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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

71 participants

Study Classification

OBSERVATIONAL

Study Start Date

2004-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Hypercholesterolemia Dyslipidaemias Obesity

Interventions

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GW501516

Intervention Type DRUG

GW590735

Intervention Type DRUG

Other Intervention Names

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GW501516

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes