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

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 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

Study Overview

• Status: Completed
• Conditions: LDL Cholesterol
• Intervention / Treatment: Biological: LIB003

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.

• Study Type: Interventional
• Enrollment (Actual): 81
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Indiana
    • Indianapolis, Indiana, United States, 46260
      • Midwest Institute for Clinical Research
  • Kentucky
    • Louisville, Kentucky, United States, 40213
      • Louisville Metabolic and Atherosclerosis Research Center
  • Ohio
    • Cincinnati, Ohio, United States, 45219
      • The Lindner Research Center
    • Cincinnati, Ohio, United States, 45219
      • Sterling Research Group
    • Cincinnati, Ohio, United States, 45227
      • Metabolic & Atherosclerosis Research Center (MARC)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: LIB003 150 mg or matching placebo; SC LIB003 150 mg or placebo every 4 weeks	Biological: LIB003; LIB003 or placebo
Experimental: LIB003 300 mg or matching placebo; SC LIB003 300 mg or placebo every 4 weeks	Biological: LIB003; LIB003 or placebo
Experimental: LIB003 350 mg or matching placebo; SC LIB003 350 mg or placebo every 4 weeks	Biological: LIB003; LIB003 or placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent reduction in Low Density Lipoprotein Cholesterol (LDL-C) at week 12	Change in serum LDL-C from baseline after 12 weeks	baseline to 12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The incidence and severity of treatment emergent adverse events (TEAEs)	safety and tolerability will be based on the incidence and severity of treatment emergent adverse events	baseline to 12 weeks
Percent reduction in apolipoprotein B (Apo B) at week 12	Change in serum Apo B from baseline after 12 weeks	baseline to 12 weeks
Percent reduction in lipoprotein (a) [Lp(a)] at week 12	Change in serum Lp(a) from baseline after 12 weeks	baseline to 12 weeks
Percent reduction in free PCSK9 at week 12	Change in serum free PCSK9 from baseline after 12 weeks	baseline to 12 weeks
Presence of anti LIB003 antibodies (ADAs)	Measurement of ADAs at baseline and various intervals	baseline to 12 weeks

Collaborators and Investigators

• Sponsor: LIB Therapeutics LLC
• Collaborators: Medpace, Inc.
• Investigators: Study Director: Evan A Stein, MD, LIB Therapeutics LLC

Study record dates

Study Major Dates

• Study Start (Actual): May 22, 2018
• Primary Completion (Actual): November 9, 2018
• Study Completion (Actual): November 30, 2018

Study Registration Dates

• First Submitted: May 22, 2018
• First Submitted That Met QC Criteria: June 5, 2018
• First Posted (Actual): June 7, 2018

Study Record Updates

• Last Update Posted (Actual): February 18, 2019
• Last Update Submitted That Met QC Criteria: February 14, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Keywords: PCSK9; low density lipoprotein cholesterol
• Other Study ID Numbers: LIB003-002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No