An Exploratory Study To Look At The Effect Of Two Investigational Drugs On Body Fat And Inflammation
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ClinicalTrials.gov Identifier: NCT00388180 |
Recruitment Status :
Completed
First Posted : October 16, 2006
Last Update Posted : March 19, 2012
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Condition or disease | Intervention/treatment |
---|---|
Hypercholesterolemia Dyslipidaemias Obesity | Drug: GW501516 Drug: GW590735 |
Study Type : | Observational |
Actual Enrollment : | 71 participants |
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 |
Study Start Date : | December 2004 |

- Drug: GW501516
- Drug: GW590735
Other Name: GW501516
- Body fat levels
- 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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Ages Eligible for Study: | 18 Years to 55 Years (Adult) |
Sexes Eligible for Study: | Male |
Accepts Healthy Volunteers: | Yes |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00388180
United States, Louisiana | |
GSK Investigational Site | |
Baton Rouge, Louisiana, United States, 70808 |
Study Director: | GSK Clinical Trials | GlaxoSmithKline |
Responsible Party: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00388180 |
Other Study ID Numbers: |
PAD100958 |
First Posted: | October 16, 2006 Key Record Dates |
Last Update Posted: | March 19, 2012 |
Last Verified: | February 2011 |
cholesterol inflammation fat |
Hypercholesterolemia Dyslipidemias Inflammation Pathologic Processes |
Hyperlipidemias Lipid Metabolism Disorders Metabolic Diseases |