Phase 3
Completed N=304
Two-year Research Study Investigating How Well Semaglutide Works in People Suffering From Overweight or Obesity
Source: ClinicalTrials.gov NCT03693430 ↗Enrolled (actual)
304
Serious AEs
9.9%
Results posted
Mar 2022
Primary outcomePrimary: Percentage Change From Baseline (Week 0) to Week 104 in Body Weight — -15.9; -1.9; -17.3; -2.0 percentage change — p=<.0001
◆ Published Evidence
Highly cited
764citations · ~191 / year
Two-year effects of semaglutide in adults with overweight or obesity: the STEP 5 trial.
Summary
This study will look at the change in body weight from the start to the end of the study. Researchers will compare the weight loss in people taking semaglutide (a new medicine) to people taking "dummy" medicine. In addition to taking the medicine, participants will also have talks with study staff about healthy food choices, how the participant can be more physically active and what participants can do to lose weight. Participants will either get semaglutide or "dummy" medicine - which treatment the participant gets is decided by chance. Participants will need to take 1 injection once a week. The study medicine is injected with a thin needle in a skin fold in the stomach, thigh or upper arm. The study will last for about 2 years. The participants will have 19 clinic visits and 15 phone calls with the study doctor.
Linked Publications (3)
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Two-year effects of semaglutide in adults with overweight or obesity: the STEP 5 trial.
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Psychiatric Safety of Semaglutide for Weight Management in People Without Known Major Psychopathology: Post Hoc Analysis of the STEP 1, 2, 3, and 5 Trials.
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Effect of semaglutide 2.4 mg once weekly on 10-year type 2 diabetes risk in adults with overweight or obesity.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage Change From Baseline (Week 0) to Week 104 in Body Weight |
-15.9; -1.9; -17.3; -2.0 | <.0001 sig |
| PRIMARY Number of Participants Who Achieved (Yes/no): Body Weight Reduction More Than or Equal to 5% |
111; 44; 33; 84; 110; 38 | <0.0001 sig |
| SECONDARY Number of Participants Who Achieved (Yes/no): Body Weight Reduction More Than or Equal to 10% |
89; 17; 55; 111 | — |
| SECONDARY Number of Participants Who Achieved (Yes/no): Body Weight Reduction More Than or Equal to 15% |
75; 9; 69; 119 | — |
| SECONDARY Number of Participants Who Achieved (Yes/no): Body Weight Reduction More Than or Equal to 20% |
52; 3; 92; 125 | — |
| SECONDARY Change From Baseline (Week 0) to Week 104 in Waist Circumference |
-15.2; -4.3 | — |
| SECONDARY Change From Baseline (Week 0) to Week 104 in Body Weight (kg) |
-16.9; -2.1 | — |
| SECONDARY Change From Baseline (Week 0) to Week 104 in Body Mass Index (BMI) |
-6.2; -0.7 | — |
| SECONDARY Change From Baseline (Week 0) to Week 104 in Systolic Blood Pressure |
-6; -1 | — |
| SECONDARY Change From Baseline (Week 0) to Week 104 in Diastolic Blood Pressure |
-4; -1 | — |
| SECONDARY Change in Total Cholesterol-ratio to Baseline |
0.96; 1.02 | — |
| SECONDARY Change in High Density Lipoprotein (HDL) Cholesterol-ratio to Baseline |
1.09; 1.08 | — |
| SECONDARY Change in Low Density Lipoprotein (LDL) Cholesterol-ratio to Baseline |
0.93; 0.99 | — |
| SECONDARY Change in Very Low Density Lipoprotein (VLDL) Cholesterol-ratio to Baseline |
0.79; 1.03 | — |
| SECONDARY Change in Free Fatty Acids-ratio to Baseline |
0.99; 1.07 | — |
| SECONDARY Change in Triglycerides-ratio to Baseline |
0.79; 1.03 | — |
| SECONDARY Change in High Sensitivity C-reactive Protein (hsCRP)-Ratio to Baseline |
0.41; 0.99 | — |
| SECONDARY Change in Glycated Haemoglobin (HbA1c) (Percent [%]) |
-0.5; -0.1 | — |
| SECONDARY Change From Baseline (Week 0) to Week 104 in HbA1c (mmol/Mol) |
-5.1; -1.0 | — |
| SECONDARY Change From Baseline (Week 0) to Week 104 in Fasting Plasma Glucose (FPG) (mmol/L) |
-0.5; 0.1 | — |
| SECONDARY Change From Baseline (Week 0) to Week 104 in FPG (mg/dL) |
-8.3; 1.8 | — |
| SECONDARY Change in Fasting Serum Insulin-ratio to Baseline (Pmol/L) |
0.68; 0.96 | — |
| SECONDARY Change in Fasting Serum Insulin-ratio to Baseline (mIU/mL) |
0.68; 0.96 | — |
| SECONDARY Percentage Change From Baseline (Week 0) to Week 52 in Body Weight |
-15.8; -3.3 | — |
| SECONDARY Change From Baseline (Week 0) to Week 52 in Body Weight (kg) |
-16.7; -3.5 | — |
| SECONDARY Change From Baseline (Week 0) to Week 52 in Body Mass Index (BMI) |
-6.1; -1.3 | — |
| SECONDARY Change From Baseline (Week 0) to Week 52 in Waist Circumference |
-14.3; -4.5 | — |
| SECONDARY Number of Participants Who at 52 Weeks Achieved (Yes/no): Body Weight Reduction More Than or Equal to 5% |
132; 38; 17; 91 | — |
| SECONDARY Number of Participants Who at 52 Weeks Achieved (Yes/no): Body Weight Reduction More Than or Equal to 10% |
102; 17; 47; 112 | — |
| SECONDARY Number of Participants Who at 52 Weeks Achieved (Yes/no): Body Weight Reduction More Than or Equal to 15% |
78; 7; 71; 122 | — |
| SECONDARY Number of Participants Who at 52 Weeks Achieved (Yes/no): Body Weight Reduction More Than or Equal to 20% |
52; 3; 97; 126 | — |
| SECONDARY Number of Treatment-emergent Adverse Events (TEAEs) |
1645; 1059 | — |
| SECONDARY Number of Serious Adverse Events (SAEs) |
18; 20 | — |
| SECONDARY Change From Baseline (Week 0) to Week 104 in Pulse |
3; -1 | — |
| SECONDARY Change From Baseline (Week 0) to Week 104 in Amylase |
1.13; 1.02 | — |
| SECONDARY Change From Baseline (Week 0) to Week 104 in Lipase |
1.47; 1.00 | — |
| SECONDARY Change From Baseline (Week 0) to Week 104 in Calcitonin |
0.99; 0.97 | — |
Eligibility Criteria
Inclusion Criteria
- Male or female, age more than or equal to 18 years at the time of signing informed consent
- Body mass index (BMI) more than or equal to 30 kg/m^2 or more than or equal to 27 kg/m^2 with the presence of at least one of the following weight-related comorbidities (treated or untreated): hypertension, dyslipidaemia, obstructive sleep apnoea or cardiovascular disease
- History of at least one self-reported unsuccessful dietary effort to lose body weight
Exclusion criteria
- HbA1c more than or equal to 48 mmol/mol (6.5%) as measured by the central laboratory at screening
- A self-reported change in body weight more than 5 kg (11 lbs) within 90 days before screening irrespective of medical records
Data sourced from ClinicalTrials.gov (NCT03693430) and the linked publication. 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. Informational only — not medical advice.