A Phase 3 interventional study of Inclisiran in Heterozygous or Homozygous Familial Hypercholesterolemia, sponsored by Novartis Pharmaceuticals. Recruiting at 52 sites in 26 countries. Open to participants aged 2 Years to 100 Years. Per ClinicalTrials.gov, last updated 2026-09-18.
Sponsored by Novartis Pharmaceuticals (part of Novartis) · Phase 3, Interventional, and Treatment
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.
This is an open-label, single arm, multicenter study designed to evaluate long-term safety and tolerability of inclisiran. In addition, the study will provide participants the opportunity to have continued access to treatment with inclisiran.
68 studies on the registry are indexed under Homozygous Familial Hypercholesterolemia; 13 are open to participants now.
This study's planned enrollment of 195 is above the median of 21 across 51 interventional studies indexed under Homozygous Familial Hypercholesterolemia.
Browse Homozygous Familial Hypercholesterolemia studies →Novartis Pharmaceuticals is the lead sponsor of 2,718 studies on the registry; 221 are open to participants now.
Of its 585 completed or terminated interventional studies of FDA-regulated products, 438 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Key inclusion:
Key exclusion:
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.
Drug: Inclisiran
Solution for injection
Also known as: KJX839
Number of participants with treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs)
Safety and tolerability: TEAEs, TESAEs (incidence, severity, relationship to study drug and discontinuation due to TEAEs)
Time frame: From Day 1 in the study up to the end of study visit; up to 1080 days
Percentage and absolute change in LDL-C from baseline in the feeder study to end of study
Evaluate the long-term effect of inclisiran (from baseline of feeder study to end of study) in lowering LDL-C
Time frame: Baseline (of feeder study) and Day 1080
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Plan to share: Yes — Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
No publications or documents are linked to this record.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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Studies of the drug tested here: Inclisiran
Homozygous Familial Hypercholesterolemia →