Study to Evaluate Efficacy and Safety of Inclisiran in Children With Heterozygous 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 6 to \<12 years) with heterozygous familial hypercholesterolemia (HeFH) 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-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
Record
- Archive ID
- nct:NCT06597019
- Published
- Sep 19, 2024
- Updated
- May 15, 2026
- Venue
- ClinicalTrials.gov
- ClinicalTrials.gov
- NCT06597019
- Categories
- Familial Hypercholesterolemia - Heterozygous
- License
- ClinicalTrials.gov terms (attribution, processing date, modifications noted)
- Provenance
- clinicaltrials