Overview

A Comparative Study of KES524 in Patients With Obesity Disease

Status:
Completed
Trial end date:
2007-03-01
Target enrollment:
Participant gender:
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).
Phase:
Phase 3
Details
Lead Sponsor:
Eisai Limited
Treatments:
Sibutramine