18+ · Research Use Only · Not for Human Consumption
Semaglutide · Phase 3 · Completed
STEP 1
In STEP 1, a phase 3 trial of semaglutide in adults with BMI of 30 or greater (27 or greater with at least one weight-related coexisting condition), without diabetes (n=1,961), mean body weight fell 14.9% on 2.4 mg over 68 weeks, against 2.4% on placebo (treatment-policy estimand; Wilding JPH et al. N Engl J Med 2021;384:989-1002).
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Results
Side effects reported
STEP 1: Discontinuation for adverse events is not given in the abstract; discontinuation for gastrointestinal adverse events was 4.5% against 0.8% on placebo.
Design
Trial design and sources
- Compound
- Semaglutide
- Phase
- 3
- Population
- Adults with BMI of 30 or greater (27 or greater with at least one weight-related coexisting condition), without diabetes
- Participants randomised
- 1,961
- Duration
- 68 weeks
- Primary endpoint
- Coprimary: percentage change in body weight and weight reduction of at least 5% (week 68)
- Estimand
- treatment-policy
- Read out
- 10 February 2021
Discontinuation for adverse events is not given in the abstract; discontinuation for gastrointestinal adverse events was 4.5% against 0.8% on placebo. The estimand is described in the abstract (effects regardless of treatment discontinuation or rescue) without being named.
Questions
STEP 1, answered
What did STEP 1 find?
In STEP 1, a phase 3 trial of semaglutide in adults with BMI of 30 or greater (27 or greater with at least one weight-related coexisting condition), without diabetes (n=1,961), mean body weight fell 14.9% on 2.4 mg over 68 weeks, against 2.4% on placebo (treatment-policy estimand; Wilding JPH et al. N Engl J Med 2021;384:989-1002).
What side effects were reported in STEP 1?
STEP 1: Discontinuation for adverse events is not given in the abstract; discontinuation for gastrointestinal adverse events was 4.5% against 0.8% on placebo.
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