Study to Evaluate Efficacy and Safety of LIB003 in Patients on Lipid-Lowering Therapy Needing Additional LDL-C Reduction
Completed · Phase 2 · Has a placebo group
Conditions studied: LDL Cholesterol
In brief
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
Key facts
- Study ID
- NCT03549260
- Run by
- LIB Therapeutics LLC
- People needed
- 81
- Starts
- 2018-05-22
- Expected to finish
- 2018-11-30
- Last updated by the study team
- 2019-02-18
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Midwest Institute For Clinical Research — Indianapolis, Indiana, United States
- Louisville Metabolic and Atherosclerosis Research Center — Louisville, Kentucky, United States
- Sterling Research Group — Cincinnati, Ohio, United States
- The Lindner Research Center — Cincinnati, Ohio, United States
- Metabolic & Atherosclerosis Research Center (MARC) — Cincinnati, Ohio, United States
Full record on ClinicalTrials.gov
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