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OpenTrials
Completed

NCT Number: NCT00388180

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

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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Key information

Conditions

Hypercholesterolemia Body Weight Dyslipidaemias Dyslipidemias Hyperlipidemias Inflammation Lipid Metabolism Disorders Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathologic Processes Pathological Conditions, Signs and Symptoms Platelet Glycoprotein IV Deficiency Signs and Symptoms

Age range

18 year–55 year

Sex eligibility

Male

Study type

Observational

Primary location

GSK Investigational Site

Baton Rouge, Louisiana, 70808, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

GW501516

Drug

GW590735

Drug

Other names: GW501516

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.

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study 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

Important dates

Study start
2004
First posted
Oct 16, 2006
Registry last updated
Mar 19, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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