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

Sponsored by:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00388180

Purpose

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.

Condition	Intervention	Phase
Obesity Hypercholesterolemia	Drug: GW501516 Drug: GW590735	Phase I

Genetics Home Reference related topics: hypercholesterolemia

MedlinePlus related topics: Cholesterol Obesity

Drug Information available for: Cholest-5-en-3-ol (3beta)- GW 590735

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Parallel Assignment, Pharmacodynamics Study
Official Title:	A Randomized, Double-Blind, Parallel Group Study to Evaluate the Effect of 12-Week Treatment With GW590735X (20ug) or GW501516X (10mg) Relative to Placebo on Measures of Adiposity and Inflammation in Overweight and Obese Subjects

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

Body fat levels

Secondary Outcome Measures:

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.

Enrollment:	71
Study Start Date:	December 2004

Eligibility

Ages Eligible for Study:	18 Years to 55 Years
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00388180

Locations

United States, Louisiana
GSK Investigational Site
Baton Rouge, Louisiana, United States, 70808

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials, MD

GlaxoSmithKline

More Information

Responsible Party:	GSK ( Study Director )
Study ID Numbers:	PAD100958
Study First Received:	October 13, 2006
Last Updated:	October 9, 2008
ClinicalTrials.gov Identifier:	NCT00388180
Health Authority:	United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:

cholesterol
fat
inflammation

Study placed in the following topic categories:

Obesity
Hyperlipidemias
Metabolic Diseases
Overweight
Inflammation
Body Weight
Signs and Symptoms

Nutrition Disorders
Overnutrition
Metabolic disorder
Hypercholesterolemia
Dyslipidemias
Lipid Metabolism Disorders

Additional relevant MeSH terms:

Pathologic Processes

ClinicalTrials.gov processed this record on January 16, 2009