Eli Lilly has built a formal expanded access program for retatrutide, its experimental obesity drug, following weeks of physician inquiries about securing the same early access previously granted to a single patient.
“For 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,” a Lilly spokesperson told Becker’s. “We’ve built an expanded access program that does that and are actively reviewing requests from healthcare providers.”
The confirmation follows a June 23 STAT News report that a 79-year-old patient received early access to retatrutide in April through the FDA’s compassionate use pathway. STAT reported the request was filed by a senior clinician at the National Institutes of Health and drew interest from top health officials, raising questions about whether the recipient was well connected. The patient had been treated with tirzepatide, marketed as Zepbound, for a year with only moderate weight loss, according to the report.
Because of the unusual circumstances, STAT asked the White House multiple times whether the patient was President Donald Trump. White House spokesperson Kush Desai said that the application was not for the president.
Retatrutide has posted weight loss results rivaling bariatric surgery, producing up to 30.3% body weight loss at two years among trial participants with a BMI over 35, and an average 28.3% at 80 weeks among patients on the highest dose. Lilly has not yet submitted the drug for FDA approval, but plans to do so in early 2027.
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