Efficacy and safety of once-weekly semaglutide 2·4 mg versus placebo in people with obesity and prediabetes (STEP 10): a randomised, double-blind, placebo-controlled, multicentre phase 3 trial
Primary result · Percentage change in bodyweightResult — go to the resultEstimated treatment difference −11.2 % 95% CI −13.0 to −9.4Authors' conclusion
Semaglutide 2.4 mg provided superior reduction in bodyweight and reversion to normoglycaemia versus placebo in participants with obesity and prediabetes. The safety and tolerability profile was consistent with previous studies and with the GLP-1 receptor agonist class. These findings support the potential use of semaglutide 2.4 mg as a treatment option for individuals with obesity and prediabetes to achieve reversion to normoglycaemia.
Study context
- Population
- Adults ≥18 years with BMI ≥30 kg/m² and prediabetes (HbA1c 6.0–6.4% or FPG 5.5–6.9 mmol/L), 30 sites in Canada, Denmark, Finland, Spain and the UK; mean age 53 years, BMI 40.1 kg/m²randomised 2:1
- Participants
- 138 vs 69
- Comparison
- Once-weekly SC semaglutide 2.4 mg vs placebo, with diet and physical activity counselling
- Semaglutide 2.4 mgn = 138
- Placebon = 69reference
- Primary endpoint
- Percentage change in bodyweight and proportion reverting to normoglycaemia (HbA1c <6.0% and FPG <5.5 mmol/L)
- Follow-up
- Week 52
Methodological detailsdouble-blind, parallel-group, phase 3, multicentre, 52 weeks treatment followed by a 28-week off-treatment period
- Double-blind
- Parallel-group
- Phase 3
- Multicentre
- 52 weeks treatment followed by a 28-week off-treatment period
Primary result
Percentage change in bodyweight
Estimated treatment difference
−11.2 %
95% CI −13.0 to −9.4
P < 0.0001
Change by group
Semaglutide 2.4 mg
−13.9
SD 0.7 · %
Placebo
−2.7
SD 0.6 · %
As reported in the abstract
Further findings
| Outcome | Semaglutide 2.4 mg | Placebo | OR (95% CI) | P value | |
|---|---|---|---|---|---|
| Reversion to normoglycaemia (co-primary endpoint) · week 52Intention to treat | 81% | 14% | 19.8 (8.7–45.2) | P < 0.0001 | |
| Denominator | 127 | 64 | |||
| 0.050.21520Odds ratio (log scale) |
Safety
Serious adverse events
Adverse events leading to treatment discontinuation
Adverse events leading to treatment discontinuation
- No new safety signals were reported
Original publication
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