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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00388180
Recruitment Status : Completed
First Posted : October 16, 2006
Last Update Posted : March 19, 2012
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief 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.

Condition or disease Intervention/treatment
Hypercholesterolemia Dyslipidaemias Obesity Drug: GW501516 Drug: GW590735

Study Design

Study Type : Observational
Actual Enrollment : 71 participants
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
Study Start Date : December 2004

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Intervention Details:
    Drug: GW501516 Drug: GW590735
    Other Name: GW501516

Outcome Measures

Primary Outcome Measures :
  1. Body fat levels

Secondary Outcome Measures :
  1. 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.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00388180


Locations
United States, Louisiana
GSK Investigational Site
Baton Rouge, Louisiana, United States, 70808
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00388180     History of Changes
Other Study ID Numbers: PAD100958
First Posted: October 16, 2006    Key Record Dates
Last Update Posted: March 19, 2012
Last Verified: February 2011

Keywords provided by GlaxoSmithKline:
cholesterol
inflammation
fat

Additional relevant MeSH terms:
Inflammation
Hypercholesterolemia
Dyslipidemias
Pathologic Processes
Hyperlipidemias
Lipid Metabolism Disorders
Metabolic Diseases