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

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

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.

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