A Study of XW003 in Obese Participants With Obstructive Sleep Apnea Receiving Positive Airway Pressure Therapy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: XW003 injection, placebo with matching volume.
- Who it may be relevant to
- Registry conditions: OSA - Obstructive Sleep Apnea, Obesity. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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
Overview
The aim of the study is to assess the efficacy and safety of XW003 injections in obese participants with OSA 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
Interventions
- Drug XW003 injection
subcutaneous injection - Drug placebo with matching volume
subcutaneous injection
Primary outcome measures
- Change from baseline in Apnea-Hypopnea Index (AHI) [Time frame: at week 48]
Secondary outcome measures (4)
- Percent Change From Baseline in AHI [Time frame: at week 48]
- Percentage of Participants With ≥50% AHI Reduction From Baseline [Time frame: 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]
- Percent Change From Baseline in body weight [Time frame: at week 48]
Eligibility criteria
Inclusion criteria
- 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 criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
China · 1 center
- Rui Jin Hospital — Shanghai
Identifiers
NCT: NCT07434050 · SCW0502-5032