STAT+: Lilly’s retatrutide has been offered to a single person via ‘compassionate use’ program

Eli Lilly and Company granted one individual access to its experimental obesity drug, retatrutide, through the U.S. Food and Drug Administration's (FDA) compassionate use program. This program allows patients with serious or life-threatening conditions to access investigational drugs outside of clinical trials when no comparable or satisfactory alternative therapy exists. Retatrutide, also known as LY3437844, is a triple agonist targeting glucagon, GLP-1, and GIP receptors, and has shown significant weight loss results in clinical trials. In a Phase 2 study, retatrutide achieved an average weight loss of 24% in participants over 48 weeks, a figure that surpassed the results of other leading obesity medications like semaglutide (Wegovy) and tirzepatide (Zepbound). Eli Lilly is currently conducting Phase 3 trials for retatrutide, with results anticipated in the coming years. The company has not yet submitted a New Drug Application (NDA) to the FDA for retatrutide, and its approval timeline remains uncertain. This compassionate use case offers a glimpse into the potential of retatrutide for individuals struggling with severe obesity who have not responded to existing treatments.