Trial to Evaluate the Effect of Inclisiran Treatment on Low Density Lipoprotein Cholesterol (LDL-C) in Subjects With Heterozygous Familial Hypercholesterolemia (HeFH) (ORION-9)
Placebo-Controlled, Double-Blind, Randomized Trial to Evaluate the Effect of 300 mg of Inclisiran Sodium Given as Subcutaneous Injections in Subjects With Heterozygous Familial Hypercholesterolemia (HeFH) and Elevated Low-Density Lipoprotein Cholesterol (LDL-C).
Sponsor: The Medicines Company
Listed as NCT03397121, this PHASE3 trial focuses on Elevated Cholesterol and Heterozygous Familial Hypercholesterolemia and remains completed. Sponsored by The Medicines Company, it has been updated 14 times since 2017, reflecting substantial change activity. This study adds to the evidence base for this therapeutic area through structured, versioned documentation.
Status Flow
Change History
14 versions recorded-
Sep 2025 — Present [monthly]
Completed PHASE3
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Sep 2024 — Sep 2025 [monthly]
Completed PHASE3
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Jul 2024 — Sep 2024 [monthly]
Completed PHASE3
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Jan 2023 — Jul 2024 [monthly]
Completed PHASE3
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Dec 2022 — Jan 2023 [monthly]
Completed PHASE3
▶ Show 9 earlier versions
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Jan 2021 — Dec 2022 [monthly]
Completed PHASE3
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Nov 2020 — Jan 2021 [monthly]
Completed PHASE3
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Sep 2020 — Nov 2020 [monthly]
Completed PHASE3
Status: Active Not Recruiting → Completed
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Oct 2019 — Sep 2020 [monthly]
Active Not Recruiting PHASE3
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May 2019 — Oct 2019 [monthly]
Active Not Recruiting PHASE3
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Jan 2019 — May 2019 [monthly]
Active Not Recruiting PHASE3
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Jun 2018 — Jan 2019 [monthly]
Active Not Recruiting PHASE3
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May 2018 — Jun 2018 [monthly]
Active Not Recruiting PHASE3
Status: Recruiting → Active Not Recruiting
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Feb 2018 — May 2018 [monthly]
Recruiting PHASE3
First recorded
Nov 2017
Trial started
Per CT.gov start date — pre-dates our first snapshot
Eligibility Summary
No eligibility information available.
Contact Information
- The Medicines Company
For direct contact, visit the study record on ClinicalTrials.gov .