A Comparative Study of KES524 in Patients With Obesity Disease

Condition(s) targeted: Obesity

Intervention: Sibutramine Hydrochloride Monohydrate (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Eisai Limited

Official(s) and/or principal investigator(s):
Yutaka Takeuchi, Study Director, Affiliation: Development Clinical Research Dept., Clinical Research Center

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).

Official title: A Double-Blind, Placebo-Controlled, Comparative Study of KES524 in Patients With Obesity Disease

Study design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study

Primary outcome: Change and percent change in body weight

Secondary outcome:

Proportion of subjects achieving ≧5% weight reduction

Change in BMI

Change in waist circumference

Change in visceral fat area, subcutaneous fat area, and V/S ratio by abdominal CT scan

Change in HbA1c

Change and percent change in fasting serum lipids (TG, HDL-C)

Minimum age: 20 Years. Maximum age: 64 Years. Gender(s): Both.

Criteria:

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

Chiba, Chiba Prefecture 260-0856, Japan

Kashiwa, Chiba Prefecture 277-0004, Japan

Sakura, Chiba Prefecture 285-0841, Japan

Fukushima, Fukushima Prefecture 960-1247, Japan

Koriyama, Fukushima Prefecture 963-8022, Japan

Maebashi, Gunma Prefecture 371-0034, Japan

Tsuchiura, Ibaraki Prefecture 300-0053, Japan

Hitachiota, Ibaraki Prefecture 313-0014, Japan

Tsukuba, Ibaraki Prefecture 305-0005, Japan

Mito, Ibaraki Prefecture 311-4153, Japan

Naka, Ibaraki Prefecture 311-0113, Japan

Sendai, Miyagi Prefecture 980-0011, Japan

Sendai, Miyagi Prefecture 980-0872, Japan

Itabashi-ku, Tokyo 173-0032, Japan

Shibuya-ku, Tokyo 150-0012, Japan

Chuo-ku, Tokyo 103-0026, Japan

Chiyoda-ku, Tokyo 101-0062, Japan

Chiyoda-ku, Tokyo 102-0071, Japan

Minato-ku, Tokyo 105-0003, Japan

Hachioji, Tokyo 193-0944, Japan

Starting date: July 2004
Ending date: November 2007
Last updated: May 8, 2008