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Trial intelligence / Profile preview
ORION-16 inclisiran study in adolescents with heterozygous familial hypercholesterolemia
NL-OMON54301Phase 3Completed
- Sponsor
- Novartis
- Start
- Apr 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
- 1
01
Overview
Phase 3, randomised, double-blind trial in familial hypercholesterolemia (FH) 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 Apr 2021; status: completed.
02
Drugs
inclisiran
03
Conditions
familial hypercholesterolemia (FH)
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