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RECRUITING Phase 3 ClinicalTrials.gov

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

Sponsor: Novartis Pharmaceuticals • ClinicalTrials.gov ID: NCT05682378

Registry updated: 2026-09-18
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Description

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.

Interventions

  • Inclisiran (Drug)
    Solution for injection

Eligibility criteria

Key inclusion: * Male and female participants with a diagnosis of HeFH or HoFH who completed the ORION-16, ORION-13, ORION-20 or ORION-19 studies * Per investigator's clinical judgment, participant derived benefit from treatment with inclisiran in the ORION-16, ORION-13, ORION-20 or ORION-19 studies Key exclusion: * Participants who in the feeder ORION-16, ORION-13, ORION-20, or ORION-19 studies either screen failed or permanently discontinued from the treatment/study for any reason or had serious safety or tolerability issues related to inclisiran treatment * Any uncontrolled or serious disease, or any medical, physical, or surgical condition, that may either interfere with participation in the clinical study or interpretation of clinical study results, and/or put the participant at significant risk

Conditions

Heterozygous or Homozygous Familial Hypercholesterolemia

Locations

  • Excel Medical Clinical Trials LLC — Boca Raton, Florida, United States
  • Icahn School of Med at Mt Sinai — New York, New York, United States
  • Cincinnati Childrens Hospital MC — Cincinnati, Ohio, United States
  • Childrens Hosp Pittsburgh UPMC — Pittsburgh, Pennsylvania, United States
  • 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
  • Novartis Investigative Site — Freiburg im Breisgau, Germany
  • 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
  • Novartis Investigative Site — Irbid, Jordan
  • Novartis Investigative Site — Beirut, Lebanon
  • Novartis Investigative Site — Beirut, Lebanon
  • Novartis Investigative Site — Sungai Buloh, Selangor, Malaysia
  • Novartis Investigative Site — Kuala Lumpur, Malaysia
  • Novartis Investigative Site — Amsterdam, North Holland, Netherlands
  • Novartis Investigative Site — Rotterdam, South Holland, Netherlands
  • Novartis Investigative Site — Oslo, Norway
  • Novartis Investigative Site — Gdansk, Poland
  • Novartis Investigative Site — Lodz, Łódź Voivodeship, Poland
  • Novartis Investigative Site — Kemerovo, Russia
  • Novartis Investigative Site — Moscow, Russia
  • Novartis Investigative Site — Poprad, Slovakia
  • Novartis Investigative Site — Ljubljana, Slovenia
  • Novartis Investigative Site — Bloemfontein, Free State, South Africa
  • Novartis Investigative Site — Cape Town, Western Cape, South Africa
  • Novartis Investigative Site — Pamplona, Navarre, Spain
  • Novartis Investigative Site — Oviedo, Principality of Asturias, Spain
  • Novartis Investigative Site — A Coruña, Spain
  • Novartis Investigative Site — Córdoba, Spain
  • Novartis Investigative Site — Geneva, Switzerland
  • Novartis Investigative Site — Taipei, Taiwan
  • Novartis Investigative Site — Istanbul, Fatih, Turkey (Türkiye)
  • Novartis Investigative Site — Adana, Saricam, Turkey (Türkiye)
  • Novartis Investigative Site — Ankara, Yenimahalle, Turkey (Türkiye)
  • Novartis Investigative Site — Izmir, Turkey (Türkiye)
  • Novartis Investigative Site — Middlesex, United Kingdom
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record