Study S002819

A Multicenter, Randomized, Double-Blind, Parallel, Placebo-Controlled Phase 3 Study to Evaluate the Efficacy and Safety of GZR18 Injection in Obese Subjects With Moderate to Severe Obstructive Sleep Apnea（OSA） Not Treated With Positive Airway Pressure（PAP）

ClinicalTrials.gov record

Registration

Registration: NCT07493057
Study type: INTERVENTIONAL
Allocation: RANDOMIZED
Phase: PHASE3
Masking: DOUBLE
Status: NOT_YET_RECRUITING
Enrollment: 140
Start: 2026-04-27
Primary completion: 2027-11-14
Lead sponsor: Gan & Lee Pharmaceuticals.
Conditions: Obstructive Sleep Apnea (OSA)
Interventions: DRUG:Placebo; DRUG:GZR18 injection
Results posted: FALSE

Registered primary outcomes

Change from baseline in Apnea-Hypopnea Index (AHI) after 52 weeks of treatment [52 weeks]

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