Retatrutide (LY3437943) \u2014 Eli Lilly's triple agonist \u2014 showed ~24.2% weight loss in Phase 2, the highest ever recorded in the GLP-1 class. Here is the complete TRIUMPH Phase 3 program tracker, timeline, and estimated FDA approval outlook.
All four TRIUMPH trials have reported positive results: TRIUMPH-4 (Dec 2025), TRIUMPH-1 (21 May 2026, \u221228.3% at 80 weeks), TRIUMPH-2 and TRIUMPH-3 (23 Jul 2026). Lilly says the data package is complete and it plans to file a Biologics License Application in Q1 2027; nothing has been filed yet and there is no FDA decision date. The table and timeline below are the dated record.
First-in-human ascending-dose study; safety and pharmacokinetics established
48-week obesity trial; 12 mg dose −24.2% — published in NEJM, June 2023
TRIUMPH-1 (NCT05929066) begins enrolment; TRIUMPH-2, -3 and -4 follow
−28.7% at 68 weeks in obesity with knee osteoarthritis
−28.3% at 80 weeks on 12 mg — the pivotal obesity result
Both met primary endpoints; Lilly first guides to a Q1 2027 BLA
Lilly: registrations supported for obesity, OSA and knee OA pain; BLA planned Q1 2027
Full results in a retatrutide symposium, Milan
Filing follows completion of the manufacturing (CMC) data
Standard review ~10–12 months from filing; no date set, no priority voucher announced
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Biologics License Application (BLA) to the U.S. FDA planned for the first quarter of 2027; the clinical data package is complete for obesity, obstructive sleep apnea and knee osteoarthritis pain.
A Q1 2027 filing puts a standard-review decision in late 2027 or 2028. No date has been set and Lilly has not announced a priority voucher or breakthrough designation.
Retatrutide is not approved for human use and the trial results on this page are Lilly's. The research-grade market sells it under coded names (GLP-3 R, MA-3RT, PG-3RT and similar); the vendors below are scored on documentation, and every price was read from the vendor's own product page on the date shown.
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The Phase 2 obesity trial (NCT05394519, published in NEJM 2023) is the benchmark against which TRIUMPH-1 will be judged. The 12 mg dose showed ~24.2% mean body weight reduction at 48 weeks. Phase 3 trials typically enroll broader populations and may show modest regression from Phase 2 results.
| Dose | Weight Loss at 24 wks | Weight Loss at 48 wks | GI Discontinuation | Nausea Rate |
|---|---|---|---|---|
| 1 mg | ~5.2% | ~8.7% | ~2% | ~25% |
| 4 mg | ~10.4% | ~17.3% | ~5% | ~38% |
| 8 mg | ~14.1% | ~22.8% | ~8% | ~47% |
| 12 mg ★ | ~17.5% | ~24.2% | ~12% | ~58% |
| Placebo | ~1.6% | ~2.1% | ~1% | ~14% |
\u2605 = expected Phase 3 maintenance dose. Data from NCT05394519 (NEJM 2023). Phase 3 results may differ.
| Parameter | Semaglutide | Tirzepatide | Retatrutide |
|---|---|---|---|
| Mechanism | GLP-1 (single) | GLP-1 + GIP (dual) | GLP-1 + GIP + Glucagon (triple) |
| Pivotal weight loss | ~15% (STEP 1, 68 wks) | ~20.9% (SURMOUNT-1, 72 wks, 15 mg) | −28.3% (TRIUMPH-1, 80 wks, 12 mg) |
| Phase 3 program | STEP (complete) | SURMOUNT (complete) | TRIUMPH (all four reported) |
| FDA approval status | Approved (Ozempic/Wegovy) | Approved (Mounjaro/Zepbound) | Not approved; BLA planned Q1 2027 |
| Nausea rate | ~30–44% | ~33–45% | ~47–58% |
| GI discontinuation | ~5–8% | ~6–9% | 11.3% on 12 mg vs 4.9% placebo (TRIUMPH-1) |
| CV outcomes trial | SELECT (complete) | SURPASS-CVOT (complete) | TRIUMPH-3 pre-specified MACE-5 analysis (HR 0.82); no dedicated CVOT reported |
| Additional indications | CV risk reduction (SELECT) | OSA (Zepbound) | OSA and knee OA pain in the planned filing (TRIUMPH-4: −28.7%) |
| Manufacturer | Novo Nordisk | Eli Lilly | Eli Lilly |
Phase 3 weight loss data may be lower than Phase 2 (~24.2%) due to broader population selection. A result below ~20% would narrow differentiation from tirzepatide.
Glucagon receptor agonism increases heart rate (~3–5 bpm in Phase 2). TRIUMPH-3 will be critical; any MACE signal could require label restrictions.
Phase 2 showed ~12% GI discontinuation at 12 mg — higher than tirzepatide (~6–9%). Phase 3 real-world adherence may be lower than trial conditions.
Glucagon receptor agonism is a novel mechanism in approved obesity drugs. FDA may request additional data on hepatic effects, bone density, or long-term safety.
Phase 3 is complete for the obesity programme. All four TRIUMPH trials have reported: TRIUMPH-4 (obesity with knee osteoarthritis) in December 2025, TRIUMPH-1 (the pivotal obesity trial) on 21 May 2026, and TRIUMPH-2 (obesity with type 2 diabetes) and TRIUMPH-3 (obesity with established cardiovascular disease) on 23 July 2026. Lilly said on 5 August 2026 that the clinical data package is complete for obesity, obstructive sleep apnea and knee osteoarthritis pain, and that it plans to file a Biologics License Application with the FDA in the first quarter of 2027. As of 9 October 2026 nothing has been filed and retatrutide is not approved.
TRIUMPH-1 (2,339 participants, 80 weeks): −28.3% on 12 mg (70.3 lb), −25.9% on 9 mg, −19.0% on 4 mg, against −2.2% on placebo; 45.3% of the 12 mg arm lost at least 30% of body weight. TRIUMPH-2 (with type 2 diabetes): up to −20.8% with A1C down by up to 1.6 points. TRIUMPH-3 (BMI ≥35 with cardiovascular disease): up to −22.6%. TRIUMPH-4 (knee osteoarthritis): −28.7% at 68 weeks. These are Lilly's topline figures; TRIUMPH-1 has since been published in the New England Journal of Medicine and TRIUMPH-2 was presented in full at EASD on 30 September 2026.
TRIUMPH is Eli Lilly's Phase 3 programme for retatrutide in obesity. TRIUMPH-1 is obesity or overweight without type 2 diabetes; TRIUMPH-2 is obesity with type 2 diabetes; TRIUMPH-3 is BMI ≥35 with established cardiovascular disease and carries a pre-specified cardiovascular safety analysis (MACE-5 hazard ratio 0.82); TRIUMPH-4 is obesity with knee osteoarthritis pain. A separate TRANSCEND programme covers type 2 diabetes as a primary indication.
No date exists. Lilly's stated plan is a BLA submission in Q1 2027, after completing the manufacturing (CMC) part of the application. A Q1 2027 filing with a standard 10–12 month review puts a decision in late 2027 or 2028; a priority review would be faster but none has been announced. An earlier 2026 filing target was pushed back for manufacturing data, not because of the clinical results.
Retatrutide is a triple agonist (GLP-1 + GIP + glucagon) while tirzepatide is a dual agonist (GLP-1 + GIP). On the Phase 3 numbers now public, retatrutide's −28.3% at 80 weeks (TRIUMPH-1, 12 mg) sits above tirzepatide's −20.9% at 72 weeks in SURMOUNT-1 (15 mg). These are different trials with different populations and durations, so the gap is indicative rather than a head-to-head result. Discontinuation for adverse events on the 12 mg dose was 11.3% vs 4.9% on placebo — gastrointestinal events were the most common.
Not as a medicine. It is not approved anywhere and is not available on prescription or through a pharmacy. Research-chemical vendors sell a product labelled retatrutide — often as GLP-3 R or GLP-3 RT — for laboratory use only; it is not Lilly's drug and nothing about those vials is covered by the TRIUMPH data. Our compound page lists which vendors sell it, at what verified price, with which lab-checked certificate.
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