Lilly Says Foundayo Weight-Loss Pill Eased Sleep Apnea in Late-Stage Trial

Eli Lilly says its once-daily weight-loss pill Foundayo reduced the severity of obstructive sleep apnea in a late-stage clinical program, adding to evidence that treatments for obesity may also improve sleep-related breathing problems.

The 52-week ATTAIN-OSA program included two placebo-controlled studies involving 712 adults with moderate-to-severe obstructive sleep apnea and obesity or overweight. One study enrolled people not using positive airway pressure therapy, while the other included participants who continued that treatment.

Lilly said Foundayo reduced the apnea-hypopnea index, a measure of breathing interruptions, by 43.8% in the study without positive airway pressure and by 27.5% in the study using it. In the first study, 31.5% of participants taking the drug met the criteria for remission or mild disease.

The company also reported improvements in oxygen-related measures and body weight. It said the safety profile was generally consistent with earlier trials.

Foundayo is approved in the United States for weight management, but the sleep-apnea use discussed in these results is not yet approved. Lilly plans to submit the drug for that indication to the FDA by the end of 2026.

The results were presented at the American Heart Association's Scientific Sessions and published in JAMA. The findings do not mean patients should stop prescribed sleep-apnea treatment without medical advice.