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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

Tracking Information
First Submitted Date  ICMJE May 22, 2018
First Posted Date  ICMJE June 7, 2018
Last Update Posted Date February 18, 2019
Actual Study Start Date  ICMJE May 22, 2018
Actual Primary Completion Date November 9, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 5, 2018)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 5, 2018)
  • 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
  • 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
  • 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
  • Percent reduction in free PCSK9 at week 12 [ Time Frame: baseline to 12 weeks ]
    Change in serum free PCSK9 from baseline after 12 weeks
  • Presence of anti LIB003 antibodies (ADAs) [ Time Frame: baseline to 12 weeks ]
    Measurement of ADAs at baseline and various intervals
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study to Evaluate Efficacy and Safety of LIB003 in Patients on Lipid-Lowering Therapy Needing Additional LDL-C Reduction
Official Title  ICMJE 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
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE 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
Condition  ICMJE LDL Cholesterol
Intervention  ICMJE Biological: LIB003
LIB003 or placebo
Study Arms  ICMJE
  • Experimental: LIB003 150 mg or matching placebo
    SC LIB003 150 mg or placebo every 4 weeks
    Intervention: Biological: LIB003
  • Experimental: LIB003 300 mg or matching placebo
    SC LIB003 300 mg or placebo every 4 weeks
    Intervention: Biological: LIB003
  • Experimental: LIB003 350 mg or matching placebo
    SC LIB003 350 mg or placebo every 4 weeks
    Intervention: Biological: LIB003
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 14, 2019)
81
Original Estimated Enrollment  ICMJE
 (submitted: June 5, 2018)
80
Actual Study Completion Date  ICMJE November 30, 2018
Actual Primary Completion Date November 9, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03549260
Other Study ID Numbers  ICMJE LIB003-002
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party LIB Therapeutics LLC
Study Sponsor  ICMJE LIB Therapeutics LLC
Collaborators  ICMJE Medpace, Inc.
Investigators  ICMJE
Study Director: Evan A Stein, MD LIB Therapeutics LLC
PRS Account LIB Therapeutics LLC
Verification Date February 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP