Back to resultsA Study of RTA 402 in Obese Adults
Primary Purpose
Obese Adult Male
Status
Completed
Phase
Phase 1
Locations
Japan
Study Type
Interventional
Intervention
Bardoxolone methyl
Placebo
Sponsored by
About this trial
This is an interventional other trial for Obese Adult Male focused on measuring Bardoxolone Methyl, Obese adult, body weight, body composition
Eligibility Criteria
Inclusion Criteria:
- Written voluntary informed consent to participate in the study
- 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 who have undergone weight control procedures (weight loss medicine, surgical therapy, exercise therapy, bariatric diet, etc.) at a medical institution within 3 months before the screening
- 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)
Sites / Locations
- Applied Bio-Pharmatech Kurume Clinical Pharmacology Clinic
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
RTA 402 5mg or 10mg oral administration
Placebo
Arm Description
Outcomes
Primary Outcome Measures
Changes from baseline in weight measured by Bioelectrical Impedance Analysis
Changes from baseline in fat mass measured by Dual Energy X-ray Absorption
Changes from baseline in lean body mass measured by Dual Energy X-ray Absorption
Changes from baseline in skeletal muscle mass index measured by Dual Energy X-ray Absorption
Changes from baseline in waist
Changes from baseline in grip
Changes from baseline in visceral adipose tissue measured by Magnetic Resonance Imaging
Changes from baseline in abdominal subcutaneous adipose tissue measured by Magnetic Resonance Imaging
Changes from baseline in muscle mass measured by Magnetic Resonance Imaging
Changes from baseline in body fat mass measured by Bioelectrical Impedance Analysis
Changes from baseline in segmental muscle mass measured by Bioelectrical Impedance Analysis
Changes from baseline in total body water measured by Bioelectrical Impedance Analysis
Changes from baseline in extracellular water measured by Bioelectrical Impedance Analysis
Changes from baseline in basal metabolic rate measured by Bioelectrical Impedance Analysis
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04018339
Brief Title
A Study of RTA 402 in Obese Adults
Official Title
Phase I Study of RTA 402 in Obese Adults
Study Type
Interventional
2. Study Status
Record Verification Date
June 2020
Overall Recruitment Status
Completed
Study Start Date
August 20, 2019 (Actual)
Primary Completion Date
May 28, 2020 (Actual)
Study Completion Date
June 18, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kyowa Kirin Co., Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
To investigate changes in body weight and body composition in obese adults after repeated oral administration of RTA 402 once daily for 16 weeks, using placebo as a control.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obese Adult Male
Keywords
Bardoxolone Methyl, Obese adult, body weight, body composition
7. Study Design
Primary Purpose
Other
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
22 (Actual)
8. Arms, Groups, and Interventions
Arm Title
RTA 402 5mg or 10mg oral administration
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Bardoxolone methyl
Other Intervention Name(s)
RTA 402
Intervention Description
Bardoxolone methyl 5 mg capsules
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Capsules containing an inert placebo
Primary Outcome Measure Information:
Title
Changes from baseline in weight measured by Bioelectrical Impedance Analysis
Time Frame
Through study completion, approximately 6 months
Title
Changes from baseline in fat mass measured by Dual Energy X-ray Absorption
Time Frame
Through study completion, approximately 6 months
Title
Changes from baseline in lean body mass measured by Dual Energy X-ray Absorption
Time Frame
Through study completion, approximately 6 months
Title
Changes from baseline in skeletal muscle mass index measured by Dual Energy X-ray Absorption
Time Frame
Through study completion, approximately 6 months
Title
Changes from baseline in waist
Time Frame
Through study completion, approximately 6 months
Title
Changes from baseline in grip
Time Frame
Through study completion, approximately 6 months
Title
Changes from baseline in visceral adipose tissue measured by Magnetic Resonance Imaging
Time Frame
Through study completion, approximately 6 months
Title
Changes from baseline in abdominal subcutaneous adipose tissue measured by Magnetic Resonance Imaging
Time Frame
Through study completion, approximately 6 months
Title
Changes from baseline in muscle mass measured by Magnetic Resonance Imaging
Time Frame
Through study completion, approximately 6 months
Title
Changes from baseline in body fat mass measured by Bioelectrical Impedance Analysis
Time Frame
Through study completion, approximately 6 months
Title
Changes from baseline in segmental muscle mass measured by Bioelectrical Impedance Analysis
Time Frame
Through study completion, approximately 6 months
Title
Changes from baseline in total body water measured by Bioelectrical Impedance Analysis
Time Frame
Through study completion, approximately 6 months
Title
Changes from baseline in extracellular water measured by Bioelectrical Impedance Analysis
Time Frame
Through study completion, approximately 6 months
Title
Changes from baseline in basal metabolic rate measured by Bioelectrical Impedance Analysis
Time Frame
Through study completion, approximately 6 months
10. Eligibility
Sex
Male
Gender Based
Yes
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
49 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Written voluntary informed consent to participate in the study
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 who have undergone weight control procedures (weight loss medicine, surgical therapy, exercise therapy, bariatric diet, etc.) at a medical institution within 3 months before the screening
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)
Facility Information:
Facility Name
Applied Bio-Pharmatech Kurume Clinical Pharmacology Clinic
City
Kurume
State/Province
Fukuoka
ZIP/Postal Code
830-0011
Country
Japan
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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A Study of RTA 402 in Obese Adults
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