Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03549260
Recruitment Status : Completed
First Posted : June 7, 2018
Last Update Posted : February 18, 2019
Sponsor:
Collaborator:
Medpace, Inc.
Information provided by (Responsible Party):
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

Condition or disease Intervention/treatment Phase
LDL Cholesterol Biological: LIB003 Phase 2

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 81 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized, Double-Blind, Placebo-Controlled trial to evaluate LDL-C reduction with 3 different doses of LIB003 compared to placebo
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Double-Blind and Placebo-Controlled - Study drug administered by unmasked nurse who is not involved in any other aspects of the trial
Primary Purpose: Treatment
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
Actual Study Start Date : May 22, 2018
Actual Primary Completion Date : November 9, 2018
Actual Study Completion Date : November 30, 2018

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Percent reduction in Low Density Lipoprotein Cholesterol (LDL-C) at week 12 [ Time Frame: baseline to 12 weeks ]
    Change in serum LDL-C from baseline after 12 weeks


Secondary Outcome Measures :
  1. The incidence and severity of treatment emergent adverse events (TEAEs) [ Time Frame: baseline to 12 weeks ]
    safety and tolerability will be based on the incidence and severity of treatment emergent adverse events

  2. Percent reduction in apolipoprotein B (Apo B) at week 12 [ Time Frame: baseline to 12 weeks ]
    Change in serum Apo B from baseline after 12 weeks

  3. Percent reduction in lipoprotein (a) [Lp(a)] at week 12 [ Time Frame: baseline to 12 weeks ]
    Change in serum Lp(a) from baseline after 12 weeks

  4. Percent reduction in free PCSK9 at week 12 [ Time Frame: baseline to 12 weeks ]
    Change in serum free PCSK9 from baseline after 12 weeks

  5. Presence of anti LIB003 antibodies (ADAs) [ Time Frame: baseline to 12 weeks ]
    Measurement of ADAs at baseline and various intervals



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03549260


Locations
Layout table for location information
United States, Indiana
Midwest Institute For Clinical Research
Indianapolis, Indiana, United States, 46260
United States, Kentucky
Louisville Metabolic and Atherosclerosis Research Center
Louisville, Kentucky, United States, 40213
United States, Ohio
Sterling Research Group
Cincinnati, Ohio, United States, 45219
The Lindner Research Center
Cincinnati, Ohio, United States, 45219
Metabolic & Atherosclerosis Research Center (MARC)
Cincinnati, Ohio, United States, 45227
Sponsors and Collaborators
LIB Therapeutics LLC
Medpace, Inc.
Investigators
Layout table for investigator information
Study Director: Evan A Stein, MD LIB Therapeutics LLC
  Study Documents (Full-Text)

Documents provided by LIB Therapeutics LLC:
Informed Consent Form  [PDF] May 18, 2018
Study Protocol  [PDF] July 24, 2018


Layout table for additonal information
Responsible Party: LIB Therapeutics LLC
ClinicalTrials.gov Identifier: NCT03549260     History of Changes
Other Study ID Numbers: LIB003-002
First Posted: June 7, 2018    Key Record Dates
Last Update Posted: February 18, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by LIB Therapeutics LLC:
low density lipoprotein cholesterol
PCSK9