Study to Evaluate Efficacy and Safety of LIB003 in Patients on Lipid-Lowering Therapy Needing Additional LDL-C Reduction

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

81 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-05-22

Study Completion Date

2018-11-30

Brief Summary

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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

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Detailed Description

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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.

Conditions

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LDL Cholesterol

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized, Double-Blind, Placebo-Controlled trial to evaluate LDL-C reduction with 3 different doses of LIB003 compared to placebo

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Double-Blind and Placebo-Controlled - Study drug administered by unmasked nurse who is not involved in any other aspects of the trial

Study Groups

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LIB003 150 mg or matching placebo

SC LIB003 150 mg or placebo every 4 weeks

Group Type EXPERIMENTAL

LIB003

Intervention Type BIOLOGICAL

LIB003 or placebo

LIB003 300 mg or matching placebo

SC LIB003 300 mg or placebo every 4 weeks

Group Type EXPERIMENTAL

LIB003

Intervention Type BIOLOGICAL

LIB003 or placebo

LIB003 350 mg or matching placebo

SC LIB003 350 mg or placebo every 4 weeks

Group Type EXPERIMENTAL

LIB003

Intervention Type BIOLOGICAL

LIB003 or placebo

Interventions

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LIB003

LIB003 or placebo

Intervention Type BIOLOGICAL

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No