Actively Recruiting

Phase 3
Age: 18Years - 75Years
All Genders
NCT07434050

A Study of XW003 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

120 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 receiving PAP

CONDITIONS

Official Title

A Study of XW003 in Obese Participants With Obstructive Sleep Apnea Receiving Positive Airway Pressure Therapy

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Body mass index (BMI) greater than or equal to 28.0 kg/m2
  • Diagnosis of obstructive sleep apnea with an Apnea-Hypopnea Index (AHI) of 15 or higher at screening
  • On positive airway pressure (PAP) therapy for at least 3 consecutive months before screening and plan to continue during the study
  • History of at least one unsuccessful attempt to lose body weight through diet
Not Eligible

You will not qualify if you...

  • History of endocrine disorders that significantly affect body weight
  • Diagnosis of diabetes (except gestational diabetes), ketoacidosis, or hypertonic state/coma
  • Hemoglobin A1c (HbA1c) 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 could affect trial results
  • Diagnosis of Obesity Hypoventilation Syndrome or daytime high carbon dioxide levels
  • Body weight change greater than 5% within 3 months prior to screening
  • Prior or planned surgical treatment for obesity (except liposuction or abdominoplasty performed more than 1 year before screening)
  • Use of medications for weight loss or blood glucose lowering, or medications 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

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Trial Site Locations

Total: 1 location

1

Rui Jin Hospital

Shanghai, Shanghai Municipality, China, 200025

Actively Recruiting

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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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A Study of XW003 in Obese Participants With Obstructive Sleep Apnea Receiving Positive Airway Pressure Therapy | DecenTrialz