Phase I Study of RTA 402 in Obese Adults

Phase 1

Completed

• Conditions: Obese adult male

• Registration Number: JPRN-jRCT2080224778
• Lead Sponsor: Kyowa Kirin Co., Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-07-10
• Study Completion: 2020-11-06
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: completed
• Sex: Male
• Target Recruitment: 18

Inclusion Criteria

1) Written voluntary informed consent to participate in the study
2) Male aged >= 20 and < 50 years at the time of consent
3) BMI >= 25.0 kg/m2 measured at screening
4) Waist circumference (umbilical position) >= 85 cm measured at screening.
5) MRI-measured visceral fat area >= 100 cm2 measured at screening

Exclusion Criteria

1) 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
2) Subjects with conditions requiring treatment other than obesity
3) 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 & Design

• Study Type: Interventional
• Study Design: Not specified