Actively Recruiting
A Study of XW003 in Obese Participants With Obstructive Sleep Apnea But Not Receive Positive Airway Pressure Therapy
Led by Hangzhou Sciwind Biosciences Co., Ltd. · Updated on 2026-04-14
140
Participants Needed
1
Research Sites
96 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The aim of the study is to assess the efficacy and safety of XW003 injections in obese participants with OSA but not receiving PAP
CONDITIONS
Official Title
A Study of XW003 in Obese Participants With Obstructive Sleep Apnea But Not Receive Positive Airway Pressure Therapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Body mass index (BMI) 64; 28.0 kg/m2
- Diagnosis of obstructive sleep apnea with apnea-hypopnea index (AHI) 64; 15 at screening
- No use of positive airway pressure (PAP) therapy for at least 4 weeks before screening and no use during the study
- History of at least one unsuccessful dietary effort to lose body weight
You will not qualify if you...
- History of endocrine disorders significantly affecting body weight
- Diagnosis of diabetes (except gestational diabetes), ketoacidosis, or hypertonic state/coma
- HbA1c 64; 6.5% at screening
- Fasting blood glucose 64; 7.0 mmol/L or 2-hour oral glucose tolerance test (OGTT) blood glucose 64; 11.1 mmol/L at screening; OGTT required if fasting glucose between 6.1 and 7.0 mmol/L
- Diagnosis of Cheyne Stokes Respiration or central/mixed sleep apnea with 50% or more central or mixed apneas/hypopneas
- Respiratory or neuromuscular diseases that could affect trial results
- Diagnosis of Obesity Hypoventilation Syndrome or daytime hypercapnia
- Body weight change greater than 5% within 3 months before screening
- Prior or planned surgical treatment for obesity, except liposuction or abdominoplasty done more than 1 year before screening
- Use of medications for weight loss, blood glucose lowering, or medications that may cause significant weight gain within 3 months before screening
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Peking University People's Hospital
Beijing, Beijing Municipality, China
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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