A Comparative Study of KES524 in Patients With Obesity Disease

Eisai

Status and phase

Completed

Phase 3

Conditions

Obesity

Treatments

Drug: Sibutramine Hydrochloride Monohydrate

Study type

Interventional

Funder types

Industry

Identifiers

NCT00165685

KES524-J081-161

Details and patient eligibility

About

To investigate the efficacy and safety of KES524 in patients with obesity (visceral fat obesity with type 2 diabetes and dyslipidemia), a 52-week, double-blind, placebo-controlled comparative study is conducted. This study aims to examine superiority of KES524 to placebo by employing change and percent change in body weight (primary endpoints) and changes in proportion of subjects achieving ≧ 5% weight reduction, BMI, waist circumference, visceral fat area, subcutaneous fat area, V/S ratio by abdominal CT scan, HbA1c, TG and HDL-C (secondary endpoints).

Sex

All

Ages

20 to 64 years old

Volunteers

No Healthy Volunteers

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:
1. Patients with previously diagnosed type 2 diabetes and HbA1c between ≧6.1% and <9.0% at the start of observation period
2. 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