Study to Evaluate Safety, Tolerability and Efficacy of Inclisiran in Children With Homozygous Familial Hypercholesterolemia (ORION-19)
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 (2 to Less Than 12 Years) With Homozygous Familial Hypercholesterolemia and Elevated LDL-cholesterol
Sponsor: Novartis Pharmaceuticals
This PHASE3 trial investigates Familial Hypercholesterolemia - Homozygous and is currently actively recruiting participants. Novartis Pharmaceuticals leads this study, which shows 10 recorded versions since 2025 — indicating substantial longitudinal coverage. The change history captured here reflects the iterative nature of clinical trial conduct.
Status Flow
Change History
10 versions recorded-
Feb 2026 — Present [monthly]
Recruiting PHASE3
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Jan 2026 — Feb 2026 [monthly]
Recruiting PHASE3
-
Nov 2025 — Jan 2026 [monthly]
Recruiting PHASE3
-
Sep 2025 — Nov 2025 [monthly]
Recruiting PHASE3
-
Jul 2025 — Sep 2025 [monthly]
Recruiting PHASE3
▶ Show 5 earlier versions
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May 2025 — Jul 2025 [monthly]
Recruiting PHASE3
-
Apr 2025 — May 2025 [monthly]
Recruiting PHASE3
Status: Not Yet Recruiting → Recruiting
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Dec 2024 — Apr 2025 [monthly]
Not Yet Recruiting PHASE3
-
Nov 2024 — Dec 2024 [monthly]
Not Yet Recruiting PHASE3
-
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 .