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ORION-16 inclisiran in adolescents with heterozygous familial hypercholesterolemia
2020-002757-18Phase 3Completed
- Sponsor
- Novartis
- Start
- Oct 2020
- 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 heterozygous familial hypercholesterolemia (HeFH) comparing Inclisiran first-year arm with Placebo first-year arm (2 arms). Primary endpoints: Percentage change in LDL-cholesterol at Day 330 (Year 1) and Time-adjusted percentage change in LDL-cholesterol over Year 1. Started Oct 2020; status: completed.
02
Drugs
inclisiran
03
Conditions
heterozygous familial hypercholesterolemia (HeFH)
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