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

STEP 1: mean percent change in body weight by armSTEP 1 treatment-policy estimand2.4 mg-14.9%Placebo-2.4%
Mean percent change in body weight by arm, as each source reports it. Bars from different trials are not a head-to-head comparison: populations, durations and estimands differ.

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.

  • Wilding JPH et al. N Engl J Med 2021;384:989-1002 open · checked 23 September 2026
  • ClinicalTrials.gov NCT03548935 open · checked 23 September 2026
  • Registry: NCT03548935

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.