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Open-Label Extension to Evaluate the Longer Term Efficacy and Safety of LIB003

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: NCT03847974
Recruitment Status : Completed
First Posted : February 20, 2019
Results First Posted : February 10, 2022
Last Update Posted : March 2, 2022
Sponsor:
Information provided by (Responsible Party):
LIB Therapeutics LLC

Study Description
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Brief Summary:
To assess the longer term safety, tolerability, and LDL C lowering efficacy after 52 weeks of additional treatment with LIB003 with subcutaneous (SC) dosing every 4 weeks (Q4W)

Condition or disease Intervention/treatment Phase
Hypercholesterolemia Drug: LIB003 Phase 2

Detailed Description:
To assess the longer term safety, tolerability, immunogenicity, PK, PD and LDL C lowering efficacy after 52 weeks of additional treatment with LIB003 with subcutaneous (SC) dosing every 4 weeks (Q4W) in patients on stable maximally tolerated statins with or without ezetimibe who completed the phase 2 dose ranging trial LIB003-002
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: open-label
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Open-Label Extension, Phase 2b Study to Evaluate the Longer Term Efficacy and Safety of LIB003 in Patients on Stable Lipid Lowering Therapy Requiring Additional LDL-C Reduction
Actual Study Start Date : February 14, 2019
Actual Primary Completion Date : April 7, 2020
Actual Study Completion Date : August 31, 2020
Arms and Interventions
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Arm Intervention/treatment
Experimental: LIB003
LIB003
 Drug: LIB003
300 mg SC Q4W
Other Name: lerodalcibep


Outcome Measures
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Primary Outcome Measures :
  1. Number of Participants With Treatment Emergent Adverse Events (TEAEs) [ Time Frame: 52 weeks ]
    safety and tolerability will be based on the incidence and severity of treatment emergent adverse events


Secondary Outcome Measures :
  1. Percent Change in LDL-C at 52 Weeks [ Time Frame: 52 weeks ]
    percent change in serum LDL-C from baseline at 52 weeks


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. men and women 18 years or older
  2. Elevated LDL-C on current lipid lowering therapy and; prior atherosclerotic cardiovascular disease (CVD) event or evidence of CVD or without CVD but at high risk for CVD based on American Heart Association/American College of Cardiology (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. patients who met original entry criteria in, and completed, the double-blind, placebo-controlled 16-week Phase 2 study (LIB003-002)

Exclusion Criteria:

  1. patients who did not who complete the double-blind, placebo-controlled 16-week Phase 2 study (LIB003-002)
  2. <18 years of age
  3. pregnant or women of childbearing potential not using acceptable birth control
Contacts and Locations
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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): NCT03847974


Locations
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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
Investigators
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Study Director: Evan A Stein, MD PhD LIB Therapeutics
  Study Documents (Full-Text)

Documents provided by LIB Therapeutics LLC:
Study Protocol  [PDF] March 18, 2020
Statistical Analysis Plan  [PDF] January 20, 2020

More Information
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Responsible Party: LIB Therapeutics LLC
ClinicalTrials.gov Identifier: NCT03847974    
Other Study ID Numbers: LIB003-010
First Posted: February 20, 2019    Key Record Dates
Results First Posted: February 10, 2022
Last Update Posted: March 2, 2022
Last Verified: February 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hypercholesterolemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases