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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: 15 Dec 2023

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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

    • 08 Dec 2023 Planned End Date changed from 31 Dec 2023 to 28 Feb 2024.
    • 01 Dec 2023 This trial has been completed in Norway, according to European Clinical Trials Database record.
    • 14 Nov 2023 According to a LIB Therapeutics media release, company is planning to submit a biologics license application to the Food and Drug Administration and marketing authorization application to the European Medicines Agency in 1H 2024 based on registration-enabling Phase 3 LIBerate Program.
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