Lilly announces more next-gen obesity drug data, plans Q1 2027 FDA application

Eli Lilly on Thursday said two more Phase 3 trials of its experimental obesity drug retatrutide showed positive results and it plans to submit an application to the U.S. Food and Drug Administration in the first quarter of next year. Retatrutide is designed to target three different metabolic hormones: GLP-1, GIP and glucagon. The company's current injectable obesity drug, Zepbound, targets GLP-1 and GIP, while rival Novo Nordisk's Wegovy targets just GLP-1. Lilly said an 80-week trial of adults with severe obesity and established heart disease showed average weight loss of 22.6% for the highest weekly dose of retatrutide. The company said major cardiovascular events occurred less frequently than expected in both the treatment and placebo groups. But when measuring just the three most severe events - heart attack, stroke and death - patients on retatrutide had a 12% higher risk than the placebo group. A different 80-week trial of overweight or obese patients who also had type 2 diabetes showed that participants given the highest dose lost 20.8% of their body weight and lowered A1C levels by 1.6%. The most common side effects in both trials were nausea and diarrhea. Lilly had previously announced that patients with obesity but not diabetes lost an average of 28.3% of their weight in an 80-week trial of retatrutide. Positive results were also seen in Phase 3 studies of the drug's impact on knee osteoarthritis pain and obstructive sleep apnea. "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,” Lilly Executive Vice President Kenneth Custer said in a statement. Lilly said it plans to submit a biologics license application for retatrutide to the FDA in the first quarter of next year. The company also said full results of the latest trials will be published in medical journals at a later date.