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A Single-Dose, Open-Label, Parallel-Group Study to Assess the Pharmacokinetics of Inclisiran in Subjects With Renal Impairment Compared to Subjects With Normal Renal Function (ORION-7)

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Trial Profile

A Single-Dose, Open-Label, Parallel-Group Study to Assess the Pharmacokinetics of Inclisiran in Subjects With Renal Impairment Compared to Subjects With Normal Renal Function (ORION-7)

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 17 Sep 2021

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At a glance

  • Drugs Inclisiran (Primary)
  • Indications Hypercholesterolaemia
  • Focus Pharmacokinetics
  • Acronyms ORION-7
  • Sponsors The Medicines Company
  • Most Recent Events

    • 17 Oct 2019 Results assessing safety and pharmacodynamics of inclisiran in patients with renal impairment from two studies (ORION-1 and ORION-7), published in the Mayo Clinic Proceedings.
    • 27 May 2019 According to The Medicines Company media release, results of combined analysis of data (n=279) from ORION-1 and ORION-7 studies, presented at the 87th European Atherosclerosis Society (EAS) Congress 2019.
    • 27 May 2019 Results of combined analysis (n=279) of data from ORION-1 and ORION-7 studies, presented in The Medicines Company media release.

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