A Study of RTA 402 in Obese Adults

Study Overview
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Brief Summary
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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.

Official Title
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Phase I Study of RTA 402 in Obese Adults

Conditions
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Obese Adult Male

Intervention / Treatment
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* Drug: Bardoxolone methyl
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 49 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: RTA 402 5mg or 10mg oral administration<br> | Drug: Bardoxolone methyl<br>* Bardoxolone methyl 5 mg capsules<br>* Other names: RTA 402;|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Capsules containing an inert placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bardoxolone Methyl, Obese adult, body weight, body composition