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The aim of the study is to compare the efficacy and safety of two XW003 doses versus dulaglutide as add-on therapy to metformin in participants with type 2 diabetes mellitus (T2DM)
In this Phase 3 study, eligible participants will be randomized in a 1:1:1 ratio to receive once-weekly subcutaneous XW003 (high or dose) or active comparator dulaglutide as add-on to metformin treatment for 52 weeks, including a dose-escalation period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| B1: XW003+MET | Experimental | High dosage of XW003 once weekly |
|
| B2: XW003+MET | Experimental | Low dosage of XW003 once weekly |
|
| B3: Dulaglutide+MET | Active Comparator | 1.5mg Dulaglutide once weekly |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ecnoglutide high dosage | Drug | Administered subcutaneously |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in HbA1c | Baseline, week 32 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Xiaoying Li, Dr | Shanghai Zhongshan Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ZHONGSHAN Hospital | Shanghai | Shanghai Municipality | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40854315 | Derived | He Y, Mi N, Cheng Z, Xue H, Han J, Wang H, Wang H, Wu J, Shi X, Zhao S, Duan B, Zhu Y, Zhou Y, Li F, Wang X, Ling H, Wang S, Li Q, Jiang F, Yang M, Bing S, Zheng Q, Ning J, Guo M, Bu Y, Guan L, Li Y, Yang L, Guo W, Pan H, Li X. Efficacy and safety of cAMP-biased GLP-1 receptor agonist ecnoglutide versus dulaglutide in patients with type 2 diabetes and elevated glucose concentrations on metformin monotherapy (EECOH-2): a 52-week, multicentre, open-label, non-inferiority, randomised, phase 3 trial. Lancet Diabetes Endocrinol. 2025 Oct;13(10):863-873. doi: 10.1016/S2213-8587(25)00196-2. Epub 2025 Aug 22. |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C555680 | dulaglutide |
| D008687 | Metformin |
| ID | Term |
|---|---|
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
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| Ecnoglutide low dosage | Drug | Administered subcutaneously |
|
|
| Dulaglutide | Drug | Administered subcutaneously |
|
| Metformin | Drug | Administered orally |
|
| 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 |
| D004700 | Endocrine System Diseases |