drugset
drugset / Trial / NCT06597006

Study to Evaluate Safety, Tolerability and Efficacy of Inclisiran in Children With Homozygous Familial Hypercholesterolemia

NCT06597006 ↗

Phase 3 Recruiting 9 enrolled Novartis Pharmaceuticals
RandomizedParallel-groupDouble-blindTreatment

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).

Timeline

Start
2025-02-28
Primary completion
2028-03-23
Completion
2029-04-15

Drugs

EvaluationDrugModalityDoseRoute
Subject Inclisiran Small interfering RNA (siRNA) 100 mg Subcutaneous
Subject Inclisiran Small interfering RNA (siRNA) 180 mg Subcutaneous
Subject Inclisiran Small interfering RNA (siRNA) 300 mg Subcutaneous

Indications

homozygous familial hypercholesterolemia