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Study to Evaluate the Long-Term Efficacy and Safety of LIB003 in Patients With 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 on Stable Lipid-Lowering Therapy Requiring Additional LDL-C Reduction

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 14 Feb 2025

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At a glance

  • Drugs Lerodalcibep (Primary) ; Bempedoic acid; Bezafibrate; Bile acids and salts; Ezetimibe; Fenofibrate; HMG-CoA reductase inhibitors; Nicotinic acids; Omega-3-fatty-acid
  • Indications Hypercholesterolaemia
  • Focus Registrational; Therapeutic Use
  • Acronyms LIBerate-005; LIBerate-CVD
  • 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 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

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