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TIRZE-PAP

Not yet recruitingPhase 2, PHASE3

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

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

Asset

Tirzepatide

Subcutaneous · GLP-1 / GIP dual

Listed sites

1

Recruiting sites

-

Estimated enrollment

256

Study population

Obesity / overweight, Sleep apnea

Eligibility highlights

•BMI ≥27

Primary endpoint

•Breathing Disturbance Index (BDI)

Registered trial locations

Locations reported to ClinicalTrials.gov for this trial snapshot. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT07846865
Org study ID20081

Timeline

Milestones

Study first posted2026-09-29actual
Study start2026-10-01estimated
Last update posted2026-11-02actual
Primary completion2028-12-01estimated
Study completion2028-12-01estimated

Assets

Investigational agents

Tirzepatide

Who this study enrolls

Obesity / overweightSleep apnea

Who can enroll

Minimum age18 Years
SexAll
Healthy volunteersNot accepted

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

Endpoints (35)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Other (unclassified)
15
Cardiometabolic biomarkers
11
Weight & body composition
5
Glycemic / diabetes
2
Patient-reported / QoL
2

Weight & body composition

5 endpoints
Other/protocol endpoint

Anthropometry - Body Mass Index (kg/m^2)

Time frame:Baseline and Week 52

descriptive

Other/protocol endpoint

Anthropometry - Weight (kg)

Time frame:Baseline and Week 52

descriptive

Other/protocol endpoint

Anthropometry - Body Weight (% change)

Time frame:Baseline and Week 52

percent change from baseline, improvement

Other/protocol endpoint

Anthropometry - Waist Circumference

Time frame:Baseline and Week 52

descriptive

Other/protocol endpoint

Anthropometry - Weight (Self-Measured)

Time frame:At Baseline, 3, 6, and 9 months

descriptive

Glycemic / diabetes

2 endpoints
Secondary/protocol endpoint

Cardiometabolic Fasted Blood Markers - HbA1c

Time frame:Screening and Week 52

descriptive

Other/protocol endpoint

Cardiometabolic Fasted Blood Markers - Glucose

Time frame:Screening and Week 52

descriptive

Cardiometabolic biomarkers

11 endpoints
Secondary/protocol endpoint

Ambulatory Blood Pressure - Sleep Systolic Blood Pressure (SBP)

Time frame:Baseline and Week 52

descriptive

Secondary/protocol endpoint

Cardiometabolic Fasted Blood Markers - Low-Density Lipoproteins (LDL)

Time frame:Screening and Week 52

descriptive

Other/protocol endpoint

Cardiometabolic Fasted Blood Markers - Triglycerides [TAG]

Time frame:Screening and Week 52

descriptive

Other/protocol endpoint

Cardiometabolic Fasted Blood Markers - High-Density Lipoproteins (HDL)

Time frame:Screening and Week 52

descriptive

Other/protocol endpoint

Cardiometabolic Fasted Blood Markers - Total Cholesterol

Time frame:Screening and Week 52

descriptive

Other/protocol endpoint

Ambulatory Blood Pressure - Sleep Diastolic Blood Pressure (DBP)

Time frame:Baseline and Week 52

descriptive

Other/protocol endpoint

Ambulatory Blood Pressure - Wake Systolic Blood Pressure (SBP)

Time frame:Baseline and Week 52

descriptive

Other/protocol endpoint

Ambulatory Blood Pressure - Wake Diastolic Blood Pressure (DBP)

Time frame:Baseline and Week 52

descriptive

Other/protocol endpoint

Ambulatory Blood Pressure - 24-hour Mean Arterial Pressure (MAP)

Time frame:Baseline and Week 52

descriptive

Other/protocol endpoint

Office Blood Pressure - Systolic Blood Pressure (SBP)

Time frame:Baseline and Week 52

descriptive

Other/protocol endpoint

Office Blood Pressure - Diastolic Blood Pressure (DBP)

Time frame:Baseline and Week 52

descriptive

Patient-reported / QoL

2 endpoints
Secondary/protocol endpoint

Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep-Related Impairment Short Form 8a Score

Time frame:Collected at Baseline and 3,6,9 and 12 months.

descriptive

Other/protocol endpoint

Short Form Functional Outcomes of Sleep Questionnaire (FOSQ-10)

Time frame:Baseline and 3, 6, 9 and 12 months.

descriptive

Other (unclassified)

15 endpoints
Primary/protocol endpoint/low confidence

Breathing Disturbance Index (BDI)

Time frame:The mean BDI measured over 28 nights of monitoring is calculated for baseline (Weeks -4 to 0) and follow-up (Weeks 48 to 52)

descriptive

Secondary/protocol endpoint/low confidence

Hypoxia - Oxygen Desaturation Index (ODI 3%)

Time frame:ODI 3% will be determined as a mean of 7-10 nights of data acquired at baseline and a mean of 7-10 nights of data acquired at 12month follow-up.

ratio, improvement

Secondary/protocol endpoint/low confidence

Epworth Sleepiness Scale (ESS)

Time frame:Collected at Baseline and 3,6,9 and 12 months.

descriptive

Other/protocol endpoint/low confidence

Hypoxic Burden

Time frame:The mean nightly hypoxic burden measured over 7-10 nights of monitoring is calculated for baseline and 12 month follow-up.

descriptive

Other/protocol endpoint/low confidence

Anthropometry - Neck Circumference

Time frame:Baseline and Week 52

descriptive

Other/protocol endpoint/low confidence

CAmbridge Neuropsychological Test Automated Battery (CANTAB) Multitasking Test

Time frame:Baseline and Week 52

descriptive

Other/protocol endpoint/low confidence

CANTAB Spatial Working Memory Task

Time frame:Baseline and Week 52

descriptive

Other/protocol endpoint/low confidence

Psychomotor Vigilance Task (PVT)

Time frame:Baseline and Week 52

descriptive

Other/protocol endpoint/low confidence

Blood-Based Neurodegeneration Biomarkers - Amyloid Beta

Time frame:Baseline and Week 52

ratio, improvement

Other/protocol endpoint/low confidence

Blood-Based Neurodegeneration Biomarkers - Phosphorylated Tau

Time frame:Baseline and Week 52

ratio, improvement

Other/protocol endpoint/low confidence

Blood-Based Neurodegeneration Biomarkers - Glial Fibrillary Acidic Protein (GFAP)

Time frame:Baseline and Week 52

ratio, improvement

Other/protocol endpoint/low confidence

Hypoxia - Time Spent With SpO2<88%

Time frame:Hypoxia outcomes will be determined as a mean of 7-10 nights of data acquired at baseline and a mean of 7-10 nights of data acquired at 12months.

descriptive

Other/protocol endpoint/low confidence

Hypoxia - Minimum SpO2

Time frame:Hypoxia outcomes will be determined as a mean of 7-10 nights of data acquired at baseline and a mean of 7-10 nights of data acquired at 12 month follow-up

descriptive

Other/protocol endpoint/low confidence

Hypoxia - Average Desaturation

Time frame:Hypoxia outcomes will be determined as a mean of 7-10 nights of data acquired at baseline and a mean of 7-10 nights of data acquired at 12 month follow-up

ratio, improvement

Other/protocol endpoint/low confidence

Breathing Disturbance Index (BDI)

Time frame:Nightly for 12-month treatment duration.

descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateNovember 5, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the November 5, 2026 snapshot.