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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00388180
Other study ID # PAD100958
Secondary ID
Status Completed
Phase N/A
First received October 13, 2006
Last updated March 15, 2012
Start date December 2004

Study information

Verified date February 2011
Source GlaxoSmithKline
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 71
Est. completion date
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years to 55 Years
Eligibility 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

Study Design

N/A


Intervention

Drug:
GW501516

GW590735


Locations

Country Name City State
United States GSK Investigational Site Baton Rouge Louisiana

Sponsors (1)

Lead Sponsor Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Body fat levels
Secondary 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.
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