Clinical trial
A Study of XW003 in Obese Participants With Obstructive Sleep Apnea Receiving Positive Airway Pressure Therapy
Recruiting now · Phase 3 · 1 countries · Registry ID NCT07434050
Recruiting nowPhase 3Interventional
What this study is about
The aim of the study is to assess the efficacy and safety of XW003 injections in obese participants with OSA receiving PAP
A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.
Basic eligibility
Age18 Years to 75 Years
SexAll
Healthy volunteersNot accepted
ConditionOSA - Obstructive Sleep Apnea, Obesity
Full registry 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.
Treatments and study arms
XW003 injection
Drug
subcutaneous injection
placebo with matching volume
Drug
subcutaneous injection
Primary outcomes
Change from baseline in Apnea-Hypopnea Index (AHI)at week 48
Study locations
1 locations were listed when this page was built. The first 40 are shown.
Rui Jin Hospital🇨🇳 Shanghai, Shanghai Municipality, China
Qingyun Li, DrContact