Eli Lilly's Foundayo cuts sleep apnea events up to 43.8% in trials

Eli Lilly said Monday its obesity pill Foundayo cut the number of breathing interruptions during sleep by as much as 43.8% in a late-stage program in adults with moderate-to-severe obstructive sleep apnea and excess weight, and the company plans to ask the Food and Drug Administration to approve it for the condition by the end of the year.

Approval would give Lilly a daily pill for a disorder that affects nearly 1 billion adults worldwide, most of them undiagnosed, and that many patients now manage with cumbersome positive airway pressure machines. Lilly's injectable Zepbound became the first drug approved for sleep apnea in December 2024.

The program ran two studies over 52 weeks. In 363 patients who could not or would not use a breathing machine, Foundayo cut apnea and hypopnea events by an average of 21.1 an hour, a 43.8% reduction, compared with 4.8 events for placebo, CNBC reported. About 31.5% of those patients reached remission or mild disease.

In a second study of 349 patients who kept using their machines, the pill cut events by 18.3 an hour, or 27.5%, against 5.5 for placebo. The results were presented at the American Heart Association's Scientific Sessions in Chicago and published in JAMA.

The pill also reduced how deeply and how long oxygen levels fell during sleep, by 55.9% in patients off the machines and 45.8% in those on them. Patients lost roughly 11% of their body weight.

“A convenient daily pill may help expand access to treatment for sleep apnea,” said Vaishnavi Kundel, the study's presenting author, in a statement from the heart association.

Side effects were mostly gastrointestinal and mild to moderate. About 12% of Foundayo patients not using a machine stopped treatment because of side effects, compared with 3.8% on placebo. Lilly said it will submit the results to the FDA by the end of the year.