NCT00388180

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
71

participants targeted

Target at P25-P50 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2004

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

October 13, 2006

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 16, 2006

Completed
Last Updated

March 19, 2012

Status Verified

February 1, 2011

First QC Date

October 13, 2006

Last Update Submit

March 15, 2012

Conditions

HypercholesterolemiaDyslipidaemiasObesity

Keywords

cholesterolinflammationfat

Outcome Measures

Primary Outcomes (1)

  • Body fat levels

Secondary Outcomes (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.

Interventions

GW501516DRUG
GW590735DRUG
Also known as: GW501516

Eligibility Criteria

Age18 Years - 55 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Body Mass Index in the range of 27 - 43 kg/m2
  • Waist circumference \> 95cm

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

GSK Investigational Site

Baton Rouge, Louisiana, 70808, United States

Location

Related Publications (1)

  • 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.

    PMID: 22814748DERIVED

MeSH Terms

Conditions

HypercholesterolemiaObesityInflammationPlatelet Glycoprotein IV Deficiency

Interventions

GW 5015162-methyl-2-(4-(((4-methyl-2-(4-trifluoromethylphenyl)-thiazol-5-ylcarbonyl)amino)methyl)phenoxy)propionic acid

Condition Hierarchy (Ancestors)

HyperlipidemiasDyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesOverweightOvernutritionNutrition DisordersBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsPathologic Processes

Study Officials

  • GSK Clinical Trials

    GlaxoSmithKline

    STUDY DIRECTOR

Study Design

Study Type
observational
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 13, 2006

First Posted

October 16, 2006

Study Start

December 1, 2004

Last Updated

March 19, 2012

Record last verified: 2011-02

Locations

US(1)