The Investor
09 Nov 2026, 19:28
Lilly’s Foundayo Cuts Sleep Apnea Severity in Phase 3, Supporting FDA Filing
Eli Lilly (NYSE: LLY) reported positive Phase 3 results for Foundayo, or orforglipron, showing significant reductions in obstructive sleep apnea severity in adults with obesity or overweight, with and without positive airway pressure therapy.
At 52 weeks, Foundayo reduced the apnea-hypopnea index by 43.8% in patients not using PAP therapy and by 27.5% in those using PAP. Among patients not using PAP, 31.5% achieved remission or mild disease, while 19.6% of PAP users reached that threshold.
The drug also reduced sleep apnea-specific hypoxic burden by 55.9% in patients not using PAP and by 45.8% in those using PAP, suggesting meaningful improvement in overnight oxygen-related stress. Participants also lost about 11% of body weight on average and showed reductions in systolic blood pressure and inflammation.
The overall safety profile was consistent with earlier Foundayo studies, with gastrointestinal side effects including nausea, diarrhea, constipation and vomiting among the most common adverse events.
Lilly plans to submit Foundayo to the FDA for moderate-to-severe obstructive sleep apnea by the end of 2026. Foundayo is already approved in the U.S. for obesity, giving Lilly a potential pathway to broaden the drug’s commercial use into another major obesity-related condition.
The Phase 3 data strengthen Lilly’s cardiometabolic franchise by showing that oral GLP-1 therapy may deliver benefits beyond weight loss, including clinically meaningful improvements in sleep apnea and associated cardiovascular risk factors.
Eli Lilly (NYSE: LLY) reported positive Phase 3 results for Foundayo, or orforglipron, showing significant reductions in obstructive sleep apnea severity in adults with obesity or overweight, with and without positive airway pressure therapy.
At 52 weeks, Foundayo reduced the apnea-hypopnea index by 43.8% in patients not using PAP therapy and by 27.5% in those using PAP. Among patients not using PAP, 31.5% achieved remission or mild disease, while 19.6% of PAP users reached that threshold.
The drug also reduced sleep apnea-specific hypoxic burden by 55.9% in patients not using PAP and by 45.8% in those using PAP, suggesting meaningful improvement in overnight oxygen-related stress. Participants also lost about 11% of body weight on average and showed reductions in systolic blood pressure and inflammation.
The overall safety profile was consistent with earlier Foundayo studies, with gastrointestinal side effects including nausea, diarrhea, constipation and vomiting among the most common adverse events.
Lilly plans to submit Foundayo to the FDA for moderate-to-severe obstructive sleep apnea by the end of 2026. Foundayo is already approved in the U.S. for obesity, giving Lilly a potential pathway to broaden the drug’s commercial use into another major obesity-related condition.
The Phase 3 data strengthen Lilly’s cardiometabolic franchise by showing that oral GLP-1 therapy may deliver benefits beyond weight loss, including clinically meaningful improvements in sleep apnea and associated cardiovascular risk factors.
