Eli Lilly announced Monday that a limited number of patients can apply for early access to its experimental weight-loss drug, retatrutide, prior to its anticipated FDA approval. The move comes as concerns grow over a black market for the drug, which has shown significant weight loss in clinical trials.
The pharmaceutical company is making authentic retatrutide available through an expanded access program for patients who meet specific medical criteria and cannot enroll in a clinical trial. To be eligible, patients must be 18 or older, have obesity that has not responded to the highest approved doses of other weight-loss medications they can safely take, and have at least two serious obesity-related health conditions.
Retatrutide, nicknamed 'exercise in a jab' and sometimes referred to as 'Godzilla,' is a triple agonist, targeting three hormone receptors to aid in weight loss. This is a more complex mechanism than Ozempic, which targets one receptor, and Mounjaro, which targets two.
"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 STAT News. The company is actively reviewing requests from healthcare providers for this program.
Eli Lilly is currently in the third phase of clinical trials for retatrutide, investigating its effectiveness for obesity, type 2 diabetes, knee osteoarthritis pain, and sleep apnea. Early results published on July 23 indicated that adults with severe obesity and heart disease lost an average of 55.8 pounds after 80 weeks. Phase two results in 2023 showed patients with obesity and type 2 diabetes lost up to 49.6 pounds over the same period.
The company plans to file for FDA approval of retatrutide in the first quarter of 2027. This offering of early access follows a single-patient request granted through the FDA's 'compassionate use' program to a 79-year-old man with severe obesity, obstructive sleep apnea, and pulmonary hypertension. While some speculated the patient could be former President Trump, a White House spokesperson denied this.
Health officials and Eli Lilly have issued warnings about unapproved versions of retatrutide, often sourced online and sold through influencers or beauty clinics, particularly from China. These unauthorized products may pose serious health risks, and their actual contents and purity are unknown. The FDA has issued warning letters to sellers of unapproved drugs marketed without clearance in the U.S. A British woman reportedly suffered a near-fatal incident after injecting herself with a weight-loss drug bought online, which was later identified as a synthetic version of insulin.