Dyslipidaemias, Hypercholesterolemia, Obesity
Conditions
Keywords
cholesterol, inflammation, fat
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.
Sponsors
GlaxoSmithKline
Eligibility
Sex/Gender
MALE
Age
18 Years to 55 Years
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Body fat levels | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
United States
Outcome results
None listed