XW014 in Healthy Subjects and Patients With Type 2 Diabetes Mellitus (T2DM)
NCT ID: NCT05579314
Last Updated: 2025-09-19
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
PHASE1
127 participants
INTERVENTIONAL
2022-09-26
2024-11-16
Brief Summary
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Detailed Description
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Part B and Part B-EXT - MAD in healthy participants with elevated BMI: Healthy subjects with BMI in the range of ≥30 kg/m2 to ≤40.0 kg/m2 will be randomized to receive oral doses of XW014 or placebo in each of the planned MAD cohorts.
Part C - MAD in patients with T2DM: Patients with T2DM for at least 6 months, having hemoglobin A1c (HbA1c) in the range of 6.5% to 8.5% will be randomized to receive oral doses of XW014 or placebo in each of the planned MAD cohorts.
Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
TREATMENT
DOUBLE
Study Groups
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SAD Cohort A - XW014
Single oral XW014 administration
XW014
Oral capsules
SAD Cohort A - Placebo
Single oral placebo administration
Placebo
Matched oral placebo capsules
MAD Cohort B - XW014
MAD in Healthy Subjects with Elevated BMI
XW014
Oral capsules
MAD Cohort B - Placebo
MAD in Healthy Subjects with Elevated BMI
Placebo
Matched oral placebo capsules
MAD Cohort C - XW014
MAD in Patients with T2DM
XW014
Oral tablets
MAD Cohort C - Placebo
MAD in Patients with T2DM
Placebo
Matched oral placebo tablets
MAD Cohort B-EXT - XW014
MAD in Healthy Subjects with Elevated BMI
XW014
Oral tablets
MAD Cohort B-EXT - Placebo
MAD in Healthy Subjects with Elevated BMI
Placebo
Matched oral placebo tablets
Interventions
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XW014
Oral tablets
Placebo
Matched oral placebo tablets
XW014
Oral capsules
Placebo
Matched oral placebo capsules
Eligibility Criteria
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Inclusion Criteria
2. Sex: male or female
3. Weight: \>50 kg, inclusive, at screening
4. Age:
1. For Part A 18 to 70 years, inclusive, at screening
2. For Part B, Part B-EXT, and C 18 to 55 years, inclusive, at screening
5. Body Mass Index
1. For Part A: ≥18.5 kg/m2 and ≤35.0 kg/m2, inclusive, at screening
2. For Part B and Part B-EXT: ≥30.0 kg/m2 and ≤40.0 kg/m2, inclusive, at screening
3. For Part C: ≥25.0 kg/m2 and ≤40.0 kg/m2, inclusive, at screening
6. Patients with T2DM for at least 6 months, having HbA1c of 6.5% to 8.5% (Part C)
Exclusion Criteria
2. Uncontrolled hypertension
3. History of type 1 diabetes mellitus
4. History or current diagnosis of acute or chronic pancreatitis or factors for pancreatitis
5. Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2 or subjects with suspected medullary thyroid carcinoma
6. Existence of any surgical or medical condition that, in the judgment of the Investigator, might interfere with the absorption, distribution, metabolism, or excretion of the investigational product
18 Years
70 Years
ALL
Yes
Sponsors
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Sciwind Biosciences USA Co., Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Susan Xu, MD
Role: STUDY_CHAIR
Sciwind Biosciences
Locations
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ICON - Early Development Services
Lenexa, Kansas, United States
ICON - Early Development Services
San Antonio, Texas, United States
ICON - Early Development Services
Salt Lake City, Utah, United States
Countries
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Other Identifiers
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XW014-001
Identifier Type: -
Identifier Source: org_study_id
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