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A Comparative Study of KES524 in Patients With Obesity Disease

Obesity Clinical Trial

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

Clinical Trial Summary

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).

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00165685
Study type Interventional
Source Eisai Inc.
Contact
Status Completed
Phase Phase 3
Start date July 2004
Completion date March 2007
View Details
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