| Trial ID: | L3921 |
| Source ID: | NCT06256523
|
| Associated Drug: |
Gzr18
|
| Title: |
A Study of GZR18 Injection in Chinese Adult Patients With Type 2 Diabetes Mellitus (T2DM)
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Type 2 Diabetes
|
| Interventions: |
DRUG: GZR18|OTHER: Placebo
|
| Outcome Measures: |
Primary: Number of adverse events and serious adverse events, 29 weeks|Changes from baseline in hemoglobin A1c (HbA1c) at the end of the study, 26 weeks | Secondary: Trough concentrations of GZR18 following consecutive doses, 26 weeks|HbA1c control rate (proportions of subjects with HbA1c < 6.5 % and HbA1c < 7.0 %), 26 weeks
|
| Sponsor/Collaborators: |
Sponsor: Gan and Lee Pharmaceuticals, USA
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE1|PHASE2
|
| Enrollment: |
72
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2022-06-29
|
| Completion Date: |
2023-09-28
|
| Results First Posted: |
|
| Last Update Posted: |
2024-02-23
|
| Locations: |
Gan & Lee Pharmaceuticals Co., Ltd, Beijing, China
|
| URL: |
https://clinicaltrials.gov/show/NCT06256523
|
