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

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

Study Overview

• Status: Recruiting
• Conditions: Obesity; OSA - Obstructive Sleep Apnea
• Intervention / Treatment: Drug: XW003 injection; Drug: placebo with matching volume

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

Study Locations

• China
  • Beijing Municipality
    • Beijing, Beijing Municipality, China
      • Recruiting
      • Peking University People's Hospital
      • Contact: Linong Ji, Dr; Phone Number: (86)010-88324516; Email: jiln@bjmu.edu.cn

Participation Criteria

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. 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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: XW003 Injection; once weekly	Drug: XW003 injection; subcutaneous injection; Other Names: Ecnoglutide 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)	at week 48

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Hangzhou Sciwind Biosciences Co., Ltd.
• Investigators: Principal Investigator: Linong Ji, Dr, Peking University People's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 9, 2026
• Primary Completion (Estimated): December 16, 2027
• Study Completion (Estimated): December 16, 2027

Study Registration Dates

• First Submitted: January 28, 2026
• First Submitted That Met QC Criteria: January 28, 2026
• First Posted (Actual): February 4, 2026

Study Record Updates

• Last Update Posted (Actual): April 14, 2026
• Last Update Submitted That Met QC Criteria: April 9, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Obesity; GLP-1; OSA; Ecnoglutide; XW003
• Additional Relevant MeSH Terms: Nervous System Diseases; Nutrition Disorders; Overnutrition; Body Weight; Respiratory Tract Diseases; Respiration Disorders; Sleep Wake Disorders; Overweight; Apnea; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Apnea Syndromes; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Obesity; Sleep Apnea, Obstructive
• Other Study ID Numbers: SCW0502-5031

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No