Type 2 DiabetesPhase 3AMBITION 7NCT07797335

AMBITION 7: A Research Study Investigating How Well Zenagamtide Lowers Blood Sugar and Body Weight Compared to Insulin Glargine in People With Type 2 Diabetes and Increased Risk of Diseases That Affect the Heart and Blood Vessels Treated With 1-3 Other Diabetes Medications

A Phase 3 study testing Zenagamtide and Insulin glargine U-100 in people with Type 2 Diabetes and Cardiovascular Risk, run by Novo Nordisk A/S at 330 sites in 16 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts

Official record

Search all trials

Trial summary

Who is it for?: Ages 45 years and older
Conditions the study is for: Type 2 Diabetes, Cardiovascular Risk
What is being tested?: Zenagamtide and Insulin glargine U-100
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 1,778 participants
Where: 330 sitesin 16 countries
Study dates: 24 Aug 2026to 20 Sep 2028
Phase: Phase 3
Are there results?: Not yet: the study is under way

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 study-related activities. Study-related activities are any procedures that are carried out as part of the study, including activities to determine suitability for the study.
Male or female (sex assigned at birth, inclusive of all gender identities).
Age 45 years or above at the time of signing the informed consent.
Diagnosed with type 2 diabetes (T2D) greater than or equal to (≥) 180 days before screening.
Treatment with 1-3 marketed oral glucose-lowering medications (metformin, glinide, thiazolidinedione, sodium-glucose cotransporter-2 inhibitors (SGLT2i), α-glucosidase inhibitors (AGI), or sulfonylureas (SU) as a single agent or in combination) according to local label. Treatment with oral glucose-lowering medications must be stable (same drug(s), stable daily dose(s)) before screening.
Have HbA1c as determined by central laboratory at screening, if background glucose-lowering medications does not include a SU, or if background glucose-lowering medications includes a SU.

Show all 20Show fewer

Increased risk of cardiovascular events as evidenced by at least one of the following (a-e):
Prior myocardial infarction (MI)
Documented coronary artery disease defined by at least one of the following:
-≥ 50% stenosis of coronary artery on angiography or other imaging modality.
Ischaemia documented by stress test with any imaging modality.
Prior unstable angina with electrocardiogram (ECG) changes.
Prior coronary artery bypass graft or prior percutaneous coronary intervention.
Prior stroke (ischemic or haemorrhagic stroke).
History of chronic kidney disease based on medical records or as judged by the investigator as determined by central laboratory at screening.
Symptomatic peripheral arterial disease (PAD) defined as at least one of the following:
Intermittent claudication with an ankle-brachial index (ABI) < 0.85 at rest.
Intermittent claudication with a ≥ 50% stenosis in a lower extremity peripheral artery documented by X-ray angiography, magnetic resonance (MR) angiography, computer tomography (CT) angiography or Doppler ultrasound.
Prior revascularisation procedure of a lower extremity peripheral artery.
Lower extremity amputation at or above ankle due to atherosclerotic disease (excluding e.g., trauma or osteomyelitis)

Who cannot join

Myocardial infarction, stroke, transient ischaemic attack or hospitalisation for unstable angina pectoris within 60 days before screening.
Planned coronary, carotid or peripheral artery revascularisation.
Chronic or intermittent haemodialysis or peritoneal dialysis within 90 days before screening.
Diabetes- or weight related:
Treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria before screening. However, insulin treatment for gestational diabetes is allowed as well as short term insulin treatment for a maximum of 14 consecutive days.
Treatment with glucagon-like-peptide-1 (GLP-1) receptor agonists (RA), dual GLP1/gastric inhibitory peptide (GIP) RAs (or any other GLP-1 based treatment), dipeptidyl peptidase 4 (DPP-4) inhibitors or amylin analogues before screening.

Show all 10Show fewer

Participant with diabetic retinopathy or maculopathy who received treatment with retinal photocoagulation, vitrectomy or anti-Vascular Endothelial Growth Factor (anti-VEGF) within 180 days before screening or are expected to require treatment within 180 days after screening. Diabetic retinopathy or maculopathy must be verified by an eye examination performed before screening or in the period between screening and randomisation. Pharmacological pupil-dilation is a requirement unless using a digital fundus photography camera specified for non-dilated examination.
Known hypoglycaemic unawareness as indicated by the investigator according to Clarke's questionnaire question.
Any episodes of diabetic ketoacidosis before screening.
Uncontrolled thyroid disease as per investigator's discretion.

Trial locations and contacts

330 sites in 16 countries. Contact the study team or a site near you to ask about taking part.

Novo Nordisk contact

(+1) 866-867-7178

clinicaltrials@novonordisk.com

Country

City, postcode or hospital

Sites recruiting now only

330 sites in 16 countries

United States109 sites, 109 recruiting

Javara/Privia Med Grp GA,LLC
Albany, Georgia, 31707
Recruiting
PharmaTex Research
Amarillo, Texas, 79106
Not yet recruiting
Pinnacle Clinical Research
Austin, Texas, 78757
Not yet recruiting
Ascension Saint Agnes Heart Ca
Baltimore, Maryland, 21229
Not yet recruiting
MedStar Good Samaritan Hosp
Baltimore, Maryland, 21239
Not yet recruiting
Heritage Valley Medical Group
Beaver, Pennsylvania, 15009
Not yet recruiting
Univ of Alabama Birmingham
Birmingham, Alabama, 35294
Not yet recruiting
Brigham & Women's Hospital
Boston, Massachusetts, 02115
Not yet recruiting
Progressive Clinical Research UT
Bountiful, Utah, 84010
Not yet recruiting
Holston Medical Group Pc
Bristol, Tennessee, 37620-7352
Recruiting
Univ of Cincinnati Med Cent
Cincinnati, Ohio, 45267
Not yet recruiting
Innovative Research of W FL
Clearwater, Florida, 33756
Recruiting
Javara Inc. / Privia Medical Group Gulf Coast PLLC
Conroe, Texas, 77384
Recruiting
David Kavtaradze MD, Inc.
Cordele, Georgia, 31015
Not yet recruiting
Osvaldo A. Brusco MD
Corpus Christi, Texas, 78414
Not yet recruiting
West Broadway Clinic
Council Bluffs, Iowa, 51501
Recruiting
Louisiana Heart Center
Covington, Louisiana, 70433
Not yet recruiting
Nature Coast Clin Rsrch_Crystal River
Crystal River, Florida, 34429
Not yet recruiting
Thyroid Endocrinology & Diabetes PA
Dallas, Texas, 75208
Recruiting
Baylor Jack and Jane Hamilton
Dallas, Texas, 75226
Not yet recruiting
Florida Premier Cardiology
Delray Beach, Florida, 33484
Not yet recruiting
Henry Ford Health System
Detroit, Michigan, 48202
Not yet recruiting
Eastern Shore Rsrch Inst, LLC
Fairhope, Alabama, 36532
Recruiting
Elite Research Center
Flint, Michigan, 48532
Recruiting
Piedmont Research Partners, LLC
Fort Mill, South Carolina, 29707
Recruiting
Diabetes and Thyroid Ctr of FW
Fort Worth, Texas, 76132
Not yet recruiting
American Health Network of IN LLC_Franklin
Franklin, Indiana, 46131
Not yet recruiting
American Health Network of Indiana, LLC_Greenfield
Greenfield, Indiana, 46140
Not yet recruiting
Elevate Clinical Research
Gurnee, Illinois, 60031
Recruiting
Chicago Medical Research LLC
Hazel Crest, Illinois, 60429
Recruiting
Encore Medical Research LLC
Hollywood, Florida, 33024
Recruiting
PrimeCare Medical Group
Houston, Texas, 77024
Recruiting
JCCT- Juno NW Houston
Houston, Texas, 77040
Recruiting
Biopharma Informatic_Houston
Houston, Texas, 77043
Recruiting
Northwest Houston Cardiology, P.A.
Houston, Texas, 77070
Recruiting
Endocrine And Psychiatry Center
Houston, Texas, 77095
Not yet recruiting
Rocky Mountain Diab&Osteo Ctr
Idaho Falls, Idaho, 83404
Recruiting
University of Iowa Prev Inter Ctr
Iowa City, Iowa, 52772
Not yet recruiting
East Coast Institute For Research
Jacksonville, Florida, 32216
Not yet recruiting
Jacksonville Ctr for Clin Res
Jacksonville, Florida, 32216
Not yet recruiting
Johnson County ClinTrials
Kansas City, Missouri, 64112
Not yet recruiting
Prem Internal Med Asso Houston
Katy, Texas, 77493
Recruiting
The Alliance for Multispecialty Research LLC AMR
Knoxville, Tennessee, 37909
Not yet recruiting
Clinical Research of Cent FL
Lakeland, Florida, 33805
Recruiting
First Valley Medical Group
Lancaster, California, 93534
Recruiting
Palm Research Center Inc-Vegas
Las Vegas, Nevada, 89128
Not yet recruiting
Alpine Research Association
Layton, Utah, 84041
Recruiting
The Research Group of Lexington LLC
Lexington, Kentucky, 40503
Recruiting
Headlands Research CTR Lincoln
Lincoln, California, 95648
Recruiting
Torrance Clin Res Inst, Inc.
Lomita, California, 90717
Recruiting
DCOL Ctr for Clin Res
Longview, Texas, 75605
Recruiting
Pacific Clinical Studies
Los Alamitos, California, 90720
Recruiting
VAGLAHS Clinical Research Center (CRC)
Los Angeles, California, 90073
Not yet recruiting
Texas Inst, Kdny & Endo Disor
Lufkin, Texas, 75904
Recruiting
Carient Heart and Vascular
Manassas, Virginia, 20109
Not yet recruiting
Central New York Clinical Research CNYCR
Manlius, New York, 13104
Not yet recruiting
Advanced Med Res Maumee
Maumee, Ohio, 43537
Recruiting
PRX Research
Mesquite, Texas, 75149
Not yet recruiting
Life Spring Research Foundation LLC
Miami, Florida, 33130
Recruiting
Optimus U, Corp
Miami, Florida, 33135
Not yet recruiting
Flourish Research - North Miami
Miami, Florida, 33138
Not yet recruiting
Inpatient Research Clinic LLC
Miami Lakes, Florida, 33014
Not yet recruiting
San Marcus Res Clin Miami Lakes
Miami Lakes, Florida, 33014
Recruiting
Trujillo Medical Centers
Miramar, Florida, 33027
Recruiting
Chambliss Clinical Trials, LLC
Montgomery, Alabama, 36106
Recruiting
Carteret Medical Group
Morehead City, North Carolina, 28557
Recruiting
Accellacare US Inc._SC
Mt. Pleasant, South Carolina, 29464
Not yet recruiting
American Health Network of IN LLC
Muncie, Indiana, 47304
Not yet recruiting
Trial Management Associates
Myrtle Beach, South Carolina, 29572
Recruiting
MidState Endocrine Associates
Nashville, Tennessee, 37203
Recruiting
Suncoast Clinical Research, Inc.
New Port Richey, Florida, 34652
Not yet recruiting
Mid Hudson Med Res-New Windsor
New Windsor, New York, 12553
Recruiting
Harlem Cardiology_Madison ave
New York, New York, 10035
Not yet recruiting
Capital Area Research LLC
Newport, Pennsylvania, 17074
Recruiting
Lynn Institute of Norman
Norman, Oklahoma, 73072
Recruiting
Valley Clinical Trials, Inc.
Northridge, California, 91325
Recruiting
Genesis Orthopedics & Sports Medicine
Oak Brook, Illinois, 60523
Not yet recruiting
Ocala Cardiovascular Research
Ocala, Florida, 34471
Recruiting
Methodist Phys. Clinic
Omaha, Nebraska, 68114
Recruiting
Suncoast Clinical Research, Inc.
Palm Harbor, Florida, 34684
Not yet recruiting
Suncoast Research Associates LLC
Pembroke Pines, Florida, 33024
Not yet recruiting
Methodist Medical Center of Illinois
Peoria, Illinois, 61636
Not yet recruiting
Dominion Medical Associates
Richmond, Virginia, 23219
Not yet recruiting
St Johns Center for Clin. Res
Saint Augustine, Florida, 32086
Recruiting
VA Medical Center_Salem
Salem, Virginia, 24153
Not yet recruiting
Wasatch Clinical Research, LLC
Salt Lake City, Utah, 84107
Not yet recruiting
Clinical Advancement Center
San Antonio, Texas, 78212
Recruiting
The IMA Group IMA Clinical Trials of America Inc. CTA
San Antonio, Texas, 78229
Not yet recruiting
Univ Of Texas Hlth Science Cntr
San Antonio, Texas, 78229
Not yet recruiting
VIP Trials
San Antonio, Texas, 78230
Recruiting
NE Clin Res of San Antonio
San Antonio, Texas, 78233
Recruiting
Paradigm Clinical Research
San Diego, California, 92108
Recruiting
N America Res Inst - San Dimas
San Dimas, California, 91773
Recruiting
Honor Health
Scottsdale, Arizona, 85258
Not yet recruiting
Encompass Clinical Research_Spring Valley
Spring Valley, California, 91978
Recruiting
Amicis Centers of Clinical Research
St Louis, Missouri, 63128
Recruiting
Piedmont Healthcare/Research
Statesville, North Carolina, 28625
Recruiting
Simcare Medical Research, LLC
Sugar Land, Texas, 77478
Recruiting
NYC Health + Hospitals/Lincoln
The Bronx, New York, 10451
Not yet recruiting
Prime Global Research Inc.
The Bronx, New York, 10456
Recruiting
Cotton O'Neil Diab & Endo Ctr
Topeka, Kansas, 66606
Recruiting
Arcturus Healthcare, PLC.
Troy, Michigan, 48098
Recruiting
Atlanta Heart Specialist
Tucker, Georgia, 30084
Not yet recruiting
Valley Diab. & Endo Comp Ctr
Weslaco, Texas, 78596
Not yet recruiting
Iowa Diab & Endo Res Center
West Des Moines, Iowa, 50266
Not yet recruiting
Southgate Medical Group, LLP
West Seneca, New York, 14224
Not yet recruiting
Selma Medical Associates
Winchester, Virginia, 22601-3834
Recruiting
Accellacare
Winston-Salem, North Carolina, 27103
Recruiting
Trinity Health Michigan Heart
Ypsilanti, Michigan, 48197
Not yet recruiting

Other trials in United States

China34 sites, 34 recruiting

Chinese Academy of Medical Sciences Fuwai Hospital-Endocrinology
Beijing, Beijing Municipality, 100037
Not yet recruiting
Peking University People's Hospital-Endocrinology
Beijing, Beijing Municipality, 100044
Not yet recruiting
Cangzhou People's Hospital-Endocrinology
Cangzhou, Hebei, 061000
Not yet recruiting
The First Bethune hospital of Jilin University-Endocrinology
Changchun, Jilin, 130061
Not yet recruiting
The First People's Hospital of Changde City-Endocrinology
Changde, Hunan, 415003
Not yet recruiting
The First People's Hospital of Changzhou-Endocrinology
Changzhou, Jiangsu, 213004
Not yet recruiting
Changzhou No.2 People's Hospital-Endocrinology
Changzhou, Jiangsu, 213164
Not yet recruiting
Sichuan Academy of Medical Science & Sichuan Provincial People's Hospital; Affiliated Hospital of UESTC-Endocrinology
Chengdu, Sichuan, 610071
Not yet recruiting
The Second Affiliated Hospital of Chongqing Medical University-Endocrinology
Chongqing, Chongqing Municipality, 400010
Not yet recruiting
Chongqing University Three Gorges Hospital-Endocrinology
Chongqing, Chongqing Municipality, 404199
Not yet recruiting
The Second People's Hospital of Hefei-Endocrinology
Hefei, Anhui, 230012
Not yet recruiting
The Second Hospital of Anhui Medical University-Endocrinology
Hefei, Anhui, 230061
Not yet recruiting
Huzhou Central Hospital-Endocrinology
Huzhou, Zhejiang, 313000
Not yet recruiting
The Second Norman Bethune Hospital of Jilin University-Endocrinology
Jilin City, Jilin, 130041
Not yet recruiting
Jinan Central Hospital-General Medicine
Jinan, Shandong, 250013
Not yet recruiting
Huaihe Hospital of Henan University-Endocrinology
Kaifeng, Henan, 475000
Not yet recruiting
Hebei PetroChina Central Hospital-Endocrinology
Langfang, Hebei, 065099
Not yet recruiting
Luoyang First People's Hospital-Endocrinology
Luoyang, Henan, 471002
Not yet recruiting
The First Affiliated Hospital of Henan University of Science and Technology-Endocrinology
Luoyang, Henan, 471003
Not yet recruiting
Nanjing First Hospital-Endocriniology
Nanjing, Jiangsu, 210006
Not yet recruiting
The Second Affiliated Hospital of Nanjing Medical University-Endocrinology
Nanjing, Jiangsu, 210011
Not yet recruiting
Nanjing Jiangning Hospital-Endocrinology
Nanjing, Jiangsu, 211199
Not yet recruiting
The First Affiliated Hospital of Nanyang Medical College-Endocrinology
Nanyang, Henan, 473058
Not yet recruiting
Panjin Liaoyou Gemflower Hospital-Endocrinology
Panjin, Liaoning, 124120
Not yet recruiting
Central Hospital of Minhang District, Shanghai-Endocrinology
Shanghai, Shanghai Municipality, 201199
Not yet recruiting
The Second People's Hospital of Shenzhen-Endocrinology
Shenzhen, Guangdong, 518035
Not yet recruiting
The Second Hospital of Hebei Medical University-Endocrinology
Shijiazhuang, Hebei, 050000
Not yet recruiting
The First Hospital of Hebei Medical University-Endocrinology
Shijiazhuang, Hebei, 050023
Not yet recruiting
Shiyan Taihe Hospital (Affiliated Hospital of Hubei University of Medicine)-Endocrinology
Shiyan, Hubei, 442008
Not yet recruiting
The Second Affiliated Hospital of Soochow University-Endocrinology
Suzhou, Jiangsu, 215004
Not yet recruiting
Qinghai Provincial People's Hospital-Endocrinology
Xining, Qinghai, 810007
Not yet recruiting
The Second Affiliated Hospital of Zhengzhou University-Endocrinology
Zhengzhou, Henan, 450003
Not yet recruiting
The First Affiliated Hospital of Zhengzhou University-Endocrinology
Zhengzhou, Henan, 450052
Not yet recruiting
The Affiliated Hospital of Jiangsu University-Endocrinology
Zhenjiang, Jiangsu, 212001
Not yet recruiting

Other trials in China

Poland25 sites, 25 recruiting

NZOZ Vita-Diabetica Malgorzata Buraczyk
Bialystok, Podlaskie Voivodeship, 15-879
Not yet recruiting
Uniwersytecki Szpital Kliniczny w Bialymstoku
Bialystok, 15-269
Not yet recruiting
Osteo-Medic s.c. A. Racewicz, J. Supronik
Bialystok, 15-351
Not yet recruiting
Kresmed Sp. z o. o.
Bialystok, 15-481
Not yet recruiting
Zespol Opieki Zdrowotnej w Boleslawcu
Bolesławiec, 59-700
Not yet recruiting
M2M Med. Badania Sp. z o.o.
Chorzów, Silesian Voivodeship, 41-500
Not yet recruiting
Diab Serwis Popenda Spółka Jawna
Chorzów, 41-516
Not yet recruiting
Gyncentrum Sp. z o. o.
Katowice, 40-600
Not yet recruiting
Centrum Medyczne MBB-MED Marta Blach-Burek
Libiąż, 32-590
Not yet recruiting
Gabinet Lekarski Malgorzata Saryusz-Wolska
Lodz, 90-132
Not yet recruiting
Amicare Sp. z o.o. S.K.
Lodz, 91-495
Not yet recruiting
Zana-Med Medical Group Sp. z o.o.
Lublin, Lublin Voivodeship, 20-601
Not yet recruiting
Velocity Nova Sp. z o.o.
Lublin, 20-362
Not yet recruiting
Etyka Osrodek Badan Klinicznych Tomasz Pesta S.K.A.
Olsztyn, 10-117
Not yet recruiting
Irmed Klimkiewicz Rudziewicz-Kowalska sp. j.
Piotrkow Trybunalski, 97-300
Not yet recruiting
Centrum Zdrowia Metabolicznego Paweł Bogdański
Poznan, 60-589
Not yet recruiting
Maciej Wiza Gaja Poradnie Lekarskie
Poznan, 61-251
Not yet recruiting
Velocity Nova Sp. z o.o.
Puławy, 24-100
Not yet recruiting
Centrum Medyczne Medyk Sp.zo.o. Sp.k.
Rzeszów, 35-055
Not yet recruiting
Medicover Integrated Clinical Services Sp. z o.o.
Torun, 87-100
Not yet recruiting
Szpital Czerniakowski Sp. z o.o.
Warsaw, 00-739
Not yet recruiting
PANSTWOWY INSTYTUT MEDYCZNY MSWiA
Warsaw, 02-507
Not yet recruiting
Regionalna Poradnia Diabetologiczna-Zytkiewicz-Jaruga, Stasinska Spolka Partnerska Lekarzy
Wroclaw, 50-127
Not yet recruiting
Velocity Nova Sp. z o.o.
Zamość, 22-400
Not yet recruiting
Prywatna Praktyka Lekarska Anna Chudoba
Żyrardów, 96-300
Not yet recruiting

Other trials in Poland

India21 sites, 21 recruiting

Life Care Hospital and Research Centre
Bangalore, Karnataka, 560092
Not yet recruiting
All India Institute of Medical Sciences (AIIMS), Bhubaneswar
Bhubaneswar, Odisha, 751019
Not yet recruiting
KG Hospital and PG Medical Institute & Research Centre
Coimbatore, Tamil Nadu, 641018
Not yet recruiting
Endolife Specialty Hospitals
Guntur, Andhra Pradesh, 522001
Not yet recruiting
Osmania General Hospital_Hyderabad
Hyderabad, Telangana, 500012
Not yet recruiting
NIZAM'S Institute of Medical Sciences
Hyderabad, Telangana, 500082
Not yet recruiting
TOTALL Diabetes Hormone Institute
Indore, Madhya Pradesh, 452010
Not yet recruiting
Diabetes, Thyroid and Endocrine Centre
Jaipur, Rajasthan, 302006
Not yet recruiting
SMS Hospital
Jaipur, 302004
Not yet recruiting
Amrita Institute Of Medical Sciences & Research Centre
Kochi, Kerala, 682041
Not yet recruiting
Government Medical College, Kozhikode
Kozhikode, Kerala, 673008
Not yet recruiting
Deep Healthcare Private Limited.
Ludhiana, Punjab, 141002
Not yet recruiting
BSES MG hospital
Mumbai, Maharashtra, 400058
Not yet recruiting
Sunil's Diabetes Care n' Research Centre Pvt Ltd
Nagpur, Maharashtra, 440010
Not yet recruiting
All India Institute of Medical Sciences (AIIMS)
New Delhi, 110029
Not yet recruiting
Chellaram Diabetes Institute
Pune, Maharashtra, 411021
Not yet recruiting
All India Institute of Medical Sciences (AIIMS), Raipur
Raipur, Chhattisgarh, 492099
Not yet recruiting
Nirmal Hospital Pvt. Ltd.
Surat, Gujarat, 395001
Not yet recruiting
Ashirwad Hospital and Research Centre
Thane, Maharashtra, 421004
Not yet recruiting
SSG Hospital, Baroda
Vadodara, Gujarat, 390001
Not yet recruiting
Christian Medical College Hospital, Vellore
Vellore, Tamil Nadu, 632004
Not yet recruiting

Other trials in India

Argentina19 sites, 19 recruiting

Instituto de Investigaciones Clínicas Bahia Blanca
Bahía Blanca, Buenos Aires, B8000
Not yet recruiting
OMI- Organización Médica de Investigación
Buenos Aires, C1015
Not yet recruiting
Hospital Sirio Libanes
Buenos Aires, C1419
Not yet recruiting
Centro Medico Dra. Laura Maffei e Investigacion Clínica Apli
Buenos Aires, C1425AGC
Not yet recruiting
CEMEDIC
CABA, Buenos Aires, C1440CFD
Not yet recruiting
CIPREC Arenales
CABA, C1061AAS
Not yet recruiting
Centro Médico Viamonte SRL
CABA, C1120AAC
Not yet recruiting
CENUDIAB Centro Médico de Nutrición v Diabetes
CABA, C1440AAD
Not yet recruiting
Dolz Investigacion Clinica
Ciudad Autónoma de Buenos Aires, Buenos Aires, C1048
Not yet recruiting
Fundación Respirar
Ciudad Autónoma de Buenos Aires, Buenos Aires, C1426
Not yet recruiting
Centro Diabetologico Cordoba Dr. Waitman
Córdoba, 5000
Not yet recruiting
Centro médico privado Cemaic
Córdoba, X5008
Not yet recruiting
CIPADI
Godoy Cruz, M5501ARP
Not yet recruiting
Centro de Investigaciones Médicas Mar del Plata
Mar del Plata, Buenos Aires, B7600GNY
Not yet recruiting
Fundacion Estudios Clinicos
Rosario, Santa Fe Province, S2000DEJ
Not yet recruiting
Nuvexa
Rosario, Santa Fe Province, S2000
Not yet recruiting
Centro Oncológico de Excelencia (COE)
San Juan, San Juan Province, J5400
Not yet recruiting
Clínica Mayo de Urgencias Médicas Cruz Blanca
San Miguel de Tucumán, T4000IHE
Not yet recruiting
CIMRO
San Rafael, Mendoza Province, M5602GGS
Not yet recruiting

Other trials in Argentina

Brazil17 sites, 17 recruiting

Instituto de Ciências Farmacêuticas de Estudos e Pesquisas
Aparecida de Goiânia, Goiás, 74935-530
Not yet recruiting
Hospital Universitário João de Barros Barreto - UFPA
Belém, Pará, 66073-000
Not yet recruiting
Associação Lar São Francisco de Assis na Providência de Deus - Bragança Paulista
Bragança Paulista, São Paulo, 12916-542
Not yet recruiting
CECAP - Centro de Cardiologia Clínica e Pesquisa Dra. Juliana Souza
Brasília, Federal District, 70673-416
Not yet recruiting
Instituto de Pesquisa Clínica de Campinas
Campinas, São Paulo, 13060-080
Not yet recruiting
i9 Pesquisas Clínicas
Campinas, São Paulo, 13092-133
Not yet recruiting
Centro de Diabetes Curitiba
Curitiba, Paraná, 80810-040
Not yet recruiting
Instituto de Ensino e Pesquisa Clínica do Ceará Ltda
Fortaleza, Ceará, 60135-270
Not yet recruiting
Hospital das Clínicas da Universidade Federal de Goiás
Goiânia, Goiás, 74605-020
Not yet recruiting
CPHosp Manaus Medicina, Ensino e Pesquisa LTDA
Manaus, Amazonas, 69057-088
Not yet recruiting
Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto
Sao Jose Rio Preto, 15090-000
Not yet recruiting
Instituto de Pesquisa Clinica (IPEC)
São Paulo, São Paulo, 01223-001
Not yet recruiting
CPQuali Pesquisa Clínica Ltda
São Paulo, São Paulo, 01228-000
Not yet recruiting
Instituto do Coração - HCFMUSP
São Paulo, São Paulo, 05403-000
Not yet recruiting
CEPIC - Centro Paulista de Investigacao Clinica
São Paulo, 04266-010
Not yet recruiting
Eurolatino Medical Research Center
Uberlândia, Minas Gerais, 38400-500
Not yet recruiting
Lóbus Centro de Pesquisa Clínica LTDA
Volta Redonda, Rio de Janeiro, 27258-000
Not yet recruiting

Other trials in Brazil

Turkey (Türkiye)15 sites, 15 recruiting

Adana Şehir Eğitim ve Araştırma Hastanesi
Adana, 01060
Not yet recruiting
Başkent Üniversitesi Adana Dr. Turgut Noyan Uygulama ve Araştırma Merkezi -Endokrinoloji
Adana /yüreği̇r, 01240
Not yet recruiting
Sakarya Egitim ve Arastirma Hastanesi-Nefroloji
Adapazarı/Turkiye, 54100
Not yet recruiting
Afyonkarahisar Sağlık Bilimleri Üniversitesi Sağlık Uygulama Ve Araştırma Merkezi- Nefroloji
Afyonkarahisar, 03200
Not yet recruiting
Ankara Bilkent Şehir Hastanesi-Dahiliye
Ankara, 06800
Not yet recruiting
Gaziantep Üniversitesi Hastanesi- Endokrinoloji
Gaziantep, 27070
Not yet recruiting
Göztepe Prof. Dr.Süleyman Yalçın Şehir Hastanesi- Dahiliye
Istanbul, 34722
Not yet recruiting
Ege Üniversitesi Tip Fakultesi Hastanesi - Nefroloji
Izmir, 35100
Not yet recruiting
Erciyes Üniversitesi Hastanesi - Nefroloji
Kayseri, Melikgazi, 38039
Not yet recruiting
Erciyes Üniversitesi Hastanesi- Kardiyoloji
Kayseri, 38039
Not yet recruiting
Kocaeli Üniversitesi Araştıma ve Uygulama Hastanesi - Nefroloji
Kocaeli, 41380
Not yet recruiting
Bursa Yüksek İhtisas Eğitim ve Araştırma Merkezi-Endokrinoloji
Nilüfer/Bursa, 16140
Not yet recruiting
Eskişehir Şehir Hastanesi- Kardiyoloji
Odunpazarı /Eskişehir, 26080
Not yet recruiting
Sivas Cumhuriyet Üniversitesi Hastanesi -Endokrinoloji
Sivas, 58140
Not yet recruiting
Dicle Üniversitesi Tıp Fakültesi Sağlık Ve Araştırma Hastanesi- Nefroloji
Sur / Diyarbakır, 21280
Not yet recruiting

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Czechia13 sites, 13 recruiting

EFERTUS healthcare s.r.o.
Brno, 615 00
Not yet recruiting
Edumed s.r.o.
Broumov, 550 01
Not yet recruiting
Nemocnice Český Krumlov, a.s.
Český Krumlov, 381 01
Not yet recruiting
Poliklinika Dolní Břežany
Dolní Břežany, 252 41
Not yet recruiting
Medika Hradec Králové s.r.o.
Hradec Králové, 500 02
Not yet recruiting
Edumed s.r.o.
Náchod, 547 01
Not yet recruiting
MUDr. SRPOVÁ s.r.o.
Ostrava, 700 30
Not yet recruiting
Donmed s.r.o.
Ostrava, 710 00
Not yet recruiting
Pratia Pardubice a.s.
Pardubice, 530 02
Not yet recruiting
MUDr. Jitka Zemanova - diabetologie a interna, s.r.o.
Pilsen, 326 00
Not yet recruiting
Medicon a.s.
Prague, 140 00
Not yet recruiting
IKEM
Prague, 140 21
Not yet recruiting
Diantel s.r.o.
Prague, 17000
Not yet recruiting

Other trials in Czechia

Greece12 sites, 12 recruiting

Evangelismos S.A. - Endocrinology department
Athens, 10676
Not yet recruiting
251 Air Force General Hospital - Department of Endocrinology & Diabetes
Athens, 115 25
Not yet recruiting
Laiko General Hospital Of Athens - 1st department of Internal Medicine
Athens, 115 27
Not yet recruiting
General Hospital Of Athens G Gennimatas - Department of Endocrinology
Athens, 11527
Not yet recruiting
General Hospital Of Thessaloniki Papageorgiou - 3rd Department of Internal Medicine
Efkarpia, 564 29
Not yet recruiting
University General Hospital Of Heraklion - Nephrology Department
Heraklion, 71500
Not yet recruiting
Athens Medical Center S.A. (Iatriko Peristeriou) - Diabetes, obesity and cardiometabolic diseases department
Peristeri, 121 31
Not yet recruiting
General University Hospital of Patras,Nephrology clinic
Rio, Patra, 26504
Not yet recruiting
Ippokratio General Hospital Of Thessaloniki - 2nd Propaedeutic Department of Internal Medicine
Thessaloniki, 546 42
Not yet recruiting
Ippokratio General Hospital Of Thessaloniki - B' Internal Medicine clinic
Thessaloniki, 546 42
Not yet recruiting
Geniko Nosokomeio Thessalonikis George Papanikolaou - Internal Medicine and Diabetes Department
Thessaloniki, 570 10
Not yet recruiting
Geniko Nosokomeio Nikaias Peiraia Ag. Panteleimon Geniko Nosokomeio Dytikis Attikis I - Nephrology Department
Νikaia, 184 54
Not yet recruiting

Other trials in Greece

Canada10 sites, 10 recruiting

Centricity Research Calgary Endocrinology
Calgary, Alberta, T2H 2G4
Not yet recruiting
University of Alberta_Edmonton
Edmonton, Alberta, T6G 2B7
Not yet recruiting
Medical Arts Health Research Group_Kelowna_0
Kelowna, British Columbia, V1Y 4N7
Not yet recruiting
Kelowna Health and Memory Centre Ltd.
Kelowna, British Columbia, V1Y 5A8
Not yet recruiting
CARe Clinic Ltd.
Red Deer, Alberta, T4P 1K4
Not yet recruiting
Bluewater Clin Res Group Inc
Sarnia, Ontario, N7T 4X3
Not yet recruiting
Stouffville Medical Research Institute
Stouffville, Ontario, L4A 1H2
Not yet recruiting
Care Access Cape Breton
Sydney, Nova Scotia, B1M 0A1
Not yet recruiting
Centre de Médecine Métabolique de Lanaudière
Terrebonne, Quebec, J6X 4P7
Not yet recruiting
Centricity Research Toronto
Toronto, Ontario, M4G 3E8
Not yet recruiting

Other trials in Canada

Mexico10 sites, 10 recruiting

Centro de Estudios de Investigación Metabólicos y Cardio
Ciudad Madero, Tamaulipas, 89440
Not yet recruiting
SIYODE S.A. de C.V. Unimeden
Ciudad Madero, Tamaulipas, 89450
Not yet recruiting
Diseño y Planeación en Investigación Médica S.C.
Guadalajara, Jalisco, 44600
Not yet recruiting
Instituto Jalisciense de Investigación en Diabetes y Obesidad
Guadalajara, Jalisco, 44600
Not yet recruiting
Centro de Investigacion Clinica Endocrinologica de Jalisco
Guadalajara, Jalisco, 44670
Not yet recruiting
Investigación Médica Sonora S.C.
Hermosillo, Sonora, 83280
Not yet recruiting
Medical Care and Research S. A de C.V
Mérida, Yucatán, 97070
Not yet recruiting
Centro de Desarrollo Biomédico S.C.P.
Merida Centro, Yucatán, 97070
Not yet recruiting
Alliance CEINV Salud S.A. de C.V.
Monterrey, Nuevo León, 64020
Not yet recruiting
Instituto Nacional de Ciencias Médicas y Nutrición
Tlalpan, Mexico City, 14080
Not yet recruiting

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United Kingdom10 sites, 10 recruiting

Southmead Hospital
Bristol, BS10 5NB
Not yet recruiting
University Hospital Coventry - WISDEM Centre
Coventry, CV2 2DX
Not yet recruiting
Hull Royal Infirmary - Diabetes
Hull, HU3 2JZ
Not yet recruiting
Ipswich Hospital - Diabetes
Ipswich, IP4 5PD
Not yet recruiting
Altnagelvin Area Hospital
Londonderry, BT47 6SB
Not yet recruiting
North Coast Medical Ltd
Newquay, Cornwall, TR7 1RU
Not yet recruiting
Clifton Medical Centre
Rotherham, South Yorkshire, S65 1DA
Not yet recruiting
Joint Clinical Research Facility - Swansea
Swansea, SA2 8PP
Not yet recruiting
Egremont Medical Centre
Wallasey, CH44 8AT
Not yet recruiting
Yeovil Hospital
Yeovil, Somerset, BA21 4AT
Not yet recruiting

Other trials in United Kingdom

Bulgaria9 sites, 9 recruiting

Medical Center Diya Med EOOD
Burgas, 8000
Not yet recruiting
MC Diamedical - 2013 OOD, Dimitrovgrad
Dimitrovgrad, 6400
Not yet recruiting
Medical Center Viva Feniks OOD
Dobrich, 9300
Not yet recruiting
Medical centre Asclepius OOD
Dupnitsa, Kyustendil, 2600
Not yet recruiting
AIPSOMCEMD Dr. Velichka Zlatareva EOOD
Plovdiv, 4030
Not yet recruiting
Medical center Smolyan clinical research OOD
Smolyan, 4700
Not yet recruiting
Medical centre Vitclinic EOOD
Sofia, 1680
Not yet recruiting
Prevencia - 2000 - MCOC OOD
Stara Zagora, 6000
Not yet recruiting
MC Berbatov EOOD, Beli Drin
Yambol, 8600
Not yet recruiting

Other trials in Bulgaria

Germany9 sites, 9 recruiting

Medizinisches Versorgungszentrum Jung GbR
Deggingen, 73326
Not yet recruiting
Praxis am Markt Dr. Becker
Essen, 45355
Not yet recruiting
MVZ Diabeteszentrum Dr. Tews GmbH
Gelnhausen, 63571
Not yet recruiting
Diabetes-Zentrum-Wilhelmsburg GbR
Hamburg, 21109
Not yet recruiting
Diabetes Zentrum Wandsbek Berufsausuebungsgemeinschaft GbR
Hamburg, 22041
Not yet recruiting
Dr. Milek medikum
Hohenmölsen, 06679
Not yet recruiting
Praxisgemeinschaft Jerichow
Jerichow, 39319
Not yet recruiting
Gemeinschaftspraxis Dr. Täschner/Dr. Bonigut
Leipzig, 04249
Not yet recruiting
Sanos Clinic GmbH Ratingen
Ratingen, 40882
Not yet recruiting

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Italy9 sites, 9 recruiting

AOU Renato Dulbecco - Unità Operativa Complessa Medicina Interna
Catanzaro, Calabria, 88100
Not yet recruiting
Polo Ospedaliero di Chiavari - S.S.D. Diabetologia e Malattia Metaboliche
Chiavari, Liguria, 16043
Not yet recruiting
Università degli studi G. D'Annunzio di Chieti - CAST - Centro Ricera Clinica (CRC)
Chieti, Abruzzo, 66100
Not yet recruiting
AUSL Toscana Nord Ovest - Cittadella della Salute Campo di Marte - Diabetologia Lucca e Valle del Serchio
Lucca, Tuscany, 55100
Not yet recruiting
Ospedale San Raffaele S.r.l. - Medicina Generale Indirizzo Diabetologico ed Endocrino-Metabolico
Milan, Lombardy, 20132
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ASST Santi Paolo e Carlo - Ospedale San Paolo - Diabetologia
Milan, 20142
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AOU Federico II Di Napoli - DAI Endocr. Diab. Andro. e Nutr. - UOC Endocrinologia Diabetologia e Andrologia
Naples, Campania, 80131
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AUSL Romagna - Medicine Specialistiche Ravenna - UO Servizio di Diabetologia di Ravenna
Ravenna, Emilia-Romagna, 48121
Not yet recruiting
Policlinico Umberto I Seconda Clinica Medica
Roma, RM, 00161
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Spain8 sites, 8 recruiting

CHUAC_Endocrinología
A Coruña, 15006
Not yet recruiting
Hosp. Vall d'Hebrón_Endocrinología
Barcelona, 08035
Not yet recruiting
Clinic Barcelona_Endocrinología
Barcelona, 08036
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Hospital de Mostoles_Endocrinología
Móstoles, 28935
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H Virgen del Camino_Sanlúcar_Medicina Interna
Sanlúcar de Barrameda, 11540
Not yet recruiting
CHUS_Endocrinología
Santiago de Compostela, 15706
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Hospital General de Segovia_Endocrinología
Segovia, 40002
Not yet recruiting
Hospital General de Valencia_Endocrinología
Valencia, 46014
Not yet recruiting

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About this study

Official title: Efficacy and Safety of Zenagamtide s.c. Once Weekly Compared to Insulin Glargine s.c. Once Daily in Participants With Type 2 Diabetes and Increased Cardiovascular Risk Inadequately Controlled on 1-3 Oral Glucose-lowering Medications (AMBITION 7)

This study is being conducted to find out how well zenagamtide works and how safe it is compared to insulin glargine in participants with type 2 diabetes who are at higher risk of heart and blood vessel problems and are already taking 1 to 3 diabetes medications. There are 2 study treatments in this study taken as injections under the skin once a week. Participants will either get zenagamtide, (the treatment being tested) or insulin glargine (a comparator) and which treatment participants get is decided by chance.

Conditions: Type 2 Diabetes, Cardiovascular Risk
Being tested: Zenagamtide, Insulin glargine U-100
Medical subject headings: Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ZenagamtideDrug
Zenagamtide will be administered subcutaneously using PDS290 pre-filled pen-injectors to one of the body parts: thigh, abdomen or upper arm (administration to the same body part throughout the study).
Insulin glargine U-100Drug
Insulin glargine U-100 will be administered subcutaneously using SoloSTAR pen-injector to one of the body parts: thigh, abdomen or upper arm (rotation of the injection site within body parts).

Study groups in NCT07797335
Study group	Role	What they receive
Zenagamtide	Experimental	Participants will receive zenagamtide subcutaneously once weekly to one of the body parts: thigh, abdomen or upper arm. Receives: Drug: Zenagamtide
Insulin glargine U-100	Active comparator	Participants will receive Insulin glargine U-100 subcutaneously once daily to one of the body parts: thigh, abdomen or upper arm. Receives: Drug: Insulin glargine U-100

What is being measured

The primary outcome is the main question the study is designed to answer.

Non-inferiority of zenagamtide versus insulin glargine: change in haemoglobin A1c (HbA1c)
Measured as percentage (%)-points
Measured: From baseline (week 0) to week 52

Secondary outcomes (9)

Time to first occurrence of a 4-point major adverse cardiovascular events (MACE) endpoint consisting of: Cardiovascular (CV) death, non-fatal myocardial infarction, non-fatal stroke and hospitalisation for unstable angina
Measured as days
Measured: From baseline (week 0) to 104 weeks or more
Relative change in body weight
Measured as percentage (%) change
Measured: From baseline (week 0) to week 52
Superiority of zenagamtide versus insulin: Change in HbA1c
Measured as %-points
Measured: From baseline (week 0) to week 52
Time to first occurrence of a 3-point MACE endpoint consisting of: CV death, non-fatal myocardial infarction and non-fatal stroke
Measured as Days
Measured: From baseline (week 0) to 104 weeks or more
Change in waist circumference
Measured as centimeters
Measured: From baseline (week 0) to week 52
Change in systolic blood pressure
Measured as millimeters of mercury (mmHg)
Measured: From baseline (week 0) to week 52
Change in high-sensitivity C-reactive protein (hsCRP)
Measured as ratio to baseline
Measured: From baseline (week 0) to week 52
Change in Triglycerides
Measured as ratio to baseline
Measured: From baseline (week 0) to week 52
Change in Non-high-density lipoprotein (non-HDL) cholesterol
Measured as ratio to baseline
Measured: From baseline (week 0) to week 52

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

24 Aug 202620 Sep 2028

First posted1 Sep 2026
Study start24 Aug 2026
Primary completion31 Jul 2028 (estimated)
Study completion20 Sep 2028 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Type 2 DiabetesStudies 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: 1,778 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07797335
Sponsor's protocol ID: NN9490-8665
Other IDs: U1111-1333-6446, 2026-525209-11
Acronym: AMBITION 7
Status last verified: Aug 2026
First submitted: 26 Aug 2026
Last updated: 1 Sep 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: According to the Novo Nordisk disclosure commitment on novonordisktrials.com

Interested in taking part?

Novo Nordisk

(+1) 866-867-7178

clinicaltrials@novonordisk.com

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

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All Type 2 Diabetes trials

Study at a glance

From the registry record, last updated by the sponsor on 1 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Efficacy and Safety of Zenagamtide s.c. Once Weekly Compared to Insulin Glargine s.c. Once Daily in Participants With Type 2 Diabetes and Increased Cardiovascular Risk Inadequately Controlled on 1-3 Oral Glucose-lowering Medications (AMBITION 7)
ClinicalTrials.gov ID: NCT07797335
Acronym / sponsor ID: AMBITION 7 / NN9490-8665
Conditions: Type 2 Diabetes, Cardiovascular Risk
Phase: Phase 3
Study type: Interventional
Recruitment status: Recruiting
Enrolment: 1,778 participants (estimated)
Lead sponsor: Novo Nordisk A/SIndustry (pharma, biotech, devices)
Study start: 24 Aug 2026 (actual)
Primary completion: 31 Jul 2028 (estimated)
Study completion: 20 Sep 2028 (estimated)
First posted: 1 Sep 2026 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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
Zenagamtide	Experimental	Drug: ZenagamtideParticipants will receive zenagamtide subcutaneously once weekly to one of the body parts: thigh, abdomen or upper arm.
Insulin glargine U-100	Active comparator	Drug: Insulin glargine U-100Participants will receive Insulin glargine U-100 subcutaneously once daily to one of the body parts: thigh, abdomen or upper arm.

Who may qualify

Ages: 45 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (20 listed)

Informed consent obtained before any study-related activities. Study-related activities are any procedures that are carried out as part of the study, including activities to determine suitability for the study.
Male or female (sex assigned at birth, inclusive of all gender identities).
Age 45 years or above at the time of signing the informed consent.
Diagnosed with type 2 diabetes (T2D) greater than or equal to (≥) 180 days before screening.
Treatment with 1-3 marketed oral glucose-lowering medications (metformin, glinide, thiazolidinedione, sodium-glucose cotransporter-2 inhibitors (SGLT2i), α-glucosidase inhibitors (AGI), or sulfonylureas (SU) as a single agent or in combination) according to local label. Treatment with oral glucose-lowering medications must be stable (same drug(s), stable daily dose(s)) before screening.

Key exclusion criteria (10 listed)

Myocardial infarction, stroke, transient ischaemic attack or hospitalisation for unstable angina pectoris within 60 days before screening.
Planned coronary, carotid or peripheral artery revascularisation.
Chronic or intermittent haemodialysis or peritoneal dialysis within 90 days before screening.
Treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria before screening. However, insulin treatment for gestational diabetes is allowed as well as short term insulin treatment for a maximum of 14 consecutive days.
Treatment with glucagon-like-peptide-1 (GLP-1) receptor agonists (RA), dual GLP1/gastric inhibitory peptide (GIP) RAs (or any other GLP-1 based treatment), dipeptidyl peptidase 4 (DPP-4) inhibitors or amylin analogues before screening.

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
ZenagamtideZenagamtide will be administered subcutaneously using PDS290 pre-filled pen-injectors to one of the body parts: thigh, abdomen or upper arm (administration to the same body part throughout the study).	Drug	Zenagamtide
Insulin glargine U-100Insulin glargine U-100 will be administered subcutaneously using SoloSTAR pen-injector to one of the body parts: thigh, abdomen or upper arm (rotation of the injection site within body parts).	Drug	Insulin glargine U-100

Primary outcome

Non-inferiority of zenagamtide versus insulin glargine: change in haemoglobin A1c (HbA1c)
Time frame: From baseline (week 0) to week 52
Measured as percentage (%)-points

9 secondary outcomes

Time to first occurrence of a 4-point major adverse cardiovascular events (MACE) endpoint consisting of: Cardiovascular (CV) death, non-fatal myocardial infarction, non-fatal stroke and hospitalisation for unstable angina
Time frame: From baseline (week 0) to 104 weeks or more
Relative change in body weight
Time frame: From baseline (week 0) to week 52
Superiority of zenagamtide versus insulin: Change in HbA1c
Time frame: From baseline (week 0) to week 52
Time to first occurrence of a 3-point MACE endpoint consisting of: CV death, non-fatal myocardial infarction and non-fatal stroke
Time frame: From baseline (week 0) to 104 weeks or more
Change in waist circumference
Time frame: From baseline (week 0) to week 52
Change in systolic blood pressure
Time frame: From baseline (week 0) to week 52
Change in high-sensitivity C-reactive protein (hsCRP)
Time frame: From baseline (week 0) to week 52
Change in Triglycerides
Time frame: From baseline (week 0) to week 52
Change in Non-high-density lipoprotein (non-HDL) cholesterol
Time frame: From baseline (week 0) to week 52

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2026.
Individual participant dataSharing planned: Yes. According to the Novo Nordisk disclosure commitment on novonordisktrials.com

Related trials for Type 2 Diabetes

Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
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Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
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Not yet recruiting
Impact of Endoscopic Sleeve Gastroplasty (ESG) in Obese Adults With Type 2 Diabetes (T2D)
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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.

Novo Nordisk contact

(+1) 866-867-7178

clinicaltrials@novonordisk.com

330 sites in 16 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Zenagamtide and Insulin glargine U-100 in people with Type 2 Diabetes and Cardiovascular Risk, run by Novo Nordisk A/S at 330 sites in 16 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 20 inclusion and 10 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: looking for participants now, as of the sponsor's last update on 1 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 330 sites in United States, China, Poland, India, Argentina and 11 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. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Novo Nordisk ((+1) 866-867-7178, clinicaltrials@novonordisk.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Non-inferiority of zenagamtide versus insulin glargine: change in haemoglobin A1c (HbA1c) (time frame: From baseline (week 0) to week 52). 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 NCT07797335.

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 1 Sep 2026.