TRIUMPH-1
NCT05929066 on ClinicalTrials.gov
- Phase
- Phase 3
- Status
- Completed
- Population
- Adults with obesity or overweight without type 2 diabetes (with knee osteoarthritis and sleep apnea substudies)
- Randomized
- 2,339
- Duration
- 80 weeks (24-week extension in participants with BMI ≥35)
- Comparator
- Placebo
- Primary endpoint
- Percent change in body weight at week 80
Arms as registered or published: Retatrutide 4 mg; Retatrutide 9 mg; Retatrutide 12 mg; Placebo (1:1:1:1)
Reported results
| Arm | Reported |
|---|---|
| Retatrutide 4 mg | −17.6% |
| Retatrutide 9 mg | −23.7% |
| Retatrutide 12 mg | −25.0% |
| Placebo(comparator) | −3.9% |
Peer-reviewed publication: Jastreboff AM, et al. N Engl J Med 2026;395:1781-1793 (TRIUMPH-1)
Adverse events reported
| Event | 4 mg | 9 mg | 12 mg | Placebo |
|---|---|---|---|---|
| Nausea | 28.6% | 38.4% | 42.4% | 14.8% |
| Diarrhea | 25.2% | 34.1% | 32.0% | 13.5% |
| Constipation | 23.8% | 25.9% | 26.1% | 10.9% |
| Vomiting | 10.6% | 22.8% | 25.3% | 4.8% |
| Dysesthesia (altered skin sensation) | 5.1% | 12.3% | 12.5% | 0.9% |
| Stopped treatment because of adverse events | 4.1% | 6.9% | 11.3% | 4.9% |
Percent of participants, as reported in Eli Lilly press release, 2026-05-21 (TRIUMPH-1 topline).
- Adverse event rates are from Lilly’s 2026-05-21 topline release; Lilly’s medical-information page gives slightly different discontinuation figures from a later data cut.
- In the 532 participants with BMI ≥35 who continued to week 104, the 12 mg arm reported −29.9% (treatment-regimen estimand) in the topline release.
Sources
- Peer-reviewed publication: Jastreboff AM, et al. N Engl J Med 2026;395:1781-1793 (TRIUMPH-1) · PMID 42814954
- Sponsor topline release (not peer-reviewed): Eli Lilly press release, 2026-05-21 (TRIUMPH-1 topline)
- Trial registration: NCT05929066, ClinicalTrials.gov (checked 2026-11-08)