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Two part (double-blind inclisiran versus placebo [Year 1] followed by open-label inclisiran [Year 2]) randomized multicenter study to evaluate safety, tolerability, and efficacy of inclisiran in adolescents (12 to less than 18 years) with heterozygous familial hypercholesterolemia and elevated LDL-cholesterol (ORION-16)

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Trial Profile

Two part (double-blind inclisiran versus placebo [Year 1] followed by open-label inclisiran [Year 2]) randomized multicenter study to evaluate safety, tolerability, and efficacy of inclisiran in adolescents (12 to less than 18 years) with heterozygous familial hypercholesterolemia and elevated LDL-cholesterol (ORION-16)

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 16 Jun 2025

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At a glance

  • Drugs Inclisiran (Primary)
  • Indications Hyperlipoproteinaemia type IIa
  • Focus Registrational; Therapeutic Use
  • Acronyms ORION-16
  • Sponsors Novartis; Novartis Pharma A.G.; Novartis Pharmaceuticals

Most Recent Events

  • 29 Jan 2025 Status changed from active, no longer recruiting to completed.
  • 08 Mar 2024 This trial has been Completed in Germany, According to European Clinical Trials Database record.
  • 11 Jan 2024 This trial has been Completed in Hungary, According to European Clinical Trials Database record.

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