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

NCT07387094 | Recruiting Phase 3

• 1 other identifier: SCW0502-5031
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

OSA - Obstructive Sleep Apnea; Obesity

Keywords

XW003; Ecnoglutide; Obesity; OSA; GLP-1

Outcome Measures

Primary Outcomes (1)

• Change from baseline in Apnea-Hypopnea Index (AHI)

  at week 48

Secondary Outcomes (4)

• Percent Change From Baseline in AHI

  at week 48

• Percentage of Participants With ≥50% AHI Reduction From Baseline

  at week 48

• Percentage of Participants With AHI <5 or With AHI 5-14 With Epworth Sleepiness Scale (ESS) ≤10

  at week 48

• Percent Change From Baseline in Body Weight

  at week 48

Study Arms (2)

XW003 Injection

EXPERIMENTAL

once weekly

Drug: XW003 injection

Placebo

PLACEBO COMPARATOR

once weekly

Drug: placebo with matching volume

Interventions

placebo with matching volume DRUG

subcutaneous injection

Placebo

XW003 injection DRUG

subcutaneous injection

Also known as: Ecnoglutide injection

XW003 Injection

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• Participants must not have used PAP for at least 4 weeks prior to screening and not use PAP during the study;
• Have a history of at least 1 self-reported unsuccessful dietary effort to lose body weight.

You may not qualify if:

• 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 (self-reported);
• 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.

Sponsors & Collaborators

• Hangzhou Sciwind Biosciences Co., Ltd.: lead

Study Sites (1)

Peking University People's Hospital

Beijing, Beijing Municipality, China

RECRUITING

MeSH Terms

Conditions

Sleep Apnea, Obstructive; Obesity

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Linong Ji, Dr

  Peking University People's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 28, 2026
• First Posted: February 4, 2026
• Study Start: February 9, 2026
• Primary Completion (Estimated): December 16, 2027
• Study Completion (Estimated): December 16, 2027
• Last Updated: April 14, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)