TRIUMPH-Maintenance: Weight Maintenance After Retatrutide Treatment
NCT06051747 · Eli Lilly
- Phase
- Phase 3
- Enrollment
- 600 participants
- Est. completion
- Q3 2027
- Sponsor
- Eli Lilly
Background
TRIUMPH-Maintenance is a withdrawal trial designed to evaluate what happens when retatrutide treatment is stopped after successful weight loss. Participants who achieved ≥ 10% body weight reduction in TRIUMPH-1 are re-randomized to continued retatrutide or placebo. This design mirrors the STEP 4 semaglutide withdrawal trial, which showed ~7% weight regain after semaglutide discontinuation. The trial will inform labeling language about treatment duration and the consequences of discontinuation.
Primary endpoint
Percent change in body weight from re-randomization to 52 weeks (withdrawal phase)
Secondary endpoints
- Proportion regaining ≥ 5% of lost weight
- Proportion maintaining ≥ 80% of achieved weight loss
- Change in cardiometabolic risk factors during withdrawal
- Time to weight regain threshold
Population
Adults who completed TRIUMPH-1 and achieved ≥ 10% body weight reduction; re-randomized to continued retatrutide or placebo withdrawal
Intervention
Continued retatrutide 12 mg (or last tolerated dose) SC once weekly vs. placebo withdrawal for 52 weeks
Inclusion criteria
Completion of TRIUMPH-1; achieved ≥ 10% body weight reduction from TRIUMPH-1 baseline; no new contraindications to retatrutide
Exclusion criteria
Discontinued TRIUMPH-1 due to adverse events; new diagnosis of type 2 diabetes; new cardiovascular event during TRIUMPH-1
Trial information sourced from ClinicalTrials.gov and published literature. TryTrutide is not affiliated with Eli Lilly or any trial site. This is not medical advice.