Tirzepatide for the treatment of obstructive sleep apnea: Rationale, design, and sample baseline characteristics of the SURMOUNT -OSA phase 3 trial

Mar 28, 2024Contemporary clinical trials

Using Tirzepatide to Treat Obstructive Sleep Apnea: Study Plan and Participant Details from the SURMOUNT-OSA Phase 3 Trial

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Abstract

A total of 469 participants are enrolled in a trial to assess the efficacy and safety of tirzepatide for moderate to severe obstructive sleep apnea.

The trial evaluates participants with obesity and an established diagnosis of obstructive sleep apnea, with a focus on those with a body mass index of 30 kg/m or higher.
Participants are randomly assigned to receive either tirzepatide or a placebo over a 52-week period.
Primary outcomes include changes in the apnea hypopnea index, measured through polysomnography, between the treatment and placebo groups.
Secondary outcomes involve assessing sleep apnea-specific hypoxic burden, functional outcomes, and cardiometabolic biomarkers.
Digital wearables are utilized to monitor exploratory outcomes related to sleep and physical activity.

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BACKGROUND: Weight reduction is a standard recommendation for obstructive sleep apnea (OSA) treatment in people with obesity or overweight; however, weight loss can be challenging to achieve and maintain without bariatric surgery. Currently, no approved anti-obesity medication has demonstrated effectiveness in OSA management. This study is evaluating the efficacy and safety of tirzepatide for treatment of moderate to severe OSA in people with obesity.

METHODS: SURMOUNT-OSA, a randomized, placebo -controlled, 52-week phase 3 trial, is investigating the efficacy and safety of tirzepatide for treatment of moderate to severe OSA (apnea hypopnea- index ≥15 events/h) in participants with obesity (body mass index ≥30 kg/m) and an established OSA diagnosis. SURMOUNT-OSA is made of 2 intervention-specific appendices (ISAs): ISA-1 includes participants with no current OSA treatment, and ISA-2 includes participants using positive airway pressure therapy. Overall, 469 participants have been randomized 1:1 to receive tirzepatide or placebo across the master protocol (ISA-1, n = 234; ISA-2, n = 235). All participants are also receiving lifestyle intervention for weight reduction. 2

RESULTS: The primary endpoint for the individual ISAs is the difference in apnea hypopnea- index response, as measured by polysomnography, between tirzepatide and placebo arms at week 52. Secondary endpoints include sleep apnea-specific hypoxic burden, functional outcomes, and cardiometabolic biomarkers. The trial employs digital wearables, including home sleep testing to capture time to improvement and accelerometry for daily physical activity assessment, to evaluate exploratory outcomes.

CONCLUSION: SURMOUNT-OSA brings a novel design to investigate if tirzepatide provides clinically meaningful improvement in obesity-related OSA by targeting the underlying etiology.

TRIAL REGISTRATION: ClinicalTrials.gov, NCT05412004.

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Tirzepatide for the treatment of obstructive sleep apnea: Rationale, design, and sample baseline characteristics of the SURMOUNT -OSA phase 3 trial

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