Lilly's Foundayo (orforglipron) cuts OSA severity and hypoxic burden in Phase 3 ATTAIN-OSA

Phase 3 outcomes

The ATTAIN-OSA program met its primary endpoint at 52 weeks, showing significant reductions in apnea-hypopnea index (AHI) and improvements in weight and selected cardiovascular risk factors; results were presented at the AHA Scientific Sessions and published in JAMA.

Efficacy details

In participants not using PAP therapy, AHI fell by 21.1 events per hour (43.8%) from a baseline of 50.7 events/hr, with 47.2% achieving ≥50% AHI reduction and 31.5% reaching remission or mild disease. In participants using PAP, AHI fell by 18.3 events per hour (27.5%) from a baseline of 57.6 events/hr, with 33.7% achieving ≥50% reduction and 19.6% reaching remission or mild disease.

Oxygenation and cardiometabolic effects

Sleep-apnea specific hypoxic burden decreased by 81.4 percent‑minutes/hr (55.9%) without PAP and by 75.0 percent‑minutes/hr (45.8%) with PAP. Mean weight loss was 28.0 lb (11.5%) without PAP and 28.2 lb (11.2%) with PAP. High-sensitivity CRP fell by 48.9% and 38.6%, and systolic blood pressure declined by 8.6 mmHg and 7.3 mmHg, respectively.

Safety and regulatory plans

Safety and tolerability were consistent with prior trials; the most common adverse events were gastrointestinal and generally mild to moderate. Discontinuation rates due to adverse events were 12.2% vs 3.8% (no PAP) and 6.8% vs 0.6% (with PAP). The company plans to submit these data to the U.S. FDA for treatment of moderate-to-severe OSA in adults with obesity or overweight by the end of 2026.