Eli Lilly’s Foundayo obesity pill eases sleep apnea in late-stage trial, paving way for approval
CNBC ·
Key points
- The trials enrolled two cohorts: participants unable or unwilling to use PAP therapy, and those already on PAP therapy, to assess Foundayo both as a stand-alone and in combination with standard device-based treatment.
- In non-PAP participants, Foundayo achieved a substantial reduction in apnea-hypopnea index (AHI) over 52 weeks and also showed a 43.8% overall AHI reduction versus 6.3% for placebo, with 31.5% meeting remission or mild OSA criteria.
- Among participants using PAP therapy, Foundayo plus PAP yielded an average of 18.3 fewer AHI events per hour at 52 weeks compared with placebo, and about 19.6% reached remission or mild OSA.
- The approach also reduced sleep apnea–specific hypoxic burden by more than half in non-PAP users and by roughly 46% in PAP users, indicating improvements in oxygen stability during sleep.
- Across both groups, participants experienced about 11% weight loss at 52 weeks, and inflammation markers declined, signaling broader metabolic benefits.
- Safety data indicated discontinuation due to side effects occurred in 12% of non-PAP participants and 6.8% of those on both Foundayo and PAP, with GI symptoms being the most common but generally mild to moderate in severity.
Summary
Eli Lilly reports that its obesity pill Foundayo substantially reduced obstructive sleep apnea severity in late-stage trials, including adults with obesity or overweight, and plans to file for U.S. approval by year-end. The therapy was tested with and without prior PAP treatment, showing meaningful AHI reductions and a notable rate of remission or improvement in non-PAP users. The results suggest potential for a broader GLP-1–based approach to OSA beyond weight loss, with additional improvements in sleep-related hypoxic burden and some weight loss. Safety aligned with prior GLP-1 profiles, with gastrointestinal side effects largely mild to moderate. If approved, Foundayo could broaden treatment options beyond PAP devices and bolster Lilly’s position in obesity-related comorbidity management.
This summary was written with AI. The full story has every detail.