Trial intelligence / Profile preview

ORION-16 inclisiran trial in adolescents with heterozygous familial hypercholesterolemia

MOH_2021-02-28_009791Phase 3Active, not recruiting

Sponsor
Novartis
Start
Jan 2021
Modality
Chemically Modified siRNA → Small Interfering RNA (siRNA) → Small RNA Therapeutics → RNA Therapeutics → Nucleic Acid Therapeutics, Conjugated siRNA → Small Interfering RNA (siRNA) → Small RNA Therapeutics → RNA Therapeutics → Nucleic Acid Therapeutics, MicroRNA (miRNA) → Small RNA Therapeutics → RNA Therapeutics → Nucleic Acid Therapeutics
Countries
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Overview

Phase 3, randomised, double-blind trial in heterozygous familial hypercholesterolemia (HeFH) comparing Inclisiran then open-label inclisiran with Placebo then open-label inclisiran (2 arms). Primary endpoint: Percent change in LDL-C at Day 330. Started Jan 2021; status: active, not recruiting.

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Drugs

inclisiran
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Conditions

heterozygous familial hypercholesterolemia (HeFH)

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