New clinical trial shows daily GLP-1 pill significantly improves sleep apnea
Foundayo, a daily pill, successfully reduced obstructive sleep apnea, according to clinical trial data
By Mary Randolph edited by Claire Cameron
Eli Lilly will submit Foundayo to the FDA as a sleep apnea treatment before the end of the year. Tada Images/Shutterstock
Foundayo, an oral antiobesity pill, significantly improved obstructive sleep apnea, according to new clinical trial data. The results signal the potential uses of the GLP-1 (glucagonlike peptide 1) drug beyond weight loss.
Foundayo is the brand name for the drug orforglipron, which is made by Eli Lilly. It was approved for treating obesity by the Food and Drug Administration in April. At the same time, the pharmaceutical company has been probing the drug’s potential to treat other obesity-related conditions, including obstructive sleep apnea. The condition is characterized by pauses in air flow to the lungs during sleep that are longer than 10 seconds; it can cause loud snoring, choking, sleep deprivation, headaches and other symptoms. Globally, as many as 936 million adults are estimated to experience the condition, although most are never formally diagnosed.
Because it causes drops in oxygen, obstructive sleep apnea can also increase the risks of heart problems. That suggests treatment with Foundayo may also have cardiovascular health benefits, says Daniel Drucker, an endocrinologist at the Lunenfeld-Tanenbaum Research Institute in Ontario. Drucker was not involved with the new trial but has previously worked as a consultant for Eli Lilly.
“Every time we tinker with the GLP-1 backbone, the question of overall safety and cardiovascular safety resurfaces,” he says.
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“We know there’s a two-way relationship between sleep and cardiovascular health, and the repeated drops in oxygen that happen with obstructive sleep apnea can strain blood pressure and the heart over time,” said study co-author Vaishnavi Kundel, an associate professor of medicine at the Icahn School of Medicine at Mount Sinai, who has also consulted for Eli Lilly, in a statement. “Foundayo significantly reduced breathing interruptions and drops in oxygen during sleep, while also improving blood pressure and inflammation.”
In the new clinical trial results, published today in the Journal of the American Medical Association, after 52 weeks, the drug reduced the severity of sleep apnea by 43.8 percent in participants who were clinically classified as being overweight or having obesity and did not use a positive airway pressure (PAP) machine—such devices are commonly employed to treat sleep apnea. The GLP-1 pill reduced severity of sleep apnea symptoms by 27.5 percent in participants who were overweight or had obesity who did use a PAP machine. Both groups also lost around 28 pounds of weight on average over the course of the study.
The results add to other evidence suggesting that Eli Lilly’s injectable GLP-1 medications may improve obstructive sleep apnea, too, Drucker says. “If approved, orforglipron may represent a new option for individuals preferring once-daily administration of a GLP-1 medicine for treatment of [obstructive sleep apnea],” he adds.
Eli Lilly plans to submit the drug for FDA review for the treatment moderate to severe obstructive sleep apnea in adults who are overweight or have obesity by the end of the year, according to a company statement.
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