ObesityPhase 3NCT05649137
A Research Study to See How Semaglutide Helps People With Excess Weight and Type 2 Diabetes Lose Weight
A Phase 3 study testing Semaglutide in people with Obesity and Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 76 sites in 8 countries.
Trial summary
This study will look at how much weight participants will lose and how much blood sugar control they achieve from the start to the end of the study. The weight loss in participants taking the investigational high dose of semaglutide will be compared to the weight loss in people taking "dummy" medicine and a lower dose… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obesity, Diabetes Mellitus, Type 2
- What is being tested?
- Semaglutide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 512 participants
- Where
- 76 sitesin 8 countries
- Study dates
- 4 Jan 2023to 13 Dec 2024
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female.
- Age above or equal to 18 years at the time of signing informed consent.
- BMI greater than or equal to 30.0 kilograms per square meter (kg/m^2).
- Diagnosed with type 2 diabetes (T2D) greater than or equal to 180 days prior to the day of screening.
- History of at least one self-reported unsuccessful dietary effort to lose body weight.
- HbA1c 7.0-10.0 percent (53-86 millimoles per mole [mmol/mol]) (both inclusive) as measured by central laboratory at screening.
Who cannot join
- A self-reported change in body weight greater than 5 kilograms (kg) (11 pounds [lbs]) within 90 days before screening irrespective of medical records.
- Personal or first-degree relative(s) history of multiple endocrine neoplasia type 2 or medullary thyroid carcinoma.
- Renal impairment with estimated Glomerular Filtration Rate (eGFR) less than 30 milliliters per minute per 1.73 square meter (30 mL/min/1.73 m^2) (less than 45 mL/min/1.73 m^2 in participants treated with Sodium-glucose Cotransporter-2 [SGLT2i]) according to Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) creatinine equation as defined by Kidney Disease: Improving Global Outcomes (KDIGO) 2012 by the central laboratory at screening.
- Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a fundus examination performed within 90 days before screening or in the period between screening and randomization. Pharmacological pupil-dilation is a requirement unless using a digital fundus photography camera specified for non-dilated examination.
Trial locations and contacts
76 sites in 8 countries.
76 sites in 8 countries
United States23 sites
AMC Community Endocrinology
Albany, New York, 12203
Amarillo Med Spec LLP
Amarillo, Texas, 79106
Elligo Clin Res Centre
Austin, Texas, 78704
Univ of Alabama Birmingham
Birmingham, Alabama, 35222
University of North Carolina
Chapel Hill, North Carolina, 27514
John Muir Physicians Network
Concord, California, 94520
Hope Clin Res & Wellness
Conyers, Georgia, 30094
Velocity Clin Res, Dallas
Dallas, Texas, 75230
UT Southwestern Medical Center - Lingvay
Dallas, Texas, 75390
ARS- Deland CRU
DeLand, Florida, 32720
New West Physicians PC
Golden, Colorado, 80401
PharmQuest Life Sciences LLC
Greensboro, North Carolina, 27408
PlanIt Research, PLLC
Houston, Texas, 77079
Jacksonville Ctr for Clin Res
Jacksonville, Florida, 32216
DCOL Ctr for Clin Res
Longview, Texas, 75605
Velocity Clinical Research Westlake
Los Angeles, California, 90057
Chambliss Clinical Trials, LLC
Montgomery, Alabama, 36106
Florida Inst For Clin Res LLC
Orlando, Florida, 32825
Oviedo Medical Research, LLC
Oviedo, Florida, 32765
National Clin Res Inc.
Richmond, Virginia, 23294
Sugar Lakes Family Practice PA
Sugar Land, Texas, 77479
Diablo Clinical Research, Inc.
Walnut Creek, California, 94598
Selma Medical Associates
Winchester, Virginia, 22601-3834
South Africa11 sites
Medi-Clinic Bloemfontein
Bloemfontein, Free State, 9301
Maxwell Centre
Durban, KwaZulu-Natal, 4001
Precise Clinical Solutions (Pty) Ltd
Durban, KwaZulu-Natal, 4092
Dr N.K. Gounden Medical Centre
Durban, KwaZulu-Natal, 4093
Lenmed Shifa Private Hospital
Durban, KwaZulu-Natal, 4901
Dr T Padayachee
eMkhomazi, KwaZulu-Natal, 4170
Soweto Clinical Trial Centre
Johannesburg, Gauteng, 1818
Deepak Lakha
Johannesburg, Gauteng, 1820
Hemant Makan
Johannesburg, Gauteng, 1827
Wits Bara Clinical Trial Site
Johannesburg, Gauteng, 2013
Phoenix Pharma
Port Elizabeth, Eastern Cape, 6001
Bulgaria9 sites
MHAT - Blagoevgrad AD, Department of Internal Diseases
Blagoevgrad, 2700
IPSOMC - Dr. Georgi Marinov
Burgas, 8000
Medical Center Viva Feniks OOD
Dobrich, 9300
UMHAT Pulmed OOD - Pazardzhik, Department of Internal Diseases
Pazardzhik, 4400
MHAT Sveta Karidad EAD
Plovdiv, 4004
MHAT Hadzhi Dimitar OOD
Sliven, 8800
DCC VII - Sofia EOOD, Endocrinology
Sofia, 1233
UMHAT Prof. Dr. Stoyan Kirkovich AD
Stara Zagora, 6003
MHAT Sveti Panteleimon - Yambol AD
Yambol, 8600
Poland8 sites
Kresmed Sp. z o. o.
Bialystok, Podlaskie Voivodeship, 15-481
Centrum Medyczne Pratia Gdynia
Gdynia, Pomeranian Voivodeship, 81-338
Uniwersyteckie Centrum Kliniczne SUM w Katowicach
Katowice, 40-752
Med. Cent. Diabet. Endo. Metabol. DIAB-ENDO-MET
Krakow, Lesser Poland Voivodeship, 31-261
NZOZ Przychodnia Specjalistyczna Medica
Lublin, Lubelski, 20-538
NZOZ "CenterMed Lublin" Sp. z o.o.
Lublin, Lublin Voivodeship, 20-044
NBR Polska Tomasz Klodawski
Warsaw, 00-710
PANSTWOWY INSTYTUT MEDYCZNY MSWiA
Warsaw, 02-507
Hungary7 sites
Lausmed Kft.
Baja, Bács-Kiskun county, 6500
ClinDiab Egészségügyi Szolgáltató és Kereskedelmi Kft.
Budapest, 1089
Bajcsy-Zsilinszky Kórház
Budapest, 1106
MED-TIMA Kft.
Budapest, 1132
Belinus Bt.
Debrecen, Hajdú-Bihar, 4025
Borbánya Praxis E.Ü. Kft.
Nyíregyháza, Szabolcs-Szatmar Varmegye, 4405
Fejér Megyei Szent György Oktatókórház
Székesfehérvár, 8000
Canada6 sites
Nova Scotia Hlth Halifax
Halifax, Nova Scotia, B3H 1V7
Premier Clinical Trial Research Network (PCTRN)
Hamilton, Ontario, L8L 5G4
Wharton Medical Clinic Clinical Trials (Hamilton)
Hamilton, Ontario, L8L 5G8
Milestone Research
London, Ontario, N5W 6A2
G.A. Research Associates Ltd.
Moncton, New Brunswick, E1G 1A7
Ocean West Research Clinic
Surrey, British Columbia, V3Z 2N6
Portugal6 sites
APDP - Associação Protectora dos Diabéticos de Portugal
Lisbon, 1250-230
Unidade Local De Saúde De Lisboa Ocidental E.P.E. - Hospital Egas Moniz
Lisbon, 1349-019
Hospital da Luz Lisboa, S.A.
Lisbon, 1500-650
ULS De São João, E.P.E. - Hospital de São João
Porto, 4200-319
ULS De Matosinhos E.P.E.- Hospital Pedro Hispano
Senhora Da Hora, Matosinhos, Matosinhos, 4464-513
Hospital da Luz Arrabida, S.A.
Vila Nova de Gaia, 4400-346
Slovakia6 sites
DIADA s.r.o.
Bardejov, 08501
DIADA, s.r.o.
Bardejov, 08501
Diab - Int, s.r.o.
Bytča, 014 01
ENDOMED, s.r.o.
Košice, 04013
MED-DIA CENTRUM s.r.o.
Považská Bystrica, 01701
DIABETOL, s.r.o.
Prešov, 080 01
About this study
Official title: Effect and Safety of Semaglutide 7.2 mg Once-weekly in Participants With Obesity and Type 2 Diabetes
This study will look at how much weight participants will lose and how much blood sugar control they achieve from the start to the end of the study. The weight loss in participants taking the investigational high dose of semaglutide will be compared to the weight loss in people taking "dummy" medicine and a lower dose of semaglutide. In addition to taking the medicine, participants will have talks with study staff about healthy food choices and how to be more physically active. Participants will either get semaglutide or "dummy" medicine. Which treatment participants get is decided by chance. Participants are more likely (4 out of 5) to get semaglutide than the "dummy" medicine. The study medicine will be injected briefly, under skin, with a thin needle, typically in the stomach, thighs, or upper arms. After receiving first dose, the dose of semaglutide will be gradually increased until reaching the target dose. The study will last for about 1.5 years
- Conditions
- Obesity, Diabetes Mellitus, Type 2
- Being tested
- Semaglutide, Placebo
- Medical subject headings
- Obesity, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SemaglutideDrug
Participants will receive once-weekly s.c. injections of semaglutide in escalating doses (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg, 2.4 mg and 7.2 mg) every fourth week. Treatment will be continued on the maintenance dose of 7.2 mg once-weekly for an additional 52 weeks. Injections may be administered in the thigh, abdomen, or upper arm, at any time of day irrespective of meals.
SemaglutideDrug
Participants will receive once-weekly s.c. injections of semaglutide in escalating doses (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg, and 2.4 mg) every fourth week. Treatment will be continued on the maintenance dose of 2.4 mg once-weekly for an additional 52 weeks. Injections may be administered in the thigh, abdomen, or upper arm, at any time of day irrespective of meals.
PlaceboDrug
Participants will receive once-weekly s.c. injection of placebo matched to semaglutide for 72 weeks. Injections may be administered in the thigh, abdomen, or upper arm, at any time of day irrespective of meals.
| Study group | Role | What they receive |
|---|---|---|
| Semaglutide 7.2 mg | Experimental | Participants will receive once-weekly injection of semaglutide subcutaneously (s.c.) in 20 week dose escalation period with dose escalation (0.25 milligram [mg], 0.5 mg, 1.0 mg, 1.7 mg, 2.4 mg, and 7.2 mg) every fourth week. Treatment will be continued on the maintenance dose of 7.2 mg once-weekly for an additional 52 weeks until week 72. Receives: Drug: Semaglutide |
| Semaglutide 2.4 mg | Experimental | Participants will receive once-weekly s.c. injection of semaglutide in 20 week dose escalation period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg, and 2.4 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. Treatment will be continued on the maintenance dose of 2.4 mg once-weekly for an additional 52 weeks until week 72. Receives: Drug: Semaglutide |
| Placebo | Placebo comparator | Participants will receive once-weekly s.c. injection of placebo matched to semaglutide for 72 weeks. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relative Change in Body Weight
Relative change in body weight from baseline (week 0) to end of treatment (week 72) is presented.
Measured: Baseline (week 0), End of treatment (week 72)
Number of Participants Who Achieve Body Weight Reduction Greater Than or Equal to (>=) 5% (Yes/no)
Number of participants who achieve body weight reduction >=5% is presented. Yes defines participants who achieved body weight reduction >= 5% and No defines participants who did not achieve body weight reduction >=5%.
Measured: At week 72
Secondary outcomes (34)
Number of Participants Who Achieve Body Weight Reduction >= 10% (Yes/no)
Number of participants who achieve body weight reduction >=10% is presented. Yes defines participants who achieved body weight reduction greater than or equal to 10% and No defines participants who did not achieve body weight reduction greater than or equal to 10%.
Measured: At week 72
Number of Participants Who Achieve Body Weight Reduction >= 15% (Yes/no)
Number of participants who achieve body weight reduction >=15% is presented. Yes defines participants who achieved body weight reduction greater than or equal to 15% and No defines participants who did not achieve body weight reduction greater than or equal to 15%.
Measured: At week 72
Number of Participants Who Achieve Body Weight Reduction >= 20% (Yes/no)
Number of participants who achieve body weight reduction >=20% is presented. Yes defines participants who achieved body weight reduction greater than or equal to 20% and No defines participants who did not achieve body weight reduction greater than or equal to 20%.
Measured: At week 72
Change in Waist Circumference
Change in waist circumference from baseline (week 0) to end of treatment (week 72) is presented.
Measured: Baseline (week 0), End of treatment (week 72)
Change in Glycated Haemoglobin (HbA1c)
Change in HbA1c from baseline (week 0) to end of treatment (week 72) is presented.
Measured: Baseline (week 0), End of treatment (week 72)
Change in Body Weight
Change in body weight from baseline (week 0) to end of treatment (week 72) is presented.
Measured: Baseline (week 0), End of treatment (week 72)
Change in Body Mass Index (BMI)
Change in BMI from baseline (week 0) to end of treatment (week 72) is presented.
Measured: Baseline (week 0), End of treatment (week 72)
Change in Systolic Blood Pressure
Change in systolic blood pressure from baseline (week 0) to end of treatment (week 72) is presented.
Measured: Baseline (week 0), End of treatment (week 72)
Change in Diastolic Blood Pressure
Change in diastolic blood pressure from baseline (week 0) to end of treatment (week 72) is presented.
Measured: Baseline (week 0), End of treatment (week 72)
Change in Total Cholesterol (Millimoles Per Liter [mmol/L]) - Ratio to Baseline
Change in total cholesterol in mmol/L from baseline (week 0) to end of treatment (week 72) as ratio to baseline is presented.
Measured: Baseline (week 0), End of treatment (week 72)
Change in Total Cholesterol (Milligrams Per Deciliter [mg/dL]) - Ratio to Baseline
Change in total cholesterol in mg/dL from baseline (week 0) to end of treatment (week 72) as ratio to baseline is presented.
Measured: Baseline (week 0), End of treatment (week 72)
Change in High-density Lipoprotein (HDL) Cholesterol (mmol/L) - Ratio to Baseline
Change in HDL cholesterol in mmol/L from baseline (week 0) to end of treatment (week 72) as ratio to baseline is presented.
Measured: Baseline (week 0), End of treatment (week 72)
Change in HDL Cholesterol (mg/dL) - Ratio to Baseline
Change in HDL cholesterol in mg/dL from baseline (week 0) to end of treatment (week 72) as ratio to baseline is presented.
Measured: Baseline (week 0), End of treatment (week 72)
Change in Low-density Lipoprotein (LDL) Cholesterol (mmol/L) - Ratio to Baseline
Change in LDL cholesterol in mmol/L from baseline (week 0) to end of treatment (week 72) as ratio to baseline is presented.
Measured: Baseline (week 0), End of treatment (week 72)
Change in LDL Cholesterol (mg/dL) - Ratio to Baseline
Change in LDL cholesterol in mg/dL from baseline (week 0) to end of treatment (week 72) as ratio to baseline is presented.
Measured: Baseline (week 0), End of treatment (week 72)
Change in Very-low-density Lipoprotein (VLDL) Cholesterol (mmol/L) - Ratio to Baseline
Change in VLDL cholesterol in mmol/L from baseline (week 0) to end of treatment (week 72) as ratio to baseline is presented.
Measured: Baseline (week 0), End of treatment (week 72)
Change in VLDL Cholesterol (mg/dL) - Ratio to Baseline
Change in VLDL cholesterol in mg/dL from baseline (week 0) to end of treatment (week 72) as ratio to baseline is presented.
Measured: Baseline (week 0), End of treatment (week 72)
Change in Triglycerides (mmol/L) - Ratio to Baseline
Change in triglycerides in mmol/L from baseline (week 0) to end of treatment (week 72) as ratio to baseline is presented.
Measured: Baseline (week 0), End of treatment (week 72)
Change in Triglycerides (mg/dL) - Ratio to Baseline
Change in triglycerides in mg/dL from baseline (week 0) to end of treatment (week 72) as ratio to baseline is presented.
Measured: Baseline (week 0), End of treatment (week 72)
Change in Free Fatty Acids (mmol/L) - Ratio to Baseline
Change in free fatty acids in mmol/L from baseline (week 0) to end of treatment (week 72) as ratio to baseline is presented.
Measured: Baseline (week 0), End of treatment (week 72)
Change in Free Fatty Acids (mg/dL) - Ratio to Baseline
Change in free fatty acids in mg/dL from baseline (week 0) to end of treatment (week 72) as ratio to baseline is presented.
Measured: Baseline (week 0), End of treatment (week 72)
Change in High-sensitivity C-reactive Protein (hsCRP) - Ratio to Baseline
Change in hsCRP in mg/L from baseline (week 0) to end of treatment (week 72) as ratio to baseline is presented.
Measured: Baseline (week 0), End of treatment (week 72)
Change in Fasting Plasma Glucose
Change in fasting plasma glucose from baseline (week 0) to end of treatment (week 72) is presented.
Measured: Baseline (week 0), End of treatment (week 72)
Change in Fasting Serum Insulin (Picomoles Per Liter [Pmol/L]) - Ratio to Baseline
Change in fasting serum insulin in pmol/L from baseline (week 0) to end of treatment (week 72) as ratio to baseline is presented.
Measured: Baseline (week 0), End of treatment (week 72)
Change in Fasting Serum Insulin (Milliinternational Units Per Milliliter [mIU/mL]) - Ratio to Baseline
Change in fasting serum insulin in mIU/ml from baseline (week 0) to end of treatment (week 72) as ratio to baseline is presented.
Measured: Baseline (week 0), End of treatment (week 72)
Number of Participants With HbA1c Less Than 7.0 % (53 Millimoles Per Mole [mmol/Mol])
Number of participants with HbA1c less than 7.0 % (53 mmol/mol) at week 72 is presented.
Measured: At week 72
Number of Participants With HbA1c Less Than or Equal to 6.5% (48 mmol/Mol)
Number of participants with HbA1c less than or equal to 6.5% (48 mmol/mol) at week 72 is presented.
Measured: At week 72
Semaglutide 7.2 mg Versus Placebo: Number of Adverse Events (AEs)
Number of AEs is reported. An AE is any untoward medical occurrence in a clinical study participant that is temporally associated with the use of investigational medicinal product (IMP), whether or not considered related to the IMP.
Measured: At week 81
Semaglutide 7.2 mg Versus Placebo: Number of Serious Adverse Events (SAEs)
Number of SAEs is reported. A SAE is any untoward medical occurrence that fulfils at least one of the following criteria: results in death, is life threatening, requires inpatient hospitalisation or prolongation of existing hospitalisation, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or important medical event.
Measured: At week 81
Change in Pulse
Change in pulse from baseline (week 0) to end of treatment (week 72) is presented.
Measured: Baseline (week 0), End of treatment (week 72)
Semaglutide 7.2 mg Versus Placebo: Number of Treatment Emergent Severe or Blood Glucose Confirmed Symptomatic Hypoglycaemic Episodes
Number of treatment emergent severe or blood glucose confirmed symptomatic hypoglycaemic episodes is presented.
Measured: At week 81
Semaglutide 7.2 mg Versus Semaglutide 2.4 mg: Number of AEs
Number of AEs is reported. An AE is any untoward medical occurrence in a clinical study participant that is temporally associated with the use of IMP, whether or not considered related to the IMP.
Measured: At week 81
Semaglutide 7.2 mg Versus Semaglutide 2.4 mg: Number of SAEs
Number of SAEs is reported. A SAE is any untoward medical occurrence that fulfils at least one of the following criteria: results in death, is life threatening, requires inpatient hospitalisation or prolongation of existing hospitalisation, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or important medical event.
Measured: At week 81
Semaglutide 7.2 mg Versus Semaglutide 2.4 mg: Number of Treatment Emergent Severe or Blood Glucose Confirmed Symptomatic Hypoglycaemic Episodes
Number of treatment emergent severe or blood glucose confirmed symptomatic hypoglycaemic episodes is presented.
Measured: At week 81
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2022
- Study start4 Jan 2023
- Primary completion28 Oct 2024
- Study completion13 Dec 2024
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 (1)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies 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
- 512 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
- NCT05649137
- Sponsor's protocol ID
- NN9536-7545
- Other IDs
- 2022-002235-60, U1111-1279-0359
- Status last verified
- Apr 2026
- First submitted
- 5 Dec 2022
- Last updated
- 27 Apr 2026
- Results posted
- Yes, on ClinicalTrials.gov
- 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
Publications
Lingvay I, Bergenheim SJ, Buse JB, Freitas P, Garvey WT, Harder-Lauridsen NM, Rosenstock J, Sahu K, Wharton S; STEP UP T2D trial group. Once-weekly semaglutide 7.2 mg in adults with obesity and type 2 diabetes (STEP UP T2D): a randomised, controlled, phase 3b trial. Lancet Diabetes Endocrinol. 2025 Nov;13(11):935-948. doi: 10.1016/S2213-8587(25)00225-6. Epub 2025 Sep 14.
PubMed 40961953
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect and Safety of Semaglutide 7.2 mg Once-weekly in Participants With Obesity and Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT05649137
- Acronym / sponsor ID
- NN9536-7545
- Conditions
- Obesity, Diabetes Mellitus, Type 2
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 512 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- 4 Jan 2023 (actual)
- Primary completion
- 28 Oct 2024 (actual)
- Study completion
- 13 Dec 2024 (actual)
- First posted
- 13 Dec 2022 (actual)
- Results
- Posted 27 Apr 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will look at how much weight participants will lose and how much blood sugar control they achieve from the start to the end of the study. The weight loss in participants taking the investigational high dose of semaglutide will be compared to the weight loss in people taking "dummy" medicine and a lower dose of semaglutide. In addition to taking the medicine, participants will have talks with study staff about healthy food choices and how to be more physically active. Participants will either get semaglutide or "dummy" medicine. Which treatment participants get is decided by chance. Participants are more likely (4 out of 5) to get semaglutide than the "dummy" medicine. The study medicine will be injected briefly, under skin, with a thin needle, typically in the stomach, thighs, or upper arms. After receiving first dose, the dose of semaglutide will be gradually increased until reaching the target dose. The study will last for about 1.5 years
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Semaglutide 7.2 mg | Experimental | Drug: SemaglutideParticipants will receive once-weekly injection of semaglutide subcutaneously (s.c.) in 20 week dose escalation period with dose escalation (0.25 milligram [mg], 0.5 mg, 1.0 mg, 1.7 mg, 2.4 mg, and 7.2 mg) every fourth week. Treatment will be continued on the maintenance dose of 7.2 mg once-weekly for an additional 52 weeks until week 72. |
| Semaglutide 2.4 mg | Experimental | Drug: SemaglutideParticipants will receive once-weekly s.c. injection of semaglutide in 20 week dose escalation period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg, and 2.4 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. Treatment will be continued on the maintenance dose of 2.4 mg once-weekly for an additional 52 weeks until week 72. |
| Placebo | Placebo comparator | Drug: PlaceboParticipants will receive once-weekly s.c. injection of placebo matched to semaglutide for 72 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male or female.
- Age above or equal to 18 years at the time of signing informed consent.
- BMI greater than or equal to 30.0 kilograms per square meter (kg/m^2).
- Diagnosed with type 2 diabetes (T2D) greater than or equal to 180 days prior to the day of screening.
- History of at least one self-reported unsuccessful dietary effort to lose body weight.
Key exclusion criteria (4 listed)
- A self-reported change in body weight greater than 5 kilograms (kg) (11 pounds [lbs]) within 90 days before screening irrespective of medical records.
- Personal or first-degree relative(s) history of multiple endocrine neoplasia type 2 or medullary thyroid carcinoma.
- Renal impairment with estimated Glomerular Filtration Rate (eGFR) less than 30 milliliters per minute per 1.73 square meter (30 mL/min/1.73 m^2) (less than 45 mL/min/1.73 m^2 in participants treated with Sodium-glucose Cotransporter-2 [SGLT2i]) according to Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) creatinine equation as defined by Kidney Disease: Improving Global Outcomes (KDIGO) 2012 by the central laboratory at screening.
- Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a fundus examination performed within 90 days before screening or in the period between screening and randomization. Pharmacological pupil-dilation is a requirement unless using a digital fundus photography camera specified for non-dilated examination.
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 |
|---|---|---|
| SemaglutideParticipants will receive once-weekly s.c. injections of semaglutide in escalating doses (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg, 2.4 mg and 7.2 mg) every fourth week. Treatment will be continued on the maintenance dose of 7.2 mg once-weekly for an additional 52 weeks. Injections may be administered in the thigh, abdomen, or upper arm, at any time of day irrespective of meals. | Drug | Semaglutide 7.2 mg |
| SemaglutideParticipants will receive once-weekly s.c. injections of semaglutide in escalating doses (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg, and 2.4 mg) every fourth week. Treatment will be continued on the maintenance dose of 2.4 mg once-weekly for an additional 52 weeks. Injections may be administered in the thigh, abdomen, or upper arm, at any time of day irrespective of meals. | Drug | Semaglutide 2.4 mg |
| PlaceboParticipants will receive once-weekly s.c. injection of placebo matched to semaglutide for 72 weeks. Injections may be administered in the thigh, abdomen, or upper arm, at any time of day irrespective of meals. | Drug | Placebo |
Primary outcome
Relative Change in Body Weight
Time frame: Baseline (week 0), End of treatment (week 72)
Relative change in body weight from baseline (week 0) to end of treatment (week 72) is presented.
Number of Participants Who Achieve Body Weight Reduction Greater Than or Equal to (>=) 5% (Yes/no)
Time frame: At week 72
Number of participants who achieve body weight reduction >=5% is presented. Yes defines participants who achieved body weight reduction >= 5% and No defines participants who did not achieve body weight reduction >=5%.
34 secondary outcomes
Number of Participants Who Achieve Body Weight Reduction >= 10% (Yes/no)
Time frame: At week 72
Number of Participants Who Achieve Body Weight Reduction >= 15% (Yes/no)
Time frame: At week 72
Number of Participants Who Achieve Body Weight Reduction >= 20% (Yes/no)
Time frame: At week 72
Change in Waist Circumference
Time frame: Baseline (week 0), End of treatment (week 72)
Change in Glycated Haemoglobin (HbA1c)
Time frame: Baseline (week 0), End of treatment (week 72)
Change in Body Weight
Time frame: Baseline (week 0), End of treatment (week 72)
Change in Body Mass Index (BMI)
Time frame: Baseline (week 0), End of treatment (week 72)
Change in Systolic Blood Pressure
Time frame: Baseline (week 0), End of treatment (week 72)
Change in Diastolic Blood Pressure
Time frame: Baseline (week 0), End of treatment (week 72)
Change in Total Cholesterol (Millimoles Per Liter [mmol/L]) - Ratio to Baseline
Time frame: Baseline (week 0), End of treatment (week 72)
Change in Total Cholesterol (Milligrams Per Deciliter [mg/dL]) - Ratio to Baseline
Time frame: Baseline (week 0), End of treatment (week 72)
Change in High-density Lipoprotein (HDL) Cholesterol (mmol/L) - Ratio to Baseline
Time frame: Baseline (week 0), End of treatment (week 72)
Change in HDL Cholesterol (mg/dL) - Ratio to Baseline
Time frame: Baseline (week 0), End of treatment (week 72)
Change in Low-density Lipoprotein (LDL) Cholesterol (mmol/L) - Ratio to Baseline
Time frame: Baseline (week 0), End of treatment (week 72)
Change in LDL Cholesterol (mg/dL) - Ratio to Baseline
Time frame: Baseline (week 0), End of treatment (week 72)
Change in Very-low-density Lipoprotein (VLDL) Cholesterol (mmol/L) - Ratio to Baseline
Time frame: Baseline (week 0), End of treatment (week 72)
Change in VLDL Cholesterol (mg/dL) - Ratio to Baseline
Time frame: Baseline (week 0), End of treatment (week 72)
Change in Triglycerides (mmol/L) - Ratio to Baseline
Time frame: Baseline (week 0), End of treatment (week 72)
Change in Triglycerides (mg/dL) - Ratio to Baseline
Time frame: Baseline (week 0), End of treatment (week 72)
Change in Free Fatty Acids (mmol/L) - Ratio to Baseline
Time frame: Baseline (week 0), End of treatment (week 72)
Change in Free Fatty Acids (mg/dL) - Ratio to Baseline
Time frame: Baseline (week 0), End of treatment (week 72)
Change in High-sensitivity C-reactive Protein (hsCRP) - Ratio to Baseline
Time frame: Baseline (week 0), End of treatment (week 72)
Change in Fasting Plasma Glucose
Time frame: Baseline (week 0), End of treatment (week 72)
Change in Fasting Serum Insulin (Picomoles Per Liter [Pmol/L]) - Ratio to Baseline
Time frame: Baseline (week 0), End of treatment (week 72)
Change in Fasting Serum Insulin (Milliinternational Units Per Milliliter [mIU/mL]) - Ratio to Baseline
Time frame: Baseline (week 0), End of treatment (week 72)
Number of Participants With HbA1c Less Than 7.0 % (53 Millimoles Per Mole [mmol/Mol])
Time frame: At week 72
Number of Participants With HbA1c Less Than or Equal to 6.5% (48 mmol/Mol)
Time frame: At week 72
Semaglutide 7.2 mg Versus Placebo: Number of Adverse Events (AEs)
Time frame: At week 81
Semaglutide 7.2 mg Versus Placebo: Number of Serious Adverse Events (SAEs)
Time frame: At week 81
Change in Pulse
Time frame: Baseline (week 0), End of treatment (week 72)
Semaglutide 7.2 mg Versus Placebo: Number of Treatment Emergent Severe or Blood Glucose Confirmed Symptomatic Hypoglycaemic Episodes
Time frame: At week 81
Semaglutide 7.2 mg Versus Semaglutide 2.4 mg: Number of AEs
Time frame: At week 81
Semaglutide 7.2 mg Versus Semaglutide 2.4 mg: Number of SAEs
Time frame: At week 81
Semaglutide 7.2 mg Versus Semaglutide 2.4 mg: Number of Treatment Emergent Severe or Blood Glucose Confirmed Symptomatic Hypoglycaemic Episodes
Time frame: At week 81
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40961953Lingvay I, Bergenheim SJ, Buse JB, Freitas P, Garvey WT, Harder-Lauridsen NM, Rosenstock J, Sahu K, Wharton S; STEP UP T2D trial group. Once-weekly semaglutide 7.2 mg in adults with obesity and type 2 diabetes (STEP UP T2D): a randomised, controlled, phase 3b trial. Lancet Diabetes Endocrinol. 2025 Nov;13(11):935-948. doi: 10.1016/S2213-8587(25)00225-6. Epub 2025 Sep 14.
- Individual participant dataSharing planned: Yes. According to the Novo Nordisk disclosure commitment on novonordisktrials.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
76 sites in 8 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 Obesity and Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 76 sites in 8 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 6 inclusion and 4 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 27 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 76 sites in United States, South Africa, Bulgaria, Poland, Hungary and 3 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 27 Apr 2026). 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?
Relative Change in Body Weight (time frame: Baseline (week 0), End of treatment (week 72)). The study lists 2 primary outcomes in all. 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 NCT05649137, which also lists 1 linked publication.
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 27 Apr 2026.