Skip to main content
OpenTrials
Completed

NCT Number: NCT04018339

A 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Obese Adult Male Body Weight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

20 year–49 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Applied Bio-Pharmatech Kurume Clinical Pharmacology Clinic

Kurume, Fukuoka, 830-0011, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Bardoxolone Methyl

Drug

Bardoxolone methyl 5 mg capsules

Other names: RTA 402

Placebo

Drug

Capsules containing an inert placebo

Primary outcomes

  1. Changes from baseline in weight measured by Bioelectrical Impedance Analysis

    Time frame: Through study completion, approximately 6 months

  2. Changes from baseline in fat mass measured by Dual Energy X-ray Absorption

    Time frame: Through study completion, approximately 6 months

  3. Changes from baseline in lean body mass measured by Dual Energy X-ray Absorption

    Time frame: Through study completion, approximately 6 months

  4. Changes from baseline in skeletal muscle mass index measured by Dual Energy X-ray Absorption

    Time frame: Through study completion, approximately 6 months

  5. Changes from baseline in waist

    Time frame: Through study completion, approximately 6 months

  6. Changes from baseline in grip

    Time frame: Through study completion, approximately 6 months

  7. Changes from baseline in visceral adipose tissue measured by Magnetic Resonance Imaging

    Time frame: Through study completion, approximately 6 months

  8. Changes from baseline in abdominal subcutaneous adipose tissue measured by Magnetic Resonance Imaging

    Time frame: Through study completion, approximately 6 months

  9. Changes from baseline in muscle mass measured by Magnetic Resonance Imaging

    Time frame: Through study completion, approximately 6 months

  10. Changes from baseline in body fat mass measured by Bioelectrical Impedance Analysis

    Time frame: Through study completion, approximately 6 months

  11. Changes from baseline in segmental muscle mass measured by Bioelectrical Impedance Analysis

    Time frame: Through study completion, approximately 6 months

  12. Changes from baseline in total body water measured by Bioelectrical Impedance Analysis

    Time frame: Through study completion, approximately 6 months

  13. Changes from baseline in extracellular water measured by Bioelectrical Impedance Analysis

    Time frame: Through study completion, approximately 6 months

  14. Changes from baseline in basal metabolic rate measured by Bioelectrical Impedance Analysis

    Time frame: Through study completion, approximately 6 months

Sponsors and collaborators

Lead sponsor

Kyowa Kirin Co., Ltd.

Industry

Registry information

Official study title

Phase I Study of RTA 402 in Obese Adults

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Jul 12, 2019
Registry last updated
Jun 23, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.