Back to resultsAn Exploratory Study To Look At The Effect Of Two Investigational Drugs On Body Fat And Inflammation
Primary Purpose
Hypercholesterolemia, Dyslipidaemias, Obesity
Status
Completed
Phase
Locations
United States
Study Type
Observational
Intervention
GW501516
GW590735
Sponsored by
About this trial
This is an observational trial for Hypercholesterolemia focused on measuring cholesterol, inflammation, fat
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
Sites / Locations
- GSK Investigational Site
Outcomes
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00388180
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
Study Type
Observational
2. Study Status
Record Verification Date
February 2011
Overall Recruitment Status
Completed
Study Start Date
December 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlaxoSmithKline
4. Oversight
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypercholesterolemia, Dyslipidaemias, Obesity
Keywords
cholesterol, inflammation, fat
7. Study Design
Enrollment
71 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
GW501516
Intervention Type
Drug
Intervention Name(s)
GW590735
Other Intervention Name(s)
GW501516
Primary Outcome Measure Information:
Title
Body fat levels
Secondary Outcome Measure Information:
Title
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.
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
GSK Investigational Site
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70808
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
22814748
Citation
Olson EJ, Pearce GL, Jones NP, Sprecher DL. Lipid effects of peroxisome proliferator-activated receptor-delta 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.
Results Reference
derived
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An Exploratory Study To Look At The Effect Of Two Investigational Drugs On Body Fat And Inflammation
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