Weekly XW003 injections for people with obesity and obstructive sleep apnea not using PAP
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
This will see if once-weekly XW003 injections help adults with obesity and moderate-to-severe obstructive sleep apnea who are not using positive airway pressure (PAP) therapy.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 140 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Hangzhou Sciwind Biosciences Co., Ltd. Industry-sponsored |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Trial ID | NCT07387094 on ClinicalTrials.gov |
What this trial studies
In this Phase 3 randomized, placebo-controlled trial, adults with obesity and polysomnography-confirmed obstructive sleep apnea who are not using PAP will be assigned 1:1 to once-weekly subcutaneous XW003 or matching placebo. The dosing includes a planned dose-escalation period followed by maintenance dosing for up to 48 weeks. Key eligibility requires BMI ≥28 kg/m2, AHI ≥15, no PAP use for at least four weeks prior to screening, and exclusion of diabetes or certain endocrine, respiratory, or neuromuscular disorders. The study collects safety data and measures efficacy outcomes such as changes in apnea-hypopnea index and body weight.
Who should consider this trial
Good fit: Adults with BMI ≥28 kg/m2 and polysomnography-confirmed OSA (AHI ≥15) who have not used PAP for at least four weeks and meet the study's glucose and respiratory health criteria are ideal candidates.
Not a fit: People with diabetes (HbA1c ≥6.5% or qualifying hyperglycemia), predominantly central or mixed sleep apnea, significant endocrine disorders affecting weight, or those who require PAP therapy are unlikely to qualify or gain benefit from this intervention.
Why it matters
Potential benefit: If successful, XW003 could reduce sleep apnea severity and produce weight loss, improving sleep quality and daytime symptoms for affected patients who are not using PAP.
How similar studies have performed: Other GLP-1 receptor agonists have produced weight loss and some improvements in OSA severity in prior trials, so the approach has precedent, although XW003 itself is less well studied.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Beijing, Beijing Municipality
- Peking University People's Hospital — Beijing, Beijing Municipality, China (Recruiting)
Study contacts
- Principal investigator: Linong Ji, Dr — Peking University People's Hospital
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.