An Exploratory Study To Look At The Effect Of Two Investigational Drugs On Body Fat And Inflammation

Completed

• Conditions: Hypercholesterolemia; Dyslipidaemias; Obesity

• Registration Number: NCT00388180
• Lead Sponsor: GlaxoSmithKline

Brief Summary

The investigational drugs administered in this study activate proteins called PPARs. Data in the scientific literature on PPARs, as well as animal data and early clinical data generated by GSK with these drugs, suggest that activation of PPARs may cause the body to increase its use of fatty acids for energy, and lead to a reduction in body fat. There are also data to suggest a role for PPARs in regulating lipid (e.g., cholesterol) levels and inflammation. These and other activities of PPARs are being further explored in this clinical study.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-12
• Study First Submitted: 2006-10-13
• Study First Submitted QC: 2006-10-13
• Study First Posted: 2006-10-16
• Status Verified: 2011-02
• Last Update Submitted: 2012-03-15
• Last Update Posted: 2012-03-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 71

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Body fat levels

Secondary Outcome Measures

Name	Time	Method
Levels of multiple proteins/biomarkers in blood and fat tissue, as well as specific lipid in muscle and liver (via imaging). Gene expression in blood and fat tissue.

Trial Locations

Locations (1)

GSK Investigational Site; 🇺🇸 Baton Rouge, Louisiana, United States