Open-Label Extension to Evaluate the Longer Term Efficacy and Safety of LIB003
Status: | Enrolling by invitation |
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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 |
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)
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
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