Obese Adult Male
Conditions
Keywords
Bardoxolone Methyl, Obese adult, body weight, body composition
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.
Interventions
Bardoxolone methyl 5 mg capsules
DRUGPlacebo
Capsules containing an inert placebo
Sponsors
Kyowa Kirin Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
MALE
Age
20 Years to 49 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes from baseline in weight measured by Bioelectrical Impedance Analysis | Through study completion, approximately 6 months |
| Changes from baseline in fat mass measured by Dual Energy X-ray Absorption | Through study completion, approximately 6 months |
| Changes from baseline in lean body mass measured by Dual Energy X-ray Absorption | Through study completion, approximately 6 months |
| Changes from baseline in skeletal muscle mass index measured by Dual Energy X-ray Absorption | Through study completion, approximately 6 months |
| Changes from baseline in waist | Through study completion, approximately 6 months |
| Changes from baseline in grip | Through study completion, approximately 6 months |
| Changes from baseline in visceral adipose tissue measured by Magnetic Resonance Imaging | Through study completion, approximately 6 months |
| Changes from baseline in abdominal subcutaneous adipose tissue measured by Magnetic Resonance Imaging | Through study completion, approximately 6 months |
| Changes from baseline in muscle mass measured by Magnetic Resonance Imaging | Through study completion, approximately 6 months |
| Changes from baseline in body fat mass measured by Bioelectrical Impedance Analysis | Through study completion, approximately 6 months |
| Changes from baseline in segmental muscle mass measured by Bioelectrical Impedance Analysis | Through study completion, approximately 6 months |
| Changes from baseline in total body water measured by Bioelectrical Impedance Analysis | Through study completion, approximately 6 months |
| Changes from baseline in extracellular water measured by Bioelectrical Impedance Analysis | Through study completion, approximately 6 months |
| Changes from baseline in basal metabolic rate measured by Bioelectrical Impedance Analysis | Through study completion, approximately 6 months |
Countries
Japan
Outcome results
None listed