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)
Latest Information Update: 03 Feb 2025
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.