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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00388180
First received: October 13, 2006
Last updated: March 15, 2012
Last verified: February 2011
  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
Hypercholesterolemia
Dyslipidaemias
Obesity
Drug: GW501516
Drug: GW590735

Study Type: Observational
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

Resource links provided by NLM:


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
Intervention Details:
    Drug: GW501516 Drug: GW590735
    Other Names:
    • GW590735
    • GW501516
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 GlaxoSmithKline
  More Information

No publications provided by GlaxoSmithKline

Additional 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
Study First Received: October 13, 2006
Last Updated: March 15, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
cholesterol
inflammation
fat

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

ClinicalTrials.gov processed this record on October 19, 2014