Retatrutide in adults with obesity and type 2 diabetes (TRIUMPH-2): a double-blind, parallel-group, randomised, placebo-controlled, phase 3 trial
Authors' conclusion
Treatment with retatrutide resulted in substantial improvements in bodyweight and was associated with improvements in glycaemic control in participants with obesity and type 2 diabetes, with a safety profile generally consistent with other molecules with GLP-1 receptor agonism.
Study context
- Population
- Adults ≥18 years with BMI ≥27 kg/m² and T2D (HbA1c 6.5–10.5%) on stable T2D treatment ≥90 days, with ≥1 unsuccessful dietary weight-loss effort; mean age 55.1 years, mean BMI 38.2 kg/m²randomised 1:1:1:1
- Participants
- 1,152 adults
- Comparison
- Once-weekly SC retatrutide 4 mg, 9 mg or 12 mg vs placebo
- Retatrutide 4 mgn = 292
- Retatrutide 9 mgn = 284
- Retatrutide 12 mgn = 287
- Placebon = 289reference
- Primary endpoint
- Percentage change in bodyweight from baseline, retatrutide 9 mg and 12 mg vs placebo
- Follow-up
- Week 80
Methodological detailsdouble-blind, parallel-group, placebo-controlled, phase 3, multicentre (92 centres, 8 countries), 965 (84%) of 1152 completed study drug
- Double-blind
- Parallel-group
- Placebo-controlled
- Phase 3
- Multicentre (92 centres, 8 countries)
- 965 (84%) of 1152 completed study drug
Primary result
As reported in the abstract
Percentage change in bodyweight
Retatrutide 9 mg
−16.8
mean · SE 0.7 · %
Retatrutide 12 mg
−18.8
mean · SE 0.7 · %
Placebo
−5.1
mean · SE 0.7 · %
Each group vs placeboEstimated treatment difference, % (95% CI)P value
Retatrutide 9 mg
−11.8(−13.7 to −9.8)
P < 0.0001Retatrutide 12 mg
−13.8(−15.8 to −11.8)
P < 0.0001Secondary outcomes
Mean, %
| Outcome | Retatrutide 4 mg | Retatrutide 9 mg | Retatrutide 12 mg | Placebo | Estimated treatment difference (%) (95% CI) | P value | |
|---|---|---|---|---|---|---|---|
| Key secondary: percentage change in bodyweight, retatrutide 4 mgvs placebo · week 80Treatment regimen estimand | −11.9 (SE 0.6) | — not stated in the abstract | — not stated in the abstract | −5.1 (SE 0.7) | −6.9 (−8.7 to −5.1) | P < 0.0001 | |
| −10−505Difference, % (linear scale) |
— not stated in the abstract
Events
| Outcome | Retatrutide 4 mg | Retatrutide 9 mg | Retatrutide 12 mg | Placebo |
|---|---|---|---|---|
| Deaths | 2 | 3 | 1 | 1 |
- Deaths: all deemed unrelated to study intervention by the investigator
Safety
Diarrhoea
Nausea
Dysesthesia
Permanent treatment discontinuation due to adverse events or death
| Outcome | Retatrutide 4 mg | Retatrutide 9 mg | Retatrutide 12 mg | Placebo |
|---|---|---|---|---|
| Hypotension | 1% | 5% | 6% | <1% |
- Diarrhoea: of 292, 284, 286 and 287 participants
Original publication
Retatrutide in adults with obesity and type 2 diabetes (TRIUMPH-2): a double-blind, parallel-group, randomised, placebo-controlled, phase 3 trial. Lancet. Published 29 September 2026. doi:10.
Composed by AI from the published abstract and checked against it. How Briefs are made →