Open-Label Extension to Evaluate the Longer Term Efficacy and Safety of LIB003



Status:Enrolling by invitation
Conditions:High Cholesterol
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - Any
Updated:2/22/2019
Start Date:February 14, 2019
End Date:November 30, 2019

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Open-Label Extension, Phase 2b Study to Evaluate the Longer Term Efficacy and Safety of LIB003 in Patients on Stable Lipid Lowering Therapy Requiring Additional LDL-C Reduction

To assess the longer term safety, tolerability, and LDL C lowering efficacy after 36 weeks of
additional treatment with LIB003 with subcutaneous (SC) dosing every 4 weeks (Q4W)


Inclusion Criteria:

1. men and women 18 years or older

2. Elevated LDL-C on current lipid lowering therapy and; prior atherosclerotic
cardiovascular disease (CVD) event or evidence of CVD or without CVD but at high risk
for CVD based on American Heart Association/American College of Cardiology (AHA/ACC)
CVD risk calculator, or aged 40 years and older with diabetes and moderate- to
high-intensity statin, or pre-treatment LDL-C 190 mg/dL or greater or heterozygous
familial hypercholesterolemia (HeFH)

3. patients who met original entry criteria in, and completed, the double-blind,
placebo-controlled 16-week Phase 2 study (LIB003-002)

Exclusion Criteria:

1. patients who did not who complete the double-blind, placebo-controlled 16-week Phase 2
study (LIB003-002)

2. <18 years of age

3. pregnant or women of childbearing potential not using acceptable birth control
We found this trial at
3
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Cincinnati, Ohio 45219
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Cincinnati, Ohio 45219
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mi
from
Cincinnati, OH
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mi
from
Cincinnati, OH
Click here to add this to my saved trials