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Clinical Trial ● Currently Recruiting Phase III NCT06597019

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

Study to Evaluate Efficacy and Safety of Inclisiran in Children With Heterozygous Familial Hypercholesterolemia — Recruiting • Phase III • Cardiology / Cardiovascular • NCT06597019.

📅 15 May 2026 ⏱ 1 min read
Currently Recruiting
This trial is actively seeking participants in the UK. Discuss eligibility with your patient before referring.
Status
Currently Recruiting
Phase
Phase III
NCT ID
NCT06597019
Sponsor
Novartis Pharmaceuticals
Start
2024-12-09
ClinicaliQ Trial Snapshot
  • Study to Evaluate Efficacy and Safety of Inclisiran in Children With Heterozygous Familial Hypercholesterolemia — Recruiting • Phase III • Cardiology / Cardiovascular • NCT06597019.
  • What is being tested: Inclisiran, a small interfering RNA (siRNA) therapeutic that lowers LDL cholesterol by inhibiting PCSK9 production, is being evaluated for safety, tolerability, and efficacy in paediatric patients with heterozygous familial hypercholesterolaemia (HeFH).
  • Patient eligibility overview: The trial includes children aged 6 years and above diagnosed with HeFH, representing a young population at significant cardiovascular risk who currently have limited treatment options beyond statins and ezetimibe.
Use This Page For
  • Quick orientation before opening the registry record.
  • Checking recruitment status, phase and sponsor at a glance.
  • Connecting this trial to nearby guidelines, Drug Science and education.
What This Trial Is Studying

This is a pivotal phase III study designed to evaluate safety, tolerability, and efficacy of inclisiran in children (aged 6 to

Eligibility Snapshot
  • : * Male or female participants, 6 to 130 mg/dL (3.4 mmol/L) at screening * For participants 8 to 2x ULN (except patients with Gilbert's syndrome) * Pregnant or nursing females * Recent and/or planned use of other investigational medicinal products or devices

Use the source registry for the full inclusion and exclusion criteria before discussing referral or enrolment.

Full Trial Details
View this trial on the source registry
Eligibility criteria, protocol, and results when available
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