placebo with matching volume: subcutaneous injection
Study summary
The aim of the study is to assess the efficacy and safety of XW003 injections in obese participants with OSA receiving PAP
Eligibility
Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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. Have been on PAP therapy for at least 3 consecutive months prior to screening and plan to continue PAP therapy 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 (selfreported);
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.
Primary outcome measure(s)
Change from baseline in Apnea-Hypopnea Index (AHI) — at week 48
Trial sites (1)
Facility
City
Region
Status
Rui Jin Hospital
Shanghai
Shanghai Municipality
Recruiting
More Hangzhou Sciwind Biosciences Co., Ltd. trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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