In an extremely odd case, a single 79-year-old patient was granted early access to Eli Lilly’s powerful, still-experimental obesity drug retatrutide through the Food and Drug Administration’s “compassionate use” program—raising immediate questions if that sole patient is President Donald Trump, according to a report by Stat News.
Lilly’s retatrutide is a highly anticipated next-generation obesity drug that targets GIP and glucagon hormones in addition to GLP-1. It is currently in late-stage trials to treat obesity, diabetes, sleep apnea, and other conditions. Data from a Phase 3 trial that Lilly released in May indicates that patients with obesity (but without diabetes) who took the drug for 80 weeks lost 28 percent of their weight, an amount comparable to bariatric surgery.
Millions of Americans with obesity are eager to get the drug, with options being limited so far to enrolling in a clinical trial or trying to obtain it by dodgy methods.
But according to a barebones public notice and Stat’s sources, a single person has been granted early access through the expanded access, aka “compassionate use” pathway, which is typically used to grant access to patients with a “serious or immediately life-threatening disease or condition” and who are not able to enroll in a clinical trial, often because they are too ill.
The access request was first made in April, when the person was 79 years old (Trump turned 80 on June 14). It was made by a senior clinician at the National Institutes of Health named Ranganath Muniyappa, who requested it on behalf of a patient with refractory obesity, obstructive sleep apnea, and pulmonary hypertension, which is high blood pressure in the lungs. Sources told Stat this patient had spent a year on tirzepatide, a drug that targets the GLP-1 and GIP hormones. But the patient had achieved only moderate weight loss on the drug.
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