Chicago, IL – November 9, 2026 – Eli Lilly and Company’s groundbreaking oral medication, Foundayo (orforglipron), has demonstrated substantial efficacy in treating adults with moderate-to-severe obstructive sleep apnea (OSA) who are also grappling with obesity or overweight. The findings, revealed today at the American Heart Association (AHA) Scientific Sessions 2026 and simultaneously published in the prestigious journal JAMA, signal a pivotal advancement in addressing a complex and widespread health challenge, extending the drug’s potential far beyond its initial approval for weight management.
This pivotal Phase III ATTAIN-OSA trial (NCT06649045) has positioned Foundayo as a potential game-changer for the millions of individuals worldwide suffering from the debilitating effects of OSA, a condition often intertwined with cardiovascular risks. The study’s robust results not only underscore Foundayo’s ability to significantly reduce the severity of sleep apnea events but also highlight its positive impact on weight loss and crucial cardiovascular biomarkers.
Foundayo’s Dual Impact: Tackling Sleep Apnea and Obesity
The ATTAIN-OSA trial meticulously evaluated Foundayo’s effectiveness in adults with moderate-to-severe OSA and obesity or overweight, comparing it against a placebo. The study design thoughtfully incorporated two distinct arms: one group receiving positive airway pressure (PAP) therapy alongside their assigned treatment, and another group receiving their assigned treatment without PAP. This comprehensive approach allowed researchers to assess Foundayo’s impact both independently and as an adjunct to existing OSA treatments.
At the 52-week mark, the trial achieved its primary endpoint, showcasing Foundayo’s remarkable ability to significantly reduce the Apnoea-Hypopnoea Index (AHI). The AHI, a critical metric representing the number of breathing pauses per hour of sleep, is the gold standard for measuring OSA severity. The positive outcomes in this trial suggest that Foundayo can offer a tangible solution for individuals whose lives are disrupted by repeated awakenings and oxygen desaturations during sleep.
Quantifying the Benefits: A Deeper Dive into the Data
The data emerging from the ATTAIN-OSA trial is compelling and offers a clear picture of Foundayo’s therapeutic power.
In patients not utilizing PAP therapy:
- Foundayo demonstrated a significant reduction in AHI events, decreasing them by an average of 21.1 events per hour, a 43.8% improvement from a baseline average of 50.7 events per hour.
- Remarkably, nearly half (47.2%) of these participants achieved a clinically significant reduction in AHI of 50% or more, with a substantial proportion (31.5%) reaching remission or experiencing mild disease severity.
- In stark contrast, the placebo group saw a more modest reduction of only 5.5 AHI events per hour.
In patients who were receiving PAP therapy:
- Foundayo also yielded significant benefits, reducing AHI events by an average of 18.3 events per hour, representing a 27.5% improvement from a baseline average of 57.6 events per hour.
- Among this group, 33.7% achieved an AHI reduction of 50% or more, and 19.6% attained remission or mild disease.
- The placebo group in this arm experienced a reduction of 4.3 AHI events per hour.
Beyond the AHI, Foundayo also proved effective in mitigating sleep apnoea-specific hypoxic burden. This measure quantifies the extent and duration of oxygen level drops during sleep, a critical factor in OSA-related complications. Foundayo reduced this burden by an impressive 81.4 percent minutes per hour (55.9%) in participants not using PAP, and by 75.0 percent minutes per hour (45.8%) in those using PAP.
Crucially, the trial reaffirmed Foundayo’s established role in weight management. Participants treated with Foundayo experienced an average weight loss of 28.0 lbs (11.5%) in the non-PAP group and 28.2 lbs (11.2%) in the PAP group. This dual action of improving sleep apnea symptoms while simultaneously promoting significant weight loss offers a holistic approach to managing these interconnected health issues.
The benefits of Foundayo extended to critical cardiovascular risk factors as well. The study observed significant reductions in high-sensitivity C-reactive protein (hsCRP), a key indicator of inflammation, by an average of 48.9% and 38.6% in the non-PAP and PAP groups, respectively. Furthermore, systolic blood pressure saw a notable decrease of 8.6 mmHg and 7.3 mmHg in the respective groups. These improvements underscore Foundayo’s potential to mitigate the long-term cardiovascular consequences associated with OSA.
A Look Back: The Journey of Foundayo and its Predecessors
Foundayo’s journey to this significant milestone has been marked by strategic development and regulatory milestones. The drug initially gained approval in the United States for weight loss in January 2026. Following its US debut, it subsequently secured approval in the European Union for the same indication. This dual approval paved the way for widespread patient access for weight management purposes.
More recently, Foundayo’s trajectory has seen further expansion. It gained US approval for weight loss in October 2026, and its performance in the subsequent quarter was robust, generating $184 million in global sales, with $124 million originating from the United States.
This latest development with Foundayo in OSA treatment follows a similar pathway for another of Eli Lilly’s innovative drugs, Zepbound (tirzepatide). Zepbound, a glucagon-like peptide-1 receptor agonist (GLP-1RA), also demonstrated efficacy in treating OSA patients with obesity or overweight. Tirzepatide achieved approval for this indication in December 2024, further solidifying the role of GLP-1-based therapies in addressing complex metabolic and respiratory conditions.
Official Responses and Expert Endorsements
The implications of these findings have been met with enthusiasm from both the pharmaceutical company and the medical community. Eli Lilly has indicated its intention to submit Foundayo to the U.S. Food and Drug Administration (FDA) for the treatment of moderate-to-severe OSA in adults with obesity or overweight by the end of 2026. This proactive approach underscores the company’s confidence in the drug’s potential to address an unmet medical need.
Dr. Vaishnavi Kundel, an associate professor of medicine in the division of pulmonary, critical care, and sleep medicine at the Icahn School of Medicine at Mount Sinai, commented on the significance of the findings. "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," Dr. Kundel stated. "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."
Broader Implications: Addressing a Global Health Crisis
Obstructive sleep apnea is a prevalent and often underdiagnosed condition, affecting an estimated 936 million adults worldwide. The consequences of untreated OSA are severe, contributing to a cascade of health problems including hypertension, heart failure, atrial fibrillation, coronary artery disease, and stroke. The chronic disruption of sleep and intermittent oxygen deprivation place significant strain on the cardiovascular system.
The development of effective treatments for OSA, particularly those that can also address the underlying obesity, is therefore of paramount importance. Foundayo’s dual action offers a promising avenue for improving both the quality of life for patients and their long-term health outcomes.
The obesity market itself is a significant and growing global concern. A report by GlobalData, the parent company of Clinical Trials Arena, projects that the obesity market, valued at $34.6 billion across seven major markets in 2025, is set to expand dramatically to $118.2 billion by 2035. This burgeoning market underscores the immense demand for effective weight management solutions, and Foundayo’s proven efficacy in this area, coupled with its new potential in OSA treatment, positions it as a highly valuable asset.
The general safety and tolerability profile of Foundayo in the ATTAIN-OSA trial was consistent with previous studies from the ACHIEVE and ATTAIN programs, with the most frequently reported adverse events being gastrointestinal in nature. This established safety profile further bolsters confidence in its therapeutic potential.
In conclusion, the positive results from the ATTAIN-OSA trial mark a significant leap forward in the management of obstructive sleep apnea, particularly for individuals struggling with obesity. Eli Lilly’s Foundayo is poised to become a crucial tool in addressing this complex health challenge, offering a beacon of hope for millions seeking improved sleep, better health, and a higher quality of life. The potential for this oral medication to transform the lives of OSA patients, extending its impact beyond weight loss, underscores the ongoing innovation and progress in pharmaceutical research.
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