Once-weekly semaglutide 7·2 mg in adults with obesity (STEP UP): a randomised, controlled, phase 3b trial
Authors' conclusion
Semaglutide 7.2 mg was superior to placebo and 2.4 mg for bodyweight reduction in adults with obesity, while retaining a favourable risk-benefit profile.
Study context
- Population
- Adults with BMI ≥30 kg/m² without diabetes; 73.7% female, mean age 47 years, mean bodyweight 113.0 kg, mean BMI 39.9 kg/m²randomized 5:1:1
- Participants
- 1,407 adults
- Comparison
- Once-weekly SC semaglutide 7.2 mg vs semaglutide 2.4 mg vs placebo, with lifestyle intervention
- Semaglutide 7.2 mgn = 1,005
- Semaglutide 2.4 mgn = 201
- Placebon = 201reference
- Primary endpoint
- Coprimary: % change in bodyweight and proportion with bodyweight reduction ≥5%, semaglutide 7.2 mg vs placebo (treatment policy estimand)
- Follow-up
- Baseline to week 72
Methodological detailsphase 3b, double-blind, placebo-controlled, active-controlled, multicentre (95 sites, 11 countries), Jan 1, 2023 to Nov 26, 2024
- Phase 3b
- Double-blind
- Placebo-controlled
- Active-controlled
- Multicentre (95 sites, 11 countries)
- Jan 1, 2023 to Nov 26, 2024
Primary result
As reported in the abstract
% change in bodyweight; bodyweight reduction ≥5% · week 72
Semaglutide 7.2 mg
−18.7%
mean · SE 0.4
Placebo
−3.9%
mean · SE 0.6
Semaglutide 7.2 mg vs PlaceboETD (95% CI)P value
% change in bodyweight
−14.8%(−16.2 to −13.4)
P < 0.0001Semaglutide 7.2 mg vs PlaceboOdds ratio (95% CI)P value
Bodyweight reduction ≥5%
12.1(8.3–17.6)
P < 0.0001Secondary outcomes
Mean
| Outcome | Semaglutide 7.2 mg | Semaglutide 2.4 mg | ETD (95% CI) | P value | |
|---|---|---|---|---|---|
| % change in bodyweight, 7.2 mgvs 2.4 mg · week 72 | −18.7% (SE 0.4) | −15.6% (SE 0.7) | −3.1% (−4.7 to −1.6) | P < 0.0001 | |
| −6−4−202Difference (linear scale) |
| Outcome | OR (CI) | P value | |
|---|---|---|---|
| Bodyweight reductions ≥10%, ≥15%, ≥20%, ≥25%, 7.2 mgvs placebo · week 72≥10% | 14.5 (9.6–21.9) | P < 0.0001 | |
| Bodyweight reductions ≥10%, ≥15%, ≥20%, ≥25%, 7.2 mgvs placebo · week 72≥15% | 20.3 (11.2–36.8) | P < 0.0001 | |
| Bodyweight reductions ≥10%, ≥15%, ≥20%, ≥25%, 7.2 mgvs placebo · week 72≥20% | 27.3 (10.9–68.0) | P < 0.0001 | |
| Bodyweight reductions ≥10%, ≥15%, ≥20%, ≥25%, 7.2 mgvs placebo · week 72≥25% | 127.4 (36.8–441.4) | P < 0.0001 | |
| Bodyweight reductions ≥20% and ≥25%, 7.2 mgvs 2.4 mg · week 72≥20% | 1.8 (1.3–2.4) | P = 0.0006 | |
| Bodyweight reductions ≥20% and ≥25%, 7.2 mgvs 2.4 mg · week 72≥25% | 2.4 (1.6–3.5) | P < 0.0001 | |
| 0.050.21520Odds ratio (log scale) |
| Outcome | ETD (cm) (95% CI) | P value | |
|---|---|---|---|
| Change in waist circumference, 7.2 mgvs placebo · week 72 | −11.7 (−13.0 to −10.4) | P < 0.0001 | |
| −20−10010Difference, cm (linear scale) |
Safety
Gastrointestinal adverse events
Dysaesthesia
Serious adverse events
- Gastrointestinal adverse events: safety population: 1004 / 201 / 201
Original publication
Once-weekly semaglutide 7·2 mg in adults with obesity (STEP UP): a randomised, controlled, phase 3b trial. Lancet Diabetes Endocrinol. Published 14 September 2025. doi:10.
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