Overview

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

Status:
Completed
Trial end date:
1969-12-31
Target enrollment:
0
Participant gender:
Male
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.
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
GlaxoSmithKline
Criteria
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