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Long-term Safety of Inclisiran for Familial Hypercholesterolemia

This study is looking at the long-term safety of inclisiran, a medication for people with high cholesterol due to genetic conditions called Heterozygous Familial Hypercholesterolemia (HeFH) or Homozygous Familial Hypercholesterolemia (HoFH). You can join this study if you are between 12 and 100 years old and have already completed one of the ORION-16, ORION-13, ORION-20, or ORION-19 studies, and your doctor believes you benefited from inclisiran. The main goal is to track any side effects you might experience while taking inclisiran over a long period, up to about three years. The study is currently unclear on its recruitment status and plans to enroll 195 participants.

Study design
This is an open-label, single-arm study, meaning all participants will receive inclisiran and everyone involved will know what treatment is being given. It aims to enroll 195 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed from Day 1 up to the end of the study visit, which can be up to 1080 days (approximately 3 years).

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05682378

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
PHASE3Ages 12+InterventionalTreatment
Novartis Pharmaceuticals
~195 participants
Updated 2026-05-15 on ClinicalTrials.gov
What's tested:Inclisiran

At a glance

Recruiting sites
1 of 52 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of participants with treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs)
Measured over From Day 1 in the study up to the end of study visit; up to 1080 days

Conditions

Heterozygous or Homozygous Familial Hypercholesterolemia

Explore related trials

Familial hypercholesterolemia - heterozygousFamilial hypercholesterolemia - homozygous

NCT05682378

Where you'd take part

This study runs at 52 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Novartis Investigative Site

    Taipei, Taiwanno site contact published

    Recruiting

  • Childrens Hosp Pittsburgh UPMC

    Pittsburgh, Pennsylvaniano site contact published

    Active, not recruiting

  • Cincinnati Childrens Hospital MC

    Cincinnati, Ohiono site contact published

    Completed

  • Excel Medical Clinical Trials LLC

    Boca Raton, Floridano site contact published

    Completed

  • Icahn School of Med at Mt Sinai

    New York, New Yorkno site contact published

    Active, not recruiting

  • Novartis Investigative Site

    Formosa, Formosa Province, Argentinano site contact published

    Active, not recruiting

  • Novartis Investigative Site

    Fortaleza, Ceará, Brazilno site contact published

    Active, not recruiting

  • Novartis Investigative Site

    São Paulo, São Paulo, Brazilno site contact published

    Completed

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Novartis Pharmaceuticals · STUDY_DIRECTOR · Novartis Pharmaceuticals

Who to contact

Novartis Pharmaceuticals
[email protected]
1-888-669-6682
Email the study team

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What this trial measures

  • Number of participants with treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs)From Day 1 in the study up to the end of study visit; up to 1080 days

    Safety and tolerability: TEAEs, TESAEs (incidence, severity, relationship to study drug and discontinuation due to TEAEs)