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JAMA

Orforglipron reduced sleep apnea severity in two trials

Over 52 weeks, average hourly breathing disruptions fell by 17.8 with orforglipron versus 4.5 with placebo in one trial, and 17.3 versus 5.3 in the other.

Paper by Atul Malhotra, Daniel J Gottlieb, Holger Woehrle, +7 more authorsATTAIN-OSA Investigators · University of California · Icahn School of Medicine at Mount Sinai
Figure 1 from JAMA
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Figure 1. Malhotra et al.

Our read

Interventions
Studied:
Randomized trial in adults with sleep apnea and overweight or obesity, 52 weeks, against placebo (Double-blind, placebo-controlled, multicenter, registered NCT06649045)
What changed:
Orforglipron reduced hourly breathing disruptions by 17.8 versus 4.5 with placebo in one trial, and 17.3 versus 5.3 in another
The catch:
Follow-up lasted 52 weeks, leaving longer-term benefits and harms unresolved
In the record:
The 32nd paper on orforglipron with results in people; 79 on record in all. Its result on gastrointestinal adverse events agrees with all 5 other findings on record.

Editor of record: Boris Djordjevic · AgingResearch.News

Paper
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Adults with moderate to severe obstructive sleep apnea—repeated airway collapse during sleep—and overweight or obesity entered two randomized, placebo-controlled trials. Trial 1 enrolled 363 people not using positive airway pressure, which keeps airways open; their mean age was 48.4 years and 31.4% were female. Trial 2 enrolled 349 people using it; their mean age was 51.1 years and 26.9% were female.

Participants took daily oral orforglipron or placebo for 52 weeks. Maximum tolerated doses were equivalent to 9-, 14.5- or 17.2-mg tablets. Orforglipron reduced breathing pauses or episodes of shallow breathing per hour more than placebo in both trials. Digestive problems affected 123 (68.0%) on orforglipron versus 68 (37.4%) on placebo in trial 1, and 125 (70.6%) versus 63 (36.6%), respectively, in trial 2.

Why it matters

Sleep apnea’s association with heart and metabolic disease makes it relevant to health in later life. The authors concluded that oral orforglipron has potential to improve sleep-disordered breathing in adults with moderate to severe obstructive sleep apnea and overweight or obesity.

Caveats

Follow-up lasted 52 weeks, leaving longer-term benefits and harms unresolved. The trials did not address people with milder sleep apnea or a body mass index below 27.

Where the evidence stands

Orforglipron

Humans: replicated by independent labs. Mice: a single group. Cells and worms or flies: nothing yet.

C, W, M, H: cells, worms or flies, mice, humans. Dark: independent labs found the same change there. Light: one lab or one study. Outline: nothing yet.

Labs are independent when their papers share no last author and no institution.

Against: findings that point the other way from most findings on the same outcome.

No results posted: trials that ended over a year ago with no results on ClinicalTrials.gov and no paper reporting them.

Company ties: findings with an author at a company, or from a paper whose competing-interests statement declares ties to one.

  • 22 independent labs in 9 countries
  • 1 finding against
  • 36 trials, 1 with no results posted
  • Funder: Eli Lilly and Company
  • 35 of 80 findings with company ties
  • 35 of 36 trials sponsored by its developers

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