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Trial record 1 of 1 for:    04790513
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Trial to Evaluate Efficacy and Safety of LIB003, Evolocumab and Alirocumab in High-risk CVD Patients (LIBerate-H2H)

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ClinicalTrials.gov Identifier: NCT04790513
Recruitment Status : Active, not recruiting
First Posted : March 10, 2021
Last Update Posted : July 14, 2022
Sponsor:
Information provided by (Responsible Party):
LIB Therapeutics LLC

Brief Summary:
Comparison of LDL-C reductions at Week 12 of monthly (Q4W[≤ 31 days]) dosing of LIB003 300 mg administered subcutaneously (SC) to Q4W dosing of evolocumab (Repatha) 420 mg and alirocumab (Praluent) 300 mg in patients with CVD or at high risk for CVD on a stable diet and high intensity statin and other LDL-C-lowering drug therapy.

Condition or disease Intervention/treatment Phase
Hypercholesterolemia Cardiovascular Diseases Biological: lerodalcibep Biological: evolocumab Biological: alirocumab Phase 3

Detailed Description:
This is a randomized, open-label Phase 3 study of 12 weeks duration comparing Q4W SC doses of LIB003 300 mg, evolocumab (Repatha) 420 mg and alirocumab (Praluent) 300 mg. Approximately 220 males and females aged ≥18 years who fulfill all of the inclusion and exclusion criteria will be enrolled at up to 25 sites in the United States. Patients will be stratified by baseline LDL-C and randomized in a 2:2:1 ratio to LIB003 (88 patients), Repatha (88 patients) or Praluent (44 patients) administered SC Q4W (≤31 days). The study will consist of a Screening Period and a Treatment Period. The total study duration will be up to 21 weeks which includes up to 9-week Screening Period (depending on period required for washout of PCSK9 mAb and/or intensification of statin treatment) and 12 weeks of study drug treatment.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 204 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: randomized, open-label with blinded lipid levels
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: lipid levels measured and central laboratory will be blinded to participants, investigators, and sponsor, DSMB and CEC (Cardiovascular Events Committee)
Primary Purpose: Treatment
Official Title: Randomized, Open-label, Phase 3 Study to Evaluate the Efficacy and Safety of LIB003, Evolocumab and Alirocumab in CVD Patients, or at High Risk for CVD, on Stable Lipid-Lowering Therapy Requiring Additional LDL-C Reduction (LIBerate-H2H)
Actual Study Start Date : April 22, 2021
Estimated Primary Completion Date : August 30, 2022
Estimated Study Completion Date : October 31, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: LIB003 (lerodalcibep)
300 mg SC Q4W
Biological: lerodalcibep
anti-PCSK9 small binding protein
Other Name: LIB003

Active Comparator: evolocumab
420 mg SC Q4W
Biological: evolocumab
monoclonal antibody to PCSK9
Other Name: Repatha

Active Comparator: alirocumab
300 mg SC Q4W
Biological: alirocumab
monoclonal antibody to PCSK9
Other Name: Praluent




Primary Outcome Measures :
  1. LDL-C reduction from baseline at 12 weeks [ Time Frame: 12 weeks ]
    LS Mean percent change from baseline to week 12


Secondary Outcome Measures :
  1. Achieved ESC/EAS LDL-C goals [ Time Frame: 12 weeks ]
    Percent of patients achieving ESC/EAS 2019 LDL-C target

  2. tolerability and safety of each treatment: injection site reactions [ Time Frame: 12 weeks ]
    ISR (injection site reactions) after each dose



Information from the National Library of Medicine

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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:

  • signed informed consent
  • diagnosed with CVD or a high risk of CVD based on 2019 ESC/EAS guidelines
  • Weight of ≥40 kg (88 lb) and body mass index (BMI) ≥17 and ≤42 kg/m2
  • LDL-C ≥90 mg/dL and TG ≤400 mg/dL while on stable diet & lipid-lowering oral drug therapy (ie, high intensity statin with or without ezetimibe) and no PCSK9 mAb for 4 weeks if previously on Q2W dosing or 8 weeks if on Q4W dosing.
  • Females of childbearing potential must be using a highly effective form of birth control if sexually active and have a negative urine pregnancy test at the last Screening Visit

Exclusion Criteria:

  • at screening visit: not on high intensity statin; mipomersen or lomitapide within 6 months; gemfibrozil within 6 weeks; bempedoic acid within 4 weeks; inclisiran within 12 months; apheresis within 8 weeks
  • HoFH defined clinically and/or genetically
  • History of prior or active clinical condition or acute and/or unstable systemic disease compromising patient inclusion, at the discretion of the Investigator
  • estimated glomerular filtration rate <30 mL/min/1.73m2 at screening
  • Active liver disease or hepatic dysfunction, history of liver transplant, and/or AST or ALT >2.5 × the ULN
  • Uncontrolled Type 1 or Type 2 diabetes mellitus, defined as fasting glucose ≥200 mg/dL or glycated hemoglobin (HbA1c) of ≥9%
  • NY Heart Association class III-IV heart failure; or patients with last documented left ventricular ejection fraction <30%; planned PCI, CABG or cardiac surgery
  • Uncontrolled hypertension defined as evidenced by a reproducible (repeated 5 minutes apart) sitting blood pressure ≥160 mmHg systolic or ≥100 mmHg diastolic;
  • Enrolled in another investigational device or drug study, or less than 30 days or 5 half-lives since ending another investigational device or drug study(ies), or receiving PCSK9 or Lp(a) siRNA or locked nucleic acid-reducing agents within 12 months of the Screening Visit;
  • Have any other finding which, in the opinion of the Investigator, would compromise the patient's safety or participation in the study;

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): NCT04790513


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
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Responsible Party: LIB Therapeutics LLC
ClinicalTrials.gov Identifier: NCT04790513    
Other Study ID Numbers: LIB003-011
First Posted: March 10, 2021    Key Record Dates
Last Update Posted: July 14, 2022
Last Verified: July 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
Keywords provided by LIB Therapeutics LLC:
lerodalcibep
evolocumab
alirocumab
Additional relevant MeSH terms:
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Cardiovascular Diseases
Hypercholesterolemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Evolocumab
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents