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

GlaxoSmithKline (GSK)

Status: Completed

Conditions: Dyslipidaemias; Hypercholesterolemia; Obesity

Treatments: Drug: GW590735; Drug: GW501516

Study type: Observational

Funder types: Industry

Identifiers

NCT00388180

PAD100958

Details and patient eligibility

About

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.

Enrollment: 71 patients

Sex: Male

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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