Ignite Creation Date:
2024-05-05 @ 4:49 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00327002
Status:
COMPLETED
Last Update Posted:
2015-12-11
First Post:
2006-05-15
Brief Title:
A Mechanistic Study of the Effects of LY518674 on High-Density Lipoprotein Cholesterol HDL-C Metabolism
Sponsor:
University of Pennsylvania
Organization:
University of Pennsylvania
Study Overview
Official Title:
A Mechanistic Study of the Effects of LY518674 on HDL C Metabolism
Status:
COMPLETED
Status Verified Date:
2009-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
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
Detailed Description:
Study Objectives
I Primary Objective
To determine the effects of LY518674 on the Apo A-I production rate calculated from the fractional synthetic rate and the fractional catabolic rate in subjects with the metabolic syndrome and low HDL-C
II Secondary Objectives
To determine the effects of LY518674 on markers of reverse cholesterol transport by analyzing changes in serum cholesterol efflux capacity an in vitro cell-based assay
To determine the effects of LY518674 on the activity of lecithin cholesterol acyltransferase LCAT cholesterol ester transfer protein CETP lipoprotein lipase hepatic lipase and endothelial lipase
To determine the effects of LY518674 on plasma lipids lipid subfractions free fatty acids and the free fatty acid metabolite beta-OH butyrate
To determine the effects of LY518674 on high-density lipoprotein HDL low-density lipoprotein LDL and very low-density lipoprotein VLDL particle size using nuclear magnetic resonance NMR
To determine the effects of LY518674 on Apo A-II and Apo B-100 kinetics
To determine the effects of LY518674 on hsCRP
To determine the safety and tolerability of LY518674
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 mcgday 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
I Primary Objective
To determine the effects of LY518674 on the Apo A-I production rate calculated from the fractional synthetic rate and the fractional catabolic rate in subjects with the metabolic syndrome and low HDL-C
II Secondary Objectives
To determine the effects of LY518674 on markers of reverse cholesterol transport by analyzing changes in serum cholesterol efflux capacity an in vitro cell-based assay
To determine the effects of LY518674 on the activity of lecithin cholesterol acyltransferase LCAT cholesterol ester transfer protein CETP lipoprotein lipase hepatic lipase and endothelial lipase
To determine the effects of LY518674 on plasma lipids lipid subfractions free fatty acids and the free fatty acid metabolite beta-OH butyrate
To determine the effects of LY518674 on high-density lipoprotein HDL low-density lipoprotein LDL and very low-density lipoprotein VLDL particle size using nuclear magnetic resonance NMR
To determine the effects of LY518674 on Apo A-II and Apo B-100 kinetics
To determine the effects of LY518674 on hsCRP
To determine the safety and tolerability of LY518674
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 mcgday 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| GCRC 0995 | None | None | None |