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Randomized Open Label, Phase 3 Study to Compare the Efficacy and Safety of Lerodalcibep (LIB003) to Inclisiran in Patients at Very High or High Risk for CVD, on Stable Lipid-Lowering Therapy Requiring Additional LDL-C Reduction

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Trial Profile

Randomized Open Label, Phase 3 Study to Compare the Efficacy and Safety of Lerodalcibep (LIB003) to Inclisiran in Patients at Very High or High Risk for CVD, on Stable Lipid-Lowering Therapy Requiring Additional LDL-C Reduction

Status: Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 30 May 2024

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At a glance

  • Drugs Lerodalcibep (Primary) ; Inclisiran
  • Indications Hypercholesterolaemia
  • Focus Registrational; Therapeutic Use
  • Acronyms LIBerate-VI
  • Sponsors LIB Therapeutics

    • Most Recent Events

    • 29 May 2024 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 later this year based on registration-enabling Phase 3 LIBerate Program.
    • 29 May 2024 According to a LIB Therapeutics media release, Primary endpoint (LDL-C reduction) has been met.
    • 29 May 2024 According to a LIB Therapeutics media release, data from the study were presented at the 92nd European Atherosclerosis Society Congress in Lyon, France, May 26-29, 2024.
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