A Study of RTA 402 in Obese Adults

Kyowa Kirin

Status and phase: Completed; Phase 1

Conditions: Obese Adult Male

Treatments: Drug: Bardoxolone methyl; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT04018339

RTA 402-010

Details and patient eligibility

About

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.

Enrollment: 22 patients

Sex: Male

Ages: 20 to 49 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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22 participants in 2 patient groups, including a placebo group

RTA 402 5mg or 10mg oral administration

Experimental group

Treatment:

Drug: Bardoxolone methyl

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo