Atherosclerosis Clinical Trial
Official title:
Effect of Alirocumab on Reverse Cholesterol Transport in Humans
Alirocumab is an injectable treatment for elevated blood cholesterol. The hypothesis of this study is that it also increases cholesterol excretion from the body into the stool, a process sometimes called reverse cholesterol transport. A cholesterol metabolic study will be done before and after 6 weeks of alirocumab treatment. If alirocumab increases reverse cholesterol transport, it is possible that this action provides additional protection from cardiovascular disease.
This study is a single-site, randomized, placebo-controlled clinical trial in which about 24
subjects are expected to complete an 8-week study period. The performance site is Washington
University School of Medicine. Even though alirocumab is an approved drug, the investigators
consider this to be a phase I trial because it is a physiological study in which the primary
endpoint is change in fecal cholesterol excretion and measures of reverse cholesterol
transport. It is not a treatment protocol and uses healthy subjects.
Subjects with greater than ideal cholesterol but not taking cholesterol lowering drugs will
be studied. All receive whole body cholesterol metabolism tests before and after treatment
for 6 weeks with either alirocumab or placebo. Each test takes 2 weeks. On the first day the
subjects receive about 35 mg cholesterol-d7 intravenously and blood samples are obtained in
order to measure cholesterol turnover rate, pool size, esterification rate, transfer from HDL
to LDL and removal from the plasma compartment. Fecal cholesterol excretion and related
parameters are measured on days 13 and 14 after a relative steady-state is obtained. During
this time the subjects consume a metabolic kitchen diet controlled in cholesterol and
phytosterol content and consume oral tracer capsules consisting of cholesterol-d5 and
sitostanol-d4. Plasma and stool samples are analyzed by gas chromatography/tandem mass
spectrometry to determine daily percent cholesterol excretion from rapidly-mixing body
cholesterol pools, fecal cholesterol mass and percent cholesterol absorption. The cholesterol
metabolic test is repeated on day 43 and final measurements are made on day 57. Treatment
effect, defined as the difference between active and placebo treatments is then calculated.
Based on animal data it is expected that alirocumab will increase the efficiency of
cholesterol excretion from body pools and the rate of removal of cholesterol ester from
plasma.
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