Once-weekly semaglutide 7·2 mg in adults with obesity and type 2 diabetes (STEP UP T2D): a randomised, controlled, phase 3b trial
An erratum to this article was published (Lancet Diabetes Endocrinol, Jun 2026 ↗)
Authors' conclusion
Among people with obesity and type 2 diabetes, semaglutide 7.2 mg was superior to placebo in reducing bodyweight, waist circumference, and HbA1c. Safety and tolerability were comparable between semaglutide 7.2 mg and 2.4 mg, except for the imbalance in dysaesthesia.
Study context
- Population
- Adults aged 18 years or older with obesity and T2D (BMI ≥30.0 kg/m², HbA1c 7.0–10.0% [53–86 mmol/mol]), 68 hospitals, specialist clinics and medical centres in Bulgaria, Canada, Hungary, Poland, Portugal, Slovakia, South Africa and the USA; mean age 56 years, 51.8% female, mean BMI 38.6 kg/m², mean HbA1c 8.1%randomized 3:1:1
- Participants
- 512 adults
- Comparison
- Once-weekly SC semaglutide 7.2 mg vs 2.4 mg vs placebo, with lifestyle intervention
- Semaglutide 7.2 mgn = 307
- Semaglutide 2.4 mgn = 103
- Placebon = 102reference
- Primary endpoint
- Coprimary: % change in bodyweight and proportion reaching bodyweight reduction ≥5%, semaglutide 7.2 mg vs placebo
- Follow-up
- 72 weeks
Methodological detailsphase 3b, double-blind, three-arm, parallel-group, multicentre (68 sites)
- Phase 3b
- Double-blind
- Three-arm
- Parallel-group
- Multicentre (68 sites)
Primary result
As reported in the abstract
% change in bodyweight; bodyweight reduction ≥5%
Semaglutide 7.2 mg
−13.2%
mean
Placebo
−3.9%
mean
Semaglutide 7.2 mg vs PlaceboEstimated treatment difference, % (95% CI)P value
% change in bodyweight
−9.3(−11.0 to −7.7)
P < 0.0001Semaglutide 7.2 mg vs PlaceboOdds ratio (95% CI)P value
Bodyweight reduction ≥5%
10.0(6.0–16.9)
P < 0.0001Secondary outcomes
| Outcome | OR (CI) | P value | |
|---|---|---|---|
| Bodyweight reduction ≥10%Semaglutide 7.2 mgvs Placebo | 11.3 (5.9–21.4) | P < 0.0001 | |
| Bodyweight reduction ≥15%Semaglutide 7.2 mgvs Placebo | 8.1 (3.7–17.7) | P < 0.0001 | |
| Bodyweight reduction ≥20%Semaglutide 7.2 mgvs Placebo | 12.3 (3.0–51.0) | P = 0.0006 | |
| 0.050.21520Odds ratio (log scale) |
| Outcome | Estimated treatment difference (cm) (95% CI) | P value | |
|---|---|---|---|
| Waist circumferenceSemaglutide 7.2 mgvs Placebo | −6.5 (−9.0 to −4.1) | P < 0.0001 | |
| −10−505Difference, cm (linear scale) |
| Outcome | Estimated treatment difference (%) (95% CI) | P value | |
|---|---|---|---|
| HbA1cSemaglutide 7.2 mgvs Placebo | −1.5 (−1.8 to −1.2) | P < 0.0001 | |
| −2−101Difference, % (linear scale) |
Safety
Gastrointestinal events
Serious adverse events
| Outcome | Semaglutide 7.2 mg | Semaglutide 2.4 mg | Placebo |
|---|---|---|---|
| Dysaesthesia | 18.9% | 4.9% | 0 events |
Level 2-3 hypoglycaemia
- Risk low and comparable between semaglutide doses and placebo
Original publication
Once-weekly semaglutide 7·2 mg in adults with obesity and type 2 diabetes (STEP UP T2D): a randomised, controlled, phase 3b trial. Lancet Diabetes Endocrinol. Published 14 September 2025. doi:10.
Composed by AI from the published abstract and checked against it. How Briefs are made →