NCT07501832

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

A Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Phase III Clinical Trial to Evaluate the Efficacy and Safety of GZR18 Injection in Obese Subjects With Moderate to Severe Obstructive Sleep Apnea Receiving Positive Airway Pressure (PAP) Therapy

• Status: Not Yet Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 140 (estimated)
• Sponsor: Gan & Lee Pharmaceuticals. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Obstructive Sleep Apnea (OSA)

Interventions

Type	Name	Description
DRUG	GZR18 injection	subcutaneous administration
DRUG	Placebo	subcutaneous administration

Timeline

• Start date: 2026-03-27
• Primary completion: 2028-09-28
• Completion: 2028-09-28
• First posted: 2026-03-30
• Last updated: 2026-04-03

Locations

1 site across 1 country: China