A Study of RTA 402 in Obese Adults

June 22, 2020 updated by: Kyowa Kirin Co., Ltd.

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
22

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Changes from baseline in weight measured by Bioelectrical Impedance Analysis
Time Frame: Through study completion, approximately 6 months
Through study completion, approximately 6 months
Changes from baseline in fat mass measured by Dual Energy X-ray Absorption
Time Frame: Through study completion, approximately 6 months
Through study completion, approximately 6 months
Changes from baseline in lean body mass measured by Dual Energy X-ray Absorption
Time Frame: Through study completion, approximately 6 months
Through study completion, approximately 6 months
Changes from baseline in skeletal muscle mass index measured by Dual Energy X-ray Absorption
Time Frame: Through study completion, approximately 6 months
Through study completion, approximately 6 months
Changes from baseline in waist
Time Frame: Through study completion, approximately 6 months
Through study completion, approximately 6 months
Changes from baseline in grip
Time Frame: Through study completion, approximately 6 months
Through study completion, approximately 6 months
Changes from baseline in visceral adipose tissue measured by Magnetic Resonance Imaging
Time Frame: Through study completion, approximately 6 months
Through study completion, approximately 6 months
Changes from baseline in abdominal subcutaneous adipose tissue measured by Magnetic Resonance Imaging
Time Frame: Through study completion, approximately 6 months
Through study completion, approximately 6 months
Changes from baseline in muscle mass measured by Magnetic Resonance Imaging
Time Frame: Through study completion, approximately 6 months
Through study completion, approximately 6 months
Changes from baseline in body fat mass measured by Bioelectrical Impedance Analysis
Time Frame: Through study completion, approximately 6 months
Through study completion, approximately 6 months
Changes from baseline in segmental muscle mass measured by Bioelectrical Impedance Analysis
Time Frame: Through study completion, approximately 6 months
Through study completion, approximately 6 months
Changes from baseline in total body water measured by Bioelectrical Impedance Analysis
Time Frame: Through study completion, approximately 6 months
Through study completion, approximately 6 months
Changes from baseline in extracellular water measured by Bioelectrical Impedance Analysis
Time Frame: Through study completion, approximately 6 months
Through study completion, approximately 6 months
Changes from baseline in basal metabolic rate measured by Bioelectrical Impedance Analysis
Time Frame: Through study completion, approximately 6 months
Through study completion, approximately 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Kyowa Kirin Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 20, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 28, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 18, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 10, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 11, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 12, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 23, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 22, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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