Retatrutide Clinical Trials Tracker
This tracker provides the latest information on all retatrutide clinical trials as of April 2026. The TRIUMPH Phase 3 program represents the largest clinical development effort for the triple agonist, with results that will determine FDA approval timing (Jastreboff et al., NEJM 2023).
Medical Disclaimer: This article is for informational purposes only. Retatrutide is an investigational drug not yet approved by the FDA. Trial information is based on publicly available data from ClinicalTrials.gov and Eli Lilly press releases.
TRIUMPH Phase 3 Program Overview
| Trial | Population | Enrollment | Status | Expected Results |
|---|---|---|---|---|
| TRIUMPH-1 | Obesity (BMI 30+ or 27+ with comorbidity) | ~2,000+ | Enrolling/Active | 2026-2027 |
| TRIUMPH-2 | Type 2 diabetes | ~1,500+ | Enrolling/Active | 2026-2027 |
| TRIUMPH-3 | MASH (liver disease) | TBD | Planning/Early enrollment | 2027+ |
| TRIUMPH-4 | Long-term safety/extension | TBD | Planned | Ongoing |
Completed Trials
Phase 2 Obesity Trial (Published)
Results: 24.2% weight loss at 12mg over 48 weeks. Published in NEJM, July 2023. 338 participants. Weight loss curves had not plateaued, suggesting potential for greater loss with longer treatment.
Phase 2 Diabetes Trial (Published)
Results: Significant HbA1c reductions and weight loss in type 2 diabetes. Published 2023. Demonstrated glycemic efficacy alongside weight loss.
What Phase 3 Will Tell Us
- Efficacy confirmation: Does the 24% weight loss replicate in larger, more diverse populations?
- Long-term safety: Side effect profile over 52-72 weeks in thousands of patients
- MASH histology: Does retatrutide improve liver biopsy findings in MASH patients?
- Cardiovascular outcomes: Potential CV benefit data (may require separate CVOT)
- Special populations: Safety in elderly, kidney disease, diverse ethnic groups
Projected FDA Timeline
| Milestone | Estimated Timing |
|---|---|
| Phase 3 topline results | Late 2026 - Early 2027 |
| FDA submission (NDA) | 2027 |
| FDA review (standard: 10-12 months) | 2027-2028 |
| Potential FDA approval | Late 2027 - 2028 |
| Market availability | Within months of approval |
Timelines are estimates and subject to change based on trial outcomes and FDA review.
GLP-1 Treatment Available Today
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Frequently Asked Questions
Can I join a retatrutide clinical trial?
Check ClinicalTrials.gov for active enrollment sites near you. Eligibility criteria include BMI requirements, age limits, and specific health conditions. Trial participation provides free medication and medical monitoring.
When will retatrutide be approved?
The earliest realistic approval date is late 2027, depending on Phase 3 results and FDA review timeline. Priority review designation could accelerate this by several months.
Will Phase 3 results match Phase 2?
Phase 3 results may differ slightly from Phase 2 due to larger, more diverse populations and potentially different trial designs. However, dramatic weight loss in the 20%+ range is expected based on the Phase 2 signal.
What if Phase 3 trials fail?
Given the dramatic Phase 2 results, outright failure is unlikely. More realistic concerns include side effects that appear in larger populations or a narrower approved indication than hoped. The weight loss efficacy signal is strong.
More on Retatrutide
Sources & References
- Wilding JPH et al. Once-Weekly Semaglutide in Adults with Overweight or Obesity. NEJM 2021;384:989-1002.
- Jastreboff AM et al. Tirzepatide Once Weekly for the Treatment of Obesity. NEJM 2022;387:205-216.
- Lincoff AM et al. Semaglutide and Cardiovascular Outcomes in Obesity without Diabetes. NEJM 2023;389:2221-2232.
- FDA Prescribing Information for Wegovy (semaglutide) and Zepbound (tirzepatide).