Inclisiran: Inclisiran (inclisiran sodium 300 mg subcutaneous (s.c.) for participants with body weight ≥23 kg and inclisiran sodium 180 mg s.c. for participants with body weight \<23 kg. The dose level is based on the participant's body weight on Day 1 (for Part 1) and Day 360 (for Part 2), respectively.
Placebo: Sterile normal saline (0.9% sodium chloride in water for subcutaneous injection)
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).
| Facility | City | Region | Status |
|---|---|---|---|
| UC San Francisco Medical Center | San Francisco | California | Recruiting |
| UC San Francisco Medical Center | San Francisco | California | Recruiting |
| Children's National Hospital | Washington D.C. | District of Columbia | Not Yet Recruiting |
| Childrens National Hospital | Washington D.C. | District of Columbia | Recruiting |
| Excel Medical Clinical Trials LLC | Boca Raton | Florida | Recruiting |
| Icahn School of Med at Mt Sinai | New York | New York | Recruiting |
| Primary Childrens Medical Center | Salt Lake City | Utah | Not Yet Recruiting |
| Primary Childrens Medical Center | Salt Lake City | Utah | Recruiting |
| Virginia Commonwealth University | Richmond | Virginia | Recruiting |
| West Virginia Childrens Hospital | Morgantown | West Virginia | Recruiting |
| West Virginia Childrens Hospital | Morgantown | West Virginia | Recruiting |
| Novartis Investigative Site | Buenos Aires | Argentina | Recruiting |
| Novartis Investigative Site | CABA | Argentina | Recruiting |
| Novartis Investigative Site | Salzburg | Austria | Recruiting |
| Novartis Investigative Site | Vienna | Austria | Recruiting |
| Novartis Investigative Site | Brussels | Belgium | Recruiting |
| Novartis Investigative Site | Leuven | Belgium | Recruiting |
| Novartis Investigative Site | Fortaleza | Ceará | Recruiting |
| Novartis Investigative Site | Rio de Janeiro | Rio de Janeiro | Recruiting |
| Novartis Investigative Site | Porto Alegre | Rio Grande do Sul | Recruiting |
| Novartis Investigative Site | São Paulo | São Paulo | Recruiting |
| Novartis Investigative Site | Beijing | Beijing Municipality | Recruiting |
| Novartis Investigative Site | Shanghai | China | Recruiting |
| Novartis Investigative Site | Prague | Czechia | Recruiting |
| Novartis Investigative Site | Prague | Czechia | Recruiting |
| Novartis Investigative Site | Marseille | France | Recruiting |
| Novartis Investigative Site | Nantes | France | Recruiting |
| Novartis Investigative Site | Paris | France | Recruiting |
| Novartis Investigative Site | Freiburg im Breisgau | Baden-Wurttemberg | Recruiting |
| Novartis Investigative Site | Frankfurt am Main | Hesse | Recruiting |
| Novartis Investigative Site | Hanover | Germany | Recruiting |
| Novartis Investigative Site | Athens | Greece | Recruiting |
| Novartis Investigative Site | Ioannina | Greece | Recruiting |
| Novartis Investigative Site | Hong Kong | Hong Kong | Recruiting |
| Novartis Investigative Site | Budapest | Hungary | Recruiting |
| Novartis Investigative Site | Jerusalem | Israel | Recruiting |
| Novartis Investigative Site | Ramat Gan | Israel | Recruiting |
| Novartis Investigative Site | Milan | MI | Recruiting |
| Novartis Investigative Site | Roma | RM | Recruiting |
| Novartis Investigative Site | Torino | TO | Recruiting |
+ 26 more sites — see the full list on the official registry below.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06597019 on ClinicalTrials.gov ↗ ← All trials in the UK