The pharmaceutical powerhouse Eli Lilly announced Monday that it will give access to the experimental obesity drug, retatrutide, to a limited number of eligible patients before the drug is FDA approved
The company, which announced plans to build a $6.5 billion biomanufacturing plant in northeast Houston last September, said retatrutide is being studied to help with a “broad range of conditions, including difficult-to-treat obesity.”
“Obesity is a serious disease that, if left untreated, can lead to life-threatening conditions,” said Eli Lilly spokesperson Misty Fuller
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What is retatrutide?
Retatrutide is an injectable weight loss drug targeting three hormone receptors. The drug targets GIP, GLP-1 and glucagon, while Eli Lilly’s current injectable obesity drug, Zepbound, targets only GLP-1 and GIP
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Targeting the three hunger- and metabolism-regulating receptors is meant to increase the feeling of fullness and improve body fat breakdown, among other effects, according to drugs.com
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Who’s eligible?
To be eligible to take the drug before FDA approval, patients must first be unable to enroll in a clinical trial. Then, there are three more criteria. Patients must be 18 or older, have refractory obesity even while participating in the highest approved dose of obesity therapy, and be receiving care for at least two serious or life-threatening health complications that can be attributed to obesity
“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,” Fuller said. “We’ve built an expanded access program that does that and are actively reviewing requests from health care providers.”
What does it mean that it’s in a clinical trial stage?
Retatrutide is currently in Phase 3 clinical trials, meaning it is only legally available to consumers by participating in a trial. It has not yet been approved by the FDA or any regulatory agency. The trials are currently studying the drug’s effect on patients with obesity, type 2 diabetes and obstructive sleep apnea, among other health issues. The Eli Lilly website says patients should not take anything claiming to be retatrutide outside of an Eli Lilly clinical trial
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