Retatrutide TRIUMPH-2 and -3, in one table
Lilly reported up to 20.8% weight loss in TRIUMPH-2 and 22.6% in TRIUMPH-3 at 80 weeks on retatrutide 12 mg. Still investigational; a BLA is planned for Q1 2027.
Key takeaways
- TRIUMPH-2 (type 2 diabetes, n = 1,152): −12.7%, −19.1%, −20.8% on 4, 9, 12 mg vs −4.0% placebo at 80 weeks.
- TRIUMPH-3 (severe obesity + cardiovascular disease, n = 1,949): −21.6% and −22.6% on 9 and 12 mg vs −3.2% placebo.
- Lilly plans to submit a Biologics License Application in Q1 2027.
- Retatrutide is not approved and, per Lilly, cannot be legally sold for human use.
On July 23, 2026, Eli Lilly announced topline results from two more Phase 3 trials of retatrutide, its investigational once-weekly agonist of the GIP, GLP-1 and glucagon receptors. Lilly says the drug has now succeeded in five Phase 3 studies.
The numbers
| Trial | Population | Dose | Mean weight change at 80 weeks |
|---|---|---|---|
| TRIUMPH-2 | Obesity/overweight + type 2 diabetes | 4 mg | −12.7% |
| TRIUMPH-2 | 9 mg | −19.1% | |
| TRIUMPH-2 | 12 mg | −20.8% | |
| TRIUMPH-2 | Placebo | −4.0% | |
| TRIUMPH-3 | BMI ≥35 + cardiovascular disease | 9 mg | −21.6% |
| TRIUMPH-3 | 12 mg | −22.6% | |
| TRIUMPH-3 | Placebo | −3.2% |
Figures are Lilly’s efficacy-estimand results. In TRIUMPH-2, A1C fell by up to 1.6 percentage points from a baseline of 7.7%.
Safety and tolerability
Gastrointestinal effects dominated. Discontinuation because of adverse events was 3.8%, 11.6% and 7.7% on 4, 9 and 12 mg in TRIUMPH-2 (placebo 4.9%), and 9.8% and 13.5% on 9 and 12 mg in TRIUMPH-3 (placebo 4.8%). Dysesthesia — an altered skin sensation — was reported in 4.5–7.3% of retatrutide participants in TRIUMPH-2 versus 0.7% on placebo.
The escalation used in the trials
Both trials started at 2 mg weekly and stepped up every four weeks. We reproduce that design, with sources, on the retatrutide 12 mg trial schedule page. It is a research protocol, not a treatment plan.
Regulatory status
Retatrutide is not approved anywhere. Lilly says it is completing its manufacturing (CMC) data package and plans to submit a BLA to the FDA in Q1 2027. Products sold online as “retatrutide” are not Lilly’s trial drug. See our retatrutide profile and tirzepatide vs retatrutide.
What the evidence does not show
- A cardiovascular benefit: TRIUMPH-3 MACE hazard ratios had confidence intervals crossing 1.
- How retatrutide compares head-to-head with tirzepatide or semaglutide.
Frequently asked questions
How much weight did people lose on retatrutide in TRIUMPH-3?
An average of 22.6% at 80 weeks on 12 mg and 21.6% on 9 mg, compared with 3.2% on placebo (efficacy estimand, per Lilly).
When could retatrutide be approved?
Lilly says it plans to submit a BLA to the FDA in Q1 2027. Approval timing would depend on FDA review.
What side effects were most common?
Diarrhea, nausea, constipation, decreased appetite and vomiting in TRIUMPH-2; dysesthesia (altered skin sensation) was also more frequent than placebo.
Sources
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