Clinical trial NCT04018339: A Study of RTA 402 in Obese Adults
Official title: Phase I Study of RTA 402 in Obese Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Obese Adult Male
Keywords: Bardoxolone Methyl
Obese adult
body weight
body composition
Lead sponsor: Kyowa Kirin Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2019-07-12
Enrollment: 22
Sex: MALE
Minimum age (years): 20
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


Eligibility 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)

Primary outcomes:
measure: Changes from baseline in weight measured by Bioelectrical Impedance Analysis
timeFrame: Through study completion, approximately 6 months
measure: Changes from baseline in fat mass measured by Dual Energy X-ray Absorption
timeFrame: Through study completion, approximately 6 months
measure: Changes from baseline in lean body mass measured by Dual Energy X-ray Absorption
timeFrame: Through study completion, approximately 6 months
measure: Changes from baseline in skeletal muscle mass index measured by Dual Energy X-ray Absorption
timeFrame: Through study completion, approximately 6 months
measure: Changes from baseline in waist
timeFrame: Through study completion, approximately 6 months
measure: Changes from baseline in grip
timeFrame: Through study completion, approximately 6 months
measure: Changes from baseline in visceral adipose tissue measured by Magnetic Resonance Imaging
timeFrame: Through study completion, approximately 6 months
measure: Changes from baseline in abdominal subcutaneous adipose tissue measured by Magnetic Resonance Imaging
timeFrame: Through study completion, approximately 6 months
measure: Changes from baseline in muscle mass measured by Magnetic Resonance Imaging
timeFrame: Through study completion, approximately 6 months
measure: Changes from baseline in body fat mass measured by Bioelectrical Impedance Analysis
timeFrame: Through study completion, approximately 6 months
measure: Changes from baseline in segmental muscle mass measured by Bioelectrical Impedance Analysis
timeFrame: Through study completion, approximately 6 months
measure: Changes from baseline in total body water measured by Bioelectrical Impedance Analysis
timeFrame: Through study completion, approximately 6 months
measure: Changes from baseline in extracellular water measured by Bioelectrical Impedance Analysis
timeFrame: Through study completion, approximately 6 months
measure: Changes from baseline in basal metabolic rate measured by Bioelectrical Impedance Analysis
timeFrame: Through study completion, approximately 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Kurume
country: Japan
facility: Applied Bio-Pharmatech Kurume Clinical Pharmacology Clinic
state: Fukuoka
Study officials:
References: