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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
Led by Hangzhou Sciwind Biosciences Co., Ltd. · Updated on 2026-04-14
140
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate the effectiveness and safety of XW003 injections in obese adults who have obstructive sleep apnea (OSA) but are not using positive airway pressure (PAP) therapy. The study focuses on participants with a body mass index of 28 or higher and those diagnosed with OSA based on specific sleep study criteria. It is a Phase III randomized clinical trial designed to provide detailed insights into this treatment approach. Participants will be randomly assigned to receive either a once-weekly subcutaneous injection of XW003 or a placebo for up to 48 weeks. The study includes a dose-escalation period to carefully monitor dosing effects. Both groups receive injections following the same schedule to compare the treatment and placebo outcomes effectively. During the study, participants will undergo assessments including sleep studies to measure changes in the Apnea-Hypopnea Index (AHI) at baseline and after 48 weeks. Additional evaluations include monitoring body weight changes and sleepiness scales. Researchers will track safety and treatment adherence throughout the study, which lasts nearly a year from start to finish.
CONDITIONS
Brief 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) 28.0 kg/m2 or higher
- Diagnosis of obstructive sleep apnea with an apnea-hypopnea index (AHI) 15 or higher at screening
- No use of positive airway pressure (PAP) therapy for at least 4 weeks prior to screening and no PAP use during the study
- History of at least one unsuccessful attempt to lose body weight through diet
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 of 6.5% or higher at screening
- Fasting blood glucose 7.0 mmol/L or higher, or 2-hour blood glucose 11.1 mmol/L or higher after oral glucose tolerance test at screening
- Diagnosis of Cheyne Stokes Respiration or central/mixed sleep apnea with 50% or more central or mixed apneas/hypopneas
- Respiratory or neuromuscular diseases that may affect trial results
- Diagnosis of obesity hypoventilation syndrome or daytime hypercapnia
- Body weight change greater than 5% within 3 months prior to screening
- Prior or planned surgical treatment for obesity (except liposuction or abdominoplasty done over 1 year before screening)
- Use of medications for weight loss or blood glucose control, or drugs causing significant weight gain within 3 months prior to screening
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 48 weeks
Participants receive a dose-escalation period of the study drug or placebo.
Once-weekly subcutaneous injections
Duration - Up to 48 weeks
Participants continue receiving once-weekly subcutaneous injections of XW003 or placebo for up to 48 weeks.
Once-weekly subcutaneous injections
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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