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NCT06597019Phase 3RECRUITING

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

Study 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).

Conditions
Familial Hypercholesterolemia - Heterozygous
Interventions / Drugs
InclisiranPlacebo
View on ClinicalTrials.gov ↗
Sponsor
NVS
Novartis AG
Diversified Pharma
D36/100
Study Details
Enrollment51 participants
Primary Completion—
Lead SponsorNovartis Pharmaceuticals
Data Retrieved2026-04-11 02:55:49.152146+00:00
What This Trial Means for Biotech Investors
Trial Phase Context

Phase 3 trials are pivotal studies with large patient populations (hundreds to thousands) designed to prove efficacy and safety for FDA submission. A successful Phase 3 readout is typically the last major hurdle before a New Drug Application (NDA) or BLA filing.

Status & Expected Data

Currently recruiting: the trial is enrolling patients. A data readout is not expected until after enrollment closes and the follow-up period is complete.

Enrolled: 51 participants
Sponsor Catalyst Profile

Novartis AG (NVS) is the sponsoring company for this trial. BiotechSign currently grades this company D (36/100) based on composite catalyst signals across its full pipeline. This trial is one data point in that overall catalyst picture.

NVS Full Pipeline →All Companies →
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