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

NCT06597019

This study is recruiting at 9 US sites in 7 states, according to its ClinicalTrials.gov record last updated .

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).

Shortened from the sponsor's brief summary. View official record on ClinicalTrials.gov

Conditions studied

  • Familial Hypercholesterolemia - Heterozygous

Eligibility basics and study details

Study type
Interventional
Phase
Phase 3
Ages
6 to 11 years
Sex
All
Healthy volunteers
Not accepted
Sponsor
Novartis Pharmaceuticals
Last updated on ClinicalTrials.gov
May 15, 2026

These are the basic criteria only. The full inclusion and exclusion criteria are on the official record, and the study team decides who can take part.

US recruiting sites

California · 2

  • UC San Francisco Medical Center · San Francisco, CA
  • UC San Francisco Medical Center · San Francisco, CA

District of Columbia · 1

  • Childrens National Hospital · Washington D.C., DC

Florida · 1

  • Excel Medical Clinical Trials LLC · Boca Raton, FL

New York · 1

  • Icahn School of Med at Mt Sinai · New York, NY

Utah · 1

  • Primary Childrens Medical Center · Salt Lake City, UT

Virginia · 1

  • Virginia Commonwealth University · Richmond, VA

West Virginia · 2

  • West Virginia Childrens Hospital · Morgantown, WV
  • West Virginia Childrens Hospital · Morgantown, WV

Source: ClinicalTrials.gov, data processed . Recruiting US sites filtered by distance and site status; summaries shortened.