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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. Identifier: NCT00388180
Recruitment Status : Completed
First Posted : October 16, 2006
Last Update Posted : March 19, 2012
Information provided by (Responsible Party):

Tracking Information
First Submitted Date October 13, 2006
First Posted Date October 16, 2006
Last Update Posted Date March 19, 2012
Study Start Date December 2004
Primary Completion Date Not Provided
Current Primary Outcome Measures
 (submitted: October 13, 2006)
Body fat levels
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: October 13, 2006)
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.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title An Exploratory Study To Look At The Effect Of Two Investigational Drugs On Body Fat And Inflammation
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
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.
Detailed Description Not Provided
Study Type Observational
Study Design Not Provided
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Not Provided
Study Population Not Provided
  • Hypercholesterolemia
  • Dyslipidaemias
  • Obesity
  • Drug: GW501516
  • Drug: GW590735
    Other Name: GW501516
Study Groups/Cohorts Not Provided
Publications * Olson EJ, Pearce GL, Jones NP, Sprecher DL. Lipid effects of peroxisome proliferator-activated receptor-δ agonist GW501516 in subjects with low high-density lipoprotein cholesterol: characteristics of metabolic syndrome. Arterioscler Thromb Vasc Biol. 2012 Sep;32(9):2289-94. doi: 10.1161/ATVBAHA.112.247890. Epub 2012 Jul 19.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: November 9, 2007)
Original Enrollment
 (submitted: October 13, 2006)
Study Completion Date Not Provided
Primary Completion Date Not Provided
Eligibility 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
Sexes Eligible for Study: Male
Ages 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
Administrative Information
NCT Number NCT00388180
Other Study ID Numbers PAD100958
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Current Responsible Party GlaxoSmithKline
Original Responsible Party Not Provided
Current Study Sponsor GlaxoSmithKline
Original Study Sponsor Same as current
Collaborators Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
PRS Account GlaxoSmithKline
Verification Date February 2011