Study to Evaluate Efficacy and Safety of Inclisiran in Children With Heterozygous Familial Hypercholesterolemia (ORION-20)
Two Part (Double-blind Inclisiran Versus Placebo [Year 1] Followed by Open-label Inclisiran [Year 2]) Randomized Multicenter Study to Evaluate Safety, Tolerability and Efficacy of Inclisiran in Children (6 to Less Than 12 Years) With Heterozygous Familial Hypercholesterolemia and Elevated LDL- Cholesterol
Sponsor: Novartis Pharmaceuticals
A PHASE3 clinical study on Familial Hypercholesterolemia - Heterozygous, this trial is actively recruiting participants. The trial is conducted by Novartis Pharmaceuticals and has accumulated 10 data snapshots since 2024. Longitudinal tracking of this trial contributes to a broader understanding of treatment development timelines.
Status Flow
Change History
10 versions recorded-
Dec 2025 — Present [monthly]
Recruiting PHASE3
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Sep 2025 — Dec 2025 [monthly]
Recruiting PHASE3
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Aug 2025 — Sep 2025 [monthly]
Recruiting PHASE3
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Jul 2025 — Aug 2025 [monthly]
Recruiting PHASE3
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Jun 2025 — Jul 2025 [monthly]
Recruiting PHASE3
▶ Show 5 earlier versions
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May 2025 — Jun 2025 [monthly]
Recruiting PHASE3
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Apr 2025 — May 2025 [monthly]
Recruiting PHASE3
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Jan 2025 — Apr 2025 [monthly]
Recruiting PHASE3
Status: Not Yet Recruiting → Recruiting
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Nov 2024 — Jan 2025 [monthly]
Not Yet Recruiting PHASE3
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Oct 2024 — Nov 2024 [monthly]
Not Yet Recruiting PHASE3
First recorded
Eligibility Summary
No eligibility information available.
Contact Information
- Novartis Pharmaceuticals
For direct contact, visit the study record on ClinicalTrials.gov .
Study Locations
Adana, Turkey (Türkiye) , Amsterdam, Netherlands , Ankara, Turkey (Türkiye) , Athens, Greece , Badalona, Spain , Barcelona, Spain , Beijing, China , Bialystok, Poland , Bloemfontein, South Africa , Boca Raton, United States and 49 more locations