Eli Lilly reported that Foundayo, its obesity pill approved for use in the U.S. in April, demonstrated significant clinical benefits for patients with obstructive sleep apnea in a late-stage trial. The company intends to submit findings to the FDA by the end of the year seeking approval for treating moderate-to-severe obstructive sleep apnea in adults with obesity or who are overweight.
Obstructive sleep apnea refers to breathing interruptions during sleep caused by narrowed or blocked airways, leading to oxygen drops and blood pressure increases associated with serious health complications including hypertension, heart failure, and stroke. The condition affects approximately 1 billion adults globally, including 80 million people ages 20 and over in the United States, though most remain undiagnosed. Treatment options are currently limited, with many patients relying on positive airway pressure machines, commonly known as PAP devices.
The trial evaluated Foundayo across two independent studies involving patients with different treatment backgrounds. One study included 363 patients unable or unwilling to use PAP therapy, while the second enrolled 349 individuals already using PAP therapy for at least three months. Researchers measured the apnea-hypopnea index, which records breathing-restricted or blocked airway events per hour, to assess treatment effectiveness.
Patients not using PAP therapy who took Foundayo experienced an average reduction of 21.1 apnea-hypopnea index events per hour at 52 weeks, compared to 4.8 per hour with placebo. Overall reduction reached 43.8% compared to 6.3% for placebo, with 31.5% of participants achieving remission or improvement to mild sleep apnea. For patients combining Foundayo with PAP therapy, the medication produced an average reduction of 18.3 events per hour versus 5.5 for placebo, with an overall reduction of approximately 27.5% compared to 3% for placebo. The medication also reduced oxygen deprivation during sleep and contributed to weight loss of approximately 11% across groups.
Common side effects included gastrointestinal issues such as nausea, diarrhea, constipation, and vomiting, generally mild to moderate in severity. Discontinuation rates due to adverse effects were higher for Foundayo compared to placebo across both study groups, though safety profiles remained consistent with previous trials of the medication.
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