Lilly's triple-agonist retatrutide hits in two more Phase 3 trials

Retatrutide met primary endpoints in Phase 3 TRIUMPH-2 and TRIUMPH-3, with up to 22.6% weight loss. The triple agonist is investigational, not FDA-approved.

Published July 23, 2026·injector.world Editorial Team
Quick answer

Eli Lilly's investigational triple agonist retatrutide met its primary endpoints in two more Phase 3 trials. TRIUMPH-2 cut body weight up to 20.8 percent in adults with type 2 diabetes, and TRIUMPH-3 cut it up to 22.6 percent in obesity with cardiovascular disease. Retatrutide is not FDA-approved; Lilly plans a 2027 filing.

At a glance
  • TRIUMPH-2 (type 2 diabetes, 1,152 adults): up to 20.8 percent weight loss at 80 weeks versus 4.0 percent on placebo.
  • TRIUMPH-3 (severe obesity plus cardiovascular disease, 1,949 adults): up to 22.6 percent weight loss versus 3.2 percent on placebo.
  • Retatrutide is a triple agonist targeting GIP, GLP-1, and glucagon receptors, given as a once-weekly injection.
  • A1C fell by up to 1.6 percentage points in TRIUMPH-2; side effects were mostly gastrointestinal.
  • Retatrutide is investigational and NOT FDA-approved for any indication.
  • Lilly plans a Biologics License Application to the FDA in the first quarter of 2027.

On July 23, 2026, Eli Lilly reported that retatrutide, its once-weekly investigational triple agonist, succeeded in two more Phase 3 studies. TRIUMPH-2 enrolled adults with type 2 diabetes and obesity or overweight, while TRIUMPH-3 enrolled adults with severe obesity and established cardiovascular disease. Both trials met their primary weight-loss endpoints at 80 weeks. Retatrutide is not approved by the FDA for any use; it remains investigational and is available only through clinical trials.

What happened

In TRIUMPH-2, which enrolled 1,152 adults with type 2 diabetes, participants taking retatrutide lost an average of 12.7 percent (4 mg), 19.1 percent (9 mg), and 20.8 percent (12 mg) of body weight at 80 weeks, versus 4.0 percent on placebo. That translates to roughly 49.6 pounds at the highest dose. A1C, a measure of blood sugar, fell by up to 1.6 percentage points versus 0.2 for placebo.

TRIUMPH-3 enrolled 1,949 adults with a body mass index of 35 or higher and established cardiovascular disease. Participants lost an average of 21.6 percent (9 mg) and 22.6 percent (12 mg) of body weight at 80 weeks, about 55.8 pounds at the top dose, versus 3.2 percent on placebo. Lilly reported these as topline results, and full detailed data have not yet been published.

Why it matters

Retatrutide is a single-molecule drug that activates three gut and metabolic hormone pathways at once: GIP, GLP-1, and glucagon. Approved incretin drugs act on fewer targets. Semaglutide (Wegovy, Ozempic) is a single GLP-1 agonist, and tirzepatide (Zepbound, Mounjaro) is a dual GIP and GLP-1 agonist. Adding glucagon is intended to raise energy expenditure alongside appetite reduction.

With TRIUMPH-2 and TRIUMPH-3, retatrutide adds two more positive readouts to its Phase 3 program. The results extend its data into two harder-to-treat groups: people with type 2 diabetes, where weight loss is typically blunted, and people with obesity plus known heart disease. Even so, none of this changes its status: retatrutide is investigational and not FDA-approved, and these are company-reported topline figures, not peer-reviewed publications.

What to watch

Lilly says it plans to submit a Biologics License Application to the FDA in the first quarter of 2027, so any potential approval would come later. The most common side effects across the program were gastrointestinal, including diarrhea, nausea, and constipation, consistent with other incretin drugs; discontinuation rates due to adverse events ranged from about 3.8 to 13.5 percent on retatrutide versus roughly 4.9 percent on placebo.

TRIUMPH-3 also tracked cardiovascular outcomes in people with established heart disease. The trial was not designed to prove a reduction in major adverse cardiac events, and pre-specified analyses of those events did not reach statistical significance. Consumers should also note that any product sold online as retatrutide is unapproved and unverified, and no one should start, stop, or change treatment based on trial headlines.

Frequently asked questions

Is retatrutide FDA-approved?
No. Retatrutide is investigational and not approved by the FDA for weight loss, diabetes, or any other use. It is available only through clinical trials. Eli Lilly plans to file for approval in the first quarter of 2027, so any decision would come after that.
How much weight did people lose in the new trials?
In TRIUMPH-2, adults with type 2 diabetes lost up to 20.8 percent of body weight at 80 weeks. In TRIUMPH-3, adults with severe obesity and cardiovascular disease lost up to 22.6 percent. Both figures are company-reported topline results at the highest 12 mg dose.
How is retatrutide different from Ozempic or Mounjaro?
Semaglutide (Ozempic, Wegovy) targets one receptor, GLP-1. Tirzepatide (Mounjaro, Zepbound) targets two, GIP and GLP-1. Retatrutide targets three by adding glucagon. All are prescription drugs except retatrutide, which is not yet FDA-approved.
What are the main side effects of retatrutide?
The most common side effects reported in the trials were gastrointestinal, including diarrhea, nausea, and constipation, similar to other GLP-1 based medicines. Discontinuation due to side effects ranged from roughly 3.8 to 13.5 percent depending on dose. Full safety data are pending peer review.