Eli Lilly’s Foundayo, approved in the United States for weight management, reduced nighttime breathing interruptions in adults with obstructive sleep apnea in two 52-week trials, supporting the company’s plan to seek approval for that additional use.
The study tested orforglipron in an investigational capsule formulation, with doses equivalent to the approved Foundayo tablets, according to results published Monday, Nov. 9, in JAMA. The trials enrolled 712 adults with moderate to severe sleep apnea and obesity or overweight. Of those, 363 did not use positive airway pressure (PAP) therapy and 349 did. Foundayo refers to the drug in the results below.
In the trial without PAP, the primary analysis showed an average decrease of 17.8 breathing interruptions per hour among participants assigned Foundayo, compared with 4.5 per hour for those given a placebo. In the PAP group, the corresponding decreases were 17.3 and 5.3 per hour. PAP users stopped therapy for seven days before each required sleep assessment. The devices help keep airways open during sleep.
Digestive adverse events affected 68.0% of Foundayo recipients in the trial without PAP and 70.6% in the PAP trial. The rates among placebo recipients were 37.4% and 36.6%. Adverse events led 12.2% and 6.8% of Foundayo recipients in the two trials to stop treatment, compared with 3.8% and 0.6% of those given placebo.
The U.S. Food and Drug Administration (FDA) authorized Foundayo for weight management in April 2026. In December 2024, the FDA approved Lilly’s injected Zepbound for moderate to severe sleep apnea in adults with obesity, its first medication approval for the condition.
The study authors said weight loss probably contributed to the improvement, but the mechanism remains uncertain. The trials did not establish whether Foundayo prevents heart attacks or strokes. In a treatment-regimen analysis, researchers found no statistically significant difference in a pooled patient-reported measure of sleep-related impairment; a separate analysis assuming all participants remained on treatment found a significant difference. Lilly funded the studies and participated in their design, conduct and analysis. The company said it plans to submit an application to the FDA for the sleep apnea use by the end of 2026.
