A Study of XW003 in Obese Participants With Obstructive Sleep Apnea Receiving Positive Airway Pressure Therapy

Sponsor
Hangzhou Sciwind Biosciences Co., Ltd.
Study ID
NCT07434050
Phase
PHASE3
Status
Recruiting
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Conditions

  • OSA - Obstructive Sleep Apnea
  • Obesity

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • XW003 injection — DRUG
    subcutaneous injection
  • placebo with matching volume — DRUG
    subcutaneous injection

Study Details

The aim of the study is to assess the efficacy and safety of XW003 injections in obese participants with OSA receiving PAP

Key Dates

Start date
Mar 2, 2026
Status verified
Jan 2026
Primary completion
Jun 19, 2028
Completion
Jun 19, 2028

Study Design

Enrollment
140 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: XW003 Injection
    once weekly
  • Placebo Comparator: Placebo
    once weekly

Primary Outcome Measure

Change from baseline in Apnea-Hypopnea Index (AHI) [ Time Frame: at week 48 ]

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