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

Obesity Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00388180
• Other study ID #: PAD100958
• 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
• 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

Related Conditions & MeSH terms

• Dyslipidaemias
• Dyslipidemias
• Hypercholesterolemia
• Inflammation
• Obesity

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.