| Trial ID: | L3592 |
| Source ID: | NCT06778967
|
| Associated Drug: |
Gzr18
|
| Title: |
A Phase III Clinical Study to Evaluate the Efficacy and Safety of GZR18 Injection in Adult Type 2 Diabetes Mellitus
|
| Acronym: |
Optimum 2
|
| Status: |
NOT_YET_RECRUITING
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Type 2 Diabetes Mellitus (T2DM)
|
| Interventions: |
DRUG: GZR18|DRUG: semaglutide
|
| Outcome Measures: |
Primary: Change from Baseline in Hemoglobin A1c (HbA1c)(%), Baseline, Week 44 | Secondary: Change from baseline in mean 7-point self-measured blood glucose (SMBG), week 44|Proportion of subjects with salvage therapy., week 44|Change from baseline in weight (kg), week 44|Percent change in weight from baseline (%), week 44|Proportion of subjects with ≥ 5% and 10% decrease in weight from baseline., week 44|Treatment emergent adverse events (TEAEs), week 44
|
| Sponsor/Collaborators: |
Sponsor: Gan & Lee Pharmaceuticals.
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE3
|
| Enrollment: |
1100
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2025-01-07
|
| Completion Date: |
2026-12-11
|
| Results First Posted: |
|
| Last Update Posted: |
2025-01-16
|
| Locations: |
|
| URL: |
https://clinicaltrials.gov/show/NCT06778967
|
