drugset / Trial / NCT06597019
Study to Evaluate Efficacy and Safety of Inclisiran in Children With Heterozygous Familial Hypercholesterolemia
RandomizedParallel-groupDouble-blindTreatment
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).
Timeline
- Start
- 2024-12-09
- Primary completion
- 2028-03-21
- Completion
- 2029-04-15
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Inclisiran | Small interfering RNA (siRNA) | 180 mg | Subcutaneous |
| Subject | Inclisiran | Small interfering RNA (siRNA) | 300 mg | Subcutaneous |