Trial · Interventional

CompletedPhase 3Results postedRegistry data

A Research Study to See How Semaglutide Helps People With Excess Weight and Type 2 Diabetes Lose Weight

NCTNCT05649137Other idNN9536-7545Other id2022-002235-60Other idU1111-1279-0359

Open at ClinicalTrials.govAsk about this trial

Overview

Status: Completed
Phase: Phase 3
Enrollment: 512 participants (actual)
Sponsor: Novo Nordisk A/S · Industry
Design: Randomized · Quadruple masking
Countries: 8 countries
United States, Bulgaria, Canada, Hungary, Poland, Portugal, Slovakia, South Africa
Start: 4 Jan 2023
Primary completion: 28 Oct 2024
Completion: 13 Dec 2024
First posted: 13 Dec 2022
Last update posted: 27 Apr 2026
Conditions: Obesity · Diabetes Mellitus, Type 2

Timeline

1 trial · 1 completed · 1 with posted results

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

202320242025

Ph 3
A Research Study to See How Semaglutide Helps People With Excess Weight and Type 2 Diabetes Lose Weight
NCT05649137
4 Jan 2023 to 13 Dec 2024

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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

Interventions

SemaglutideDrug
SemaglutideDrug
PlaceboDrug

Arms3

Experimental
Semaglutide 7.2 mg
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.
Experimental
Semaglutide 2.4 mg
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.
Placebo comparator
Placebo
Participants will receive once-weekly s.c. injection of placebo matched to semaglutide for 72 weeks.

Primary outcomes2

Outcomes the sponsor listed as primary.

Relative Change in Body Weight
Time frame · Baseline (week 0), End of treatment (week 72)
Registry description
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
Registry description
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%.

Secondary outcomes(20)

Number of Participants Who Achieve Body Weight Reduction >= 10% (Yes/no)
Time frame · At week 72
Registry description
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%.
Number of Participants Who Achieve Body Weight Reduction >= 15% (Yes/no)
Time frame · At week 72
Registry description
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%.
Number of Participants Who Achieve Body Weight Reduction >= 20% (Yes/no)
Time frame · At week 72
Registry description
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%.
Change in Waist Circumference
Time frame · Baseline (week 0), End of treatment (week 72)
Registry description
Change in waist circumference from baseline (week 0) to end of treatment (week 72) is presented.
Change in Glycated Haemoglobin (HbA1c)
Time frame · Baseline (week 0), End of treatment (week 72)
Registry description
Change in HbA1c from baseline (week 0) to end of treatment (week 72) is presented.
Change in Body Weight
Time frame · Baseline (week 0), End of treatment (week 72)
Registry description
Change in body weight from baseline (week 0) to end of treatment (week 72) is presented.
Change in Body Mass Index (BMI)
Time frame · Baseline (week 0), End of treatment (week 72)
Registry description
Change in BMI from baseline (week 0) to end of treatment (week 72) is presented.
Change in Systolic Blood Pressure
Time frame · Baseline (week 0), End of treatment (week 72)
Registry description
Change in systolic blood pressure from baseline (week 0) to end of treatment (week 72) is presented.
Change in Diastolic Blood Pressure
Time frame · Baseline (week 0), End of treatment (week 72)
Registry description
Change in diastolic blood pressure from baseline (week 0) to end of treatment (week 72) is presented.
Change in Total Cholesterol (Millimoles Per Liter [mmol/L]) - Ratio to Baseline
Time frame · Baseline (week 0), End of treatment (week 72)
Registry description
Change in total cholesterol in mmol/L from baseline (week 0) to end of treatment (week 72) as ratio to baseline is presented.
Change in Total Cholesterol (Milligrams Per Deciliter [mg/dL]) - Ratio to Baseline
Time frame · Baseline (week 0), End of treatment (week 72)
Registry description
Change in total cholesterol in mg/dL from baseline (week 0) to end of treatment (week 72) as ratio to baseline is presented.
Change in High-density Lipoprotein (HDL) Cholesterol (mmol/L) - Ratio to Baseline
Time frame · Baseline (week 0), End of treatment (week 72)
Registry description
Change in HDL cholesterol in mmol/L from baseline (week 0) to end of treatment (week 72) as ratio to baseline is presented.
Change in HDL Cholesterol (mg/dL) - Ratio to Baseline
Time frame · Baseline (week 0), End of treatment (week 72)
Registry description
Change in HDL cholesterol in mg/dL from baseline (week 0) to end of treatment (week 72) as ratio to baseline is presented.
Change in Low-density Lipoprotein (LDL) Cholesterol (mmol/L) - Ratio to Baseline
Time frame · Baseline (week 0), End of treatment (week 72)
Registry description
Change in LDL cholesterol in mmol/L from baseline (week 0) to end of treatment (week 72) as ratio to baseline is presented.
Change in LDL Cholesterol (mg/dL) - Ratio to Baseline
Time frame · Baseline (week 0), End of treatment (week 72)
Registry description
Change in LDL cholesterol in mg/dL from baseline (week 0) to end of treatment (week 72) as ratio to baseline is presented.
Change in Very-low-density Lipoprotein (VLDL) Cholesterol (mmol/L) - Ratio to Baseline
Time frame · Baseline (week 0), End of treatment (week 72)
Registry description
Change in VLDL cholesterol in mmol/L from baseline (week 0) to end of treatment (week 72) as ratio to baseline is presented.
Change in VLDL Cholesterol (mg/dL) - Ratio to Baseline
Time frame · Baseline (week 0), End of treatment (week 72)
Registry description
Change in VLDL cholesterol in mg/dL from baseline (week 0) to end of treatment (week 72) as ratio to baseline is presented.
Change in Triglycerides (mmol/L) - Ratio to Baseline
Time frame · Baseline (week 0), End of treatment (week 72)
Registry description
Change in triglycerides in mmol/L from baseline (week 0) to end of treatment (week 72) as ratio to baseline is presented.
Change in Triglycerides (mg/dL) - Ratio to Baseline
Time frame · Baseline (week 0), End of treatment (week 72)
Registry description
Change in triglycerides in mg/dL from baseline (week 0) to end of treatment (week 72) as ratio to baseline is presented.
Change in Free Fatty Acids (mmol/L) - Ratio to Baseline
Time frame · Baseline (week 0), End of treatment (week 72)
Registry description
Change in free fatty acids in mmol/L from baseline (week 0) to end of treatment (week 72) as ratio to baseline is presented.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMean· Baseline (week 0), End of treatment (week 72)

Relative Change in Body Weight

Group	Value (Percentage (%) change in body weight)	Spread
Semaglutide 7.2 mg	-13.5	8.7
Semaglutide 2.4 mg	-10.7	8.1
Placebo	-4.0	6.2

Primary outcomeCount of participants· At week 72

Number of Participants Who Achieve Body Weight Reduction Greater Than or Equal to (>=) 5% (Yes/no)

Group	Value (Participants)
Semaglutide 7.2 mg	251
Semaglutide 2.4 mg	73
Placebo	33

Secondary and other outcome results(6)

Secondary outcomeCount of participants· At week 72

Number of Participants Who Achieve Body Weight Reduction >= 10% (Yes/no)

Group	Value (Participants)
Semaglutide 7.2 mg	183
Semaglutide 2.4 mg	50
Placebo	11

Secondary outcomeCount of participants· At week 72

Number of Participants Who Achieve Body Weight Reduction >= 15% (Yes/no)

Group	Value (Participants)
Semaglutide 7.2 mg	120
Semaglutide 2.4 mg	28
Placebo	7

Secondary outcomeCount of participants· At week 72

Number of Participants Who Achieve Body Weight Reduction >= 20% (Yes/no)

Group	Value (Participants)
Semaglutide 7.2 mg	62
Semaglutide 2.4 mg	14
Placebo	2

Secondary outcomeMean· Baseline (week 0), End of treatment (week 72)

Change in Waist Circumference

Group	Value (Centimeters (cm))	Spread
Semaglutide 7.2 mg	-12.6	10.5
Semaglutide 2.4 mg	-10.6	8.4
Placebo	-6.5	10.6

Secondary outcomeMean· Baseline (week 0), End of treatment (week 72)

Change in Glycated Haemoglobin (HbA1c)

Group	Value (Percentage of HbA1c)	Spread
Semaglutide 7.2 mg	-1.8	1.2
Semaglutide 2.4 mg	-1.7	1.0
Placebo	-0.3	1.3

Secondary outcomeMean· Baseline (week 0), End of treatment (week 72)

Change in Body Weight

Group	Value (Kilograms (kg))	Spread
Semaglutide 7.2 mg	-14.9	10.6
Semaglutide 2.4 mg	-11.4	8.9
Placebo	-4.6	7.1

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
Group	Deaths	Serious events	Other events
Semaglutide 7.2 mgParticipants received escalated dose of semaglutide subcutaneously (s.c.) (0.25, 0.5, 1.0, 1.7, and 2.4 milligrams \[mg\]) once weekly for 20 weeks followed by a maintenance dose of semaglutide 7.2 mg s.c. once weekly for 52 weeks.	4 / 307	30 / 307	187 / 307
Semaglutide 2.4 mgParticipants received escalated dose of semaglutide s.c. (0.25, 0.5, 1.0, 1.7 and 2.4 mg) once weekly for 20 weeks followed by a maintenance dose of semaglutide 2.4 mg s.c. once weekly for 52 weeks.	1 / 103	11 / 103	64 / 103
PlaceboParticipants received matching placebo to semaglutide s.c. once a week for 72 weeks.	1 / 102	10 / 102	40 / 102

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

More studies

1 study on this page

Indexing hint: Randomized controlled trial · 2025

Corrected

Once-weekly semaglutide 7·2 mg in adults with obesity and type 2 diabetes (STEP UP T2D): a randomised, controlled, phase 3b trial.

Lingvay et al. 2025The lancet. Diabetes & endocrinologycited by 20

PMID 40961953DOI 10.1016/s2213-8587(25)00225-6PUB-40961953

Full text at the publisher

Publisher page Read the notice

Eligibility

Who could join, as posted.

Sex: All
Age: from 18 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

Inclusion Criteria: * 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. Exclusion Criteria: * 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.

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