An Experimental Medicine Study to Evaluate Serum Biomarkers of Lipid Metabolism

Bristol-Myers Squibb150 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

SCREENING

Masking

NONE

Enrollment

150

Conditions

Atherosclerosis

Interventions

Blood drawPROCEDURE

1 day

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Hypercholesterolemia * Statin monotherapy Exclusion Criteria: * Significant acute or chronic illness * Secondary causes of hypercholesterolemia

Locations (1)

Local Institution

Montreal, Quebec, Canada

Outcomes

Primary Outcomes

Serum PCSK9 concentration

Time frame: Initial assessment will occur when Group 1 has 50 subjects enrolled and Groups 2 and 3 have 30 subjects enrolled

Secondary Outcomes

Serum LDL cholesterol concentration

Time frame: Initial assessment will occur when Groups 2 and 3 have enrolled 30 subjects

Serum HDL cholesterol concentration

Time frame: Initial assessment will occur when Groups 2 and 3 have enrolled 30 subjects

Serum TG concentration

Time frame: Initial assessment will occur when Groups 2 and 3 have enrolled 30 subjects

Serum Apo B concentration

Time frame: Initial assessment will occur when Groups 2 and 3 have enrolled 30 subjects

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.