Significant Reduction in Breathing Pauses During Sleep
Originally developed as a weight management pill, Foundayo has shown promising results in reducing sleep apnea symptoms in clinical trials.
Foundayo (orphoglipron), a medication by Eli Lilly, demonstrated a marked decrease in sleep apnea episodes over a 52-week period in two phase 3 randomized, double-blind studies involving 712 overweight adults with a BMI of 27 or higher and moderate to severe sleep apnea. Participants receiving Foundayo experienced a reduction of about 18 apnea episodes per hour, compared to a 5-episode decrease in the placebo group.
Outcomes and Side Effects
Beyond reducing apnea episodes, those treated with Foundayo lost roughly 10-11% of their body weight and saw an average drop of about 7 mmHg in systolic blood pressure. However, 12.2% of participants discontinued treatment due to side effects, whereas only 3.8% stopped in the placebo group. The most commonly reported adverse effects were:
- nausea
- diarrhea
- constipation
Eli Lilly aims to seek regulatory approval for Foundayo as a sleep apnea treatment by the end of 2026. Currently, the drug is only approved in the U.S. for weight management. Notably, in December 2024, the FDA approved the injectable Zepbound (tirzepatide) as the first medication for obstructive sleep apnea in obese adults. Despite these advances, continuous positive airway pressure (CPAP) therapy remains the standard treatment for sleep apnea.
In the trials, participants who used CPAP discontinued its use seven days prior to overnight assessments, and those not using CPAP formed a separate study group. The findings were published in JAMA and presented at the American Heart Association’s scientific sessions in Chicago. The study excluded individuals with diabetes and had a one-year follow-up period. The long-term cardiovascular effects of Foundayo are yet to be determined.
"A convenient daily pill could broaden access to sleep apnea treatment," commented Vaishnavi Kundel on the study’s outcomes.
The clinical trial results open new avenues for managing sleep apnea, especially for patients struggling with excess weight. Should Foundayo receive approval for this indication, it could significantly reshape current treatment practices, which largely rely on CPAP therapy — a method often criticized for its inconvenience. The research also highlights the need for ongoing investigation into the drug’s long-term impact on heart and vascular health, which will be crucial for its future role in clinical care.