| Trial ID: | L4383 |
| Source ID: | NCT06256549
|
| Associated Drug: |
Gzr18
|
| Title: |
A Study of GZR18 Injection in Chinese Patients With Type 2 Diabetes Mellitus
|
| Acronym: |
|
| Status: |
ACTIVE_NOT_RECRUITING
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Type 2 Diabetes
|
| Interventions: |
DRUG: GZR18|DRUG: Semaglutide
|
| Outcome Measures: |
Primary: Compared with Semaglutide, the changes of HbA1c compared with baseline after continuous administration of GZR18 injection for 24 weeks, 24 weeks | Secondary: HbA1c compliance rate (< 7.0% and ≤ 6.5% of patients), Compared with Semaglutide injection, GZR18 injection after continuous administration for 24 weeks, 24 weeks|The overall incidence of adverse events and the incidence of serious adverse events, Compared with Semaglutide injection, GZR18 injection after continuous administration for 24 weeks, 27 weeks
|
| Sponsor/Collaborators: |
Sponsor: Gan and Lee Pharmaceuticals, USA
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE2
|
| Enrollment: |
272
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2023-08-09
|
| Completion Date: |
2024-07-20
|
| Results First Posted: |
|
| Last Update Posted: |
2024-02-23
|
| Locations: |
Gan & Lee Pharmaceuticals Co., Ltd, Beijing, China
|
| URL: |
https://clinicaltrials.gov/show/NCT06256549
|