The most current available data from Eli Lilly's TRIUMPH Phase 3 program — trial status, conference presentations, and FDA approval timeline. Updated as new data is published.
What we know as of April 2026: Enrollment for both TRIUMPH-1 and TRIUMPH-2 is complete. Eli Lilly has not released topline results publicly. Conference presentations through 2024 have been consistent with Phase 2 efficacy. The slower Phase 3 titration schedule is expected to improve tolerability while potentially reducing peak weight loss slightly vs Phase 2's 24.2%.
Phase 2 full results presented. 24.2% weight loss at 12 mg confirmed. Lean mass preservation data highlighted.
First comprehensive public presentation of Phase 2 data
Subgroup analysis presented: retatrutide efficacy in T2D subgroup from Phase 2. HbA1c −2.2% at 12 mg.
Established diabetes efficacy case for TRIUMPH-2
Body composition data: ~70% of weight lost was fat mass. Lean mass preservation comparable to tirzepatide.
Addressed key concern about muscle loss with aggressive weight loss
TRIUMPH enrollment update. Slower titration protocol confirmed for Phase 3. No interim efficacy data released.
Confirmed Phase 3 design changes to address GI tolerability
Mechanistic data on glucagon receptor component. Thermogenesis and hepatic lipolysis quantified.
Strengthened scientific differentiation vs dual agonists
Based on the Phase 2 data and Phase 3 design changes, here is what the research community expects from TRIUMPH results:
The slower 24-week titration in Phase 3 (vs 12-week in Phase 2) is expected to reduce peak GI adverse events but may also reduce peak weight loss. Analysts project 20–22% average weight loss at the highest dose, vs 24.2% in Phase 2.
The Phase 2 discontinuation rate of 16% due to adverse events was the primary concern. Phase 3's slower titration is specifically designed to address this. Expect discontinuation rates closer to tirzepatide's 7%.
This is the most anticipated data point. If retatrutide shows superior HbA1c reduction and comparable or better weight loss vs tirzepatide, it will establish a clear clinical differentiation. Even non-inferiority would be commercially significant.
Phase 2 showed 82% liver fat reduction — extraordinary for NASH. If TRIUMPH-NASH results are strong, Eli Lilly may pursue NASH as the first FDA indication, similar to how resmetirom (Rezdiffra) received accelerated approval for NASH in 2024.
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As of early 2026, full Phase 3 TRIUMPH results have not been published. Eli Lilly has reported that enrollment is complete for TRIUMPH-1 and TRIUMPH-2, with topline results expected in 2025–2026. Interim data presented at medical conferences has been consistent with Phase 2 efficacy.
Eli Lilly has indicated topline results from TRIUMPH-1 are expected in 2025–2026. Full publication in a peer-reviewed journal typically follows 6–12 months after topline results. This page will be updated as data becomes available.
Phase 3 uses a slower titration schedule (24 weeks vs 12 weeks in Phase 2) to reduce GI adverse events. The population is larger (thousands vs 338 in Phase 2), the duration is longer (72 weeks vs 48 weeks), and TRIUMPH-2 includes tirzepatide as an active comparator for the first time.
TRIUMPH-2 includes tirzepatide as an active comparator, making it the first head-to-head trial. Phase 2 data suggested retatrutide produces slightly greater weight loss (24.2% vs 22.5%), but Phase 3 uses a slower titration which may reduce peak efficacy. The cardiovascular outcomes data will be critical for commercial differentiation.
As of early 2026, retatrutide is not FDA-approved. It is in Phase 3 clinical trials. Eli Lilly has not announced an NDA submission date. Analysts project potential approval in late 2026 or 2027 pending Phase 3 results.
Eli Lilly has not announced a brand name for retatrutide as of early 2026. The compound's INN (International Nonproprietary Name) is retatrutide. Brand names for tirzepatide (Mounjaro for diabetes, Zepbound for obesity) suggest Lilly may use different brand names for different indications.
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