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A Double-blind, Randomized, Placebo-controlled, Multicenter Study to Evaluate Efficacy and Safety of JS002 as Monotherapy in Patients With Primary Hypercholesterolaemia and Mixed Dyslipidemia

Trial Profile

A Double-blind, Randomized, Placebo-controlled, Multicenter Study to Evaluate Efficacy and Safety of JS002 as Monotherapy in Patients With Primary Hypercholesterolaemia and Mixed Dyslipidemia

Status: Recruiting
Phase of Trial: Phase III

Latest Information Update: 20 Sep 2024

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At a glance

  • Drugs Ongericimab (Primary)
  • Indications Dyslipidaemias; Hypercholesterolaemia
  • Focus Registrational; Therapeutic Use
  • Sponsors Shanghai Junshi Biosciences
  • Most Recent Events

    • 13 Sep 2024 Planned primary completion date changed from 30 Oct 2023 to 23 Sep 2024.
    • 13 Sep 2024 Status changed from not yet recruiting to recruiting.
    • 02 Apr 2024 According to Shanghai Junshi Biosciences media release, National Medical Products Administration (NMPA) has accepted two supplemental new drug applications (sNDA) for JS002 for the treatment of heterozygous familial hypercholesterolemia, primary hypercholesterolemia and mixed dyslipidemia, based on this study.

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