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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RTA 402 5mg or 10mg oral administration | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bardoxolone methyl | Drug | Bardoxolone methyl 5 mg capsules |
|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Applied Bio-Pharmatech Kurume Clinical Pharmacology Clinic | Kurume | Fukuoka | 830-0011 | Japan |
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| ID | Term |
|---|---|
| D001835 | Body Weight |
| ID | Term |
|---|---|
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C445068 | bardoxolone methyl |
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| Placebo | Drug | Capsules containing an inert placebo |
|
| 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 |