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RecruitingPhase 3

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

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

NCT IDNCT07387094
Org study IDSCW0502-5031

Timeline

Milestones

Study first posted2026-02-04actual
Study start2026-02-09actual
Last update posted2026-04-14actual
Primary completion2027-12-16estimated
Study completion2027-12-16estimated

Assets

Investigational agents

Study populations

Who this study enrolls

Obesity / overweightSleep apnea

Eligibility

Who can enroll

Minimum age18 Years
Maximum age75 Years
SexAll
Healthy volunteersNot accepted

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

Other clinical outcomes
4
Weight & body composition
1

Weight & body composition

1 endpoint
Secondary/protocol endpoint

Percent Change From Baseline in Body Weight

Time frame:at week 48

Body weight, % change

percent change from baseline, improvement

Other clinical outcomes

4 endpoints
Primary/protocol endpoint

Change from baseline in Apnea-Hypopnea Index (AHI)

Time frame:at week 48

AHI, change

change from baseline, improvement

Secondary/protocol endpoint

Percent Change From Baseline in AHI

Time frame:at week 48

AHI, change

percent change from baseline, improvement

Secondary/protocol endpoint

Percentage of Participants With ≥50% AHI Reduction From Baseline

Time frame:at week 48

OSA responder

threshold achievement, improvement

Secondary/protocol endpoint

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 identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 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 July 1, 2026 snapshot.