Foundayo reduced breathing interruptions during sleep by up to an average of 44% at 52 weeks in adults with moderate-to-severe obstructive sleep apnea and obesity or overweight, Sleep Review reported.
Eli Lilly and Company presented the results from its phase 3 ATTAIN-OSA trial on published in JAMA, evaluating the oral GLP-1 receptor agonist orforglipron. The findings showed that up to 31.5% of participants achieved remission or mild disease while also lowering blood pressure and systemic inflammation markers.
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, said Vaishnavi Kundel, associate professor of medicine, division of pulmonary, critical care and sleep medicine at the Icahn School of Medicine at Mount Sinai, in a release.
Participants not using positive airway pressure therapy experienced an average reduction in the apnea-hypopnea index of 21.1 events per hour, or 43.8%, from a baseline of 50.7 events per hour. In this group, 47.2% achieved an AHI reduction of 50% or more.
Participants using positive airway pressure therapy saw their AHI drop by 18.3 events per hour, or 27.5%, down from a baseline of 57.6 events per hour. Within this cohort, 33.7% reached an AHI reduction of at least 50%, while 19.6% achieved remission or mild disease.
The trial also evaluated sleep apnea-specific hypoxic burden, which measures the depth and duration of oxygen drops during sleep. This measure fell by 55.9% in non-PAP users and by 45.8% in PAP users.
Alongside improvements in breathing disruptions, participants taking Foundayo experienced significant weight loss. Individuals not using PAP therapy lost an average of 28.0 pounds, representing an 11.5% reduction. Those using PAP therapy lost an average of 28.2 pounds, or 11.2% of their body weight.
The medication also impacted cardiovascular risk factors by lowering systolic blood pressure and inflammatory markers. Systolic blood pressure decreased by an average of 8.6 mmHg in non-PAP participants and 7.3 mmHg in PAP participants. Levels of high-sensitivity C-reactive protein, a marker of inflammation, dropped by 48.9% and 38.6% across the two groups respectively.
“OSA is one of the most serious complications of obesity and is closely linked to cardiovascular disease,” said Thomas Seck, senior vice president of product development of Lilly cardiometabolic health, in a release.
The overall safety profile of Foundayo remained consistent with prior observations in the ATTAIN-OSA clinical program. Gastrointestinal issues constituted the most frequent adverse events, including nausea, diarrhea, constipation, dyspepsia, and vomiting. These events were classified as mild to moderate in severity.
Eli Lilly and Company stated plans to submit Foundayo to the United States Food and Drug Administration by the end of 2026 for the treatment of moderate-to-severe obstructive sleep apnea in adults with obesity or overweight.
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