Status:
COMPLETED
Open-Label Extension to Evaluate the Longer Term Efficacy and Safety of LIB003
Lead Sponsor:
LIB Therapeutics LLC
Conditions:
Hypercholesterolemia
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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)
Detailed Description
To assess the longer term safety, tolerability, immunogenicity, PK, PD and LDL C lowering efficacy after 52 weeks of additional treatment with LIB003 with subcutaneous (SC) dosing every 4 weeks (Q4W) ...
Eligibility Criteria
Inclusion
- men and women 18 years or older
- 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)
- patients who met original entry criteria in, and completed, the double-blind, placebo-controlled 16-week Phase 2 study (LIB003-002)
Exclusion
- patients who did not who complete the double-blind, placebo-controlled 16-week Phase 2 study (LIB003-002)
- \<18 years of age
- pregnant or women of childbearing potential not using acceptable birth control
Key Trial Info
Start Date :
February 14 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 31 2020
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT03847974
Start Date
February 14 2019
End Date
August 31 2020
Last Update
March 2 2022
Active Locations (3)
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1
Sterling Research Group
Cincinnati, Ohio, United States, 45219
2
The Lindner Research Center
Cincinnati, Ohio, United States, 45219
3
Metabolic & Atherosclerosis Research Center (MARC)
Cincinnati, Ohio, United States, 45227