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

GlaxoSmithKline71 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Hypercholesterolemia Dyslipidaemias Obesity

Interventions

GW501516DRUG

Eligibility

Sex: MALEMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Body fat levels

Secondary Outcomes

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.

Data from ClinicalTrials.gov

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