CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 141 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.

Search/NCT04652726
NCT04652726Phase 3Completed
CompareCT.gov

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 Heterozygous Familial Hypercholesterolemia and Elevated LDL-cholesterol (ORION-16)

Novartis Pharmaceuticals·interventional·Posted Dec 3, 2020·Updated Jan 13, 2026

In Brief

A Phase 3 clinical trial evaluating Inclisiran and Placebo for Familial Hypercholesterolemia - Heterozygous. Completed, enrolled 141 participants across 59 sites in 26 countries.

Detailed Summary

This was a pivotal phase III study designed to evaluate safety, tolerability, and efficacy of inclisiran in adolescents with heterozygous familial hypercholesterolemia (HeFH) and elevated low density lipoprotein cholesterol (LDL-C).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsFamilial Hypercholesterolemia - Heterozygous
CountriesArgentina, Brazil, Canada, Czechia, France, Germany, Greece, Hungary, Israel, Italy, Jordan, Lebanon, Malaysia, Netherlands, Norway, Poland, Russia, Slovakia, Slovenia, South Africa, Spain, Switzerland, Taiwan, Turkey (Türkiye), United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
202120222023202420252026
First PostedDec 3, 2020
Enrollment StartJan 27, 2021
Primary CompletionNov 9, 2023
Study CompletionNov 27, 2024
TodayJul 2, 2026
Enrollment to primary: 2.8 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 subcutaneous injection)