Tirzepatide Versus Positive Airway Pressure for the Treatment of Obstructive Sleep Apnoea

What this trial studies

The TIRZE-PAP study is a parallel randomised superiority trial comparing weight loss with weekly tirzepatide (15mg or the maximum tolerated dose) versus CPAP, in 256 people with moderate-severe OSA (AHI≥15/hr) and overweight or obesity (BMI: ≥27kg/m2). Participants allocated to CPAP will receive therapy as per usual care by their treating physician. Participants allocated to tirzepatide will undergo a 20-week stepped titration with a monthly increase of dose to a maximum 15mg (or maximum tolerated) by week 20. 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 can join: the full rules

Inclusion Criteria:

* 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.
* Fluent English literacy and able to provide informed consent.

Exclusion Criteria:

OSA or other respiratory related criteria:

* Respiratory failure including obesity hypoventilation syndrome (OHS) or daytime hypercapnia or moderate-severe chronic obstructive pulmonary disease (COPD) with FEV1/FVC ratio\<0.7 and FEV1\<80% predicted (GOLD criteria).
* 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)
* \>50% respiratory events with Cheyne-Stokes Respiration (CSR) or Central Sleep Apnoea (CSA)
* Relative or absolute contraindication to CPAP including chronic cranial injury; recurrent pneumothorax; indication for oral-pharyngeal surgery, significant craniofacial abnormalities that may affect breathing, or are unwilling to use CPAP
* Any previous or planned surgery for OSA or major ear, nose or throat surgery, including tonsillectomy and adenoidectomy that still may affect breathing (NB: Inclusion of a participant with more minor ear, nose or throat surgery (for example, deviated septum) will be at the investigator's discretion)

Glycaemia related criteria:

* HbA1c ≥ 48 mmol/mol (6.5%) at screening
* Type 1 or type 2 diabetes mellitus
* Treatment with glucose-lowering agent(s) within 90 days before screening
* Treatment with a GLP-1 receptor agonist within 90 days before screening

Obesity related criteria:

* A self-reported change in body weight \>5 kg or \>5% within 90 days before baseline
* Treatment with medication for the indication of obesity within 90 days before baseline and/or currently enrolled in a weight loss program

Other criteria:

* Pregnancy/breast feeding or planning a pregnancy during the trial period
* Relative or absolute contraindication to tirzepatide including needle phobia

Where it's running

• Woolcock Institute of Medical Research
  Macquarie Park, New South Wales, Australia

Study contacts

• Principal investigator: Craig Phillips — Woolcock Institute of Medical Research and Macquarie Medical School, Macquarie University, Sydney, NSW, Australia
• Study coordinator: Craig Phillips, PhD
• Email: c.phillips@mq.edu.au
• Phone: 02 9805 3000

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.