Long-term Safety and Tolerability of Inclisiran in Participants With HeFH or HoFH Who Have Completed the Pediatric ORION-16, ORION-13, ORION-20, or ORION-19 Studies

Recruiting now · Phase 3

Conditions studied: Heterozygous or Homozygous Familial Hypercholesterolemia

In brief

The purpose of this open-label, single arm, multicenter extension study is to evaluate the long-term safety and tolerability of inclisiran in participants with HeFH or HoFH who have completed the ORION-16 (CKJX839C12301), ORION-13 (CKJX839C12302), ORION-20 (CKJX839C12303) or ORION-19 (CKJX839C12304) studies.

Key facts

Study ID

NCT05682378

Run by

Novartis Pharmaceuticals

People needed

195

Starts

2023-02-10

Expected to finish

2032-03-28

Last updated by the study team

2026-05-15

Who can join

Age: 12 and older, up to 100. Sex: any. Healthy volunteers: not accepted.

Where it is running

• Novartis Investigative Site — Taipei, Taiwan (enrolling)
• Cincinnati Childrens Hospital MC — Cincinnati, Ohio, United States
• Novartis Investigative Site — Freiburg im Breisgau, Germany
• Primary Childrens Medical Center — Salt Lake City, Utah, United States
• Novartis Investigative Site — Formosa, Formosa Province, Argentina
• Novartis Investigative Site — Fortaleza, Ceará, Brazil
• Novartis Investigative Site — São Paulo, São Paulo, Brazil
• Novartis Investigative Site — São Paulo, São Paulo, Brazil
• Novartis Investigative Site — Québec, Quebec, Canada
• Novartis Investigative Site — Prague, Czechia
• Novartis Investigative Site — Prague, Czechia
• Novartis Investigative Site — Besançon, France
• Novartis Investigative Site — Toulouse, France
• Novartis Investigative Site — Frankfurt am Main, Hesse, Germany
• Childrens Hosp Pittsburgh UPMC — Pittsburgh, Pennsylvania, United States
• Novartis Investigative Site — Athens, Greece
• Novartis Investigative Site — Athens, Greece
• Novartis Investigative Site — Pécs, Baranya, Hungary
• Novartis Investigative Site — Jerusalem, Israel
• Novartis Investigative Site — Ramat Gan, Israel
• Novartis Investigative Site — Milan, MI, Italy
• Novartis Investigative Site — Modena, MO, Italy
• Novartis Investigative Site — Roma, RM, Italy
• Novartis Investigative Site — Roma, RM, Italy
• Icahn School of Med at Mt Sinai — New York, New York, United States

Full record on ClinicalTrials.gov

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