Eli Lilly Foundayo Obesity Pill Cuts Sleep Apnea Disruptions by 44% in Phase 3 Trial Ahead of FDA Filing

Eli Lilly reported positive Phase 3 results for Foundayo, its once-daily oral GLP-1 drug, showing significant reductions in breathing disruptions for adults with moderate-to-severe obstructive sleep apnea who are also obese or overweight. The company said it plans to submit Foundayo to the FDA for the sleep apnea indication by the end of 2026.

After 52 weeks of treatment in patients not using PAP therapy, breathing interruptions fell 43.8% compared with 6.3% on placebo, and about 31.5% of patients achieved remission or mild disease. Among patients who were using PAP therapy, breathing interruptions dropped 27.5% versus 3.0% on placebo, with 19.6% reaching remission or mild disease.

Beyond sleep apnea, the trial showed broad secondary benefits. Foundayo reduced the sleep apnea-related hypoxic burden, a measure of oxygen deprivation during sleep, by 55.9% in patients not on PAP therapy and by 45.8% in those using it. Patients also lost approximately 11% of their body weight on average, and blood pressure and inflammation markers improved. Gastrointestinal side effects were the most common adverse events reported.