Ignite Creation Date:
2024-05-05 @ 11:54 AM
Last Modification Date:
2024-10-26 @ 9:15 AM
Study NCT ID:
NCT00165685
Status:
COMPLETED
Last Update Posted:
2010-01-29
First Post:
2005-09-12
Brief Title:
A Comparative Study of KES524 in Patients With Obesity Disease
Sponsor:
Eisai Limited
Organization:
Eisai Inc
Study Overview
Official Title:
A Double-Blind Placebo-Controlled Comparative Study of KES524 in Patients With Obesity Disease
Status:
COMPLETED
Status Verified Date:
2010-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 VS ratio by abdominal CT scan HbA1c TG and HDL-C secondary endpoints
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None