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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 Receiving Positive Airway Pressure Therapy
Led by Hangzhou Sciwind Biosciences Co., Ltd. · Updated on 2026-04-13
140
Participants Needed
1
Research Sites
N/A
Total Duration
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AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of XW003 injections in adults who are obese and have obstructive sleep apnea (OSA) while receiving positive airway pressure (PAP) therapy. This Phase III study aims to understand how XW003 injections impact breathing events during sleep and body weight in this population. Participants must be adults with a diagnosis of OSA confirmed by sleep study results and a history of unsuccessful weight loss attempts. Eligible participants will be randomly assigned to receive either a once-weekly subcutaneous injection of XW003 or a matching placebo for up to 48 weeks. The study includes a dose-escalation period and is conducted under a double-blind design to compare the effects of the study drug versus placebo. Participants will continue their PAP therapy throughout the study. During the trial, participants will undergo assessments including sleep studies to measure changes in the Apnea-Hypopnea Index (AHI), body weight measurements, and evaluations of daytime sleepiness using the Epworth Sleepiness Scale. These assessments will be conducted at baseline and at week 48. Researchers will monitor safety and treatment adherence over the study period, which lasts approximately 48 weeks.
CONDITIONS
Brief Title
A Study of XW003 in Obese Participants With Obstructive Sleep Apnea Receiving Positive Airway Pressure Therapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Body mass index (BMI) of 28.0 kg/m2 or higher
- Diagnosis of obstructive sleep apnea with an Apnea-Hypopnea Index (AHI) of 15 or more at screening
- On positive airway pressure (PAP) therapy for at least 3 consecutive months before screening and planning to continue PAP therapy 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 level of 6.5% or higher at screening
- Fasting blood glucose of 7.0 mmol/L or higher, or 2-hour blood glucose of 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 mixed or central 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 before screening
- Prior or planned surgical treatment for obesity (except liposuction or abdominoplasty done over 1 year before screening)
- Use of medications for weight loss, blood glucose lowering, or drugs 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
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 48 weeks
Participants begin a dose-escalation period with once-weekly subcutaneous injections of XW003 or placebo.
Once weekly visits for injections
Duration - Up to 48 weeks
Participants continue receiving once-weekly subcutaneous injections of XW003 or placebo as part of the study treatment.
Once weekly visits for injections
Trial Site Locations
Total: 1 location
1
Rui Jin Hospital
Shanghai, Shanghai Municipality, China, 200025
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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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