Eli Lilly will provide limited early access to its experimental obesity drug, retatrutide, to eligible patients before U.S. FDA approval. The drug targets three metabolic hormones and showed significant weight loss in trials.
This move provides a potential treatment option for patients with severe obesity who have exhausted other therapeutic avenues, while also signaling Eli Lilly's confidence in retatrutide's efficacy ahead of regulatory review.
Eli Lilly announced it will offer a limited number of eligible patients early access to its experimental obesity drug, retatrutide, before it receives U.S. Food and Drug Administration (FDA) approval. The company stated this decision is consistent with FDA guidance for patients with specific medical criteria who cannot enroll in clinical trials.
To qualify for the expanded access program, patients must be 18 years or older, have refractory obesity despite tolerating the highest approved dose of obesity therapy, and have at least two serious or life-threatening obesity-related complications. They must also be unable to participate in an ongoing clinical trial for retatrutide or a similar investigational treatment.
Retatrutide is designed to target three metabolic hormones: GLP-1, GIP, and glucagon. Eli Lilly's current obesity drug, Zepbound, targets GLP-1 and GIP. In a July announcement, the company reported that an 80-week trial involving adults with severe obesity and established heart disease showed an average weight loss of 22.6% with the highest weekly dose of retatrutide.
The company intends to submit retatrutide for FDA approval in the first quarter of next year. STAT News was the first to report on the expanded access program.