A Phase 3 Study to Evaluate the Efficacy of XW003 Compared With Dulaglutide in Participants With T2DM
NCT ID: NCT05680129
Last Updated: 2025-05-08
Study Results
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Basic Information
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COMPLETED
PHASE3
623 participants
INTERVENTIONAL
2023-01-10
2024-10-12
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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B1: XW003+MET
High dosage of XW003 once weekly
Ecnoglutide high dosage
Administered subcutaneously
Metformin
Administered orally
B2: XW003+MET
Low dosage of XW003 once weekly
Ecnoglutide low dosage
Administered subcutaneously
Metformin
Administered orally
B3: Dulaglutide+MET
1.5mg Dulaglutide once weekly
Dulaglutide
Administered subcutaneously
Metformin
Administered orally
Interventions
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Ecnoglutide high dosage
Administered subcutaneously
Ecnoglutide low dosage
Administered subcutaneously
Dulaglutide
Administered subcutaneously
Metformin
Administered orally
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Sex: male or female; Age: 18 to 75 years, inclusive
3. BMI: 20.0 kg/m\^2 to 35.0 kg/m\^2, inclusive
4. Have been diagnosed with T2DM for at least 3 months and treated with a stable dose of metformin (≥1500 mg/day) in addition to diet and exercise during the 8 weeks prior to screening.
5. HbA1c ranging from 7.5% to 11.0% at screening, inclusive
6. FPG ≤13.9 mmol/L at screening
Exclusion Criteria
2. Use of insulin during the 6 months preceding screening
3. History of proliferative diabetic retinopathy, diabetic maculopathy, diabetic neuropathy, or diabetic foot during the 6 months prior to screening.
4. History of acute or chronic pancreatitis or high-risk factors for pancreatitis
5. Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2.
6. History of stomach surgeries or disorders associated with slowed emptying of the stomach during the past 6 months.
7. History of heart attack, stroke or congestive heart failure of Grade 3 or 4 in the past 6 months.
18 Years
75 Years
ALL
No
Sponsors
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Hangzhou Sciwind Biosciences Co., Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Xiaoying Li, Dr
Role: PRINCIPAL_INVESTIGATOR
Shanghai Zhongshan Hospital
Locations
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ZHONGSHAN Hospital
Shanghai, Shanghai Municipality, China
Countries
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References
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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.
Other Identifiers
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SCW0502-1032
Identifier Type: -
Identifier Source: org_study_id
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