Pulmonology · Endocrinology ·
Orforglipron Reduced Apnea-Hypopnea Index in Two Phase 3 OSA Trials
Two 52-week, phase 3 randomized trials evaluated once-daily orforglipron versus placebo in 712 adults with moderate to severe obstructive sleep apnea and overweight or obesity. Orforglipron reduced the apnea-hypopnea index more than placebo in both trials; gastrointestinal events were more frequent with treatment.
- Two phase 3 trials included 712 adults with OSA and overweight or obesity.
- AHI improved more with orforglipron than placebo in both trials.
- Gastrointestinal adverse events were more frequent with orforglipron.
- Longer-term clinical outcomes are not reported.
The two multicenter, double-blind, placebo-controlled trials enrolled adults with moderate to severe obstructive sleep apnea (OSA) and a body mass index of at least 27. Trial 1 included 363 participants not using positive airway pressure (PAP), and trial 2 included 349 participants using PAP. Participants were randomized to once-daily orforglipron, at a maximum tolerated dose, or placebo. The primary endpoint was change in apnea-hypopnea index (AHI) at week 52.
In the trial without PAP, mean AHI fell by 17.8 events per hour with orforglipron and 4.5 with placebo, a between-group difference of −13.2 (95% CI, −17.7 to −8.7). In the trial with PAP, the respective reductions were 17.3 and 5.3 events per hour, a difference of −12.0 (95% CI, −17.1 to −6.9). Six of seven key secondary endpoints also favored orforglipron. Gastrointestinal adverse events occurred in 68.0% versus 37.4% of participants in trial 1 and 70.6% versus 36.6% in trial 2.
The findings support further evaluation of oral orforglipron for OSA in adults with overweight or obesity, but do not establish a change in clinical practice. The trials lasted 52 weeks, and the primary outcome was AHI; the source does not report longer-term clinical outcomes. Participants were recruited across nine countries, and results may not apply to people outside the studied population.
In practice
For adults with moderate to severe OSA and overweight or obesity, two 52-week phase 3 trials found that once-daily orforglipron reduced AHI more than placebo, both among participants not using PAP and those receiving PAP. These results are promising but do not by themselves establish a change in practice: the reported primary outcome was AHI, follow-up was 52 weeks, and longer-term clinical outcomes are not provided in the source. Gastrointestinal events were more common with orforglipron.
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JAMA: Orforglipron for Obstructive Sleep Apnea ↗This is an automated AI-condensed summary that has not yet been reviewed by an editor. Always consult the full item at the original source.