Ignite Creation Date:
2026-03-26 @ 3:16 PM
Ignite Modification Date:
2026-03-30 @ 1:04 AM
Study NCT ID:
NCT07493057
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-25
First Post:
2026-03-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Phase III Clinical Study to Evaluate the Efficacy and Safety of GZR18 Injection in Obese Subjects With Obstructive Sleep Apnea Not Treated With Positive Airway Pressure (PAP) Therapy
Sponsor:
Gan & Lee Pharmaceuticals.
Organization:
Study Overview
Official Title:
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）
Status:
NOT_YET_RECRUITING
Status Verified Date:
2026-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study is a multicenter, randomized, double-blind, parallel, placebo-controlled Phase III clinical trial evaluating the efficacy and safety of GZR18 injection in obese subjects with moderate to severe obstructive sleep apnea who are unable or unwilling to undergo positive airway pressure (PAP) therapy.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: