Clinical Trial Details
| Trial ID: | L3495 |
| Source ID: | NCT05680155 |
| Associated Drug: | Ecnoglutide |
| Title: | A Phase 3 Study to Evaluate the Efficacy of XW003 Compared With Placebo in T2DM Patients |
| Acronym: | |
| Status: | ACTIVE_NOT_RECRUITING |
| Study Results: | NO |
| Results: | |
| Conditions: | T2DM|Type 2 Diabetes Mellitus |
| Interventions: | DRUG: Ecnoglutide|DRUG: Placebo |
| Outcome Measures: | Primary: Change from baseline in HbA1c, Baseline, Week 24 | Secondary: Change from baseline in HbA1c, Baseline, Week 5, Week 9, Week 13, Week 17, Week 29, Week 33, Week 37, Week 45, Week 52|Change from baseline in fasting plasma glucose (FPG), Baseline, Week 24 and Week 52|Change from baseline in lipid panel, Baseline, Week 24 and Week 52|Change from baseline in body weight, Baseline, Week 24 and Week 52|Pharmacokinetics: plasma trough level of XW003, Baseline, Day 29, Day 57, Day 85, D168, D364, D399 |
| Sponsor/Collaborators: | Sponsor: Hangzhou Sciwind Biosciences Co., Ltd. |
| Gender: | ALL |
| Age: | ADULT, OLDER_ADULT |
| Phases: | PHASE3 |
| Enrollment: | 211 |
| Study Type: | INTERVENTIONAL |
| Study Designs: | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT |
| Start Date: | 2022-12-29 |
| Completion Date: | 2024-10-21 |
| Results First Posted: | |
| Last Update Posted: | 2023-07-17 |
| Locations: | Nanjing Drum Tower Hospital, Nanjing, Jiangsu, 210008, China |
| URL: | https://clinicaltrials.gov/show/NCT05680155 |
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