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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: 29 Dec 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

  • 17 Dec 2025 According to a Everest Medicines media release, Lerodalcibep is currently under regulatory review by the European medicines agency.
  • 15 Dec 2025 According to LIB Therapeutics media release, based on data from LIBerate Clinical Trial Program( LIBerate-003,LIBerate-004 , LIBerate-005, LIBerate-006 and LIBerate-007 trials),the U.S. Food and Drug Administration (FDA) has approved LEROCHOL injection for subcutaneous use as an adjunct to diet and exercise to reduce low-density lipoprotein cholesterol (LDL-C) in adults with hypercholesterolemia, including heterozygous familial hypercholesterolemia (HeFH).
  • 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.

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