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RecruitingPhase 3

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

Novartis Pharmaceuticals · NCT05682378

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Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 2–100 · All sexes
Healthy volunteers
Not accepted (a condition is required)
Study type
Interventional · Phase 3
Target enrollment
195
US sites recruiting
1
Study start
February 10, 2023
Record last updated
September 18, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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.

Being studied: Inclisiran

Conditions: Heterozygous or Homozygous Familial Hypercholesterolemia

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full 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

Recruiting US locations

  • Primary Childrens Medical Center

    Salt Lake City, UT 84113

    Site contact: Linda Lambert · Linda.lambert@hsc.utah.edu

Study contacts (from the official record)

  • Novartis Pharmaceuticals · 1-888-669-6682 · novartis.email@novartis.com
  • Novartis Pharmaceuticals · +41613241111
All heart & blood pressure studies in Utah →
Long-term Safety and Tolerability of Inclisiran in Participants… (NCT05682378) | Bored Studies