A Study of XW003 in Obese Participants With Obstructive Sleep Apnea But Not Receive Positive Airway Pressure Therapy

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-75
SponsorHangzhou Sciwind Biosciences Co., Ltd.

About this trial

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

Participants must not have used PAP for at least 4 weeks prior to screening and not use PAP 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

Treatment groups

140 Participants
are divided into 2 treatment groups