Phase 3
N=1,407
A Research Study to See How Semaglutide Helps People With Excess Weight, Lose Weight (STEP UP)
Obesity
Bottom Line
View on ClinicalTrials.gov: NCT05646706 ↗Enrolled (actual)
1,407
Serious AEs
7.5%
Results posted
Apr 2026
Primary outcome: Primary: Semaglutide 7.2 mg Versus Placebo: Relative Change in Body Weight — -19.5; -3.8 Percentage (%) change in body weight — p=<0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Semaglutide (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Novo Nordisk A/S
- Primary completion
- Oct 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Semaglutide 7.2 mg Versus Placebo: Relative Change in Body Weight |
-19.5; -3.8 | <0.0001 sig |
| PRIMARY Semaglutide 7.2 mg Versus Placebo: Number of Participants Who Achieve Body Weight Reduction Greater Than or Equal to (>=) 5% (Yes/no) |
862; 63; 88; 108 | <0.0001 sig |
| SECONDARY Semaglutide 7.2 mg Versus Placebo: Number of Participants Who Achieve Body Weight Reduction >=10% (Yes/no) |
783; 35; 167; 136 | — |
| SECONDARY Semaglutide 7.2 mg Versus Placebo: Number of Participants Who Achieve Body Weight Reduction >=15% (Yes/no) |
632; 13; 318; 158 | — |
| SECONDARY Semaglutide 7.2 mg Versus Placebo: Number of Participants Who Achieve Body Weight Reduction >=20% (Yes/no) |
453; 5; 497; 166 | — |
| SECONDARY Semaglutide 7.2 mg Versus Placebo: Number of Participants Who Achieve Body Weight Reduction >=25% (Yes/no) |
296; 0; 654; 171 | — |
| SECONDARY Semaglutide 7.2 mg Versus Placebo: Change in Waist Circumference |
-18.0; -5.6 | — |
| SECONDARY Semaglutide 7.2 mg Versus Semaglutide 2.4 mg: Relative Change in Body Weight |
-19.5; -16.4 | — |
| SECONDARY Semaglutide 7.2 mg Versus Semaglutide 2.4 mg: Number of Participants Who Achieve Body Weight Reduction >=20% (Yes/no) |
453; 63; 497; 126 | — |
| SECONDARY Semaglutide 7.2 mg Versus Semaglutide 2.4 mg: Number of Participants Who Achieve Body Weight Reduction >=25% (Yes/no) |
296; 29; 654; 160 | — |
| SECONDARY Semaglutide 7.2 mg Versus Placebo: Change in Body Weight |
-21.7; -4.3 | — |
| SECONDARY Semaglutide 7.2 mg Versus Placebo: Change in Body Mass Index (BMI) |
-7.7; -1.5 | — |
| SECONDARY Semaglutide 7.2 mg Versus Semaglutide 2.4 mg: Change in Body Weight |
-21.7; -18.7 | — |
| SECONDARY Pooled Semaglutide Versus Placebo: Change in Total Fat Volume (%) |
-26.9; -2.7 | — |
| SECONDARY Pooled Semaglutide Versus Placebo: Change in Total Fat Volume (Liters) |
-11.7; -1.5 | — |
| SECONDARY Pooled Semaglutide Versus Placebo: Change in Lean Body Volume (%) |
-7.5; -0.4 | — |
| SECONDARY Pooled Semaglutide Versus Placebo: Change in Lean Body Volume (Liters) |
-1.9; -0.2 | — |
| SECONDARY Pooled Semaglutide Versus Placebo: Change in Visceral Fat Volume (%) |
-33.6; -8.8 | — |
| SECONDARY Pooled Semaglutide Versus Placebo: Change in Visceral Fat Volume (Liters) |
-1.8; -0.2 | — |
| SECONDARY Pooled Semaglutide Versus Placebo: Change in Body Weight (%) |
-18.4; -2.1 | — |
| SECONDARY Pooled Semaglutide Versus Placebo: Change in Body Weight (Kg) |
-20.6; -2.7 | — |
| SECONDARY Semaglutide 7.2 mg Versus Placebo: Change in Systolic Blood Pressure |
-10; -4 | — |
| SECONDARY Semaglutide 7.2 mg Versus Placebo: Change in Diastolic Blood Pressure |
-5; -1 | — |
| SECONDARY Semaglutide 7.2 mg Versus Placebo: Change in Total Cholesterol (Milligram Per Deciliter [mg/dL]) - Ratio to Baseline |
0.94; 1.00 | — |
| SECONDARY Semaglutide 7.2 mg Versus Placebo: Change in Total Cholesterol (Millimoles Per Liter [mmol/L]) - Ratio to Baseline |
0.94; 1.00 | — |
| SECONDARY Semaglutide 7.2 mg Versus Placebo: Change in High-density Lipoprotein (HDL) Cholesterol (mg/dL) - Ratio to Baseline |
1.08; 1.02 | — |
| SECONDARY Semaglutide 7.2 mg Versus Placebo: Change in High-density Lipoprotein (HDL) Cholesterol (mmol/L) - Ratio to Baseline |
1.08; 1.02 | — |
| SECONDARY Semaglutide 7.2 mg Versus Placebo: Change in Low-density Lipoprotein (LDL) Cholesterol (mg/dL)- Ratio to Baseline |
0.92; 0.98 | — |
| SECONDARY Semaglutide 7.2 mg Versus Placebo: Change in Low-density Lipoprotein (LDL) Cholesterol (mmol/L)- Ratio to Baseline |
0.92; 0.98 | — |
| SECONDARY Semaglutide 7.2 mg Versus Placebo: Change in Very Low-density Lipoprotein (VLDL) Cholesterol (mg/dL) - Ratio to Baseline |
0.76; 1.00 | — |
| SECONDARY Semaglutide 7.2 mg Versus Placebo: Change in Very Low-density Lipoprotein (VLDL) Cholesterol (mmol/L) - Ratio to Baseline |
0.76; 1.00 | — |
| SECONDARY Semaglutide 7.2 mg Versus Placebo: Change in Triglycerides (mg/dL) - Ratio to Baseline |
0.76; 0.99 | — |
| SECONDARY Semaglutide 7.2 mg Versus Placebo: Change in Triglycerides (mmol/L) - Ratio to Baseline |
0.76; 0.99 | — |
| SECONDARY Semaglutide 7.2 mg Versus Placebo: Change in High-sensitivity C-reactive Protein (hsCRP) - Ratio to Baseline |
0.38; 0.89 | — |
| SECONDARY Semaglutide 7.2 mg Versus Placebo: Number of Participants With Change in Lipid-lowering Treatment (Decrease, no Change, Increase) |
8; 0; 138; 22; 17; 6 | — |
| SECONDARY Semaglutide 7.2 mg Versus Placebo: Number of Participants With Change in Antihypertensive Treatment (Decrease, no Change, Increase) |
57; 6; 233; 47; 32; 6 | — |
| SECONDARY Semaglutide 7.2 mg Versus Placebo: Change in Glycated Haemoglobin (HbA1c) |
-0.3; 0.0 | — |
| SECONDARY Semaglutide 7.2 mg Versus Placebo: Change in Fasting Plasma Glucose |
-11.7; -1.7 | — |
| SECONDARY Semaglutide 7.2 mg Versus Placebo: Change in Fasting Serum Insulin (Picomoles Per Liter [Pmol/L]) - Ratio to Baseline |
0.61; 0.90 | — |
| SECONDARY Semaglutide 7.2 mg Versus Placebo: Change in Fasting Serum Insulin (Milliinternational Units Per Milliliter [mIU/mL]) - Ratio to Baseline |
0.61; 0.90 | — |
| SECONDARY Semaglutide 7.2 mg Versus Placebo: Number of Participants With Change in Glycaemic Category (Normo-glycaemia, Pre-diabetes) |
574; 75; 21; 20; 0; 2 | — |
| SECONDARY Semaglutide 7.2 mg Versus Placebo: Number of Adverse Events (AEs) |
6430; 743 | — |
| SECONDARY Semaglutide 7.2 mg Versus Placebo: Number of Serious Adverse Events (SAEs) |
100; 16 | — |
| SECONDARY Semaglutide 7.2 mg Versus Placebo: Change in Pulse |
1; -2 | — |
| SECONDARY Semaglutide 7.2 mg Versus Semaglutide 2.4 mg: Number of AEs |
6430; 1133 | — |
| SECONDARY Semaglutide 7.2 mg Versus Semaglutide 2.4 mg: Number of SAEs |
100; 31 | — |
Summary
This study will look at how much weight participants will lose 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. In the first part of the study, participants will get one injection once a week until they reach the planned dose. The second part of the study, which might last a couple of months, is a transition period, where participant will get three injections, taken right after each other, once a week. The duration of the study intervention (trial product and lifestyle intervention) will be 72 weeks followed by a 9-week follow-up period without study interventions.
Eligibility Criteria
Inclusion Criteria
- Male or female.
- Age above or equal to 18 years at the time of signing informed consent.
- Body mass index (BMI) greater than or equal to 30.0 kilogram per square meter (kg/m^2).
- History of at least one self-reported unsuccessful dietary effort to lose body weight.
Exclusion Criteria
- HbA1c greater than or equal to 48 millimoles per mole (mmol/mol) (6.5 percent) as measured by the central laboratory at screening.
- History of type 1 or type 2 diabetes.
- Treatment with glucose-lowering agent(s) within 90 days before screening.
- A self-reported change in body weight greater than 5 kilograms (kg) (11 pounds) 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.
Data sourced from ClinicalTrials.gov (NCT05646706). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.