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NOT YET RECRUITING
NCT07501832
PHASE3

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

Sponsor: Gan & Lee Pharmaceuticals.

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

140

Start Date

2026-03-27

Completion Date

2028-09-28

Last Updated

2026-04-03

Healthy Volunteers

No

Interventions

DRUG

GZR18 injection

subcutaneous administration

DRUG

Placebo

subcutaneous administration

Locations (1)

Gan & Lee Pharmaceuticals

Beijing, China