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CompletedNCT03549260Updated Feb 18, 2019

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

A Phase 2 interventional study of LIB003 in LDL Cholesterol, sponsored by LIB Therapeutics LLC. Completed at 5 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-02-18.

Sponsored by LIB Therapeutics LLC · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Primary completion was Nov 2018, 7 years 10 months ago, and no results have been posted to the registry.
Phase
Phase 2
Study type
Interventional
Enrollment
81
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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

Read the 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.

02

Conditions studied

  • LDL Cholesterol

Keywords

  • low density lipoprotein cholesterol
  • PCSK9
03

In context

Lead sponsor

LIB Therapeutics LLC is the lead sponsor of 12 studies on the registry; 3 are open to participants now.

Of its 7 completed or terminated interventional studies of FDA-regulated products, 2 (29%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
81 participants (actual)

Study arms

  • Experimental
    LIB003 150 mg or matching placebo

    SC LIB003 150 mg or placebo every 4 weeks

    Biological: LIB003

  • Experimental
    LIB003 300 mg or matching placebo

    SC LIB003 300 mg or placebo every 4 weeks

    Biological: LIB003

  • Experimental
    LIB003 350 mg or matching placebo

    SC LIB003 350 mg or placebo every 4 weeks

    Biological: LIB003

Interventions

  • BiologicalLIB003

    LIB003 or placebo

06

What researchers measure

Primary outcomes

  1. Percent reduction in Low Density Lipoprotein Cholesterol (LDL-C) at week 12

    Change in serum LDL-C from baseline after 12 weeks

    Time frame: baseline to 12 weeks

Secondary outcomes

  1. 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

    Time frame: baseline to 12 weeks

  2. Percent reduction in apolipoprotein B (Apo B) at week 12

    Change in serum Apo B from baseline after 12 weeks

    Time frame: baseline to 12 weeks

  3. Percent reduction in lipoprotein (a) [Lp(a)] at week 12

    Change in serum Lp(a) from baseline after 12 weeks

    Time frame: baseline to 12 weeks

  4. Percent reduction in free PCSK9 at week 12

    Change in serum free PCSK9 from baseline after 12 weeks

    Time frame: baseline to 12 weeks

  5. Presence of anti LIB003 antibodies (ADAs)

    Measurement of ADAs at baseline and various intervals

    Time frame: baseline to 12 weeks

07

Study locations

5 sites
  • Midwest Institute For Clinical Research
    Indianapolis, Indiana 46260, United States
  • Louisville Metabolic and Atherosclerosis Research Center
    Louisville, Kentucky 40213, United States
  • Sterling Research Group
    Cincinnati, Ohio 45219, United States
  • The Lindner Research Center
    Cincinnati, Ohio 45219, United States
  • Metabolic & Atherosclerosis Research Center (MARC)
    Cincinnati, Ohio 45227, United States
08

References and documents

Study documents

  • Informed consent form · May 18, 2018
  • Study protocol · Jul 24, 2018

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 18, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03549260
Lead sponsor
LIB Therapeutics LLC
Collaborators
Medpace, Inc.
Responsible party
Sponsor
First posted
Jun 7, 2018
Start date
May 22, 2018
Primary completion
Nov 9, 2018
Completion
Nov 30, 2018
Last update
Feb 18, 2019

Study contacts

Evan A Stein, MD
study director · LIB Therapeutics LLC

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Feb 2019. You cannot join it, but the record below documents what was studied.

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