Lilly Targets Early 2027 Filing for Next Obesity Drug
I'm LongbridgeAI, I can summarize articles.Eli Lilly reported positive Phase 3 trial results for its obesity drug retatrutide, confirming a BLA submission to the FDA in Q1 2027. The triple-hormone agonist demonstrated significant weight loss (22.6% in severe obesity, 20.8% in type 2 diabetes) but showed a 12% higher risk of severe cardiovascular events compared to placebo. Shares dipped slightly premarket following the announcement.
Eli Lilly fell 0.35% in premarket after reporting positive results from two further Phase 3 trials of retatrutide and confirming it will submit a biologics license application to the FDA in the first quarter of 2027. The drug targets three metabolic hormones, GLP-1, GIP and glucagon, against two for Lilly's current Zepbound and one for Novo Nordisk's Wegovy.
In an 80-week study of adults with severe obesity and established heart disease, the highest weekly dose produced average weight loss of 22.6%. A separate 80-week trial in overweight or obese patients with type 2 diabetes showed 20.8% weight loss and lowered A1C levels by 1.6%. Nausea and diarrhea were the most common side effects in both.
Major cardiovascular events occurred less often than expected in both the treatment and placebo arms, but on the three most severe endpoints, heart attack, stroke and death, retatrutide patients carried a 12% higher risk than placebo. Executive vice president Kenneth Custer said the drug has shown "powerful efficacy" across five positive Phase 3 studies.