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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)

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Trial Profile

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)

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 14 Feb 2025

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At a glance

  • Drugs Lerodalcibep (Primary) ; Alirocumab; Evolocumab; HMG-CoA reductase inhibitors
  • Indications Hypercholesterolaemia
  • Focus Registrational; Therapeutic Use
  • Acronyms LIBerate-H2H
  • Sponsors LIB Therapeutics

Most Recent Events

  • 10 Feb 2025 According to LIB Therapeutics media release, company announced that the U.S. Food and Drug Administration (FDA) has accepted for review the Biologics License Application (BLA) of Lerodalcibep and also has set a PDUFA (Prescription Drug User Fee Act) target action date of December 12, 2025.
  • 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
  • 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

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