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Sponsors and Collaborators: |
University of Pennsylvania Eli Lilly and Company |
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Information provided by: | University of Pennsylvania |
ClinicalTrials.gov Identifier: | NCT00327002 |
Agents that increase HDL-C via reverse cholesterol transport could provide a new therapeutic option for the prevention of atherosclerotic cardiovascular disease. The investigators propose to investigate the effects of LY518674 on components that may likely affect atherogenesis in patients with the metabolic syndrome including HDL-C metabolism and reverse cholesterol transport pathways, the inflammatory response, and oxidative stress in human subjects.
As an agonist of the nuclear peroxisome proliferator activated receptor (PPAR) alpha, LY518674 may affect the transcription of genes that encode various proteins involved in atherogenesis. This study will explore the consequences of altered transcription such as changes in messenger ribonucleic acid (mRNA) and protein levels as well as protein activity.
Condition | Intervention | Phase |
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Metabolic Syndrome X |
Drug: LY518674 |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Mechanistic Study of the Effects of LY518674 on HDL C Metabolism |
Estimated Enrollment: | 40 |
Study Start Date: | January 2006 |
Estimated Study Completion Date: | November 2006 |
Study Objectives
I. Primary Objective:
II. Secondary Objectives:
Study Design:
Study H8D-MC-EMBG is a single site, randomized, placebo-controlled, double-blind, parallel study. A minimum of 40 subjects with low HDL cholesterol and metabolic syndrome will be randomized to receive double-blind administration of LY518674 100 mcg/day or placebo for 8 weeks. There is a safety visit every 2 weeks after treatment has been initiated, resulting in 7 visits over 10 weeks. There are 2 inpatient visits at zero and eight weeks.
Ages Eligible for Study: | 18 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
At least two of the following criteria ([a], [b], [c], or [d]) listed below:
Exclusion Criteria:
Potential study subjects may not be entered into the study if any of the following apply:
Lipid-altering medications that meet any of the following criteria prior to the screening visit, are planned or are likely to be required during the course of the study:
Have thyroid-stimulating hormone (TSH) levels outside normal reference range for the central laboratory.
Subjects who are clinically euthyroid and on stable thyroid replacement therapy for 2 months prior to screening and who are anticipated to remain on this dose throughout the trial period are acceptable exceptions to this criterion.
United States, Pennsylvania | |
John Millar | |
Philadelphia, Pennsylvania, United States, 19104 |
Principal Investigator: | Daniel Rader, MD | University of Pennsylvania |
Study ID Numbers: | 804137 PALMS, GCRC # 0995 |
Study First Received: | May 15, 2006 |
Last Updated: | January 18, 2007 |
ClinicalTrials.gov Identifier: | NCT00327002 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Low HDL Metabolic syndrome low HDL Cholesterol in setting of metabolic syndrome |
Hyperinsulinism Metabolic Diseases Metabolic Syndrome X Insulin Resistance |
Glucose Metabolism Disorders Metabolic Disorder Abdominal Obesity Metabolic Syndrome |
Hyperinsulinism Metabolic Diseases Pathologic Processes Disease |
Metabolic Syndrome X Syndrome Insulin Resistance Glucose Metabolism Disorders |