drugset / Trial / NCT00165685

A Comparative Study of KES524 in Patients With Obesity Disease

NCT00165685

Phase 3 Completed Eisai Inc.
RandomizedParallel-groupDouble-blindTreatment

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).

Timeline

Start
2004-07
Primary completion
2007-03
Completion
2007-03

Drugs

EvaluationDrugModalityDoseRoute
Subject Sibutramine Small molecule

Indications