Once-weekly XW003 injections for people with obesity and obstructive sleep apnea on PAP 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 Receiving Positive Airway Pressure Therapy
This trial will test whether once-weekly XW003 (ecnoglutide) injections help people with obesity and moderate-to-severe obstructive sleep apnea who are already using positive airway pressure 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 (Shanghai, Shanghai Municipality) |
| Trial ID | NCT07434050 on ClinicalTrials.gov |
What this trial studies
This Phase III, randomized, placebo-controlled study will assign eligible participants 1:1 to receive once-weekly subcutaneous XW003 or matching placebo, including a dose-escalation period, for up to 48 weeks. Participants must have BMI ≥28 kg/m2, an AHI ≥15 on diagnostic PSG, and have used PAP therapy for at least three consecutive months prior to screening while planning to continue PAP during the study. The trial will monitor efficacy outcomes related to OSA severity and weight, along with safety and tolerability measures. Study visits and assessments will be conducted at the single investigational site in Shanghai.
Who should consider this trial
Good fit: Adults with BMI ≥28 kg/m2, a PSG-confirmed AHI ≥15, who have been on PAP therapy for at least three months and do not have uncontrolled diabetes or major endocrine disorders are the ideal candidates.
Not a fit: Patients with predominantly central or mixed sleep apnea, uncontrolled diabetes or significant endocrine causes of weight change, or BMI below 28 are unlikely to benefit from this intervention in the trial.
Why it matters
Potential benefit: If successful, XW003 could help patients lose weight and improve their sleep apnea severity and symptoms while continuing PAP therapy.
How similar studies have performed: Other GLP-1 receptor agonists have produced substantial weight loss and shown preliminary improvements in OSA measures, so this trial builds on positive evidence for the drug class.
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. Have been on PAP therapy for at least 3 consecutive months prior to screening and plan to continue PAP therapy 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 (selfreported); 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
Shanghai, Shanghai Municipality
- Rui Jin Hospital — Shanghai, Shanghai Municipality, China (Recruiting)
Study contacts
- Principal investigator: Qingyun Li, Dr — Ruijin 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.