18+ · Research Use Only · Not for Human Consumption
Semaglutide · Phase 3 · Completed
STEP 2
In STEP 2, a phase 3 trial of semaglutide in adults with BMI of at least 27 kg/m2 and HbA1c 7-10% (53-86 mmol/mol), diagnosed with type 2 diabetes at least 180 days before screening (n=1,210), mean body weight fell 9.6% on 2.4 mg over 68 weeks, against 3.4% on placebo (Davies M et al. Lancet 2021 (STEP 2)).
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Results
Side effects reported
The most frequently reported adverse events were gastrointestinal adverse events in 63.5% on 2.4 mg and 57.5% on 1.0 mg against 34.3% on placebo.
| Event | 2.4 mg | 1.0 mg | Placebo |
|---|---|---|---|
| Gastrointestinal adverse events | 63.5% | 57.5% | 34.3% |
Design
Trial design and sources
- Compound
- Semaglutide
- Phase
- 3
- Population
- Adults with BMI of at least 27 kg/m2 and HbA1c 7-10% (53-86 mmol/mol), diagnosed with type 2 diabetes at least 180 days before screening
- Participants randomised
- 1,210
- Duration
- 68 weeks
- Primary endpoint
- Coprimary: percentage change in bodyweight and achievement of weight reduction of at least 5% at 68 weeks, semaglutide 2.4 mg versus placebo
- Estimand
- Not stated in the source read
- Read out
- 2 March 2021
The abstract gives no body-weight figure for the 1.0 mg arm and does not name the estimand (intention to treat).
Questions
STEP 2, answered
What did STEP 2 find?
In STEP 2, a phase 3 trial of semaglutide in adults with BMI of at least 27 kg/m2 and HbA1c 7-10% (53-86 mmol/mol), diagnosed with type 2 diabetes at least 180 days before screening (n=1,210), mean body weight fell 9.6% on 2.4 mg over 68 weeks, against 3.4% on placebo (Davies M et al. Lancet 2021 (STEP 2)).
What side effects were reported in STEP 2?
The most frequently reported adverse events were gastrointestinal adverse events in 63.5% on 2.4 mg and 57.5% on 1.0 mg against 34.3% on placebo.
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