Add as a preferred source on GoogleEli Lilly’s Foundayo Cuts Sleep Apnea Events in Two Phase 3 Trials
The 712-person studies found fewer breathing interruptions at week 52 with the pill than placebo, with or without positive airway pressure therapy. Lilly plans to submit the results to the FDA by year-end.
Eli Lilly plans to submit results from two late-stage Foundayo (orforglipron) trials to the U.S. Food and Drug Administration (FDA) by the end of 2026, seeking approval for adults with obesity or overweight and moderate-to-severe obstructive sleep apnea.
The daily pill met the main goal in both Phase 3 trials, Lilly said Nov. 9. The studies included 712 adults: 363 who were not using positive airway pressure (PAP) therapy and 349 who were using it.
At week 52, the average apnea-hypopnea index (AHI), which counts breathing interruptions per hour, decreased by 17.8 events per hour with Foundayo versus 4.5 with placebo in the non-PAP trial. In the PAP trial, the average declined by 17.3 events per hour with Foundayo and 5.3 with placebo. Both comparisons were statistically significant.
Foundayo is approved for weight management. Lilly’s Zepbound was the first medication approved for moderate-to-severe obstructive sleep apnea in adults with obesity, in December 2024.
John Kim
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