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A Study of RTA 402 in Obese Adults

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ClinicalTrials.gov Identifier: NCT04018339
Recruitment Status : Recruiting
First Posted : July 12, 2019
Last Update Posted : July 16, 2019
Sponsor:
Information provided by (Responsible Party):
Kyowa Kirin Co., Ltd.

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.

Condition or disease Intervention/treatment Phase
Obese Adult Male Drug: Bardoxolone methyl Drug: Placebo Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 18 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Other
Official Title: Phase I Study of RTA 402 in Obese Adults
Estimated Study Start Date : August 2019
Estimated Primary Completion Date : May 2020
Estimated Study Completion Date : May 2020

Arm Intervention/treatment
Experimental: RTA 402 5mg or 10mg oral administration Drug: Bardoxolone methyl
Bardoxolone methyl 5 mg capsules
Other Name: RTA 402

Placebo Comparator: Placebo Drug: Placebo
Capsules containing an inert placebo




Primary Outcome Measures :
  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 ]


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Ages Eligible for Study:   20 Years to 49 Years   (Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04018339


Contacts
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Contact: Kyowa Kirin Co., Ltd. 090-5561-3180 clinical.info.jp@kyowakirin.com

Locations
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Japan
Applied Bio-Pharmatech Kurume Clinical Pharmacology Clinic Recruiting
Kurume, Fukuoka, Japan, 830-0011
Contact: Satoshi Yoshida    0942-35-3705    yoshida.sts@kurumecp.jp   
Sponsors and Collaborators
Kyowa Kirin Co., Ltd.

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Responsible Party: Kyowa Kirin Co., Ltd.
ClinicalTrials.gov Identifier: NCT04018339     History of Changes
Other Study ID Numbers: RTA 402-010
First Posted: July 12, 2019    Key Record Dates
Last Update Posted: July 16, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Kyowa Kirin Co., Ltd.:
Bardoxolone Methyl
Obese adult
body weight
body composition

Additional relevant MeSH terms:
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Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms