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NOT YET RECRUITING
NCT07846865
PHASE2/PHASE3

Tirzepatide Versus Positive Airway Pressure for the Treatment of Obstructive Sleep Apnoea: A Randomised Comparative Effectiveness Trial

Sponsor: Woolcock Institute of Medical Research

View on ClinicalTrials.gov

Summary

When used, continuous positive airway pressure (CPAP) is an effective treatment for obstructive sleep apnea (OSA), a condition that is mainly caused by overweight and obesity. However, CPAP is plagued by poor adherence and high rates of discontinued use leaving most patients undertreated and at risk of serious health complications. This study aims to test whether new effective weight loss pharmacotherapy is superior to CPAP for alleviating OSA and improving health outcomes.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

256

Start Date

2026-10-01

Completion Date

2028-12-01

Last Updated

2026-09-29

Healthy Volunteers

No

Interventions

DEVICE

Continuous Positive Airway Pressure

Participants allocated to CPAP will be managed by their caring sleep physician as per their normal practice. Participants may also be counselled on losing weight with diet and exercise as per usual practice.

DRUG

Tirzepatide

Patients allocated to weight loss with tirzepatide will be managed by the study dietitian. The tirzepatide formulation is administered subcutaneously once weekly using single-use injection pens. Participants will undergo a 20-week dose escalation phase followed by a dose maintenance phase for the remainder of the 12-month study period.

Locations (1)

Woolcock Institute of Medical Research

Macquarie Park, New South Wales, Australia