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Open-Label Extension Phase 3 Study to Evaluate the Long-Term Efficacy and Safety of LIB003 in Patients With HoFH and HeFH, CVD, or at High Risk for CVD, on Stable Lipid-Lowering Therapy Requiring Additional LDL-C Reduction

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Trial Profile

Open-Label Extension Phase 3 Study to Evaluate the Long-Term Efficacy and Safety of LIB003 in Patients With HoFH and HeFH, CVD, or at High Risk for CVD, on Stable Lipid-Lowering Therapy Requiring Additional LDL-C Reduction

Status: Recruiting
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; Niacin; Omega-3-fatty-acid
  • Indications Hyperlipoproteinaemia type IIa
  • Focus Adverse reactions; Registrational
  • Acronyms LIBerate-007; LIBerate-OLE
  • 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).
  • 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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