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

April 9, 2026 updated by: Hangzhou Sciwind Biosciences Co., Ltd.

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

The aim of the study is to assess the efficacy and safety of XW003 injections in obese participants with OSA receiving PAP

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

In this Phase III study, eligible participants will be randomized into one of the two cohorts in a 1:1 ratio to receive once-weekly subcutaneous XW003 injection or placebo, including a dose-escalation period, for up to 48 weeks

Study Type

Interventional

Enrollment (Estimated)

140

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China, 200025
        • Recruiting
        • Rui Jin Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: XW003 Injection
once weekly
Drug: XW003 injection
subcutaneous injection
Placebo Comparator: Placebo
once weekly
Drug: placebo with matching volume
subcutaneous injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change from baseline in Apnea-Hypopnea Index (AHI)
Time Frame: at week 48
at week 48

Secondary Outcome Measures

Outcome Measure
Time Frame
Percent Change From Baseline in AHI
Time Frame: at week 48
at week 48
Percentage of Participants With ≥50% AHI Reduction From Baseline
Time Frame: at week 48
at week 48
Percentage of Participants With AHI <5 or With AHI 5-14 With Epworth Sleepiness Scale (ESS) ≤10
Time Frame: at week 48
at week 48
Percent Change From Baseline in body weight
Time Frame: at week 48
at week 48

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hangzhou Sciwind Biosciences Co., Ltd.

Investigators

  • Principal Investigator: Qingyun Li, Dr, Ruijin Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 2, 2026

Primary Completion (Estimated)

June 19, 2028

Study Completion (Estimated)

June 19, 2028

Study Registration Dates

First Submitted

January 28, 2026

First Submitted That Met QC Criteria

February 24, 2026

First Posted (Actual)

February 25, 2026

Study Record Updates

Last Update Posted (Actual)

April 13, 2026

Last Update Submitted That Met QC Criteria

April 9, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SCW0502-5032

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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