Study to Evaluate Efficacy and Safety of Inclisiran in Adolescents With Homozygous Familial Hypercholesterolemia (ORION-13)
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 Adolescents (12 to Less Than 18 Years) With Homozygous Familial Hypercholesterolemia and Elevated LDL-cholesterol (ORION-13)
Sponsor: Novartis Pharmaceuticals
Listed as NCT04659863, this PHASE3 trial focuses on Familial Hypercholesterolemia - Homozygous and remains completed. Sponsored by Novartis Pharmaceuticals, it has been updated 24 times since 2021, reflecting substantial change activity. This study adds to the evidence base for this therapeutic area through structured, versioned documentation.
Status Flow
Change History
24 versions recorded-
Feb 2026 — Present [monthly]
Completed PHASE3
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Nov 2025 — Feb 2026 [monthly]
Completed PHASE3
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Sep 2025 — Nov 2025 [monthly]
Completed PHASE3
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Jun 2025 — Sep 2025 [monthly]
Completed PHASE3
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Feb 2025 — Jun 2025 [monthly]
Completed PHASE3
Status: Active Not Recruiting → Completed
▶ Show 19 earlier versions
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Oct 2024 — Feb 2025 [monthly]
Active Not Recruiting PHASE3
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Sep 2024 — Oct 2024 [monthly]
Active Not Recruiting PHASE3
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Jul 2024 — Sep 2024 [monthly]
Active Not Recruiting PHASE3
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Apr 2024 — Jul 2024 [monthly]
Active Not Recruiting PHASE3
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Dec 2023 — Apr 2024 [monthly]
Active Not Recruiting PHASE3
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Nov 2023 — Dec 2023 [monthly]
Active Not Recruiting PHASE3
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Aug 2023 — Nov 2023 [monthly]
Active Not Recruiting PHASE3
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Jun 2023 — Aug 2023 [monthly]
Active Not Recruiting PHASE3
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Feb 2023 — Jun 2023 [monthly]
Active Not Recruiting PHASE3
Status: Recruiting → Active Not Recruiting
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Jan 2023 — Feb 2023 [monthly]
Recruiting PHASE3
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Sep 2022 — Jan 2023 [monthly]
Recruiting PHASE3
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Jun 2022 — Sep 2022 [monthly]
Recruiting PHASE3
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Apr 2022 — Jun 2022 [monthly]
Recruiting PHASE3
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Feb 2022 — Apr 2022 [monthly]
Recruiting PHASE3
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Jan 2022 — Feb 2022 [monthly]
Recruiting PHASE3
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Nov 2021 — Jan 2022 [monthly]
Recruiting PHASE3
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Oct 2021 — Nov 2021 [monthly]
Recruiting PHASE3
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Apr 2021 — Oct 2021 [monthly]
Recruiting PHASE3
Status: Not Yet Recruiting → Recruiting
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Jan 2021 — Apr 2021 [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 .