18+ · Research Use Only · Not for Human Consumption
Semaglutide · Phase 3b · Completed
STEP 8
In STEP 8, a phase 3b trial of semaglutide in US adults with BMI of 30 or greater, or 27 or greater with 1 or more weight-related comorbidities, without diabetes (n=338), mean body weight fell 15.8% on semaglutide 2.4 mg and 6.4% on liraglutide 3.0 mg over 68 weeks, against 1.9% on placebo (pooled) (treatment-policy estimand; Rubino DM et al. JAMA 2022 (STEP 8)).
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Results
Side effects reported
In STEP 8, discontinuation because of adverse events was 3.2% on semaglutide 2.4 mg and 12.6% on liraglutide 3.0 mg, against 3.5% on placebo (pooled). The most frequently reported adverse events were gastrointestinal disorders in 84.1% on semaglutide 2.4 mg and 82.7% on liraglutide 3.0 mg against 55.3% on placebo (pooled), nausea in 61.1% on semaglutide 2.4 mg and 59.1% on liraglutide 3.0 mg against 22.4% on placebo (pooled), constipation in 38.9% on semaglutide 2.4 mg and 31.5% on liraglutide 3.0 mg against 23.5% on placebo (pooled) and diarrhoea in 27.8% on semaglutide 2.4 mg and 18.1% on liraglutide 3.0 mg against 25.9% on placebo (pooled).
| Event | Semaglutide 2.4 mg | Liraglutide 3.0 mg | Placebo (pooled) |
|---|---|---|---|
| Discontinuation for adverse events | 3.2% | 12.6% | 3.5% |
| Gastrointestinal disorders | 84.1% | 82.7% | 55.3% |
| Nausea | 61.1% | 59.1% | 22.4% |
| Constipation | 38.9% | 31.5% | 23.5% |
| Diarrhoea | 27.8% | 18.1% | 25.9% |
| Vomiting | 25.4% | 20.5% | 5.9% |
Design
Trial design and sources
- Compound
- Semaglutide
- Phase
- 3b
- Population
- US adults with BMI of 30 or greater, or 27 or greater with 1 or more weight-related comorbidities, without diabetes
- Participants randomised
- 338
- Duration
- 68 weeks
- Primary endpoint
- Percentage change in body weight, semaglutide vs liraglutide at week 68
- Estimand
- treatment-policy
- Read out
- 1 January 2022
Semaglutide against liraglutide was open-label; each was blinded against its own placebo, pooled.
Questions
STEP 8, answered
What did STEP 8 find?
In STEP 8, a phase 3b trial of semaglutide in US adults with BMI of 30 or greater, or 27 or greater with 1 or more weight-related comorbidities, without diabetes (n=338), mean body weight fell 15.8% on semaglutide 2.4 mg and 6.4% on liraglutide 3.0 mg over 68 weeks, against 1.9% on placebo (pooled) (treatment-policy estimand; Rubino DM et al. JAMA 2022 (STEP 8)).
What side effects were reported in STEP 8?
In STEP 8, discontinuation because of adverse events was 3.2% on semaglutide 2.4 mg and 12.6% on liraglutide 3.0 mg, against 3.5% on placebo (pooled). The most frequently reported adverse events were gastrointestinal disorders in 84.1% on semaglutide 2.4 mg and 82.7% on liraglutide 3.0 mg against 55.3% on placebo (pooled), nausea in 61.1% on semaglutide 2.4 mg and 59.1% on liraglutide 3.0 mg against 22.4% on placebo (pooled), constipation in 38.9% on semaglutide 2.4 mg and 31.5% on liraglutide 3.0 mg against 23.5% on placebo (pooled) and diarrhoea in 27.8% on semaglutide 2.4 mg and 18.1% on liraglutide 3.0 mg against 25.9% on placebo (pooled).
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