About this trial
The aim of the study is to assess the efficacy and safety of XW003 injections in obese participants with OSA receiving PAP
Eligibility criteria
Qualifiers
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.
Disqualifiers
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;
Trial design
Treatments tested in this trial
- XW003 injection
- placebo with matching volume