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Taking peoplePhase 3

Long-term Safety of Inclisiran in Children and Adults With Familial Hypercholesterolemia

Tests long-term safety of inclisiran in people with inherited high cholesterol who finished earlier studies.

Key facts

Who runs it
Novartis Pharmaceuticals
Where
A Coruña, Córdoba, Oviedo, and Pamplona, SpainSee the 4 sitesAlso in 25 other countries, 43 sites
Registry title
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
Status
Recruiting
Phase
Phase 3
People taking part
195 people, planned
Started
10 Feb 2023
Expected to end
28 Mar 2032
Type of study
Interventional
Treatments tested
  • Inclisiran
Record updated
18 September 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for people with heterozygous or homozygous familial hypercholesterolemia (inherited high cholesterol) who finished an earlier ORION study and benefited from inclisiran there.

Age
From 2 years to 100 years.
Sex
Both men and women can join.
Disease stage
Heterozygous familial hypercholesterolemia (HeFH) or homozygous familial hypercholesterolemia (HoFH).
Earlier treatment
Must have completed the ORION-16, ORION-13, ORION-20 or ORION-19 study. The investigator must judge that the person benefited from inclisiran in that study.

Main reasons for not taking part

  • Failed screening or permanently stopped treatment or the study in the earlier ORION study, for any reason
  • Serious safety or tolerability problems with inclisiran in the earlier study
  • Any uncontrolled or serious disease or condition that could interfere with the study or put the person at significant risk

The registry criteria, word for word

Show all 5 criteriaShow less

Other 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

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 2 and 100 years old?

Where in Spain

Also in 25 other countries, 43 sites

  • A Coruña, GaliciaHospital not named in the registryContact: Novartis PharmaceuticalsNo longer taking part
  • CórdobaHospital not named in the registryContact: Novartis PharmaceuticalsNo longer taking part
  • Oviedo, Principality of AsturiasHospital not named in the registryContact: Novartis PharmaceuticalsNo longer taking part
  • Pamplona, NavarreHospital not named in the registryContact: Novartis PharmaceuticalsNo longer taking part

About the trial

What the trial wants to find out

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.

The group in the trial

  • InclisiranTreatment being tested

    Participants who have completed ORION-16 or ORION-13 receive inclisiran sodium 300mg (equivalent to 284mg inclisiran\*) in 1.5mL solution. Participants who have completed ORION-19 and ORION-20 receive Inclisiran dose levels based on weight.

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
An Open-label, Single Arm, Multicenter Extension Study to Evaluate Long-term Safety and Tolerability of Inclisiran in Participants With Heterozygous or Homozygous Familial Hypercholesterolemia Who Have Completed the Pediatric ORION-16, ORION-13, ORION-20 or ORION-19 Studies (VICTORION-PEDS-OLE)
Plain-language title
Long-term Safety of Inclisiran in Children and Adults With Familial HypercholesterolemiaGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Fit questions
Built from NCT05682378, who can take part
Record updated
18 September 2026