Eli Lilly reports positive Phase 3 results for obesity drug retatrutide

• Eli Lilly (NYSE:LLY) reported positive topline Phase 3 results from two 80-week trials for retatrutide, an investigational triple agonist, demonstrating up to 22.6 percent body weight loss.
• In the TRIUMPH-2 trial, adults with obesity or overweight and type 2 diabetes achieved an average body weight reduction of up to 20.8 percent (49.6 lbs) and A1C reductions up to 1.6 percent.
• Management plans to complete CMC work and submit a Biologics License Application (BLA) for retatrutide to the U.S. FDA in the first quarter of 2027.

Eli Lilly (NYSE:LLY) announced positive topline Phase 3 results for its investigational triple agonist, retatrutide, from the 80-week TRIUMPH-2 and TRIUMPH-3 clinical trials.

The data showcased significant weight reduction and improvements in metabolic and cardiovascular health metrics for patients with obesity and related comorbidities.

In the TRIUMPH-2 trial, which evaluated adults with obesity or overweight and type 2 diabetes, participants received weekly doses of 4 mg, 9 mg, or 12 mg.

The treatment resulted in average body weight reductions of 12.7 percent, 19.1 percent, and 20.8 percent (up to 49.6 lbs), respectively, compared to just 4 percent for the placebo group.

Additionally, the retatrutide cohort saw A1C reductions of up to 1.6 percent, compared to a 0.2 percent reduction on placebo.

Following the announcement, the Eli Lilly share price traded near $1,151.

The TRIUMPH-3 trial focused on adults with severe obesity and established cardiovascular disease.

Patients receiving 9 mg and 12 mg weekly doses achieved profound body weight reductions of 21.6 percent and 22.6 percent (up to 55.8 lbs), respectively, compared to 3.2 percent for placebo.

The trial also demonstrated notable reductions in triglycerides, non-HDL cholesterol, systolic blood pressure, waist circumference, and hsCRP.

Regarding cardiovascular outcomes in TRIUMPH-3, Major Adverse Cardiovascular Events (MACE) were numerically described with hazard ratios for MACE-5 of 0.82 in-study and 0.73 on-treatment versus placebo.

The safety profile for retatrutide was consistent with other incretin-based therapies, with gastrointestinal events emerging as the most common adverse events, contributing to higher discontinuation rates than placebo.

The molecule remains investigational and is not currently approved for sale. Eli Lilly plans to finalize Chemistry, Manufacturing, and Controls (CMC) work before submitting a BLA to the U.S. FDA in the first quarter of 2027.