18+ · Research Use Only · Not for Human Consumption
Semaglutide · Phase 3 · Completed
STEP 5
In STEP 5, a phase 3 trial of semaglutide in adults with obesity, or overweight with at least one weight-related comorbidity, without diabetes (n=304), mean body weight fell 15.2% on 2.4 mg over 104 weeks, against 2.6% on placebo (treatment-policy estimand; Garvey WT et al. Nat Med 2022 (STEP 5)).
Primara Labs sells some of the compounds covered here. Every figure on this page links to its source and the date it was checked.
Results
Side effects reported
In STEP 5, discontinuation because of adverse events was 5.9% on 2.4 mg, against 4.6% on placebo. The most frequently reported adverse events were gastrointestinal adverse events in 82.2% on 2.4 mg against 53.9% on placebo, nausea in 53.3% on 2.4 mg against 21.7% on placebo, diarrhoea in 34.9% on 2.4 mg against 23.7% on placebo and constipation in 30.9% on 2.4 mg against 11.2% on placebo.
| Event | 2.4 mg | Placebo |
|---|---|---|
| Discontinuation for adverse events | 5.9% | 4.6% |
| Gastrointestinal adverse events | 82.2% | 53.9% |
| Nausea | 53.3% | 21.7% |
| Diarrhoea | 34.9% | 23.7% |
| Constipation | 30.9% | 11.2% |
| Vomiting | 30.3% | 4.6% |
Design
Trial design and sources
- Compound
- Semaglutide
- Phase
- 3
- Population
- Adults with obesity, or overweight with at least one weight-related comorbidity, without diabetes
- Participants randomised
- 304
- Duration
- 104 weeks
- Primary endpoint
- Co-primary: percentage change in body weight and achievement of weight loss of 5% or more at week 104
- Estimand
- treatment-policy
- Read out
- 10 October 2022
Questions
STEP 5, answered
What did STEP 5 find?
In STEP 5, a phase 3 trial of semaglutide in adults with obesity, or overweight with at least one weight-related comorbidity, without diabetes (n=304), mean body weight fell 15.2% on 2.4 mg over 104 weeks, against 2.6% on placebo (treatment-policy estimand; Garvey WT et al. Nat Med 2022 (STEP 5)).
What side effects were reported in STEP 5?
In STEP 5, discontinuation because of adverse events was 5.9% on 2.4 mg, against 4.6% on placebo. The most frequently reported adverse events were gastrointestinal adverse events in 82.2% on 2.4 mg against 53.9% on placebo, nausea in 53.3% on 2.4 mg against 21.7% on placebo, diarrhoea in 34.9% on 2.4 mg against 23.7% on placebo and constipation in 30.9% on 2.4 mg against 11.2% on placebo.
Related