Overview
Open-Label Extension to Evaluate the Longer Term Efficacy and Safety of LIB003
Status:
Completed
Completed
Trial end date:
2020-08-31
2020-08-31
Target enrollment:
0
0
Participant gender:
All
All
Summary
To assess the longer term safety, tolerability, and LDL C lowering efficacy after 52 weeks of additional treatment with LIB003 with subcutaneous (SC) dosing every 4 weeks (Q4W)Phase:
Phase 2Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
LIB Therapeutics LLC
Criteria
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