An Experimental Medicine Study to Evaluate Serum Biomarkers of Lipid Metabolism

An Experimental Medicine Study to Quantify PCSK9 Serum Concentrations and LDL Receptor Expression in Peripheral Blood Cells in Normal and Hypercholesterolemic Subjects

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00847782

Enrollment

150

Registered

2009-02-19

Start date

2009-03-31

Completion date

2009-09-30

Last updated

2009-11-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atherosclerosis

Brief summary

The purpose of this study is to validate novel assays for serum biomarkers of lipid metabolism (PCSK9 and LDL receptor) and to obtain information about how these biomarkers differ in subjects with normal or high cholesterol levels

Interventions

PROCEDUREBlood draw

1 day

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SCREENING

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

* Hypercholesterolemia * Statin monotherapy

Exclusion criteria

* Significant acute or chronic illness * Secondary causes of hypercholesterolemia

Design outcomes

Primary

Measure	Time frame
Serum PCSK9 concentration	Initial assessment will occur when Group 1 has 50 subjects enrolled and Groups 2 and 3 have 30 subjects enrolled

Secondary

Measure	Time frame
Serum LDL cholesterol concentration	Initial assessment will occur when Groups 2 and 3 have enrolled 30 subjects
Serum HDL cholesterol concentration	Initial assessment will occur when Groups 2 and 3 have enrolled 30 subjects
Serum TG concentration	Initial assessment will occur when Groups 2 and 3 have enrolled 30 subjects
Serum Apo B concentration	Initial assessment will occur when Groups 2 and 3 have enrolled 30 subjects

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026