Eli Lilly’s Foundayo obesity pill eases sleep apnea in late-stage trial, paving way for approval

Summary

• Eli Lilly reported that its obesity pill Foundayo significantly reduced the severity of obstructive sleep apnea in patients with obesity during a late-stage trial.
• The company plans to file for U.S. approval of the daily pill for moderate-to-severe obstructive sleep apnea in adults with obesity or who are overweight by the end of the year.
• Obstructive sleep apnea affects nearly 1 billion adults globally, including 80 million people ages 20 and over in the U.S., with most cases undiagnosed.
• Foundayo is one of several GLP-1 treatments showing promise for this condition, following the December 2024 U.S. approval of Lilly's injection Zepbound for the same indication.
• The trial included two independent studies: one with 363 patients unable or unwilling to use positive airway pressure therapy, and another with 349 patients continuing PAP therapy.
• Patients taking Foundayo who were not using PAP therapy experienced an average reduction of 21.1 apnea-hypopnea index events per hour at 52 weeks, compared to 4.8 for the placebo.
• In the group not using PAP therapy, Foundayo led to an overall apnea-hypopnea index reduction of 43.8% versus 6.3% for the placebo, with 31.5% of participants meeting criteria for remission or mild obstructive sleep apnea.
• Patients using both Foundayo and PAP therapy had an average reduction of 18.3 apnea-hypopnea index events per hour at 52 weeks, compared to 5.5 for the placebo.
• In the group using PAP therapy, Foundayo resulted in an overall apnea-hypopnea index reduction of approximately 27.5% versus 3% for the placebo, with 19.6% of participants meeting criteria for remission or mild obstructive sleep apnea.
• Foundayo reduced the sleep apnea-specific hypoxic burden by 55.9% in patients not using PAP therapy and by 45.8% in those using it.
• The pill helped patients lose roughly 11% of their weight across groups at 52 weeks and lowered a marker of inflammation.
• Safety data showed that 12% of patients not using PAP therapy discontinued Foundayo due to side effects, compared to 3.8% for the placebo, while 6.8% of those on Foundayo and PAP therapy discontinued versus 0.6% for the placebo.
• The most common side effects were gastrointestinal, including nausea, diarrhea, constipation, and vomiting, and were generally mild to moderate in severity.