At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 13 enrolled
Drug / intervention
Inclisiran +1 moredrug
Likely dose
Inclisiran 300 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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)
In Brief
A Phase 3 clinical trial evaluating Inclisiran and Placebo for Familial Hypercholesterolemia - Homozygous. Completed, enrolled 13 participants across 11 sites in 8 countries.
Detailed Summary
This was a pivotal phase III study designed to evaluate safety, tolerability, and efficacy of inclisiran in adolescents with homozygous familial hypercholesterolemia (HoFH) and elevated low density lipoprotein cholesterol (LDL-C).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesCanada, France, Greece, Lebanon, Malaysia, Netherlands, Turkey (Türkiye), United States
Collaborators--
Timeline
Phase 3CompletedFinished
202120222023202420252026
First PostedDec 2020
Enrollment StartFeb 2021
Primary CompletionOct 2023
Study CompletionNov 2024
TodayJul 2026
First PostedDec 9, 2020
Enrollment StartFeb 16, 2021
Primary CompletionOct 30, 2023
Study CompletionNov 18, 2024
TodayJul 2, 2026
Enrollment to primary: 2.7 yearsPosted 5.6 years ago
Interventions
Inclisirandrug
Inclisiran sodium 300 mg (equivalent to 284 mg inclisiran) in 1.5 mL solution for subcutaneous injection
Placebodrug
Sterile normal saline (0.9% sodium chloride in water for injection) for subcutaneous injection