Status:
COMPLETED
A Study of RTA 402 in Obese Adults
Lead Sponsor:
Kyowa Kirin Co., Ltd.
Conditions:
Obese Adult Male
Eligibility:
MALE
20-49 years
Phase:
PHASE1
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
- 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
- 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)
Key Trial Info
Start Date :
August 20 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 18 2020
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT04018339
Start Date
August 20 2019
End Date
June 18 2020
Last Update
June 23 2020
Active Locations (1)
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1
Applied Bio-Pharmatech Kurume Clinical Pharmacology Clinic
Kurume, Fukuoka, Japan, 830-0011