Eli Lilly’s oral weight loss drug, Foundayo (orforglipron), has shown benefit as a treatment for adults with moderate-to-severe obstructive sleep apnoea (OSA) and obesity or overweight, showing its potential beyond weight loss.
The Phase III ATTAIN-OSA trial (NCT06649045) investigated the drug against placebo both with and without the use of positive airway pressure (PAP) therapy.
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At 52 weeks, the study met its primary endpoint, with those who received Foundayo seeing a significant reduction in the apnoea-hypopnoea index (AHI), the standard measure of sleep apnoea severity, as well as improved weight and other cardiovascular risk factors.
In patients not using PAP therapy, Foundayo reduced the number of AHI events by 21.1 per hour (43.8%) at 52 weeks from an average baseline of 50.7 events per hour. Notably, 47.2% of these participants achieved an AHI reduction of 50% or more, and 31.5% achieved remission or mild disease. This was compared to a reduction of 5.5 in the placebo cohort.
In patients who did receive PAP therapy, Foundayo reduced the number of AHI events by 18.3 per hour (27.5%) at 52 weeks from an average baseline of 57.6 events per hour. Of these participants, 33.7% achieved an AHI reduction of 50% or more, and 19.6% achieved remission or mild disease. This was compared to a reduction of 4.3 in the placebo cohort.
Foundayo also reduced sleep apnoea-specific hypoxic burden, a measure of how deeply and for how long oxygen levels fall during sleep, by 81.4 percent minutes per hour (55.9%) in participants not using PAP therapy and by 75.0 percent minutes per hour (45.8%) in those using PAP therapy.
Alongside these improvements in OSA, participants taking Foundayo lost an average of 28.0lbs (11.5%) and 28.2lbs (11.2%), without and with PAP therapy, respectively.
There was also marked improvement in certain cardiovascular risk factors, lowering hsCRP, a marker of inflammation, by an average of 48.9% and 38.6%, and systolic blood pressure by an average of 8.6mmHg and 7.3mmHg, in participants not using and using PAP therapy, respectively.
The overall safety and tolerability profile of Foundayo was generally consistent with previous trials in the ACHIEVE and ATTAIN programmes, with most common adverse events (AEs) being gastrointestinal in nature.
Based on this study, Lilly plans to submit Foundayo to the US Food and Drug Administration (FDA) for the treatment of moderate-to-severe OSA in adults with obesity or overweight by the end of 2026.
The results were presented on 9 November at the American Heart Association (AHA) Scientific Sessions 2026, taking place in Chicago from 6-9 November, and simultaneously published in JAMA.
OSA affects an estimated 936 million adults worldwide, and most have never been diagnosed. In people with OSA, the airway repeatedly collapses during sleep, causing drops in oxygen and increases in blood pressure that are associated with hypertension, heart failure, atrial fibrillation, coronary artery disease and stroke.
Dr Vaishnavi Kundel, associate professor of medicine, division of pulmonary, critical care and sleep medicine at Icahn School of Medicine at Mount Sinai, said: “We know there’s a two-way relationship between sleep and cardiovascular health, and the repeated drops in oxygen that happen with obstructive sleep apnea can strain blood pressure and the heart over time. In ATTAIN-OSA, Foundayo significantly reduced breathing interruptions and drops in oxygen during sleep, while also improving blood pressure and inflammation. In addition to improving their sleep, what I care about for my patients is improving the cardiovascular risk factors that have the potential to impact long-term health.”
This is not the first drug with this mechanism of action (MOA) to show benefit in these patients. Lilly’s Zepbound (tirzepatide), which is also a glucagon-like peptide-1 receptor agonist (GLP-1RA), also showed benefit in a Phase III trial, with the drug gaining approval in these patients in December 2024.
Foundayo was approved for use in weight loss in early 2026, and in Q3 it generated $184m in global sales, including $124m from the US. It gained approval in the US in October 2026.
A GlobalData report predicts that the obesity market was worth $34.6bn across the seven major markets (7MM: US, France, Germany, Italy, Spain, UK, and Japan) in 2025, with it set to grow to a value of $118.2bn in 2035. GlobalData is the parent company of Clinical Trials Arena.
