Eli Lilly announced Monday that its obesity pill Foundayo significantly reduced obstructive sleep apnea severity in a late-stage trial. The company plans to file for U.S. approval by year-end for the daily pill to treat moderate-to-severe OSA in adults with obesity or who are overweight.
In the trial's first study of 363 patients not using PAP therapy, Foundayo reduced the apnea-hypopnea index (AHI) by an average of 21.1 events per hour at 52 weeks, compared with 4.8 for placebo. This represented a 43.8% overall reduction versus 6.3% for placebo. In that group, 31.5% of Foundayo users met criteria for remission or improvement to mild OSA.
The second study included 349 patients already on PAP therapy for at least three months. Those taking both Foundayo and PAP had an average of 18.3 fewer AHI events per hour at 52 weeks, compared with 5.5 for placebo. The pill produced a 27.5% overall AHI reduction in this group, with 19.6% meeting remission or mild OSA criteria.
Foundayo also reduced oxygen level drops during sleep by 55.9% in non-PAP users and 45.8% in PAP users. Patients lost roughly 11% of their body weight across groups.
Side effects were mostly gastrointestinal. About 12% of Foundayo users not on PAP discontinued due to side effects, compared with 3.8% on placebo. Among those on both treatments, 6.8% stopped due to side effects versus 0.6% on placebo.
Lilly's Zepbound became the first medication approved for OSA in December 2024. Foundayo rolled out in the U.S. in April as an obesity treatment.