Study to Evaluate Safety, Tolerability and Efficacy of Inclisiran in Children With Homozygous Familial Hypercholesterolemia
Novartis Pharmaceuticals
View at source ↗Clinical trial
Source: 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. Not a U.S. Government endorsement.
Brief summary
This is a pivotal phase III study designed to evaluate safety, tolerability, and efficacy of inclisiran in children (aged 2 to \<12 years) with homozygous familial hypercholesterolemia (HoFH) and elevated low density lipoprotein cholesterol (LDLC).
Source: 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. Not a U.S. Government endorsement.
Trial details
- acronym
- ORION-19
- status
- RECRUITING
- phase
- PHASE3
- study type
- INTERVENTIONAL
- enrollment
- 9
- sponsor
- Novartis Pharmaceuticals
- conditions
- Familial Hypercholesterolemia - Homozygous
- interventions
- DRUG: Inclisiran; DRUG: Placebo
- start date
- 2025-02-28
- 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
Record
- Archive ID
- nct:NCT06597006
- Published
- Sep 19, 2024
- Updated
- Jul 24, 2026
- Venue
- ClinicalTrials.gov
- ClinicalTrials.gov
- NCT06597006
- Categories
- Familial Hypercholesterolemia - Homozygous
- License
- ClinicalTrials.gov terms (attribution, processing date, modifications noted)
- Provenance
- clinicaltrials