Obese adult male
Conditions
Sponsors
Kyowa Kirin Co., Ltd.
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1) Written voluntary informed consent to participate in the study 2) Male aged >= 20 and = 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
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| exploratory Changes from baseline in the following variables: Weight, Waist, Body composition(Fat Mass, Muscle Mass etc.) | — |
Secondary
| Measure | Time frame |
|---|---|
| safety Adverse events, Laboratory data, Vital Signs, 12-Lead electrocardiogram | — |
Countries
Japan
Outcome results
None listed