Clinical Trial Details
| Trial ID: | L2728 |
| Source ID: | NCT05680129 |
| Associated Drug: | Ecnoglutide High Dosage |
| Title: | A Phase 3 Study to Evaluate the Efficacy of XW003 Compared With Dulaglutide in Participants With T2DM |
| Acronym: | |
| Status: | ACTIVE_NOT_RECRUITING |
| Study Results: | NO |
| Results: | |
| Conditions: | T2DM|Type 2 Diabetes Mellitus |
| Interventions: | DRUG: Ecnoglutide high dosage|DRUG: Ecnoglutide low dosage|DRUG: Dulaglutide|DRUG: Metformin |
| Outcome Measures: | Primary: Change from baseline in HbA1c, Baseline, week 32 | Secondary: Change from baseline in HbA1c, Baseline, Week 5, Week 9, Week 13, Week 17, Week 25, Week 43 and Week 52|Change from baseline in fasting plasma glucose (FPG), Baseline, Week 32 and Week 52|Change from baseline in lipid panel, Baseline, Week 32 and Week 52|Change from baseline in body weight, Baseline, Week 32 and Week 52|Pharmacokinetics: plasma trough level of XW003, Baseline, Day 29, Day 57, Day 85, Day 224, Day 364 and Day 399 |
| Sponsor/Collaborators: | Sponsor: Hangzhou Sciwind Biosciences Co., Ltd. |
| Gender: | ALL |
| Age: | ADULT, OLDER_ADULT |
| Phases: | PHASE3 |
| Enrollment: | 623 |
| Study Type: | INTERVENTIONAL |
| Study Designs: | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT |
| Start Date: | 2023-01-10 |
| Completion Date: | 2024-10-03 |
| Results First Posted: | |
| Last Update Posted: | 2023-07-17 |
| Locations: | ZHONGSHAN Hospital, Shanghai, Shanghai, China |
| URL: | https://clinicaltrials.gov/show/NCT05680129 |
