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A Study of XW003 in Obese Participants With Obstructive Sleep Apnea But Not Receive Positive Airway Pressure Therapy
A Multi-center, Randomized, Double-blind, Placebo-controlled Phase III Study to Assess the Efficacy and Safety of XW003 Injections in Obese Participants With Obstructive Sleep Apnea But Not Receive Positive Airway Pressure Therapy
Lead sponsor
Asset
Ecnoglutide (XW003)
GLP-1 agonist
Listed sites
1
Recruiting sites
1
Enrollment
140
estimated
Study population
Obesity / overweight, Sleep apnea
Key I/E criterion
•BMI ≥28
Primary endpoint
•AHI, change
Footprint
Where this trial recruits
Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.
Identifiers
Registered as
Timeline
Milestones
Assets
Investigational agents
Study populations
Who this study enrolls
Eligibility
Who can enroll
Inclusion criteria
1. Body mass index (BMI) ≥ 28.0 kg/m2;
2. The results of PSG meet the diagnosis criteria of OSA and with an AHI ≥15 at screening;
3. Participants must not have used PAP for at least 4 weeks prior to screening and not use PAP during the study;
4. Have a history of at least 1 self-reported unsuccessful dietary effort to lose body weight.
Exclusion criteria
1. History of endocrine disorders which have significant impact on body weight;
2. Diagnosis of diabetes (except gestational diabetes), ketoacidosis or hypertonic state/coma;
3. HbA1c ≥6.5% at screening;
4. Fasting blood glucose ≥7.0 mmol/L or 2-hour blood glucose ≥11.1 mmol/L after oral glucose tolerance test (OGTT) at screening; participants with FBG ≥6.1 mmol/L but <7.0 mmol/L require OGTT;
5. Have diagnosis of Cheyne Stokes Respiration, or diagnosis of Central or Mixed Sleep Apnea with % of mixed or central apneas/hypopneas ≥50%;
6. Respiratory and neuromuscular diseases that could interfere with the results of the trial;
7. Diagnosis of Obesity Hypoventilation Syndrome or daytime hypercapnia;
8. Change of body weight >5% within 3 months prior to screening (self-reported);
9. Have a prior or planned surgical treatment for obesity (except liposuction or abdominoplasty if performed more than 1 year prior to screening);
10. Have received any medication for body weight loss and blood glucose lowering or medication that could lead to significant body weight increase, within 3 months prior to screening.
Endpoints (5)
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
Weight & body composition
1 endpointPercent Change From Baseline in Body Weight
Time frame:at week 48
Body weight, % change
percent change from baseline, improvement
Other clinical outcomes
4 endpointsChange from baseline in Apnea-Hypopnea Index (AHI)
Time frame:at week 48
AHI, change
change from baseline, improvement
Percent Change From Baseline in AHI
Time frame:at week 48
AHI, change
percent change from baseline, improvement
Percentage of Participants With ≥50% AHI Reduction From Baseline
Time frame:at week 48
OSA responder
threshold achievement, improvement
Percentage of Participants With AHI <5 or With AHI 5-14 With Epworth Sleepiness Scale (ESS) ≤10
Time frame:at week 48
OSA responder
threshold achievement, improvement
Provenance
Sources
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 July 1, 2026 snapshot.