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

What Was Tested

In this phase 2, phase 3 trial, researchers set out to test Tirzepatide for sleep apnea (obstructive).

However, CPAP is plagued by poor adherence and high rates of discontinued use leaving most patients undertreated and at risk of serious health complications.

It had two arms (groups): Continuous Positive Airway Pressure (CPAP) (active comparator) and Tirzepatide (experimental).

The registry classes the interventions as device and drug.

More on the Plan

Participants allocated to CPAP will receive therapy as per usual care by their treating physician.

Outcomes will be collected over two 28-day periods commencing at baseline (pre-intervention weeks -4 to 0) and at follow-up (post-intervention weeks 48 to 52).

Who Took Part

Enrollment: 256 planned participants were the target.

It was open to people of any sex aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Females and Males aged ≥ 18 years at the time of signing informed consent. Moderate-severe OSA defined as an AHI ≥ 15/hr determined from a Type 1 or 2 sleep study conducted within the previous 12 months with a clinician recommendation for CPAP therapy. Moderate overweight or obesity defined as BMI ≥ 27 kg/m2. (Adjusted to BMI ≥ 25 kg/m2 for Asian populations as per WHO guidelines (WHO Expert Consultation (2004)). No contraindication to tirzepatide use as per Australian Product Information. Home internet access to enable cloud storage of SleepTracker-AI in-home BDI.

The full record lists 6 inclusion and 14 exclusion criteria; among the exclusions: driver occupation with excessive sleepiness (epworth sleepiness scale \>=16) or sleepiness-related motor vehicle accident or near accident within 12 months prior to enrolment; current or prior (≤3 months) osa treatment with mechanical therapy (cpap, mas, positional); type 1 or type 2 diabetes mellitus.

How the Study Was Run

Design: randomized, parallel-group and open-label.

The sleep apnea (obstructive) participants were allocated by chance, so the Tirzepatide group and the comparison group should start out alike.

The Tirzepatide group and the comparison group ran side by side rather than switching.

Being open-label, the Tirzepatide study did not mask who received what.

It started in 2026-10-01 with completion listed for 2028-12-01.

It ran at 1 site in Australia.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Breathing Disturbance Index (BDI).

It also tracked 6 secondary outcomes, for example Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep-Related Impairment Short Form 8a Score, Epworth Sleepiness Scale (ESS), Ambulatory Blood Pressure - Sleep Systolic Blood Pressure (SBP), Cardiometabolic Fasted Blood Markers - Low-Density Lipoproteins (LDL) and Cardiometabolic Fasted Blood Markers - HbA1c.

What This Means in Plain Language

Put simply, this is a phase 2, phase 3, randomized trial of Tirzepatide in 256 people with sleep apnea (obstructive).

Its status is not yet recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Tirzepatide compound page, Sleep apnea (obstructive) research.