Eli Lilly established an expanded access program for its experimental obesity drug, retatrutide, ahead of potential FDA approval. This program provides the medication to a limited number of patients with severe, treatment-resistant obesity who do not qualify for clinical trials. The decision follows significant public interest after a single patient previously received the drug through a compassionate use pathway.
To qualify, patients must be over 18 and have refractory obesity. Candidates must also present at least two serious weight-related health complications. Eli Lilly plans to file for formal FDA approval in early 2027.
Retatrutide is a triple-agonist drug targeting GLP-1, GIP, and glucagon metabolic hormones. This distinguishes the treatment from Lilly’s current Zepbound product, which targets two hormones. In clinical trials, some patients using retatrutide lost more than 22% of their body weight.