A Study of RTA 402 in Obese Adults
- Registration Number
- NCT04018339
- Lead Sponsor
- Kyowa Kirin Co., Ltd.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 22
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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo - RTA 402 5mg or 10mg oral administration Bardoxolone methyl -
- Primary Outcome Measures
Name Time Method 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 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 extracellular water measured by Bioelectrical Impedance Analysis 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 abdominal subcutaneous adipose tissue measured by Magnetic Resonance Imaging Through study completion, approximately 6 months Changes from baseline in weight measured by Bioelectrical Impedance Analysis 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 total body 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Applied Bio-Pharmatech Kurume Clinical Pharmacology Clinic
🇯🇵Kurume, Fukuoka, Japan