Clinical Trial

Evaluate the Efficacy and Safety of GZR18 Injection in Obese Subjects With Obstructive Sleep Apnea Receiving Positive Airway Pressure (PAP) Therapy

Not Yet Recruiting Phase 3
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Summary
The study is a multicenter, randomized, double-blind, parallel-group, placebo-controlled Phase III clinical trial to evaluate the efficacy and safety of GZR18 injection in Chinese adult obese patients with moderate-to-severe obstructive sleep apnea (OSA) who are currently using positive airway pressure (PAP) therapy. This study will assess the impact of GZR18 on OSA-related symptoms, respiratory parameters, and quality of life compared to placebo.
Protocol Amendment History 1 change
critical Primary endpoint(s) modified 2026-04-04
Trial Details
NCT Number NCT07501832
Lead Sponsor Gan & Lee Pharmaceuticals.
Conditions Obstructive Sleep Apnea (OSA)
Enrollment 140 participants
Start Date 2026-03-27
Primary Completion 2028-09-28 (estimated)
Study Completion 2028-09-28 (estimated)
Updated on ClinicalTrials.gov 2026-04-03