Study to Evaluate Efficacy and Safety of LIB003 in Patients on Lipid-Lowering Therapy Needing Additional LDL-C Reduction
- Conditions
- LDL Cholesterol
- Interventions
- Biological: LIB003
- Registration Number
- NCT03549260
- Lead Sponsor
- LIB Therapeutics LLC
- Brief Summary
Study to assess the LDL-C lowering efficacy of different doses of LIB003 administered every 4 weeks in subjects on stable statin and/or ezetimibe therapy
- Detailed Description
Randomized, Double-Blind, Placebo-Controlled, Phase 2 study to assess the LDL-C lowering efficacy at Week 12 of various doses of LIB003 administered subcutaneously (SC) every 4 weeks (Q4W) in patients with hypercholesterolemia on stable diet and oral LDL-C-lowering drug therapy.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 81
- Male or female, 18 years of age or older
- Elevated LDL-C on current lipid lowering therapy and; prior atherosclerotic cardiovascular disease (ASCVD) event or evidence of ASCVD or without ASCVD but at high risk for ASCVD based on 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)
- Body mass index (BMI) between 18 and 40 kg/m2
- Females of childbearing potential not using or willing to use an effective form of contraception, or pregnant or breastfeeding, or who have a positive serum pregnancy test at screening
- Homozygous familial hypercholesterolemia
- LDL or plasma apheresis within 2 months; lomitapide or mipomersen within 12 months
- Uncontrolled cardiac arrhythmia, myocardial infarction, unstable angina, PCI, CABG, or stroke within 3 months prior to enrollment
- Uncontrolled cardiac arrhythmia, myocardial infarction, unstable angina, PCI, CABG, or stroke within 3 months prior to enrollment
- Newly diagnosed or poorly controlled (HbA1c >9%) type 2 diabetes
- Uncontrolled hypertension
- Moderate to severe renal insufficiency
- Elevated liver function test at screening
- Uncontrolled cardiac arrhythmia or prolonged QT on EKG
- A history of prescription drug abuse, illicit drug use, or alcohol abuse
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description LIB003 300 mg or matching placebo LIB003 SC LIB003 300 mg or placebo every 4 weeks LIB003 350 mg or matching placebo LIB003 SC LIB003 350 mg or placebo every 4 weeks LIB003 150 mg or matching placebo LIB003 SC LIB003 150 mg or placebo every 4 weeks
- Primary Outcome Measures
Name Time Method Percent reduction in Low Density Lipoprotein Cholesterol (LDL-C) at week 12 baseline to 12 weeks Change in serum LDL-C from baseline after 12 weeks
- Secondary Outcome Measures
Name Time Method Percent reduction in apolipoprotein B (Apo B) at week 12 baseline to 12 weeks Change in serum Apo B from baseline after 12 weeks
Percent reduction in lipoprotein (a) [Lp(a)] at week 12 baseline to 12 weeks Change in serum Lp(a) from baseline after 12 weeks
Percent reduction in free PCSK9 at week 12 baseline to 12 weeks Change in serum free PCSK9 from baseline after 12 weeks
Presence of anti LIB003 antibodies (ADAs) baseline to 12 weeks Measurement of ADAs at baseline and various intervals
The incidence and severity of treatment emergent adverse events (TEAEs) baseline to 12 weeks safety and tolerability will be based on the incidence and severity of treatment emergent adverse events
Trial Locations
- Locations (5)
Midwest Institute For Clinical Research
🇺🇸Indianapolis, Indiana, United States
Louisville Metabolic and Atherosclerosis Research Center
🇺🇸Louisville, Kentucky, United States
The Lindner Research Center
🇺🇸Cincinnati, Ohio, United States
Sterling Research Group
🇺🇸Cincinnati, Ohio, United States
Metabolic & Atherosclerosis Research Center (MARC)
🇺🇸Cincinnati, Ohio, United States