Clinical Trial Details
| Trial ID: | L5064 |
| Source ID: | NCT04662164 |
| Associated Drug: | Hepalatide |
| Title: | A Study to Access the Efficacy in Type 2 Diabetes Mellitus on Stable Metformin |
| Acronym: | |
| Status: | WITHDRAWN |
| Study Results: | NO |
| Results: | |
| Conditions: | Type 2 Diabetes Patients |
| Interventions: | DRUG: hepalatide |
| Outcome Measures: | Primary: 24-hour weighed mean glucose (WMG), The change from baseline in the 24-hour WMG calculated is as the AUC0-24h divided by 24 using linear trapezoidal method. \[Time frame: Baseline (Day -1), to Day 28\], 28 days|AEs, Number and percentage of participants with treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs), number of subjects discontinuing due to AEs, 28 days | Secondary: fasting plasma glucose, Change from baseline in fasting plasma glucose (FPG) level \[Time frame: Baseline (Day -1), Day28\], 28 days |
| Sponsor/Collaborators: | Sponsor: Shanghai HEP Pharmaceutical Co., Ltd. |
| Gender: | ALL |
| Age: | ADULT, OLDER_ADULT |
| Phases: | PHASE1|PHASE2 |
| Enrollment: | 0 |
| Study Type: | INTERVENTIONAL |
| Study Designs: | Allocation: RANDOMIZED|Intervention Model: SEQUENTIAL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT |
| Start Date: | 2025-12 |
| Completion Date: | 2025-12 |
| Results First Posted: | |
| Last Update Posted: | 2023-12-08 |
| Locations: | |
| URL: | https://clinicaltrials.gov/show/NCT04662164 |
| Drug ID | Drug Name | Type | DrugBank ID | Targets | Category | Latest Progress |
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