Eli Lilly plans FDA submission for retatrutide weight-loss drug in 2027
(NewsNation) — Eli Lilly says it now plans to seek FDA approval in early 2027 for its next-generation weight-loss drug, retatrutide, following positive results from two late-stage clinical trials.
The drugmaker had previously indicated it could submit an application as early as 2026 for the weekly injectable treatment. According to Lilly, retatrutide works differently from other weight-loss medications currently on the market.
In two Phase 3 trials, retatrutide produced significant weight loss and improvements in blood sugar control among adults with obesity and major related health conditions, including Type 2 diabetes and cardiovascular disease.
In the first trial, adults with obesity and Type 2 diabetes lost an average of up to 20.8% of their body weight, or nearly 50 pounds, after 80 weeks of treatment.
In the second trial, adults with severe obesity and established cardiovascular disease, with or without diabetes, lost an average of up to 22.6% of their body weight, or 55.8 pounds, after 80 weeks.
“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,” Kenneth Custer, executive vice president and president of Lilly Cardiometabolic Health, said in a statement.
“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,” Custer added.
Dubbed a “triple G” drug, retatrutide targets GLP-1, GIP and glucagon receptors, unlike existing treatments that target one or two of those pathways.


