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

Completed

Conditions studied: Hypercholesterolemia, Dyslipidaemias, Obesity

In brief

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.

Key facts

Study ID

NCT00388180

Run by

GlaxoSmithKline

People needed

71

Starts

2004-12-01

Last updated by the study team

2012-03-19

Who can join

Age: 18 and older, up to 55. Sex: male. Healthy volunteers: accepted.

You may qualify if…

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

You may not qualify if…

• 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

Where it is running

• GSK Investigational Site — Baton Rouge, Louisiana, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.