A Study of RTA 402 in Obese Adults

Kyowa Kirin Co., Ltd.22 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

SINGLE

Enrollment

Conditions

Obese Adult Male

Interventions

Bardoxolone methylDRUG

Bardoxolone methyl 5 mg capsules

PlaceboDRUG

Capsules containing an inert placebo

Eligibility

Sex: MALEMin age: 20 YearsMax age: 49 Years

Medical Language ↔ Plain English

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)

Locations (1)

Applied Bio-Pharmatech Kurume Clinical Pharmacology Clinic

Kurume, Fukuoka, Japan