18+ · Research Use Only · Not for Human Consumption
Semaglutide · Phase 3 · Completed
STEP 3
In STEP 3, a phase 3 trial of semaglutide in US adults without diabetes with overweight (BMI 27 or greater) plus at least 1 comorbidity or obesity (BMI 30 or greater) (n=611), mean body weight fell 16.0% on 2.4 mg over 68 weeks, against 5.7% on placebo (treatment-policy estimand; Wadden TA et al. JAMA 2021 (STEP 3)).
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Results
Side effects reported
In STEP 3, discontinuation because of adverse events was 5.9% on 2.4 mg, against 2.9% on placebo. The most frequently reported adverse events were gastrointestinal adverse events in 82.8% on 2.4 mg against 63.2% on placebo, nausea in 58.2% on 2.4 mg against 22.1% on placebo, constipation in 36.9% on 2.4 mg against 24.5% on placebo and diarrhoea in 36.1% on 2.4 mg against 22.1% on placebo.
| Event | 2.4 mg | Placebo |
|---|---|---|
| Discontinuation for adverse events | 5.9% | 2.9% |
| Gastrointestinal adverse events | 82.8% | 63.2% |
| Nausea | 58.2% | 22.1% |
| Constipation | 36.9% | 24.5% |
| Diarrhoea | 36.1% | 22.1% |
| Vomiting | 27.3% | 10.8% |
Design
Trial design and sources
- Compound
- Semaglutide
- Phase
- 3
- Population
- US adults without diabetes with overweight (BMI 27 or greater) plus at least 1 comorbidity or obesity (BMI 30 or greater)
- Participants randomised
- 611
- Duration
- 68 weeks
- Primary endpoint
- Co-primary: percentage change in body weight and loss of 5% or more of baseline weight by week 68
- Estimand
- treatment-policy
- Read out
- 1 April 2021
Discontinuation for adverse events is 5.9% against 2.9% in the safety section; the disposition paragraph gives 6.4% against 2.9%.
Questions
STEP 3, answered
What did STEP 3 find?
In STEP 3, a phase 3 trial of semaglutide in US adults without diabetes with overweight (BMI 27 or greater) plus at least 1 comorbidity or obesity (BMI 30 or greater) (n=611), mean body weight fell 16.0% on 2.4 mg over 68 weeks, against 5.7% on placebo (treatment-policy estimand; Wadden TA et al. JAMA 2021 (STEP 3)).
What side effects were reported in STEP 3?
In STEP 3, discontinuation because of adverse events was 5.9% on 2.4 mg, against 2.9% on placebo. The most frequently reported adverse events were gastrointestinal adverse events in 82.8% on 2.4 mg against 63.2% on placebo, nausea in 58.2% on 2.4 mg against 22.1% on placebo, constipation in 36.9% on 2.4 mg against 24.5% on placebo and diarrhoea in 36.1% on 2.4 mg against 22.1% on placebo.
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