New shot could slash 'Bad' cholesterol in kids with genetic heart risk

NCT ID NCT06597019

Recruiting now Disease control Sponsor: Novartis Pharmaceuticals Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a drug called inclisiran in children aged 6 to 12 who have a genetic condition that causes very high cholesterol. The drug is given as a shot under the skin and aims to lower 'bad' LDL cholesterol. The trial compares inclisiran to a placebo for one year, then everyone gets inclisiran for a second year. About 60 children will take part to see if the drug is safe and works well.

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance: Inclisiran (a drug that lowers cholesterol by blocking a protein in the liver)
What this could lead to: If it works, this could provide a new, convenient treatment option (given as a shot every few months) to help children with inherited high cholesterol lower their LDL levels.
What could go wrong: This is a relatively small, early-stage trial in children, so results may not apply to all. The drug's long-term safety and effectiveness in this age group are still unknown.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for FAMILIAL HYPERCHOLESTEROLEMIA - HETEROZYGOUS are added.

Our safety recommendation!

By submitting, you agree to our Terms of use

Conditions

The condition(s) this trial relates to.

aortic valve stenosis cardiovascular disorder Dyslipidemias familial hypercholesterolemia heart failure Hypercholesterolemia hyperlipidemia Hyperlipoproteinemia Type II

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

FAMILIAL HYPERCHOLESTEROLEMIA - HETEROZYGOUS

Contacts and locations

Show contact details

Study contacts

Contact

Phone: •••-•••-•••• Email: •••••@•••••
Contact

Phone: •••-•••-••••

Locations

Children's National Hospital
NOT_YET_RECRUITING

Washington D.C., District of Columbia, 20010, United States

Contact Phone: •••-•••-•••• Email: •••••@•••••

Contact
Childrens National Hospital
RECRUITING

Washington D.C., District of Columbia, 20010, United States

Contact Phone: •••-•••-•••• Email: •••••@•••••

Contact
Excel Medical Clinical Trials LLC
RECRUITING

Boca Raton, Florida, 33434, United States

Contact Phone: •••-•••-•••• Email: •••••@•••••

Contact
Icahn School of Med at Mt Sinai
RECRUITING

New York, New York, 10029, United States

Contact Phone: •••-•••-•••• Email: •••••@•••••

Contact
Novartis Investigative Site
RECRUITING

Buenos Aires, C1245AAM, Argentina
Novartis Investigative Site
RECRUITING

CABA, C1181ACH, Argentina
Novartis Investigative Site
RECRUITING

Salzburg, 5020, Austria
Novartis Investigative Site
RECRUITING

Vienna, 1090, Austria
Novartis Investigative Site
RECRUITING

Brussels, 1200, Belgium
Novartis Investigative Site
RECRUITING

Leuven, 3000, Belgium
Novartis Investigative Site
RECRUITING

Fortaleza, Ceará, 60430-275, Brazil
Novartis Investigative Site
RECRUITING

Rio de Janeiro, Rio de Janeiro, 20211-340, Brazil
Novartis Investigative Site
RECRUITING

Porto Alegre, Rio Grande do Sul, 90020-020, Brazil
Novartis Investigative Site
RECRUITING

São Paulo, São Paulo, 05403 000, Brazil
Novartis Investigative Site
RECRUITING

Beijing, Beijing Municipality, 100013, China
Novartis Investigative Site
RECRUITING

Shanghai, 200127, China
Novartis Investigative Site
RECRUITING

Prague, 128 08, Czechia
Novartis Investigative Site
RECRUITING

Prague, 150 06, Czechia
Novartis Investigative Site
RECRUITING

Marseille, 13885, France
Novartis Investigative Site
RECRUITING

Nantes, 44093, France
Novartis Investigative Site
RECRUITING

Paris, 75012, France
Novartis Investigative Site
RECRUITING

Freiburg im Breisgau, Baden-Wurttemberg, 79106, Germany
Novartis Investigative Site
RECRUITING

Frankfurt am Main, Hesse, 60590, Germany
Novartis Investigative Site
RECRUITING

Hanover, 30173, Germany
Novartis Investigative Site
RECRUITING

Athens, 115 27, Greece
Novartis Investigative Site
RECRUITING

Ioannina, 455 00, Greece
Novartis Investigative Site
RECRUITING

Hong Kong, 999077, Hong Kong
Novartis Investigative Site
RECRUITING

Budapest, 1026, Hungary
Novartis Investigative Site
RECRUITING

Jerusalem, 9112001, Israel
Novartis Investigative Site
RECRUITING

Ramat Gan, 5265601, Israel
Novartis Investigative Site
RECRUITING

Milan, MI, 20162, Italy
Novartis Investigative Site
RECRUITING

Roma, RM, 00165, Italy
Novartis Investigative Site
RECRUITING

Torino, TO, 10126, Italy
Novartis Investigative Site
RECRUITING

Verona, VR, 37126, Italy
Novartis Investigative Site
RECRUITING

Kuala Lumpur, Kuala Lumpur, 50586, Malaysia
Novartis Investigative Site
RECRUITING

Amsterdam, North Holland, 1105 AZ, Netherlands
Novartis Investigative Site
RECRUITING

Bialystok, 15-274, Poland
Novartis Investigative Site
RECRUITING

Gdansk, 80 952, Poland
Novartis Investigative Site
RECRUITING

Lodz, Łódź Voivodeship, 93-338, Poland
Novartis Investigative Site
RECRUITING

Coimbra, 3000-602, Portugal
Novartis Investigative Site
RECRUITING

Lisbon, 1649-035, Portugal
Novartis Investigative Site
RECRUITING

Porto, 4050-651, Portugal
Novartis Investigative Site
RECRUITING

Porto, 4200 319, Portugal
Novartis Investigative Site
RECRUITING

Bloemfontein, Free State, 9301, South Africa
Novartis Investigative Site
RECRUITING

Elche, Alicante, 03203, Spain
Novartis Investigative Site
RECRUITING

Cadiz, Andalusia, 11009, Spain
Novartis Investigative Site
RECRUITING

Badalona, Barcelona, 08916, Spain
Novartis Investigative Site
RECRUITING

Esplugues, Barcelona, 08950, Spain
Novartis Investigative Site
RECRUITING

Pamplona, Navarre, 31008, Spain
Novartis Investigative Site
RECRUITING

Barcelona, 08041, Spain
Novartis Investigative Site
RECRUITING

Málaga, 29011, Spain
Novartis Investigative Site
RECRUITING

Seville, 41013, Spain
Novartis Investigative Site
RECRUITING

Taipei, 111045, Taiwan
Novartis Investigative Site
RECRUITING

Taipei, 11217, Taiwan
Novartis Investigative Site
RECRUITING

Adana, Saricam, 01330, Turkey (Türkiye)
Novartis Investigative Site
RECRUITING

Ankara, Yenimahalle, 06500, Turkey (Türkiye)
Novartis Investigative Site
RECRUITING

Izmir, 35100, Turkey (Türkiye)
Novartis Investigative Site
RECRUITING

West Midlands, Birmingham, B4 6NH, United Kingdom
Novartis Investigative Site
RECRUITING

London, NW3 2QG, United Kingdom
Primary Childrens Medical Center
NOT_YET_RECRUITING

Salt Lake City, Utah, 84113, United States
Primary Childrens Medical Center
RECRUITING

Salt Lake City, Utah, 84113, United States

Contact

Contact

Contact Email: •••••@•••••

Contact Phone: •••-•••-•••• Email: •••••@•••••
UC San Francisco Medical Center
RECRUITING

San Francisco, California, 94143-0348, United States

Contact Phone: •••-•••-•••• Email: •••••@•••••

Contact
UC San Francisco Medical Center
RECRUITING

San Francisco, California, 94143, United States

Contact Phone: •••-•••-•••• Email: •••••@•••••

Contact
Virginia Commonwealth University
RECRUITING

Richmond, Virginia, 23298, United States

Contact

Contact Email: •••••@•••••
West Virginia Childrens Hospital
RECRUITING

Morgantown, West Virginia, 26506, United States
West Virginia Childrens Hospital
RECRUITING

Morgantown, West Virginia, 26506, United States

Contact

Contact

Contact Phone: •••-•••-•••• Email: •••••@•••••

Contact Phone: •••-•••-•••• Email: •••••@•••••

More trials for these conditions

Other studies related to the condition(s) this trial covers.