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NCT06597019 · ClinicalTrials.gov registry record · Phase 3
Study to Evaluate Efficacy and Safety of Inclisiran in Children With Heterozygous Familial Hypercholesterolemia
A Phase 3 study of Familial Hypercholesterolemia - Heterozygous, sponsored by Novartis Pharmaceuticals.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 51
- Enrollment target
- 20
- Study locations
NCT06597019: Recruiting Phase 3 study of Familial Hypercholesterolemia - Heterozygous, sponsored by Novartis Pharmaceuticals.
NCT06597019 is a Phase 3 study of Familial Hypercholesterolemia - Heterozygous that is actively recruiting participants, run by Novartis Pharmaceuticals. The registered enrollment target is 51 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (93% lower). The trial reports 20 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06597019, a Phase 3 study of Familial Hypercholesterolemia - Heterozygous, is actively recruiting participants, sponsored by Novartis Pharmaceuticals.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 51 participants
- Enrollment target
- 20
- Study locations
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).
Primary Outcome
Demonstrate superiority of inclisiran compared to placebo in reducing LDL-C \[percent change\] at Day 330
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Inclisiran
Study Locations (20)
Other
- Novartis Investigative Site - Buenos Aires
- Novartis Investigative Site - CABA
- Novartis Investigative Site - Salzburg
- Novartis Investigative Site - Vienna
- Novartis Investigative Site - Brussels
- Novartis Investigative Site - Leuven
California
- UC San Francisco Medical Center - San Francisco
- UC San Francisco Medical Center - San Francisco
District of Columbia
- Children's National Hospital - Washington D.C.
- Childrens National Hospital - Washington D.C.
Utah
- Primary Childrens Medical Center - Salt Lake City
- Primary Childrens Medical Center - Salt Lake City
West Virginia
- West Virginia Childrens Hospital - Morgantown
- West Virginia Childrens Hospital - Morgantown
Florida
- Excel Medical Clinical Trials LLC - Boca Raton
New York
- Icahn School of Med at Mt Sinai - New York
Virginia
- Virginia Commonwealth University - Richmond
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 51 participants |
| Start Date | 2024-12-09 |
| Est. Completion | 2029-04-15 |
| Phase | Phase 3 |
What NCT06597019 shows while recruiting
NCT06597019 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 51 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (93% lower).
The record links to 1 condition, with Familial Hypercholesterolemia - Heterozygous appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT06597019 names 20 study sites across 11 states, led by Other, California, District of Columbia.
Frequently Asked Questions
What is clinical trial NCT06597019 about?
NCT06597019 is a clinical study titled "Study to Evaluate Efficacy and Safety of Inclisiran in Children With Heterozygous Familial Hypercholesterolemia". 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).
What is the current status of trial NCT06597019?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 51 participants. The study started on 2024-12-09. Estimated completion is 2029-04-15.
What conditions does trial NCT06597019 study?
This clinical trial studies the following conditions: Familial Hypercholesterolemia - Heterozygous.
What interventions are being tested in trial NCT06597019?
The interventions under investigation include: Placebo (DRUG), Inclisiran (DRUG).
Who is sponsoring clinical trial NCT06597019?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06597019 being conducted?
This trial has 20 study locations across California, District of Columbia, Florida, New York, Utah. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT06597019's enrollment target sits among peer trials
51 1843rd of 2000 higher than 157 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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