Eli Lilly announced a controlled early access pathway on Monday that will allow a limited group of patients to receive its investigational obesity drug, retatrutide, before formal approval by the U.S. Food and Drug Administration.
A company spokesperson said the program targets "a limited number of patients who meet specific medical criteria and cannot enroll in a clinical trial, we believe it is medically appropriate to make authentic retatrutide available before FDA approval, consistent with FDA’s guidance." The spokesperson added that Lilly has developed an expanded access program to implement that approach and that it is actively reviewing requests submitted by health care providers.
The eligibility requirements specified by Lilly limit access to adults aged 18 or older who continue to have refractory obesity despite tolerating the highest approved dose of an existing obesity therapy. In addition, qualifying patients must have at least two serious or life-threatening complications related to obesity for which they are receiving medical care. Candidates must also be unable to take part in any ongoing clinical trial of retatrutide or a comparable investigational treatment.
Media reporting initially identified the existence of the expanded access program. That reporting also noted that Lilly had previously granted a single special access request for retatrutide to a 79-year-old patient.
Retatrutide is designed to engage three metabolic hormone pathways - GLP-1, GIP and glucagon - distinguishing it from Lilly’s current injectable obesity product, Zepbound, which targets GLP-1 and GIP. In July, Lilly reported results from an 80-week clinical trial involving adults with severe obesity and established heart disease. The company said the highest weekly dose of retatrutide in that trial produced an average weight loss of 22.6%.
Lilly plans to submit an application for FDA approval of retatrutide in the first quarter of next year. Meanwhile, the expanded access program provides a constrained route for certain patients to obtain the therapy ahead of that regulatory decision.
The program’s limits - both in patient numbers and in strict eligibility criteria - mean access will remain narrowly targeted while the company proceeds toward a formal regulatory filing. Lilly is processing requests from clinicians as it moves toward potential market authorization.