Clinical trial NCT03549260: Study to Evaluate Efficacy and Safety of LIB003 in Patients on Lipid-Lowering Therapy Needing Additional LDL-C Reduction
Official title: Randomized, Double-Blind, Placebo-Controlled, Phase 2, Dose Finding Study to Evaluate the Efficacy and Safety of LIB003 in Patients on Stable Lipid-Lowering Therapy Requiring Additional LDL-C Reduction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: LDL Cholesterol
Keywords: low density lipoprotein cholesterol
PCSK9
Lead sponsor: LIB Therapeutics LLC
Sponsor class: INDUSTRY
Collaborators: name: Medpace, Inc.
First posted: 2018-06-07
Enrollment: 81
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, Double-Blind, Placebo-Controlled trial to evaluate LDL-C reduction with 3 different doses of LIB003 compared to placebo
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

1. Male or female, 18 years of age or older
2. 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)
3. Body mass index (BMI) between 18 and 40 kg/m2

Exclusion Criteria:

1. 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
2. Homozygous familial hypercholesterolemia
3. LDL or plasma apheresis within 2 months; lomitapide or mipomersen within 12 months
4. Uncontrolled cardiac arrhythmia, myocardial infarction, unstable angina, PCI, CABG, or stroke within 3 months prior to enrollment
5. Uncontrolled cardiac arrhythmia, myocardial infarction, unstable angina, PCI, CABG, or stroke within 3 months prior to enrollment
6. Newly diagnosed or poorly controlled (HbA1c \>9%) type 2 diabetes
7. Uncontrolled hypertension
8. Moderate to severe renal insufficiency
9. Elevated liver function test at screening
10. Uncontrolled cardiac arrhythmia or prolonged QT on EKG
11. A history of prescription drug abuse, illicit drug use, or alcohol abuse

Primary outcomes:
measure: Percent reduction in Low Density Lipoprotein Cholesterol (LDL-C) at week 12
timeFrame: baseline to 12 weeks
Secondary outcomes:
measure: The incidence and severity of treatment emergent adverse events (TEAEs)
timeFrame: baseline to 12 weeks
measure: Percent reduction in apolipoprotein B (Apo B) at week 12
timeFrame: baseline to 12 weeks
measure: Percent reduction in lipoprotein (a) [Lp(a)] at week 12
timeFrame: baseline to 12 weeks
measure: Percent reduction in free PCSK9 at week 12
timeFrame: baseline to 12 weeks
measure: Presence of anti LIB003 antibodies (ADAs)
timeFrame: baseline to 12 weeks
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Midwest Institute For Clinical Research
state: Indiana
city: Louisville
country: United States
facility: Louisville Metabolic and Atherosclerosis Research Center
state: Kentucky
city: Cincinnati
country: United States
facility: Sterling Research Group
state: Ohio
city: Cincinnati
country: United States
facility: The Lindner Research Center
state: Ohio
city: Cincinnati
country: United States
facility: Metabolic & Atherosclerosis Research Center (MARC)
state: Ohio
Study officials:
affiliation: LIB Therapeutics LLC
name: Evan A Stein, MD
role: STUDY_DIRECTOR
References: