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
22 participants
INTERVENTIONAL
2019-08-20
2020-06-18
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
OTHER
SINGLE
Study Groups
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RTA 402 5mg or 10mg oral administration
Bardoxolone methyl
Bardoxolone methyl 5 mg capsules
Placebo
Placebo
Capsules containing an inert placebo
Interventions
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Bardoxolone methyl
Bardoxolone methyl 5 mg capsules
Placebo
Capsules containing an inert placebo
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Male aged ≥ 20 and \< 50 years at the time of consent
* BMI ≥ 25.0 kg/m2 measured at screening
* Waist circumference (umbilical position) ≥ 85 cm measured at screening.
* MRI-measured visceral fat area ≥ 100 cm2 measured at screening
Exclusion Criteria
* Subjects with conditions requiring treatment other than obesity
* History of cardiac failure (e.g., a prior diagnosis of congestive cardiac failure defined as NYHA class III or IV or a history of hospitalization for cardiac failure)
20 Years
49 Years
MALE
No
Sponsors
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Kyowa Kirin Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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Applied Bio-Pharmatech Kurume Clinical Pharmacology Clinic
Kurume, Fukuoka, Japan
Countries
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Other Identifiers
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RTA 402-010
Identifier Type: -
Identifier Source: org_study_id
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