# Study to Evaluate Efficacy and Safety of Inclisiran in Children With Heterozygous Familial Hypercholesterolemia

Clinical trial · Novartis Pharmaceuticals

- Archive id: nct:NCT06597019
- Published: 2024-09-19
- Venue: ClinicalTrials.gov
- ClinicalTrials.gov: https://clinicaltrials.gov/study/NCT06597019
- Source URL: https://clinicaltrials.gov/study/NCT06597019
- Provenance: clinicaltrials

## Abstract

This is a pivotal phase III study designed to evaluate safety, tolerability, and efficacy of inclisiran in children (aged 6 to \\\<12 years) with heterozygous familial hypercholesterolemia (HeFH) and elevated low density lipoprotein cholesterol (LDLC).

_Abstract reproduced under ClinicalTrials.gov (U.S. National Library of Medicine), data processed 2026-10-29T09:00:05; modifications: selected fields only; whitespace normalized; brief summary truncated to 2,000 characters._

## Trial details

- acronym: ORION-20
- status: RECRUITING
- phase: PHASE3
- study type: INTERVENTIONAL
- enrollment: 60
- sponsor: Novartis Pharmaceuticals
- conditions: Familial Hypercholesterolemia - Heterozygous
- interventions: DRUG: Inclisiran; DRUG: Placebo
- start date: 2024-12-09
- start date type: ACTUAL
- primary completion date: 2028-03-21
- has results: false
- data source: ClinicalTrials.gov
- data processed: 2026-10-29T09:00:05
- modifications: selected fields only; whitespace normalized; brief summary truncated to 2,000 characters

Topics: [Cardiovascular Therapeutics](https://space-kitty.com/topics/cardiovascular-innovation)

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