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

Sponsor

GlaxoSmithKline (Industry)

Overall Status

Completed

CT.gov ID

NCT00388180

Collaborator

(none)

Enrollment

Location

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hypercholesterolemia Dyslipidaemias Obesity	Drug: GW501516 Drug: GW590735

Study Design

Study Type:

Observational

Actual Enrollment :

71 participants

Official Title:

A Randomized, Double-blind, Parallel Group Study to Evaluate the Effect of 12-week Treatment With GW590735X (20ug) or GW501516X (10mg) Relative to Placebo on Measures of Adiposity and Inflammation in Overweight and Obese Subjects

Study Start Date :

Dec 1, 2004

Outcome Measures

Primary Outcome Measures

Body fat levels []

Secondary Outcome Measures

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. []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 55 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Yes

Inclusion criteria:

Body Mass Index in the range of 27 - 43 kg/m2
Waist circumference > 95cm

Exclusion criteria:

Clinically relevant abnormalities on screening ECG/holter, labs or medical examination
Use of tobacco within 6 months of the study
Regular strenuous exercise
Use of prescription or non-prescription medications, including vitamins and herbal/dietary supplements
LDL < 80mg/dL; TG <100mg/dL or >400mg/dL