A Phase 3 Study to Evaluate the Efficacy of XW003 Compared With Placebo in T2DM Patients
NCT ID: NCT05680155
Last Updated: 2025-09-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
211 participants
INTERVENTIONAL
2022-12-29
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
DOUBLE
Study Groups
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C1-XW003
High dosage of XW003 once weekly
Ecnoglutide
Subcutaneous Injection
C1-Placebo
Matched Placebo once weekly
Placebo
Subcutaneous Injection with matched volume
C2-XW003
Low dosage of XW003 once weekly
Ecnoglutide
Subcutaneous Injection
C2-Placebo
Matched Placebo once weekly
Placebo
Subcutaneous Injection with matched volume
Interventions
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Ecnoglutide
Subcutaneous Injection
Placebo
Subcutaneous Injection with matched volume
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 T2DMthat is inadequately controlled with at least 3 months of diet and exercise 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 any GLP-1 analogue during the 3 months preceding to screening.
3. History of proliferative diabetic retinopathy, diabetic maculopathy, diabetic neuropathy, or diabetic foot during the 6 months preceding 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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Dalong Zhu
Role: PRINCIPAL_INVESTIGATOR
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Locations
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Nanjing Drum Tower Hospital
Nanjing, Jiangsu, China
Countries
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Other Identifiers
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SCW0502-1031
Identifier Type: -
Identifier Source: org_study_id
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