Eli Lilly's retatrutide shows positive Phase 3 results, plans Q1 2027 FDA application

Jul 23, 2026

Eli Lilly announced positive Phase 3 results for its next-generation obesity drug, retatrutide, showing up to 22.6% weight loss in patients with severe obesity and heart disease. The company plans a Q1 2027 FDA submission. However, the data also raised questions about cardiovascular safety, showing no significant benefit and a slightly higher risk of severe heart events in one analysis.

Retatrutide Phase 3 trial results

▪In an 80-week Phase 3 trial, adults with severe obesity and established heart disease lost an average of 22.6% of their weight on the highest dose of retatrutide.
▪Eli Lilly also reported positive Phase 3 results for retatrutide's impact on knee osteoarthritis pain and obstructive sleep apnea.
▪In a separate 80-week trial, overweight or obese patients with type 2 diabetes lost 20.8% of their body weight on the highest dose of retatrutide.
▪Eli Lilly plans to submit a biologics license application for retatrutide to the U.S. FDA in the first quarter of 2027.

Competitive obesity drug landscape

▪Eli Lilly's current obesity drug, Zepbound, targets two hormones (GLP-1 and GIP), while rival Novo Nordisk's Wegovy targets one (GLP-1).
▪Analysts said the data reinforced retatrutide's best-in-class weight-loss potential, though high expectations were already priced in.
▪Retatrutide is designed to target three metabolic hormones: GLP-1, GIP, and glucagon.

Cardiovascular safety signal concerns

▪The trial showed no statistically significant lower risk of major cardiovascular events for patients on retatrutide compared to placebo.
▪When measuring only heart attack, stroke, and death, patients on retatrutide had a 12% higher risk than the placebo group in the safety trial.
▪A cardiovascular safety trial in nearly 2,000 people with obesity and heart disease was not powered to study cardiovascular outcomes.
▪Earlier studies of retatrutide had raised questions about a possible increase in heart rhythm abnormalities.