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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: 29 Dec 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

  • 17 Dec 2025 According to a Everest Medicines media release, Lerodalcibep is currently under regulatory review by the European medicines agency.
  • 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

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