TRIUMPH Program · Updated June 2026
Retatrutide TRIUMPH Trials: Phase 3 Status & Completion Dates (2026)
Definitive tracker for all TRIUMPH Phase 3 trials evaluating retatrutide (LY3437943). NCT IDs, indication, enrollment, primary endpoints, current status, and the December 2025 TRIUMPH-4 readout — 28.7% weight loss at 68 weeks.
⚠ Investigational drug — not FDA-approved
Retatrutide is in Phase 3 clinical trials only. It is not available by prescription and not approved for human use outside of registered clinical trials. This page is for educational purposes only.
TRIUMPH Trial Program — Summary Table
| Trial | NCT ID | Indication | Enrollment | Primary Endpoint | Status | Est. Completion |
|---|---|---|---|---|---|---|
| TRIUMPH-1 | NCT05929066 | Obesity (master protocol; incl. OSA & OA subsets) | ~2,300 | % body weight change at Week 80 | Active | April 2026 (primary) |
| TRIUMPH-2 | NCT05929079 | Obesity + type 2 diabetes | 18,558 | HbA1c reduction + % body weight change | Active | Est. 2026–2027 |
| TRIUMPH-3 | NCT05882045 | Obesity + cardiovascular disease (weight-loss + CVD outcomes) | 1,800 | % body weight change (~113 weeks) | Active, not recruiting | Est. 2028–2029 |
| TRIUMPH-4 | NCT05931367 | Obesity + knee osteoarthritis | 445 | % body weight change + OA pain at Week 68 | Completed | Primary completion 14 Nov 2025 ✓ |
| TRIUMPH-Outcomes | NCT06383390 | Obesity — MACE + kidney composite (event-driven) | ~10,000 | MACE-3 + kidney composite endpoints | Active, not recruiting | Primary completion Feb 2029 |
| TRIUMPH-9 | NCT07357415 | Obesity — Phase 3b dose-escalation schemes | 600 | Dose escalation tolerability & weight outcomes | Active | Primary completion Oct 2028 |
Sources: ClinicalTrials.gov; BioSpace Dec 2025. [verify] items should be confirmed at ClinicalTrials.gov.
Individual Trial Deep-Dives
Phase 3 · Active — Primary Endpoint April 2026
TRIUMPH-1
Retatrutide in Adults with Obesity or Overweight — Master Protocol
NCT ID
Primary Completion
April 2026
Enrollment
~2,300 participants
Dosing Arm
2→4→8→12 mg/wk
Population: Adults with obesity or overweight, without type 2 diabetes. Nested subsets include obstructive sleep apnea (OSA) and knee osteoarthritis (OA) participants.
Design: 80-week randomized, double-blind, placebo-controlled basket trial. Optional 24-week extension period for approximately 500 participants.
Primary endpoint: Percent change in body weight from baseline at Week 80.
Significance: This is the core obesity-without-diabetes readout — the primary dataset Lilly needs for NDA submission targeting the Wegovy/Zepbound market. April 2026 primary completion is the most critical near-term milestone in the TRIUMPH program.
Phase 3 · Active
TRIUMPH-2
Retatrutide in Adults with Type 2 Diabetes and Obesity
NCT ID
Primary Completion
Est. 2026–2027
Enrollment
18,558 participants
Dual Endpoints
HbA1c + weight loss
Population: Adults with type 2 diabetes and obesity or overweight. Includes an obstructive sleep apnea subset.
Design: 89-week randomized, double-blind, placebo-controlled study.
Primary endpoints: (1) Change in HbA1c from baseline; (2) Percent change in body weight from baseline.
Significance: The T2D readout determines whether retatrutide can compete with tirzepatide (Mounjaro) and semaglutide (Ozempic) in the diabetes market — historically the larger reimbursement channel. The enrollment of 18,558 is notably large; this reflects the long-duration efficacy and safety requirements for a T2D+obesity comorbid population. Source: ClinicalTrials.gov NCT05929079.
Phase 3 · CV Outcomes Trial · Long-Duration
TRIUMPH-3
Retatrutide in Adults with Obesity and Established Cardiovascular Disease
NCT ID
Primary Completion
Est. 2028–2029
Enrollment
1,800
Primary Endpoint
% body weight change (~113 wks)
Population: Adults with obesity or overweight and established cardiovascular disease — the same profile used in semaglutide's SELECT trial.
Primary endpoint: Percent body weight change from baseline (~113 weeks). Note: this trial differs from TRIUMPH-Outcomes (NCT06383390), which is the dedicated event-driven MACE outcomes study. TRIUMPH-3 focuses on the obesity + CVD population specifically; TRIUMPH-Outcomes is the large-scale dedicated cardiovascular outcomes trial.
Why it matters: TRIUMPH-3 provides weight-loss efficacy data in patients with established cardiovascular disease. See also the cardiovascular outcomes deep-dive for both TRIUMPH-3 and TRIUMPH-Outcomes. Source: ClinicalTrials.gov NCT05882045.
Phase 3 · Completed — Primary Data Reported December 2025
TRIUMPH-4
A Phase 3 Study of LY3437943 in Participants With Obesity or Overweight and Osteoarthritis of the Knee (NCT05931367)
NCT ID / Enrollment
NCT05931367 · 445 participants
Readout Date
December 2025
Weight Loss (12 mg)
28.7% at 68 weeks
Placebo-Adjusted
26.6%
OA Pain Reduction
75%
Population: Adults with obesity or overweight and knee osteoarthritis. Duration: 68 weeks.
Key results (top-line, December 2025): 28.7% mean body-weight loss at 68 weeks on 12 mg (26.6% placebo-adjusted) — the highest ever reported for a once-weekly injectable in a Phase 3-scale trial. Knee OA pain scores reduced by 75% (vs 42% for semaglutide in a comparable trial).
New safety signal — dysesthesia: An abnormal skin sensation (tingling, crawling, or prickling) was reported in 8.8% of participants on 9 mg and 20.9% on 12 mg, versus 0.7% on placebo. This signal was not observed in Phase 2. Lilly noted that dysesthesia did not appear to drive discontinuation. Full characterization pending peer-reviewed publication.
⚠ TRIUMPH-4 Dysesthesia Signal
Dysesthesia (abnormal skin sensation) was reported in 8.8% at 9 mg and 20.9% at 12 mg vs 0.7% placebo. GI events: nausea 43%, vomiting 21%, diarrhea 33%. Discontinuation: 12.2% (9 mg), 18.2% (12 mg) vs 4% (placebo). Source: Clinical Trials Arena, December 2025; ClinicalTrials.gov: NCT05931367.
Phase 3 · Active, Not Recruiting · Event-Driven
TRIUMPH-Outcomes
The Effect of Retatrutide Once Weekly on Cardiovascular Outcomes and Kidney Outcomes in Adults Living With Obesity (NCT06383390)
Distinction from TRIUMPH-3: TRIUMPH-Outcomes is a separate dedicated cardiovascular outcomes and kidney outcomes trial — distinct from TRIUMPH-3. While TRIUMPH-3 (NCT05882045) tests retatrutide in 1,800 patients with obesity + established CVD with a weight-loss primary endpoint, TRIUMPH-Outcomes is the large-scale event-driven trial with MACE-3 and kidney composite endpoints as primary endpoints.
Primary endpoints: MACE-3 (cardiovascular death, non-fatal MI, non-fatal stroke) plus a kidney composite endpoint. Event-driven design — trial runs until sufficient events have accrued for statistical power.
Significance: A positive result would be the strongest evidence that retatrutide reduces major adverse cardiovascular events, analogous to semaglutide’s SELECT trial (NCT03574597). This is the trial most likely to unlock a full cardiovascular risk-reduction label and Medicare coverage expansion. Source: ClinicalTrials.gov NCT06383390.
FDA Submission & Approval Timeline
| Milestone | Projected Date | Confidence | Notes |
|---|---|---|---|
| TRIUMPH-4 top-line readout | December 2025 ✓ | Confirmed | 28.7% weight loss at 68 wks |
| TRIUMPH-1 primary completion | April 2026 | Registered on CT.gov | Most critical milestone for NDA |
| Remaining TRIUMPH readouts | By end of 2026 | Lilly guidance | ~6 late-stage studies still underway |
| NDA submission to FDA | Q1–Q2 2027 | Analyst consensus | Pending TRIUMPH-1/2 readouts; not Lilly-confirmed |
| FDA Standard Review | 12 mo. from NDA | Standard process | Priority review may reduce to 6 months |
| Potential FDA approval | 2027–2028 | Analyst estimate | Not confirmed by FDA or Eli Lilly |
Program Scale: 30,000+ Enrolled (Including TRIUMPH-Outcomes)
The TRIUMPH program launched in 2023. Confirmed enrollments: TRIUMPH-1 (2,300), TRIUMPH-2 (18,558), TRIUMPH-3 (1,800), TRIUMPH-4 (445), TRIUMPH-Outcomes (~10,000), TRIUMPH-9 (600). The large TRIUMPH-Outcomes enrollment reflects the event-driven design requiring sufficient MACE events. By the end of 2026, Lilly expects readouts from multiple late-stage studies in the TRIUMPH program.
Sources
- ClinicalTrials.gov — TRIUMPH-1: NCT05929066
- ClinicalTrials.gov — TRIUMPH-2: NCT05929079
- ClinicalTrials.gov — TRIUMPH-3: NCT05882045
- ClinicalTrials.gov — TRIUMPH-4: NCT05931367
- ClinicalTrials.gov — TRIUMPH-Outcomes: NCT06383390
- ClinicalTrials.gov — TRIUMPH-9: NCT07357415
- Clinical Trials Arena — TRIUMPH-4 readout (December 2025): Lilly retatrutide data Phase III trial
- Jastreboff AM et al. "Triple–Hormone-Receptor Agonist Retatrutide for Obesity — A Phase 2 Trial." NEJM 2023. https://www.nejm.org/doi/full/10.1056/NEJMoa2301972
More Retatrutide Pages
Frequently Asked Questions
When will TRIUMPH trial results be published?
Lilly's investor presentations indicate pivotal Phase 3 readout expected in 2026–2027 for the primary obesity indication. Cardiovascular outcomes data from TRIUMPH-CV is on a longer timeline (2028+) given the duration required to accumulate cardiovascular events.
How many patients are in the TRIUMPH program?
Across the TRIUMPH-1, TRIUMPH-2, TRIUMPH-3, TRIUMPH-4, and TRIUMPH-CV trials, total enrollment is in the 8,000–10,000 patient range. This is a larger Phase 3 obesity program than was conducted for either semaglutide or tirzepatide.
What endpoints is TRIUMPH measuring?
Primary endpoints include percent body weight reduction at 68 or 72 weeks (depending on trial) and proportion of participants achieving ≥5%, ≥10%, ≥15%, ≥20%, and ≥25% weight loss. Secondary endpoints cover cardiometabolic markers, body composition, quality of life, and adverse events.
Could TRIUMPH fail to meet its primary endpoint?
Possible but unlikely given Phase 2 effect size. Phase 3 trials sometimes fail to replicate Phase 2 efficacy or surface safety signals not seen in smaller trials. The Phase 2 retatrutide data was strong enough that the principal risk is on the safety side rather than the efficacy side.
When could retatrutide actually be available for prescription?
If Phase 3 results meet primary endpoints and the FDA review proceeds normally: NDA submission late 2026 or early 2027, approval mid-to-late 2027, commercial availability late 2027 or 2028. Compounded versions may appear earlier and operate in legal gray zones.