A Comparative Study of KES524 in Patients With Obesity Disease

Inclusion criteria

• Patients with ≧25 kg/m2 of BMI at the start of the observation period
• Patients with visceral fat area ≧100 cm2 measured with abdominal CT scan
• Patients with the following two health impairments:

• Patients with previously diagnosed type 2 diabetes and HbA1c between ≧6.1% and <9.0% at the start of observation period
• Patients with ≧150 mg/dL of triglyceride (TG), and/or <40 mg/dL of high-density lipoprotein cholesterol (HDL-C) for serum lipid parameters as dyslipidemic index at the start of the observation period
• Patients continuously receiving diet therapy for 8 weeks or longer before the start of the observation period
• Patients not receiving antidiabetic (12 weeks), antihyperlipidemics (4 weeks) and/or antihypertensive (4 weeks) drugs. If used, those who have received a consistent dosage and administration beginning more than 4 weeks (more than 12 weeks for antidiabetics) before the start of the observation period
• Patients with ambulatory treatment aged between ≧20 years and <65 years at the time of obtaining informed consent
• Patients who are given full explanation about the study objective and contents and can give written informed consent

Exclusion criteria

• Patients with pulse rate of ≧100/min during the observation period
• Patients with systolic blood pressure of ≧160 mmHg and/or with diastolic blood pressure of ≧100 mmHg during the observation period
• Patients with body weight loss of ≧3% as compared to that at the start of the observation period, or body mass index (BMI) that is reduced to <25 kg/m2 during the observation period
• Patients who have received insulin within 12 weeks before the start of the observation period
• Patients with present illness or past history of severe eating disorder (e.g., anorexia nervosa or bulimia nervosa)
• Patients with present illness or past history of drug allergy or severe allergic disease(s)
• Patients with present illness or past history of the following disorders:
• Coronary artery disease (myocardial infarction, angina), heart failure
• Serious diseases such as cardiovascular (severe tachycardiac heart failure), renal (renal failure), hepatic (severe hepatitis, cirrhosis), pancreatic (severe pancreatitis), psychotic (severe depression, schizophrenia, alcohol addict, drug addict) disorders
• Pregnant or lactating women, or women who intend to become pregnant during the study period
• Patients who previously participated in and were treated in another clinical study of KES524
• Patients who have received another study drug within 24 weeks before starting observation period of this study
• Patients who are judged to be ineligible for study entry by the investigator or subinvestigator