Trial results for tirzepatide in participants with obstructive sleep apnea and obesity were posted on ClinicalTrials.gov on 2025-04-30. The Phase 3 study (NCT05412004) showed that tirzepatide led to a significant reduction in the Apnea-Hypopnea Index (AHI) compared to placebo, with up to 72.40% of participants achieving at least a 50% AHI reduction.
Background
The study investigated tirzepatide for the treatment of obstructive sleep apnea (OSA) in individuals also living with obesity. The trial aimed to evaluate the drug's effect and safety in participants with moderate to severe OSA and obesity.
Trial design
The Phase 3 study (NCT05412004) was a randomized, placebo-controlled trial that enrolled 469 participants. The study investigated tirzepatide in participants with obstructive sleep apnea and obesity. It included two main groups: GPI1 for participants unwilling or unable to use Positive Airway Pressure (PAP) therapy, and GPI2 for those who were on PAP therapy and planned to continue. Participants received either tirzepatide or placebo.
Key results
The trial results demonstrated significant reductions in the Apnea-Hypopnea Index (AHI) for participants treated with tirzepatide compared to placebo across both groups.
- Change From Baseline in Apnea-Hypopnea Index (AHI):
- In participants unwilling or unable to use PAP therapy (GPI1), tirzepatide achieved a least squares mean change of -25.25 events per hour (Standard Error: 2.06), compared to -5.25 events per hour (Standard Error: 2.11) for placebo. The difference in LS Mean Change was -20.01 (95.0% CI: -25.82 to -14.2), with a p-value of 0.001.
- In participants on PAP therapy (GPI2), tirzepatide achieved a least squares mean change of -29.27 events per hour (Standard Error: 1.99), compared to -5.51 events per hour (Standard Error: 2.21) for placebo. The difference in LS Mean Change was -23.77 (95.0% CI: -29.61 to -17.93), with a p-value of 0.001.
- Percent Change From Baseline in Apnea-Hypopnea Index (AHI):
- For GPI1, tirzepatide showed a least squares mean percent change of -50.68% (Standard Error: 5.90), compared to -3.03% (Standard Error: 7.07) for placebo. The difference in LS Mean Change was -47.65 (95.0% CI: -65.76 to -29.55), with a p-value of 0.001.
- For GPI2, tirzepatide showed a least squares mean percent change of -58.72% (Standard Error: 5.28), compared to -2.50% (Standard Error: 6.95) for placebo. The difference in LS Mean Change was -56.21 (95.0% CI: -73.73 to -38.7), with a p-value of 0.001.
- Percentage of Participants With ≥50% AHI Reduction From Baseline:
- For GPI1, 61.22% of participants on tirzepatide achieved this reduction, compared to 18.96% on placebo. The Risk Difference was 42.77 (95.0% CI: 30.76 to 54.79), with a p-value of 0.001.
- For GPI2, 72.40% of participants on tirzepatide achieved this reduction, compared to 23.25% on placebo. The Risk Difference was 48.6 (95.0% CI: 36.55 to 60.65), with a p-value of 0.001.
What this means
The results indicate that tirzepatide significantly improves obstructive sleep apnea severity in patients with obesity, both those unable or unwilling to use PAP therapy and those who continue PAP therapy. The substantial reductions in AHI and the high proportion of participants achieving clinically meaningful AHI reductions suggest tirzepatide could offer a new therapeutic option for managing OSA in this population.
Source
The information for these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for study NCT05412004, titled "Obstructive Sleep Apnea Master Protocol GPIF: A Study of Tirzepatide (LY3298176) in Participants With Obstructive Sleep Apnea," were posted on 2025-04-30 on clinicaltrials.gov.