Ignite Creation Date:
2025-12-25 @ 12:37 AM
Ignite Modification Date:
2025-12-27 @ 9:33 AM
Study NCT ID:
NCT06778967
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-11-25
First Post:
2025-01-03
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 Adult Type 2 Diabetes Mellitus
Sponsor:
Gan & Lee Pharmaceuticals.
Organization:
Study Overview
Official Title:
A Multicenter, Randomized, Active-controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of GZR18 Injection in Chinese Subjects With Type 2 Diabetes Mellitus and Poor Blood Glucose Control by Metformin Monotherapy or in Combination With Sodium-dependent Glucose Transporter 2 (SGLT2) Inhibitors or Sulfonylureas
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-10
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:
Optimum 2
Brief Summary:
The main purpose of this study is to investigate the Efficacy and Safety of GZR18 Injection in Chinese Subjects with Type 2 Diabetes Mellitus and Poor Blood Glucose Control by Metformin Monotherapy or in Combination with Sodium-dependent Glucose Transporter 2 (SGLT2) Inhibitors or Sulfonylureas
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?: