Eli Lilly’s next-generation obesity drug candidate retatrutide has produced significant weight loss and blood sugar improvements in two additional Phase 3 trials, with the company preparing to seek U.S. approval in early 2027.
In the TRIUMPH-2 and TRIUMPH-3 studies, the experimental triple hormone receptor agonist helped adults with obesity achieve substantial reductions in body weight, including patients facing some of the most challenging obesity-related conditions — type 2 diabetes and established cardiovascular disease.
Lilly said it plans to submit a Biologics License Application (BLA) for retatrutide to the U.S. Food and Drug Administration in the first quarter of 2027.
In TRIUMPH-2, adults with obesity or overweight and type 2 diabetes lost an average of up to 49.6 pounds (20.8%) after 80 weeks on the highest studied dose of retatrutide. Participants also saw A1C reductions of up to an average of 1.6 percentage points.
In TRIUMPH-3, adults with severe obesity and cardiovascular disease lost up to 55.8 pounds (22.6%) at 80 weeks, while also showing improvements in several cardiovascular risk markers.
"Across five positive Phase 3 studies, retatrutide has shown powerful efficacy, and we believe it could be an important future tool in the management of cardiometabolic health," said Kenneth Custer, executive vice president and president, Lilly Cardiometabolic Health.
"With the positive results from TRIUMPH-2 and TRIUMPH-3, we now have the clinical data package to support global submissions for retatrutide as a potential treatment for obesity, knee osteoarthritis pain, and obstructive sleep apnea. We look forward to working with regulators as they evaluate this first-of-its-kind medicine."
Lilly reported that major adverse cardiovascular events occurred less frequently than expected in both the retatrutide and placebo groups. In the pre-specified analysis of MACE-5 events — including all-cause death, heart attack, stroke, heart failure events and coronary revascularization — the hazard ratio was 0.82 for retatrutide compared with placebo.
