A Study of RTA 402 in Obese Adults

• Status: Completed
• Trial end date: 2020-06-18
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Kyowa Kirin Co., Ltd.

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)