Retatrutide Clinical Trials: Results & How to Enroll
TRIUMPH-1 Phase 2 full breakdown, ongoing Phase 3 trial design, NCT numbers, enrollment eligibility, and FDA approval timeline analysis.
Trial Status Dashboard
TRIUMPH-1
TRIUMPH-3
TRIUMPH-CVOT
TRIUMPH-1 Deep Dive: What the Data Shows
Study Population
TRIUMPH-1 enrolled adults aged 18 years and older with a body mass index (BMI) of 30–50 kg/m² who did not have type 2 diabetes. Key exclusion criteria included prior GLP-1 receptor agonist use within 6 months, bariatric surgery within 2 years, and significant cardiovascular events within 6 months. The population was intentionally non-diabetic to isolate the drug's obesity-specific effects from glucose-lowering effects.
The Six Treatment Arms
| Arm | Final Dose | Mean Weight Loss at 48 Weeks | vs Placebo |
|---|---|---|---|
| Placebo | Placebo | -2.1% | — |
| Retatrutide 1mg | 1mg | -7.5% | +5.4% additional |
| Retatrutide 4mg | 4mg | -13.7% | +11.6% additional |
| Retatrutide 8mg | 8mg | -17.3% | +15.2% additional |
| Retatrutide 12mg | 12mg | -22.8% | +20.7% additional |
| Retatrutide 24mg | 24mg | -24.2% | +22.1% additional |
Why Did 24mg Outperform 12mg?
The additional 1.4 percentage points between 12mg (22.8%) and 24mg (24.2%) reflect dose-dependent receptor saturation dynamics. At higher doses, glucagon receptor occupancy increases disproportionately, driving additional thermogenesis. The titration protocol for the 24mg arm also ran longer — participants spent more weeks at the therapeutic dose before the 48-week endpoint, allowing more cumulative weight loss. Phase 3 trials will clarify whether this difference holds in larger populations.
Safety Data from TRIUMPH-1
The most common adverse events were gastrointestinal: nausea, vomiting, diarrhea, and decreased appetite — consistent with the GLP-1 class. These occurred most frequently during dose titration and diminished after reaching stable dose. Discontinuation due to GI events was higher in the 24mg arm than lower dose arms, but the majority of participants completed the trial. No unexpected safety signals emerged in Phase 2.
TRIUMPH-3: The Phase 3 Trial
TRIUMPH-3 (NCT05703841) is the pivotal Phase 3 trial Eli Lilly needs to support an FDA New Drug Application for retatrutide. It differs from TRIUMPH-1 in several important ways:
TRIUMPH-CVOT: Why a Cardiovascular Trial Matters
The FDA now requires cardiovascular outcomes trials (CVOTs) for new obesity drugs. TRIUMPH-CVOT (NCT05882045) enrolls high-cardiovascular-risk patients with obesity and tracks major adverse cardiovascular events (MACE) as the primary endpoint.
A positive CVOT dramatically changes the commercial picture. Semaglutide's SELECT trial (2023) showed 20% MACE reduction in obese patients without diabetes — this expanded Wegovy's indicated population to include cardiovascular risk patients and triggered Medicare Part D coverage. If retatrutide achieves similar results, it would be prescribed to millions of patients who currently cannot afford or access GLP-class drugs.
How to Enroll in an Active Retatrutide Trial
General Eligibility Checklist
- ✓ BMI ≥30, or ≥27 with hypertension/dyslipidemia
- ✓ No GLP-1 drug use in past 6 months
- ✓ Stable weight for 3+ months prior
- ✓ No diabetes requiring insulin
- ✓ No recent bariatric surgery (typically 2 years)
- ✗ History of MTC or MEN2 syndrome
- ✗ Active or recent pancreatitis
- ✗ Pregnant or planning pregnancy
- ✗ Severe kidney disease
- ✗ Significant cardiovascular event in past 6 months
What Trial Participation Involves
| Aspect | Typical Requirements |
|---|---|
| Study drug | Free — provided at no cost to participants |
| Study visits | Regular clinic visits (typically every 4–8 weeks) for assessments, labs, weight checks |
| Duration commitment | 12+ months for Phase 3 trials |
| Compensation | Varies by site — many reimburse travel expenses, some provide additional stipends |
| Randomization | Some participants receive placebo — you may not receive active drug |
| Monitoring | Frequent lab work, vital signs, potentially ECG and imaging |
Timeline to FDA Approval
Frequently Asked Questions
What is the NCT number for the main retatrutide trial?
TRIUMPH-1 (Phase 2, completed) has NCT ID: NCT04867785. TRIUMPH-3 (Phase 3, enrolling) is NCT05703841. TRIUMPH-CVOT (Phase 3) is NCT05882045. You can look up current enrollment status at ClinicalTrials.gov.
Where was TRIUMPH-1 published?
TRIUMPH-1 results were published in the New England Journal of Medicine on September 21, 2023 (DOI: 10.1056/NEJMoa2301972). The trial was sponsored by Eli Lilly and Company. The publication reported 24.2% mean weight loss at 24mg over 48 weeks in 338 participants.
How is TRIUMPH-3 different from TRIUMPH-1?
TRIUMPH-1 was a Phase 2 trial (N=338) designed to establish dose-response relationships and safety signals. TRIUMPH-3 is a Phase 3 trial with a larger population (broader BMI range, including those with comorbidities like hypertension), longer duration, and co-primary endpoints that include cardiovascular secondary outcomes. Phase 3 data will support the FDA New Drug Application.
Can I enroll in a retatrutide trial right now?
As of 2026, TRIUMPH-3 (NCT05703841) is actively enrolling. Eligibility typically requires: BMI ≥30, or BMI ≥27 with at least one weight-related comorbidity (hypertension, dyslipidemia, etc.), no prior GLP-1 drug use within 6 months, no type 2 diabetes requiring insulin, and stable body weight for preceding 3 months. Visit ClinicalTrials.gov and search NCT05703841 to find enrolling sites and verify current eligibility criteria.
What is the TRIUMPH-CVOT trial?
TRIUMPH-CVOT (NCT05882045) is a Phase 3 cardiovascular outcomes trial enrolling patients with obesity and high cardiovascular risk. The primary endpoint is major adverse cardiovascular events (MACE — heart attack, stroke, CV death). This type of trial is now required by the FDA for obesity drugs. Positive CVOT data, as seen with semaglutide (SELECT trial), dramatically expands the indicated population and reimbursement coverage.
References & Sources
- [1]Jastreboff AM, et al. Triple-Hormone-Receptor Agonist Retatrutide for Obesity — A Phase 2 Trial. N Engl J Med. 2023;389:514–526.
- [2]ClinicalTrials.gov NCT04867785 — TRIUMPH-1 (Phase 2, completed)
- [3]ClinicalTrials.gov NCT05703841 — TRIUMPH-3 (Phase 3, enrolling)
- [4]ClinicalTrials.gov NCT05882045 — TRIUMPH-CVOT (Phase 3 cardiovascular outcomes)
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