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
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