| Trial ID: | L6053 |
| Source ID: | NCT06777238
|
| Associated Drug: |
Gzr18
|
| Title: |
A Phase III Clinical Study to Evaluate the Efficacy and Safety of GZR18 Injection in Subjects with Type 2 Diabetes Mellitus and Poor Blood Glucose Control by Diet and Exercise
|
| Acronym: |
Optimum 1
|
| Status: |
NOT_YET_RECRUITING
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Type 2 Diabetes Mellitus (T2DM)
|
| Interventions: |
DRUG: GZR18|DRUG: Placebo
|
| Outcome Measures: |
Primary: Primary Outcome Measure, Change in HbA1c, Baseline, Week 44 | Secondary: Change in weight（Kg）., Baseline, Week 44|Change in BMI（kg/m2）., Baseline, Week 44|Change in waist circumference(cm)., Baseline, Week 44|Change in hip circumference(cm)., Baseline, Week 44
|
| Sponsor/Collaborators: |
Sponsor: Gan & Lee Pharmaceuticals.
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE3
|
| Enrollment: |
270
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2025-01-17
|
| Completion Date: |
2027-03-10
|
| Results First Posted: |
|
| Last Update Posted: |
2025-01-15
|
| Locations: |
|
| URL: |
https://clinicaltrials.gov/show/NCT06777238
|
