NCT04018339

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Aug 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 10, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 12, 2019

Completed
1 month until next milestone

Study Start

First participant enrolled

August 20, 2019

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 28, 2020

Completed
21 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 18, 2020

Completed
Last Updated

June 23, 2020

Status Verified

June 1, 2020

Enrollment Period

9 months

First QC Date

July 10, 2019

Last Update Submit

June 22, 2020

Conditions

Obese Adult Male

Keywords

Bardoxolone MethylObese adultbody weightbody composition

Outcome Measures

Primary Outcomes (14)

  • 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

Study Arms (2)

RTA 402 5mg or 10mg oral administration

EXPERIMENTAL
Drug: Bardoxolone methyl

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

Bardoxolone methylDRUG

Bardoxolone methyl 5 mg capsules

Also known as: RTA 402
RTA 402 5mg or 10mg oral administration
PlaceboDRUG

Capsules containing an inert placebo

Placebo

Eligibility Criteria

Age20 Years - 49 Years
Sexmale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Applied Bio-Pharmatech Kurume Clinical Pharmacology Clinic

Kurume, Fukuoka, 830-0011, Japan

Location

MeSH Terms

Conditions

Body Weight

Interventions

bardoxolone methyl

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 10, 2019

First Posted

July 12, 2019

Study Start

August 20, 2019

Primary Completion

May 28, 2020

Study Completion

June 18, 2020

Last Updated

June 23, 2020

Record last verified: 2020-06

Locations

JP(1)