Study to Evaluate Efficacy and Safety of Inclisiran in Children With Heterozygous Familial Hypercholesterolemia

ClinicalTrials.gov ID: NCT06597019

Public ClinicalTrials.gov record NCT06597019. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

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ClinicalTrials.gov public records Last synced May 21, 2026, 1:01 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

Two Part (Double-blind Inclisiran Versus Placebo [Year 1] Followed by Open-label Inclisiran [Year 2]) Randomized Multicenter Study to Evaluate Safety, Tolerability and Efficacy of Inclisiran in Children (6 to Less Than 12 Years) With Heterozygous Familial Hypercholesterolemia and Elevated LDL- Cholesterol

Study identification

NCT ID: NCT06597019
Recruitment status: Recruiting
Study type: Interventional
Phase: Phase 3
Lead sponsor: Novartis Pharmaceuticals; Industry
Enrollment: 60 participants

Conditions and interventions

Conditions

Familial Hypercholesterolemia - Heterozygous

Interventions

Inclisiran Drug
Placebo Drug

Drug

Eligibility (public fields only)

Age range: 6 Years to 11 Years
Sex: All
Healthy volunteers: Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Dec 8, 2024
Primary completion: Mar 20, 2028
Completion: Apr 14, 2029
Last update posted: May 14, 2026

2024 – 2029

United States locations

U.S. sites: 9
U.S. states: 7
U.S. cities: 7

Facility	City	State	ZIP	Site status
UC San Francisco Medical Center	San Francisco	California	94143-0348	Recruiting
UC San Francisco Medical Center	San Francisco	California	94143	Recruiting
Children's National Hospital	Washington D.C.	District of Columbia	20010	Not yet recruiting
Childrens National Hospital	Washington D.C.	District of Columbia	20010	Recruiting
Excel Medical Clinical Trials LLC	Boca Raton	Florida	33434	Recruiting
Icahn School of Med at Mt Sinai	New York	New York	10029	Recruiting
Primary Childrens Medical Center	Salt Lake City	Utah	84113	Recruiting
Virginia Commonwealth University	Richmond	Virginia	23298	Recruiting
West Virginia Childrens Hospital	Morgantown	West Virginia	26506	Recruiting

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 55 non-U.S. sites.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT06597019, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted May 14, 2026 · Synced May 21, 2026

Open the official record

The complete protocol, eligibility criteria, and contact information for NCT06597019 live on ClinicalTrials.gov.

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