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A Study of XW003 in Obese Participants With Obstructive Sleep Apnea But Not Receive Positive Airway Pressure Therapy | Clinical Trials | Clareo Health

NOT_YET_RECRUITINGPHASE3

A Study of XW003 in Obese Participants With Obstructive Sleep Apnea But Not Receive Positive Airway Pressure Therapy

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

NCT07387094•Hangzhou Sciwind Biosciences Co., Ltd.

View on ClinicalTrials.gov

Summary

The aim of the study is to assess the efficacy and safety of XW003 injections in obese participants with OSA but not receiving PAP

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.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

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. Participants must not have used PAP for at least 4 weeks prior to screening and not use PAP 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 (self-reported);
•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.

Locations (1)

Peking University People's Hospital

Beijing, Beijing Municipality, China

Key Dates

Start Date

March 3, 2026

Primary Completion Date

December 16, 2027

Completion Date

December 16, 2027

Last Updated

February 4, 2026

Enrollment

140

ESTIMATED participants

Conditions

OSA - Obstructive Sleep ApneaObesity

Interventions

XW003 injection

DRUG

placebo with matching volume

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 4, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

A Study of XW003 in Obese Participants With Obstructive Sleep Apnea But Not Receive Positive Airway Pressure Therapy

Inclusion Criteria

Exclusion Criteria

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