A Study of RTA 402 in Obese Adults

Phase I Study of RTA 402 in Obese Adults

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 Overview

• Status: Completed
• Conditions: Obese Adult Male
• Intervention / Treatment: Drug: Bardoxolone methyl; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 22
• Phase: Phase 1

Contacts and Locations

Study Locations

• Japan
  • Fukuoka
    • Kurume, Fukuoka, Japan, 830-0011
      • Applied Bio-Pharmatech Kurume Clinical Pharmacology Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 49 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; Capsules containing an inert placebo
Experimental: RTA 402 5mg or 10mg oral administration	Drug: Bardoxolone methyl; Bardoxolone methyl 5 mg capsules; Other Names: RTA 402

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Kyowa Kirin Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): August 20, 2019
• Primary Completion (Actual): May 28, 2020
• Study Completion (Actual): June 18, 2020

Study Registration Dates

• First Submitted: July 10, 2019
• First Submitted That Met QC Criteria: July 11, 2019
• First Posted (Actual): July 12, 2019

Study Record Updates

• Last Update Posted (Actual): June 23, 2020
• Last Update Submitted That Met QC Criteria: June 22, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Keywords: body composition; Bardoxolone Methyl; Obese adult; body weight
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity
• Other Study ID Numbers: RTA 402-010

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No