 274 01
Svitavska nemocnice Kardiologie
Svitavy, 568 25
Vseobecna kardiologicka ambulance
Tábor, 39003
Israel12 sites
Outpatient Diabetes Clinic Soroka MC
Beersheba, 84101
Diabetes and obesity center of excellence, Rambam MC
Haifa, 31096
Diabetes Unit Hadassah Ein Karem MC
Jerusalem, 91120
Hadassah Ein Kerem MC - Cardio
Jerusalem, 91120
Clinical Research Unit Meir Medical Center
Kfar Saba, 44281
Institute of Diabetes, Western Galilee MC Nahariya
Nahariya, 22100
Rabin Medical Center - Hasharon Hospital, Dept. D
Petah Tikva, 49372
Kaplan MC
Rehovot, 76100
Cardio Vascular Research Center Sourasky MC
Tel Aviv, 6423906
Institute of Endocrinology, metabolism and hypertension
Tel Aviv, 64239
Endrocrinolgy Clinic - Sheba Medical Center
Tel HaShomer, 52621
Sheba Medica Center - Clinical Research Unit
Tel HaShomer, 5265601
Spain11 sites
Complejo Hospitalario Universitario A Coruña
A Coruña, 15006
Centro Periférico de Especialidades Bola Azul
Almería, 04009
Hospital Gregorio Marañón
Madrid, 28009
Hospital Ramón y Cajal
Madrid, 28034
Hospital Universitario La Paz
Madrid, 28046
Hospital Clínico Virgen de la Victoria
Málaga, 29010
Hospital Son Llatzer
Palma de Mallorca, 07198
Clínica Nuevas Tecnologías en Diabetes y Endocrinología
Seville, 41003
Hospital Virgen de la Macarena
Seville, 41009
Hospital Infanta Luisa
Seville, 41010
Hospital La Fe - Endocrinología y Nutrición
Valencia, 46026
Argentina10 sites
Fundacion Favaloro
CABA, Buenos Aires, Argentina, C1093AAS
Sanatorio Güemes
CABA, City of Buenos Aires, C1180AAX
Centro de Investigación y Prevención Cardiovascular
CABA, C1061AAS.
Centro Médico MEDEOS
CABA, C1426EGQ
Glenny Corp. S.A
CABA, C1430CKE
Clínica Adventista Belgrano
CABA, C1430EGF
Medical Center of Diabetes and Nutrition
CABA, C1440AAD
Instituto Médico DAMIC
Córdoba, X5003DCE
Instituto de Cardiología de Corrientes
Corrientes, Buenos Aires, W3400AMZ
Sanatorio Plaza
Rosario, S2000
Netherlands10 sites
Gelre Ziekenhuizen Apeldoorn
Apeldoorn, 7334 DZ
Amphia Ziekenhuis
Breda, 4818 CK
Deventer Ziekenhuis
Deventer, 7416 SE
UMC Groningen
Groningen, 9713 GZ
Medisch Centrum Leeuwarden
Leeuwarden, 8934 AD
Alrijne Leiderdorp
Leiderdorp, 2353 GA
Bravis Ziekenhuis
Roosendaal, 4708 AE
Franciscus Gasthuis en Vlietland
Rotterdam, 3045 PM
D & A Research B.V.
Sneek, 8601 ZR
Ziekenhuis Rivierenland Tiel
Tiel, 4002 WP
Mexico9 sites
Centro de Investigación Cardiometabólica de Aguascalientes
Aguascalientes, 20230
Centro para el Desarrollo de la Medicina y la Asistencia
Culiacán, Sinaloa, 80230
Lahoja Asociación para la Investigación y Farmacovigilancia
Durango, 34000
Centro de Investigacion Clinica Endocrinologica de Jalisco
Guadalajara, Jalisco, 44670
Instituto Nacional de Cardiología Ignacio Chavez
Mexico City, México, D.F., 14080
Hospital Universitario Dr. José Eleuterio González_Monterrey
Monterrey, Nuevo León, 64460
Unidad Biomedica Avanzada Monterrey
Monterrey, Nuevo León, 64460
Centro de atención e investigación cardiovascular del Potosí
San Luis Potosí City, San Luis Potosí, 78200
CIMAB SA de CV
Torreón, Coahuila, 27000
Norway9 sites
Ålesund Sjukehus - Hjertemedisinsk poliklinikk
Ålesund, 6017
Haukeland Universitetssykehus
Bergen, 5021
Falck Norge AS
Hamar, 2317
Sykehuset Innlandet Lillehammer
Lillehammer, 2609
Akershus Universitetssykehus
Nordbyhagen, 1474
Rikshospitalet - Kardiologisk forskning
Oslo, 0372
Oslo universitetssykehus HF Ullevål
Oslo, 0450
Oslo universitetssykehus Aker
Oslo, 0586
Senter for sykelig overvekt i Helse Sør-Øst
Tønsberg, 3117
Thailand9 sites
King Chulalongkorn Memorial Hospital_Bangkok
Bangkok, 10330
Phramongkutklao Hospital-cardio
Bangkok, 10400
Phramongkutklao Hospital-neuro
Bangkok, 10400
Ramathibodi Hospital-Cardiovascular metabolic Center
Bangkok, 10400
Siriraj Hospital_Bangkok_1
Bangkok, 10700
Maharaj Nakorn Chiang Mai Hospital
Chiang Mai, Mueang Chiang Mai District, 50200
Maharaj Nakorn Chiang Mai Hospital-cardio
Chiang Mai, 50200
Srinakarind Hospital-Division of Cardiology
Khon Kaen, 40002
Thammasat University Hospital
Klong Luang, Pathumthani, Changwat Pathum Thani, 12120
Latvia8 sites
Ari Med
Daugavpils, LV5401
Meissana Ltd
Liepāja, LV-3414
Teterovska practice
Ogre, LV-5001
Stradini Cardiology
Riga, LV-1002
Medical Centre Pulss 5
Riga, LV-1011
Adoria
Riga, LV1011
Health Centre-4
Riga, LV1012
Ziemelkurzeme Regional Hospital
Ventspils, LV3601
Austria7 sites
Universitätsklinik für Innere Medizin
Graz, 8036
Univ.-Klinik für Innere Medizin I
Innsbruck, 6020
LKH Salzburg Universitätsklinikum
Salzburg, 5020
Klinik Landstraße
Vienna, 1030
Ordination Dr. Hanusch
Vienna, 1060
Universitätsklinikum AKH Wien
Vienna, 1090
Klinik Hietzing
Vienna, 1130
Belgium7 sites
Algemeen Stedelijk Ziekenhuis - Aalst - Interventional Cardiology
Aalst, 9300
Imeldaziekenhuis - Bonheiden - Department of Endocrinology
Bonheiden, 2820
CUB Hôpital Erasme_Brussels_1
Brussels, 1070
Ziekenhuis Oost-Limburg AV - Cardiology
Genk, 3600
UZ Gent - Cardiology
Ghent, 9000
UZ Gent_Gent_4
Ghent, 9000
Jessa Ziekenhuis - Hasselt - Cardiology
Hasselt, 3500
Colombia7 sites
IPS Centro Cientifico Asistencial Jose Luis Accini SAS
Barranquilla, Atlántico, 080001
Fundacion del Caribe para la Investigacion Biomedica-BIOS
Barranquilla, 080020
Clinica de la Costa
Barranquilla, 80020
Unidad de Estudios Clínicos de la Fundación Cardiovascular de Colombia
Bucaramanga-piedecuesta, Valle Del Menzuli - Santander, Santander Department, 681012
Rodrigo Botero S.A.S
Medellín, Antioquia, 050021
Centro de Investigacion Clinica Avanzada y Multidisciplinari
Medellín, 050021
CardiovidCentro Cardiovascular Colombiano ClinicaSantaMaria
Medellín, 050034
Croatia7 sites
Specijalna bolnica Krapinske Toplice - Kardiologija
Krapinske Toplice, Krapinsko Zagorska County, 49217
Klinicki bolnicki centar Osijek
Osijek, 31 000
KBC Rijeka, Zavod za kardiomiopatije
Rijeka, 51000
Poliklinika Solmed
Zagreb, City of Zagreb, 10000
KBC "Sestre milosrdnice", Kardiologija
Zagreb, 10000
KBC Zagreb, Klinika za bolesti srca i krvnih zila
Zagreb, 10000
Klinicka bolnica Sveti Duh
Zagreb, 10000
Finland7 sites
StudyCor
Jyväskylä, 40620
Health Step Finland Oy
Kuopio, 70210
Päijät-Häme Central Hospital
Lahti, 15850
OYS Sisätautien tutkimusyksikkö
Oulu, 90220
Seinäjoen keskussairaala
Seinäjoki, 60220
TAYS Sydänsairaala
Tampere, 33520
TYKS Sydänkeskus
Turku, 20520
Denmark6 sites
Aalborg Universitetshospital Kardiologisk Afdeling
Aalborg, 9000
Aarhus Universitetshospital, Skejby Hjertesygdomme
Aarhus N, 8200
Herlev og Gentofte Hospital
Hellerup, Capital Region, 2900
Regionshospitalet Gødstrup, Hjertesygdomme
Herning, 7400
Hvidovre Hospital Hjertemedicinsk
Hvidovre, 2650
Kardiologisk Odense & Svendborg
Svendborg, 5700
Hungary6 sites
Lausmed Kft.
Baja, Bács-Kiskun county, 6500
Debreceni Egyetem Klinikai Központ Belgyógyászati Klinika
Debrecen, H-4032
Bugát Pál Kórház
Gyöngyös, 3200
Szegedi Tudomanyegyetem St Györgyi Albert Klinikai Központ
Szeged, Csongrád-Csanád, H-6725
Markusovszky Egyetemi Oktatókórház
Szombathely, H-9700
Léda Platán Magánklinika
Zalaegerszeg, Zala County, 8900
Ireland6 sites
Mater Miscericordiae Hospital
Dublin, Leinster, D07 XAO9
Connolly Hospital
Dublin, Leinster, DUBLIN 15
The Heartbeat Trust
Dublin, A96 D628
St Vincent's Private Hospital
Dublin, D04 T6F4
Tallaght Hospital - Cardiology
Dublin, D24NR0A
Mallow Primary Healthcare Centre
Mallow, P51Y8EC
Portugal6 sites
Hospital Garcia de Orta
Almada, 2805-267
Centro Hospitalar e Universitário de Coimbra
Coimbra, 3000-459
Hospital da Luz
Lisbon, 1500-650
Centro Hospitalar Lisboa Norte
Lisbon, 1649-035
Unidade Local de Saúde de Matosinhos
Matosinhos Municipality, 4464-513
Centro Hospitalar de São João
Porto, 4200-319
Serbia6 sites
Clinical centre of Serbia, Clinic for cardiology
Belgrade, 11000
Clinical Centre of Serbia, Emergency Centre, Department of Cardiology
Belgrade, 11000
Emergency Internal Medicine Clinic
Belgrade, 11000
Endocrinology, Diabetes and Metabolism Diseases Clinic
Belgrade, 11000
Special Hospital "Sveti Sava"
Belgrade, 11000
Clin. Centre Vojvodina, Clin. endocr., diab. and met. dis.
Novi Sad, Vojvodina, 21000
Sweden6 sites
Lundberglab for Diab Research
Gothenburg, 413 45
Centralsjukhuset, Kristianstad
Kristianstad, 291 85
Clemenstorgets Hjärtmottagning
Lund, 222 21
Enheten för Kliniska Studier (EKS), Örebro
Örebro, 703 62
Hjärtenheten
Östersund, 831 83
Karolinska Universitetssjukhuset Solna,FOU Tema Hjärta Kärl
Stockholm, 171 76
Algeria5 sites
Cardiology department CHU Mustapha Pacha. Algiers
Algiers, 16000
Centre National De la Médecine du Sport
Algiers, 16000
CHU Issad Hassani, Beni Messous, Cardiology department
Algiers, 16000
CHU - Hussein dey Cardiology department Nafissa Hamoud
Algiers, 16040
Cardiology department, Benaouda Benzerdjeb CHU Oran
Oran, 31000
Taiwan5 sites
HsinChu MacKay Memorial Hospital
Hsinchu, 300
E-DA Hosiptal
Kaohsiung City, 82445
MacKay Memorial Hospital-Tamsui Branch
New Taipei City, 25160
National Taiwan University Hospital
Taipei, 100
Chang Gung Memorial Hospital Linkou
Taoyuan City, 333
About this study
Official title: SELECT - Semaglutide Effects on Cardiovascular Outcomes in People With Overweight or Obesity
The researchers are doing the study to see if semaglutide may reduce the risk of having cardiovascular events in patients with overweight or obesity and with prior cardiovascular disease. The participant will either get semaglutide (active medicine) or placebo ("dummy" medicine). Which treatment the participants get is decided by chance. The participant's chance of getting semaglutide or placebo is the same. The participant will get the study medicine in a pen. The participants will need to use the pen to inject the study medicine in a skinfold once a week. The study will last for about 2.5 to 5 years. Participants will have up to 25 clinic visits with the study doctor.
- Conditions
- Overweight, Obesity
- Being tested
- Semaglutide, Placebo (semaglutide)
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SemaglutideDrug
Semaglutide will be injected into a skin fold, in the stomach, thigh or upper arm once a week at the same day of the week (to the extent possible) throughout the trial. Subjects will start semaglutide treatment at 0.24 mg; dose will gradually be increased every 4 weeks up to 2.4 mg.
Placebo (semaglutide)Drug
Placebo will be injected into a skin fold, in the stomach, thigh or upper arm once a week at the same day of the week (to the extent possible) throughout the trial. Participants will receive placebo at an equivalent dose to semaglutide.
| Study group | Role | What they receive |
|---|---|---|
| Semaglutide | Experimental | Participants will receive semaglutide as an adjunct to standard-of-care. Estimated trial duration for an individual subject is from 31 to 59 months. Receives: Drug: Semaglutide |
| Placebo (semaglutide) | Placebo comparator | Participants will receive placebo (semaglutide) as an adjunct to standard-of-care. Estimated trial duration for an individual subject is from 31 to 59 months. Receives: Drug: Placebo (semaglutide) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participants From Time of Randomization to First Occurrence of a Composite Outcome Measure Consisting of: Cardiovascular (CV) Death, Non-fatal Myocardial Infarction (MI), or Non-fatal Stroke
Number of participants with first occurrence of composite outcome measure consisted of CV death (undetermined cause of death presumed CV death), non-fatal MI, or non-fatal stroke are presented. The outcome measure was evaluated based on data from in-trial observation period. In-trial observation period defined as the period from date of randomisation to one of the following dates, whichever comes first: date of follow-up visit, date when participant withdrew consent, date of last contact with participant for participants who were lost to follow-up (participant did not complete the trial and did not withdraw consent), date of death.
Measured: From randomisation (week 0) up to 240 weeks
Secondary outcomes (28)
Participants From Time of Randomisation to CV Death
Number of participants with CV death are presented. The outcome measure was evalulated based on data from in-trial observation period. In-trial observation period defined as the period from date of randomisation to one of the following dates, whichever comes first: date of follow-up visit, date when participant withdrew consent, date of last contact with participant for participants who were lost to follow-up (participant did not complete the trial and did not withdraw consent), date of death.
Measured: From randomisation (week 0) up to 240 weeks
Participants From Time of Randomisation to First Occurrence of a Composite Heart Failure (HF) Outcome Measure Consisting of: HF Hospitalisation, Urgent HF Visit or CV Death
Number of participants with first occurrence of a composite HF outcome measure consisted of HF hospitalisation, urgent HF visit or CV death are presented. The outcome measure was evaluated based on data from in-trial observation period. In-trial observation period defined as the period from date of randomisation to one of the following dates, whichever comes first: date of follow-up visit, date when participant withdrew consent, date of last contact with participant for participants who were lost to follow-up (participant did not complete the trial and did not withdraw consent), date of death.
Measured: From randomisation (week 0) up to 240 weeks
Participants From Time of Randomisation to All-cause Death
Number of participants with all-cause death are presented. The outcome measure was evaluated based on data from in-trial observation period. In-trial observation period defined as the period from date of randomisation to one of the following dates, whichever comes first: date of follow-up visit, date when participant withdrew consent, date of last contact with participant for participants who were lost to follow-up (participant did not complete the trial and did not withdraw consent), date of death.
Measured: From randomisation (week 0) up to 240 weeks
Participants From Time of Randomisation to First Occurrence of an Expanded Composite CV Outcome Measure Consisting of: CV Death, Non-fatal MI, Non-fatal Stroke, Coronary Revascularisation or Unstable Angina Pectoris (UAP) Requiring Hospitalisation
Number of participants with first occurrence of an expanded composite CV outcome measure consisted of CV death, non-fatal MI, non-fatal stroke, coronary revascularisation or UAP requiring hospitalisation are presented. The outcome measure was evaluated based on data from in-trial observation period. In-trial observation period defined as the period from date of randomisation to one of the following dates, whichever comes first: date of follow-up visit, date when participant withdrew consent, date of last contact with participant for participants who were lost to follow-up (participant did not complete the trial and did not withdraw consent), date of death.
Measured: From randomisation (week 0) up to 240 weeks
Participants From Time of Randomisation to First Occurrence of a Composite Outcome Measure Consisting of: All-cause Death, Non-fatal MI, or Non-fatal Stroke
Number of participants with first occurrence of a composite outcome measure consisted of all-cause death, non-fatal MI, or non-fatal stroke are presented. The outcome measure was evaluated based on data from in-trial observation period. In-trial observation period defined as the period from date of randomisation to one of the following dates, whichever comes first: date of follow-up visit, date when participant withdrew consent, date of last contact with participant for participants who were lost to follow-up (participant did not complete the trial and did not withdraw consent), date of death.
Measured: From randomisation (week 0) up to 240 weeks
Participants From Time of Randomisation to First Occurrence of Non-fatal MI
Number of participants with first occurrence of non-fatal MI are presented. The outcome measure was evaluated based on data from in-trial observation period. In-trial observation period defined as the period from date of randomisation to one of the following dates, whichever comes first: date of follow-up visit, date when participant withdrew consent, date of last contact with participant for participants who were lost to follow-up (participant did not complete the trial and did not withdraw consent), date of death.
Measured: From randomisation (week 0) up to 240 weeks
Participants From Time of Randomisation to First Occurrence of Non-fatal Stroke
Number of participants with first occurrence of non-fatal stroke are presented. The outcome measure was evaluated based on data from in-trial observation period. In-trial observation period defined as the period from date of randomisation to one of the following dates, whichever comes first: date of follow-up visit, date when participant withdrew consent, date of last contact with participant for participants who were lost to follow-up (participant did not complete the trial and did not withdraw consent), date of death.
Measured: From randomisation (week 0) up to 240 weeks
Participants From Time of Randomisation to First Occurrence of Coronary Revascularisation
Number of participants with first occurrence of coronary revascularisation are presented. The outcome measure was evaluated based on data from in-trial observation period. In-trial observation period defined as the period from date of randomisation to one of the following dates, whichever comes first: date of follow-up visit, date when participant withdrew consent, date of last contact with participant for participants who were lost to follow-up (participant did not complete the trial and did not withdraw consent), date of death.
Measured: From randomisation (week 0) up to 240 weeks
Participants From Time of Randomisation to First Occurrence of UAP Requiring Hospitalisation
Number of participants with first occurrence of UAP requiring hospitalisation are presented. The outcome measure was evaluated based on data from in-trial observation period. In-trial observation period defined as the period from date of randomisation to one of the following dates, whichever comes first: date of follow-up visit, date when participant withdrew consent, date of last contact with participant for participants who were lost to follow-up (participant did not complete the trial and did not withdraw consent), date of death.
Measured: From randomisation (week 0) up to 240 weeks
Participants From Time of Randomisation to First Occurrence of HF Requiring Hospitalisation or Urgent HF Visit
Number of participants with first occurrence of HF requiring hospitalisation or urgent HF visit are presented. The outcome measure was evaluated based on data from in-trial observation period. In-trial observation period defined as the period from date of randomisation to one of the following dates, whichever comes first: date of follow-up visit, date when participant withdrew consent, date of last contact with participant for participants who were lost to follow-up (participant did not complete the trial and did not withdraw consent), date of death.
Measured: From randomisation (week 0) up to 240 weeks
Participants From Time of Randomisation to First Occurrence of Glycosylated Haemoglobin (HbA1c) Greater Than Equals to (≥) 48 Millimole Per Mole (mmol/Mol) (6.5 Percentage [%])
Number of participants with first occurrence of HbA1c ≥ 48 mmol/mol (6.5%) are presented. The outcome measure was evaluated based on data from in-trial observation period. In-trial observation period defined as the period from date of randomisation to one of the following dates, whichever comes first: date of follow-up visit, date when participant withdrew consent, date of last contact with participant for participants who were lost to follow-up (participant did not complete the trial and did not withdraw consent), date of death.
Measured: From randomisation (week 0) up to 240 weeks
Participants From Time of Randomisation to First Occurrence of a 5-component Composite Nephropathy Outcome Measure
Number of participants with first occurrence of a 5-component composite nephropathy outcome measure consisted of onset of persistent macroalbuminuria (UACR > 300 milligram per gram [mg/g]), persistent 50% reduction in estimated glomerular filtration rate (eGFR) compared with baseline (randomisation), onset of persistent eGFR < 15 ml/min/1.73m^2, initiation of chronic renal replacement therapy (dialysis or transplantation) or renal death. The outcome measure was evaluated based on data from in-trial observation period. In-trial observation period defined as the period from date of randomisation to one of the following dates, whichever comes first: date of follow-up visit, date when participant withdrew consent, date of last contact with participant for participants who were lost to follow-up (participant did not complete the trial and did not withdraw consent), date of death.
Measured: From randomisation (week 0) up to 240 weeks
Participants From Time of Randomisation to HbA1c ≥ 39 mmol/Mol (5.7%) (for Participants With a Screening HbA1c <39 mmol/Mol [5.7%])
Number of participants with HbA1c ≥ 39 mmol/mol (5.7%) are presented. The outcome measure was evaluated based on data from in-trial observation period. In-trial observation period defined as the period from date of randomisation to one of the following dates, whichever comes first: date of follow-up visit, date when participant withdrew consent, date of last contact with participant for participants who were lost to follow-up (participant did not complete the trial and did not withdraw consent), date of death.
Measured: From randomisation (week 0) up to 240 weeks
Participants With HbA1c < 39 mmol/Mol (5.7%) (for Participants With a Screening HbA1c ≥ 39 mmol/Mol [5.7%])
Number of participants with HbA1c < 39 mmol/mol (5.7%) are presented. The outcome measure was evaluated based on data from in-trial observation period. In-trial observation period defined as the period from date of randomisation to one of the following dates, whichever comes first: date of follow-up visit, date when participant withdrew consent, date of last contact with participant for participants who were lost to follow-up (participant did not complete the trial and did not withdraw consent), date of death.
Measured: At week 52, week 104
Change in Systolic Blood Pressure (SBP)
Change in SBP from randomisation (week 0) to week 104 is presented. The outcome measure was evaluated based on data from in-trial observation period. In-trial observation period defined as the period from date of randomisation to one of the following dates, whichever comes first: date of follow-up visit, date when participant withdrew consent, date of last contact with participant for participants who were lost to follow-up (participant did not complete the trial and did not withdraw consent), date of death.
Measured: Week 0, week 104
Change in Diastolic Blood Pressure (DBP)
Change in DBP from randomisation (week 0) to week 104 is presented. The outcome measure was evaluated based on data from in-trial observation period. In-trial observation period defined as the period from date of randomisation to one of the following dates, whichever comes first: date of follow-up visit, date when participant withdrew consent, date of last contact with participant for participants who were lost to follow-up (participant did not complete the trial and did not withdraw consent), date of death.
Measured: Week 0, week 104
Change in Pulse
Change in pulse from randomisation (week 0) to week 104 is presented. The outcome measure was evaluated based on data from in-trial observation period. In-trial observation period defined as the period from date of randomisation to one of the following dates, whichever comes first: date of follow-up visit, date when participant withdrew consent, date of last contact with participant for participants who were lost to follow-up (participant did not complete the trial and did not withdraw consent), date of death.
Measured: Week 0, week 104
Change in High Sensitivity C-Reactive Protein (hsCRP) - Ratio to Baseline
Change in hsCRP (milligram per liter [mg/L]) from randomisation (week 0) to week 104 presented as ratio to baseline (week 0). The outcome measure was evaluated based on data from in-trial observation period. In-trial observation period defined as the period from date of randomisation to one of the following dates, whichever comes first: date of follow-up visit, date when participant withdrew consent, date of last contact with participant for participants who were lost to follow-up (participant did not complete the trial and did not withdraw consent), date of death.
Measured: Week 0, week 104
Change in Total Cholesterol - Ratio to Baseline
Change in total cholesterol (milligram per deciliter [mg/dL]) from randomisation (week 0) to week 104 is presented as ratio to baseline (week 0). The outcome measure was evaluated based on data from in-trial observation period. In-trial observation period defined as the period from date of randomisation to one of the following dates, whichever comes first: date of follow-up visit, date when participant withdrew consent, date of last contact with participant for participants who were lost to follow-up (participant did not complete the trial and did not withdraw consent), date of death.
Measured: Week 0, week 104
Change in High Density Lipoprotein (HDL) Cholesterol - Ratio to Baseline
Change in HDL (mg/dL) from randomisation (week 0) to week 104 is presented as ratio to baseline (week 0). The outcome measure was evaluated based on data from in-trial observation period. In-trial observation period defined as the period from date of randomisation to one of the following dates, whichever comes first: date of follow-up visit, date when participant withdrew consent, date of last contact with participant for participants who were lost to follow-up (participant did not complete the trial and did not withdraw consent), date of death.
Measured: Week 0, week 104
Change in Low Density Lipoprotein (LDL) Cholesterol - Ratio to Baseline
Change in LDL (mg/dL) from randomisation (week 0) to week 104 is presented as ratio to baseline (week 0). The outcome measure was evaluated based on data from in-trial observation period. In-trial observation period defined as the period from date of randomisation to one of the following dates, whichever comes first: date of follow-up visit, date when participant withdrew consent, date of last contact with participant for participants who were lost to follow-up (participant did not complete the trial and did not withdraw consent), date of death.
Measured: Week 0, week 104
Change in Triglycerides - Ratio to Baseline
Change in triglycerides (mg/dL) from randomisation (week 0) to week 104 is presented as ratio to baseline (week 0). The outcome measure was evaluated based on data from in-trial observation period. In-trial observation period defined as the period from date of randomisation to one of the following dates, whichever comes first: date of follow-up visit, date when participant withdrew consent, date of last contact with participant for participants who were lost to follow-up (participant did not complete the trial and did not withdraw consent), date of death.
Measured: Week 0, week 104
Change in Body Weight
Percentage change in body weight from randomisation (week 0) to week 104 is presented. The outcome measure was evaluated based on data from in-trial observation period. In-trial observation period defined as the period from date of randomisation to one of the following dates, whichever comes first: date of follow-up visit, date when participant withdrew consent, date of last contact with participant for participants who were lost to follow-up (participant did not complete the trial and did not withdraw consent), date of death.
Measured: Week 0, week 104
Change in Waist Circumference
Change is waist circumference from randomisation (week 0) to week 104 is presented. The outcome measure was evaluated based on data from in-trial observation period. In-trial observation period defined as the period from date of randomisation to one of the following dates, whichever comes first: date of follow-up visit, date when participant withdrew consent, date of last contact with participant for participants who were lost to follow-up (participant did not complete the trial and did not withdraw consent), date of death.
Measured: Week 0, week 104
Change From Randomisation (Week 0) in Participant Reported Outcome (PRO): EuroQol Five Dimensions Five Level Questionnaire (EQ-5D-5L) Index Score to Week 104
EQ-5D-5L is a PRO tool used to estimate impact on participant's health-related quality of life and provides a description of their problems by dimensions (descriptive system). EQ-5D has 5 dimensions: mobility, self-care, usual activities, pain, anxiety/depression, and each dimension has 5 levels: not at all, mild, moderate, severe, extreme. Participant marks most appropriate statement in each dimension, resulting in 1-digit number and digits from 5 dimensions can be combined in 5-digit number describing participant's health state. Index score records an average health status according to dimensions using an algorithm, ranges 0-1 with higher score indicates better health status. Outcome measure was evaluated based on data from in-trial observation period (defined as date of randomisation to one of the dates, whichever comes first: date of follow-up visit, date when participant withdrew consent, date of last contact with participant [who were lost to follow-up], date of death).
Measured: Week 0, week 104
Change From Randomisation (Week 0) in PRO: EuroQol Five Dimensions Visual Analogue Scale (EQ-5D-VAS) to Week 104
EQ-5D-5L is a PRO tool used to estimate impact on participant's health-related quality of life and provides a description of their problems by dimensions (descriptive system). EQ-5D has 5 dimensions: mobility, self-care, usual activities, pain, anxiety/depression, and each dimension has 5 levels: not at all, mild, moderate, severe, extreme. Participant marks most appropriate statement in each dimension, resulting in 1-digit number and digits from 5 dimensions can be combined in 5-digit number describing participant's health state. VAS component records a participant's overall self-rated health on a range of 0-100 with higher score indicates better self-reported health status. Outcome measure was evaluated based on data from in-trial observation period (defined as date of randomisation to one of the dates, whichever comes first: date of follow-up visit, date when participant withdrew consent, date of last contact with participant [who were lost to follow-up], date of death).
Measured: Week 0, week 104
Change in HbA1c - Percentage
Change in HbA1c (percentage) from randomisation (week 0) to week 104 is presented. The outcome measure was evaulated based on data from in-trial observation period. In-trial observation period defined as the period from date of randomisation to one of the following dates, whichever comes first: date of follow-up visit, date when participant withdrew consent, date of last contact with participant for participants who were lost to follow-up (participant did not complete the trial and did not withdraw consent), date of death.
Measured: Week 0, week 104
Change in HbA1c - mmol/Mol
Change in HbA1c (mmol/mol) from randomisation (week 0) to week 104 is presented. The outcome measure was evaulated based on data from in-trial observation period. In-trial observation period defined as the period from date of randomisation to one of the following dates, whichever comes first: date of follow-up visit, date when participant withdrew consent, date of last contact with participant for participants who were lost to follow-up (participant did not complete the trial and did not withdraw consent), date of death.
Measured: Week 0, week 104
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2018
- Study start24 Oct 2018
- Primary completion21 Jun 2023
- Study completion29 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (22)Papers the sponsor has linked to this study.
- Other trials for OverweightStudies of the same condition, open and under way.
- More trials run by Novo Nordisk A/SThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 17,604 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novo Nordisk A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Transparency (dept.2834), Study director, Novo Nordisk A/S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03574597
- Sponsor's protocol ID
- EX9536-4388
- Other IDs
- 2017-003380-35, U1111-1200-5564, 2017
- Acronym
- SELECT
- Status last verified
- Aug 2024
- First submitted
- 21 Jun 2018
- Last updated
- 30 Aug 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
Publications
Ryan DH, Lingvay I, Colhoun HM, Deanfield J, Emerson SS, Kahn SE, Kushner RF, Marso S, Plutzky J, Brown-Frandsen K, Gronning MOL, Hovingh GK, Holst AG, Ravn H, Lincoff AM. Semaglutide Effects on Cardiovascular Outcomes in People With Overweight or Obesity (SELECT) rationale and design. Am Heart J. 2020 Nov;229:61-69. doi: 10.1016/j.ahj.2020.07.008. Epub 2020 Jul 17.
PubMed 32916609Wilding JPH, Batterham RL, Calanna S, Davies M, Van Gaal LF, Lingvay I, McGowan BM, Rosenstock J, Tran MTD, Wadden TA, Wharton S, Yokote K, Zeuthen N, Kushner RF; STEP 1 Study Group. Once-Weekly Semaglutide in Adults with Overweight or Obesity. N Engl J Med. 2021 Mar 18;384(11):989-1002. doi: 10.1056/NEJMoa2032183. Epub 2021 Feb 10.
PubMed 33567185Lincoff AM, Brown-Frandsen K, Colhoun HM, Deanfield J, Emerson SS, Esbjerg S, Hardt-Lindberg S, Hovingh GK, Kahn SE, Kushner RF, Lingvay I, Oral TK, Michelsen MM, Plutzky J, Tornoe CW, Ryan DH; SELECT Trial Investigators. Semaglutide and Cardiovascular Outcomes in Obesity without Diabetes. N Engl J Med. 2023 Dec 14;389(24):2221-2232. doi: 10.1056/NEJMoa2307563. Epub 2023 Nov 11.
PubMed 37952131Ostrominski JW, Plutzky J, Scirica BM, Hovingh GK, Jeppesen OK, Lincoff AM, Lingvay I, Hoffmann Morville T, Quiroga M, Sofer Y, Urina-Triana M, Aroda VR; SELECT Trial Investigators. Efficacy and Safety of Semaglutide According to Frailty Status: A Post Hoc Analysis of the SELECT Randomized Clinical Trial. JAMA Cardiol. 2026 Sep 16:e263566. doi: 10.1001/jamacardio.2026.3566. Online ahead of print.
PubMed 42747817Sisodia A. Predicting GLP-1 Discontinuation From Pharmacy Claims. Am J Manag Care. 2026 Aug;32(8):426-428. doi: 10.37765/ajmc.2026.89993.
PubMed 42663544Plutzky J, Bogdanski P, Colhoun HM, Dagdelen S, Deanfield JE, Emerson SS, Hovingh GK, Kahn SE, Ekstrom K, Latkovskis G, Lehrke M, Hardt-Lindberg S, Lingvay I, Nicholls SJ, Kalayci Oral T, Terns PP, Rasmussen S, Ridker PM, Ryan DH, Lincoff AM. Effect of Semaglutide on the Inflammatory Biomarker High-Sensitivity CRP in Patients With Established Cardiovascular Disease and Overweight or Obesity in SELECT: A Prespecified Secondary Analysis. Circulation. 2026 Aug 18. doi: 10.1161/CIRCULATIONAHA.125.074482. Online ahead of print.
PubMed 42610271Meyhofer SM, Cariou B, Cercato C, Colhoun HM, Deanfield J, Long MT, Jeppesen OK, Lincoff AM, Lingvay I, Plutzky J, Newsome PN, Nicholls SJ, Quiroga M, Santini F, Sanyal AJ, Kahn SE; SELECT Trial Investigators. Semaglutide on liver fibrosis and heart outcomes in patients at high risk of liver fibrosis: a prespecified analysis of the SELECT randomized trial. Nat Med. 2026 May;32(5):1686-1693. doi: 10.1038/s41591-026-04281-1. Epub 2026 Apr 2.
PubMed 41928037Nicholls SJ, Ryan DH, Deanfield J, Ferreira D, Lang CC, Lincoff AM, Lingvay I, Lubker C, Terns PP, Rasmussen S, Stensen S, Weeke PE, Kahn SE; SELECT Trial Investigators. Semaglutide and Hospitalizations in Patients With Obesity and Established Cardiovascular Disease: An Exploratory Analysis of the SELECT Randomized Clinical Trial. JAMA Cardiol. 2026 Feb 1;11(2):156-164. doi: 10.1001/jamacardio.2025.4824.
PubMed 41433034Deanfield J, Lincoff AM, Kahn SE, Emerson SS, Lingvay I, Scirica BM, Plutzky J, Kushner RF, Colhoun HM, Hovingh GK, Stensen S, Weeke PE, Jeppesen OK, Bravo R, Wu CC, Komuro I, Santini F, Hjelmesaeth J, Urina-Triana M, Buscemi S, Ryan DH. Semaglutide and cardiovascular outcomes by baseline and changes in adiposity measurements: a prespecified analysis of the SELECT trial. Lancet. 2025 Nov 8;406(10516):2257-2268. doi: 10.1016/S0140-6736(25)01375-3. Epub 2025 Oct 22.
PubMed 41138739Lubker C, Bhavsar J, Duque do Vale R, Emerson SS, Nortoft E, Plutzky J, Roberts G, Tarp JM, Lincoff AM. The Composite Number Needed to Treat for Semaglutide in Populations with Overweight or Obesity and Established Cardiovascular Disease Without Diabetes. Adv Ther. 2025 May;42(5):2513-2525. doi: 10.1007/s12325-025-03176-w. Epub 2025 Mar 29.
PubMed 40156748McEwan P, Bog M, Faurby M, Foos V, Lingvay I, Lubker C, Miller R, Toliver JC, Yeates F, Lincoff AM. Cost-effectiveness of semaglutide in people with obesity and cardiovascular disease without diabetes. J Med Econ. 2025 Dec;28(1):268-278. doi: 10.1080/13696998.2025.2459529. Epub 2025 Feb 12.
PubMed 39882599Badve SV, Bilal A, Lee MMY, Sattar N, Gerstein HC, Ruff CT, McMurray JJV, Rossing P, Bakris G, Mahaffey KW, Mann JFE, Colhoun HM, Tuttle KR, Pratley RE, Perkovic V. Effects of GLP-1 receptor agonists on kidney and cardiovascular disease outcomes: a meta-analysis of randomised controlled trials. Lancet Diabetes Endocrinol. 2025 Jan;13(1):15-28. doi: 10.1016/S2213-8587(24)00271-7. Epub 2024 Nov 25.
PubMed 39608381Mendonca L, Moura H, Chaves PC, Neves JS, Ferreira JP. The Impact of Glucagon-Like Peptide-1 Receptor Agonists on Kidney Outcomes: A Meta-Analysis of Randomized Placebo-Controlled Trials. Clin J Am Soc Nephrol. 2025 Feb 1;20(2):159-168. doi: 10.2215/CJN.0000000584. Epub 2024 Oct 8.
PubMed 39480988Kosiborod MN, Deanfield J, Pratley R, Borlaug BA, Butler J, Davies MJ, Emerson SS, Kahn SE, Kitzman DW, Lingvay I, Mahaffey KW, Petrie MC, Plutzky J, Rasmussen S, Ronnback C, Shah SJ, Verma S, Weeke PE, Lincoff AM; SELECT, FLOW, STEP-HFpEF, and STEP-HFpEF DM Trial Committees and Investigators. Semaglutide versus placebo in patients with heart failure and mildly reduced or preserved ejection fraction: a pooled analysis of the SELECT, FLOW, STEP-HFpEF, and STEP-HFpEF DM randomised trials. Lancet. 2024 Sep 7;404(10456):949-961. doi: 10.1016/S0140-6736(24)01643-X. Epub 2024 Aug 30.
PubMed 39222642Scirica BM, Lincoff AM, Lingvay I, Bogdanski P, Buscemi S, Colhoun H, Craciun AE, Ezhov M, Hardt-Lindberg S, Kleist Jeppesen O, Matos ALSA, Node K, Schiele F, Toplak H, van Beek A, Weeke PE, Wiviott SD, Deanfield J, Ryan D. The Effect of Semaglutide on Mortality and COVID-19-Related Deaths: An Analysis From the SELECT Trial. J Am Coll Cardiol. 2024 Oct 22;84(17):1632-1642. doi: 10.1016/j.jacc.2024.08.007. Epub 2024 Aug 30.
PubMed 39217559
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SELECT - Semaglutide Effects on Cardiovascular Outcomes in People With Overweight or Obesity
- ClinicalTrials.gov ID
- NCT03574597
- Acronym / sponsor ID
- SELECT / EX9536-4388
- Conditions
- Overweight, Obesity
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17,604 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- 24 Oct 2018 (actual)
- Primary completion
- 21 Jun 2023 (actual)
- Study completion
- 29 Jun 2023 (actual)
- First posted
- 2 Jul 2018 (actual)
- Results
- Posted 30 Aug 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The researchers are doing the study to see if semaglutide may reduce the risk of having cardiovascular events in patients with overweight or obesity and with prior cardiovascular disease. The participant will either get semaglutide (active medicine) or placebo ("dummy" medicine). Which treatment the participants get is decided by chance. The participant's chance of getting semaglutide or placebo is the same. The participant will get the study medicine in a pen. The participants will need to use the pen to inject the study medicine in a skinfold once a week. The study will last for about 2.5 to 5 years. Participants will have up to 25 clinic visits with the study doctor.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Semaglutide | Experimental | Drug: SemaglutideParticipants will receive semaglutide as an adjunct to standard-of-care. Estimated trial duration for an individual subject is from 31 to 59 months. |
| Placebo (semaglutide) | Placebo comparator | Drug: Placebo (semaglutide)Participants will receive placebo (semaglutide) as an adjunct to standard-of-care. Estimated trial duration for an individual subject is from 31 to 59 months. |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial
- Male or female, age greater than or equal to 45 years at the time of signing informed consent
- Body mass index (BMI) greater than or equal to 27 kg/m^2
- Have established cardiovascular (CV) disease as evidenced by at least one of the following: prior myocardial infarction; prior stroke (ischemic or haemorrhagic stroke); or symptomatic peripheral arterial disease (PAD), as evidenced by intermittent claudication with ankle-brachial index (ABI) less than 0.85 (at rest), or peripheral arterial revascularization procedure, or amputation due to atherosclerotic disease
Key exclusion criteria (21 listed)
- Any of the following: myocardial infarction, stroke, hospitalisation for unstable angina pectoris or transient ischaemic attack within the past 60 days prior to the day of screening
- Planned coronary, carotid or peripheral artery revascularisation known on the day of screening
- Presently classified as being in New York Heart Association (NYHA) Class IV heart failure
- HbA1c greater than or equal to 48 mmol/mol (6.5 %) as measured by the central laboratory at screening
- History of type 1 or type 2 diabetes (history of gestational diabetes is allowed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SemaglutideSemaglutide will be injected into a skin fold, in the stomach, thigh or upper arm once a week at the same day of the week (to the extent possible) throughout the trial. Subjects will start semaglutide treatment at 0.24 mg; dose will gradually be increased every 4 weeks up to 2.4 mg. | Drug | Semaglutide |
| Placebo (semaglutide)Placebo will be injected into a skin fold, in the stomach, thigh or upper arm once a week at the same day of the week (to the extent possible) throughout the trial. Participants will receive placebo at an equivalent dose to semaglutide. | Drug | Placebo (semaglutide) |
Primary outcome
Participants From Time of Randomization to First Occurrence of a Composite Outcome Measure Consisting of: Cardiovascular (CV) Death, Non-fatal Myocardial Infarction (MI), or Non-fatal Stroke
Time frame: From randomisation (week 0) up to 240 weeks
Number of participants with first occurrence of composite outcome measure consisted of CV death (undetermined cause of death presumed CV death), non-fatal MI, or non-fatal stroke are presented. The outcome measure was evaluated based on data from in-trial observation period. In-trial observation period defined as the period from date of randomisation to one of the following dates, whichever comes first: date of follow-up visit, date when participant withdrew consent, date of last contact with participant for participants who were lost to follow-up (participant did not complete the trial and did not withdraw consent), date of death.
28 secondary outcomes
Participants From Time of Randomisation to CV Death
Time frame: From randomisation (week 0) up to 240 weeks
Participants From Time of Randomisation to First Occurrence of a Composite Heart Failure (HF) Outcome Measure Consisting of: HF Hospitalisation, Urgent HF Visit or CV Death
Time frame: From randomisation (week 0) up to 240 weeks
Participants From Time of Randomisation to All-cause Death
Time frame: From randomisation (week 0) up to 240 weeks
Participants From Time of Randomisation to First Occurrence of an Expanded Composite CV Outcome Measure Consisting of: CV Death, Non-fatal MI, Non-fatal Stroke, Coronary Revascularisation or Unstable Angina Pectoris (UAP) Requiring Hospitalisation
Time frame: From randomisation (week 0) up to 240 weeks
Participants From Time of Randomisation to First Occurrence of a Composite Outcome Measure Consisting of: All-cause Death, Non-fatal MI, or Non-fatal Stroke
Time frame: From randomisation (week 0) up to 240 weeks
Participants From Time of Randomisation to First Occurrence of Non-fatal MI
Time frame: From randomisation (week 0) up to 240 weeks
Participants From Time of Randomisation to First Occurrence of Non-fatal Stroke
Time frame: From randomisation (week 0) up to 240 weeks
Participants From Time of Randomisation to First Occurrence of Coronary Revascularisation
Time frame: From randomisation (week 0) up to 240 weeks
Participants From Time of Randomisation to First Occurrence of UAP Requiring Hospitalisation
Time frame: From randomisation (week 0) up to 240 weeks
Participants From Time of Randomisation to First Occurrence of HF Requiring Hospitalisation or Urgent HF Visit
Time frame: From randomisation (week 0) up to 240 weeks
Participants From Time of Randomisation to First Occurrence of Glycosylated Haemoglobin (HbA1c) Greater Than Equals to (≥) 48 Millimole Per Mole (mmol/Mol) (6.5 Percentage [%])
Time frame: From randomisation (week 0) up to 240 weeks
Participants From Time of Randomisation to First Occurrence of a 5-component Composite Nephropathy Outcome Measure
Time frame: From randomisation (week 0) up to 240 weeks
Participants From Time of Randomisation to HbA1c ≥ 39 mmol/Mol (5.7%) (for Participants With a Screening HbA1c <39 mmol/Mol [5.7%])
Time frame: From randomisation (week 0) up to 240 weeks
Participants With HbA1c < 39 mmol/Mol (5.7%) (for Participants With a Screening HbA1c ≥ 39 mmol/Mol [5.7%])
Time frame: At week 52, week 104
Change in Systolic Blood Pressure (SBP)
Time frame: Week 0, week 104
Change in Diastolic Blood Pressure (DBP)
Time frame: Week 0, week 104
Change in Pulse
Time frame: Week 0, week 104
Change in High Sensitivity C-Reactive Protein (hsCRP) - Ratio to Baseline
Time frame: Week 0, week 104
Change in Total Cholesterol - Ratio to Baseline
Time frame: Week 0, week 104
Change in High Density Lipoprotein (HDL) Cholesterol - Ratio to Baseline
Time frame: Week 0, week 104
Change in Low Density Lipoprotein (LDL) Cholesterol - Ratio to Baseline
Time frame: Week 0, week 104
Change in Triglycerides - Ratio to Baseline
Time frame: Week 0, week 104
Change in Body Weight
Time frame: Week 0, week 104
Change in Waist Circumference
Time frame: Week 0, week 104
Change From Randomisation (Week 0) in Participant Reported Outcome (PRO): EuroQol Five Dimensions Five Level Questionnaire (EQ-5D-5L) Index Score to Week 104
Time frame: Week 0, week 104
Change From Randomisation (Week 0) in PRO: EuroQol Five Dimensions Visual Analogue Scale (EQ-5D-VAS) to Week 104
Time frame: Week 0, week 104
Change in HbA1c - Percentage
Time frame: Week 0, week 104
Change in HbA1c - mmol/Mol
Time frame: Week 0, week 104
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 32916609Ryan DH, Lingvay I, Colhoun HM, Deanfield J, Emerson SS, Kahn SE, Kushner RF, Marso S, Plutzky J, Brown-Frandsen K, Gronning MOL, Hovingh GK, Holst AG, Ravn H, Lincoff AM. Semaglutide Effects on Cardiovascular Outcomes in People With Overweight or Obesity (SELECT) rationale and design. Am Heart J. 2020 Nov;229:61-69. doi: 10.1016/j.ahj.2020.07.008. Epub 2020 Jul 17.
- Results publication: PubMed 33567185Wilding JPH, Batterham RL, Calanna S, Davies M, Van Gaal LF, Lingvay I, McGowan BM, Rosenstock J, Tran MTD, Wadden TA, Wharton S, Yokote K, Zeuthen N, Kushner RF; STEP 1 Study Group. Once-Weekly Semaglutide in Adults with Overweight or Obesity. N Engl J Med. 2021 Mar 18;384(11):989-1002. doi: 10.1056/NEJMoa2032183. Epub 2021 Feb 10.
- Results publication: PubMed 37952131Lincoff AM, Brown-Frandsen K, Colhoun HM, Deanfield J, Emerson SS, Esbjerg S, Hardt-Lindberg S, Hovingh GK, Kahn SE, Kushner RF, Lingvay I, Oral TK, Michelsen MM, Plutzky J, Tornoe CW, Ryan DH; SELECT Trial Investigators. Semaglutide and Cardiovascular Outcomes in Obesity without Diabetes. N Engl J Med. 2023 Dec 14;389(24):2221-2232. doi: 10.1056/NEJMoa2307563. Epub 2023 Nov 11.
- Derived from this study: PubMed 42747817Ostrominski JW, Plutzky J, Scirica BM, Hovingh GK, Jeppesen OK, Lincoff AM, Lingvay I, Hoffmann Morville T, Quiroga M, Sofer Y, Urina-Triana M, Aroda VR; SELECT Trial Investigators. Efficacy and Safety of Semaglutide According to Frailty Status: A Post Hoc Analysis of the SELECT Randomized Clinical Trial. JAMA Cardiol. 2026 Sep 16:e263566. doi: 10.1001/jamacardio.2026.3566. Online ahead of print.
- Derived from this study: PubMed 42663544Sisodia A. Predicting GLP-1 Discontinuation From Pharmacy Claims. Am J Manag Care. 2026 Aug;32(8):426-428. doi: 10.37765/ajmc.2026.89993.
- Derived from this study: PubMed 42610271Plutzky J, Bogdanski P, Colhoun HM, Dagdelen S, Deanfield JE, Emerson SS, Hovingh GK, Kahn SE, Ekstrom K, Latkovskis G, Lehrke M, Hardt-Lindberg S, Lingvay I, Nicholls SJ, Kalayci Oral T, Terns PP, Rasmussen S, Ridker PM, Ryan DH, Lincoff AM. Effect of Semaglutide on the Inflammatory Biomarker High-Sensitivity CRP in Patients With Established Cardiovascular Disease and Overweight or Obesity in SELECT: A Prespecified Secondary Analysis. Circulation. 2026 Aug 18. doi: 10.1161/CIRCULATIONAHA.125.074482. Online ahead of print.
- Derived from this study: PubMed 41928037Meyhofer SM, Cariou B, Cercato C, Colhoun HM, Deanfield J, Long MT, Jeppesen OK, Lincoff AM, Lingvay I, Plutzky J, Newsome PN, Nicholls SJ, Quiroga M, Santini F, Sanyal AJ, Kahn SE; SELECT Trial Investigators. Semaglutide on liver fibrosis and heart outcomes in patients at high risk of liver fibrosis: a prespecified analysis of the SELECT randomized trial. Nat Med. 2026 May;32(5):1686-1693. doi: 10.1038/s41591-026-04281-1. Epub 2026 Apr 2.
- Derived from this study: PubMed 41433034Nicholls SJ, Ryan DH, Deanfield J, Ferreira D, Lang CC, Lincoff AM, Lingvay I, Lubker C, Terns PP, Rasmussen S, Stensen S, Weeke PE, Kahn SE; SELECT Trial Investigators. Semaglutide and Hospitalizations in Patients With Obesity and Established Cardiovascular Disease: An Exploratory Analysis of the SELECT Randomized Clinical Trial. JAMA Cardiol. 2026 Feb 1;11(2):156-164. doi: 10.1001/jamacardio.2025.4824.
- Derived from this study: PubMed 41138739Deanfield J, Lincoff AM, Kahn SE, Emerson SS, Lingvay I, Scirica BM, Plutzky J, Kushner RF, Colhoun HM, Hovingh GK, Stensen S, Weeke PE, Jeppesen OK, Bravo R, Wu CC, Komuro I, Santini F, Hjelmesaeth J, Urina-Triana M, Buscemi S, Ryan DH. Semaglutide and cardiovascular outcomes by baseline and changes in adiposity measurements: a prespecified analysis of the SELECT trial. Lancet. 2025 Nov 8;406(10516):2257-2268. doi: 10.1016/S0140-6736(25)01375-3. Epub 2025 Oct 22.
- Derived from this study: PubMed 40156748Lubker C, Bhavsar J, Duque do Vale R, Emerson SS, Nortoft E, Plutzky J, Roberts G, Tarp JM, Lincoff AM. The Composite Number Needed to Treat for Semaglutide in Populations with Overweight or Obesity and Established Cardiovascular Disease Without Diabetes. Adv Ther. 2025 May;42(5):2513-2525. doi: 10.1007/s12325-025-03176-w. Epub 2025 Mar 29.
- Derived from this study: PubMed 39882599McEwan P, Bog M, Faurby M, Foos V, Lingvay I, Lubker C, Miller R, Toliver JC, Yeates F, Lincoff AM. Cost-effectiveness of semaglutide in people with obesity and cardiovascular disease without diabetes. J Med Econ. 2025 Dec;28(1):268-278. doi: 10.1080/13696998.2025.2459529. Epub 2025 Feb 12.
- Derived from this study: PubMed 39608381Badve SV, Bilal A, Lee MMY, Sattar N, Gerstein HC, Ruff CT, McMurray JJV, Rossing P, Bakris G, Mahaffey KW, Mann JFE, Colhoun HM, Tuttle KR, Pratley RE, Perkovic V. Effects of GLP-1 receptor agonists on kidney and cardiovascular disease outcomes: a meta-analysis of randomised controlled trials. Lancet Diabetes Endocrinol. 2025 Jan;13(1):15-28. doi: 10.1016/S2213-8587(24)00271-7. Epub 2024 Nov 25.
- Individual participant dataSharing planned: Yes. According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Transparency (dept.2834) study director
Novo Nordisk A/S
833 sites in 42 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Semaglutide in people with Overweight and Obesity, run by Novo Nordisk A/S at 833 sites in 42 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 833 sites in United States, Japan, Russia, United Kingdom, India and 37 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 Aug 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participants From Time of Randomization to First Occurrence of a Composite Outcome Measure Consisting of: Cardiovascular (CV) Death, Non-fatal Myocardial Infarction (MI), or Non-fatal Stroke (time frame: From randomisation (week 0) up to 240 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03574597, which also lists 22 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Aug 2024.