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Study to Evaluate the Long-Term Efficacy and Safety of LIB003 in Patients With Cardiovascular Disease, or at High Risk for Cardiovascular Disease, on Stable Lipid-Lowering Therapy Requiring Additional LDL-C Reduction

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Trial Profile

Study to Evaluate the Long-Term Efficacy and Safety of LIB003 in Patients With Cardiovascular Disease, or at High Risk for Cardiovascular Disease, on Stable Lipid-Lowering Therapy Requiring Additional LDL-C Reduction

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 23 Dec 2024

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At a glance

  • Drugs Lerodalcibep (Primary)
  • Indications Hypercholesterolaemia
  • Focus Registrational; Therapeutic Use
  • Acronyms LIBerate-006; LIBerate-HR
  • Sponsors LIB Therapeutics

    • Most Recent Events

    • 16 Dec 2024 According to LIB Therapeutics media release, company announced the submission of a Biologics License Application to the U.S. Food and Drug Administration seeking approval of Lerodalcibep to reduce low-density lipoprotein cholesterol (LDL-C) for the treatment of patients with atherosclerotic cardiovascular disease (ASCVD), or very high or high risk of ASCVD, and primary hyperlipidemia, including heterozygous and homozygous familial hypercholesterolemia based on Phase 3 LIBerate studies
    • 16 Dec 2024 According to LIB Therapeutics media release, company announced that as the BLA has been submitted to the FDA, and is now preparing a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for submission by mid-2025
    • 13 Feb 2024 According to a LIB Therapeutics media release, company announced acceptance of abstract of this trial at the American College of Cardiology 2024 in Atlanta, Georgia on April 6-8, 2024.

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