Phase 3 study
Not yet recruiting Phase 3
This trial at a glance
Where this trial is running
| Site | City | State or country | Status at this site |
|---|---|---|---|
| Woolcock Institute of Medical Research | Macquarie Park | NSW | Status not stated |
voxsanity.com.au · trial sites from public registries · registry record synced 11 October 2026 · not medical advice
Who can join
The official eligibility criteria
Registry text, reproduced exactly. These are the words the trial's sponsor published on ClinicalTrials.gov. They have not been edited, shortened or rewritten, and they are written for researchers rather than for patients.
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
Dates on the record
Results, publications and the official record
- No results are posted on the official record yet.
- No publications are listed on the official record yet.
- Official record and contacts on ClinicalTrials.gov – contact details for each site are kept there, and are not copied onto this page.
Sources and dates
- ClinicalTrials.gov – the record this page reformats
- ClinicalTrials.gov processing date: 29 September 2026.
- This page last checked by Voxsanity: 11 October 2026.
Voxsanity reformats data from public registries into this layout. It does not edit, interpret or add to what the registry published.
Not medical advice.
Individual trial records are refreshed on a rolling basis rather than all at once, so a record may be up to several weeks old. Each trial page and trial card shows the date its own record was last synced. Where a record has lagged, its status, sites and enrolment can differ from the current registry state in either direction, so check the registry link on the trial page before acting on them.
Letter for your doctor
A one-page summary of this trial to print or email to your GP. It carries the registry's own record of the trial and its eligibility criteria, and nothing Voxsanity has written about whether it suits you.