RecruitingPhase 3NCT07434050

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

Sponsor

Hangzhou Sciwind Biosciences Co., Ltd.

Enrollment

140 participants

Start Date

Mar 2, 2026

Study Type

INTERVENTIONAL

Conditions

Obesity OSA - Obstructive Sleep Apnea

Summary

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

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Inclusion Criteria4

Body mass index (BMI) ≥ 28.0 kg/m2;
The results of PSG meet the diagnosis criteria of OSA and with an AHI≥15 at screening;
Have been on PAP therapy for at least 3 consecutive months prior to screening and plan to continue PAP therapy during the study;
Have a history of at least 1 self-reported unsuccessful dietary effort to lose body weight.

Exclusion Criteria10

History of endocrine disorders which have significant impact on body weight;
Diagnosis of diabetes (except gestational diabetes), ketoacidosis or hypertonic state/coma;
HbA1c ≥6.5% at screening;
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;
Have diagnosis of Cheyne Stokes Respiration, or diagnosis of Central or Mixed Sleep Apnea with % of mixed or central apneas/hypopneas ≥50%;
Respiratory and neuromuscular diseases that could interfere with the results of the trial;
Diagnosis of Obesity Hypoventilation Syndrome or daytime hypercapnia;
Change of body weight >5% within 3 months prior to screening (selfreported);
Have a prior or planned surgical treatment for obesity (except liposuction or abdominoplasty if performed more than 1 year prior to screening);
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.