OSA - Obstructive Sleep Apnea, Obesity
Conditions
Keywords
XW003, Ecnoglutide, OSA, Obesity, GLP-1
Brief summary
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
DRUGXW003 injection
subcutaneous injection
subcutaneous injection
Sponsors
Hangzhou Sciwind Biosciences Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in Apnea-Hypopnea Index (AHI) | at week 48 |
Secondary
| 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 |
Countries
China
Contacts
PRINCIPAL_INVESTIGATORQingyun Li, Dr
Ruijin Hospital
Outcome results
None listed