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NCT06597006 · ClinicalTrials.gov registry record · Phase 3
Study to Evaluate Safety, Tolerability and Efficacy of Inclisiran in Children With Homozygous Familial Hypercholesterolemia
A Phase 3 study of Familial Hypercholesterolemia - Homozygous, sponsored by Novartis Pharmaceuticals.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 9
- Enrollment target
- 18
- Study locations
NCT06597006: Recruiting Phase 3 study of Familial Hypercholesterolemia - Homozygous, sponsored by Novartis Pharmaceuticals.
NCT06597006 is a Phase 3 study of Familial Hypercholesterolemia - Homozygous that is actively recruiting participants, run by Novartis Pharmaceuticals. The registered enrollment target is 9 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (99% lower). The trial reports 18 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06597006, a Phase 3 study of Familial Hypercholesterolemia - Homozygous, is actively recruiting participants, sponsored by Novartis Pharmaceuticals.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 9 participants
- Enrollment target
- 18
- Study locations
Study Summary
This is a pivotal phase III study designed to evaluate safety, tolerability, and efficacy of inclisiran in children (aged 2 to \<12 years) with homozygous familial hypercholesterolemia (HoFH) and elevated low density lipoprotein cholesterol (LDLC).
Primary Outcome
Evaluate the effect of inclisiran compared to placebo on reducing LDL-C \[percent change\] at Day 330
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Inclisiran
Study Locations (18)
Other
- Novartis Investigative Site - Vienna
- Novartis Investigative Site - Ioannina
- Novartis Investigative Site - Thessaloniki
- Novartis Investigative Site - Taichung
- Novartis Investigative Site - Taipei
- Novartis Investigative Site - Izmir
- Novartis Investigative Site - Southampton
California
- UC San Francisco Medical Center - San Francisco
- UC San Francisco Medical Center - San Francisco
District of Columbia
- Childrens National Hospital - Washington D.C.
Missouri
- Washington Univ School Of Medicine - St Louis
Beijing Municipality
- Novartis Investigative Site - Beijing
Hesse
- Novartis Investigative Site - Frankfurt am Main
Kelantan
- Novartis Investigative Site - Kota Bharu
North Holland
- Novartis Investigative Site - Amsterdam
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 9 participants |
| Start Date | 2025-02-28 |
| Est. Completion | 2029-04-15 |
| Phase | Phase 3 |
What NCT06597006 shows while recruiting
NCT06597006 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 9 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (99% lower).
The record links to 1 condition, with Familial Hypercholesterolemia - Homozygous appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT06597006 lists 18 locations in 11 states (Other, California, District of Columbia).
Frequently Asked Questions
What is clinical trial NCT06597006 about?
NCT06597006 is a clinical study titled "Study to Evaluate Safety, Tolerability and Efficacy of Inclisiran in Children With Homozygous Familial Hypercholesterolemia". This is a pivotal phase III study designed to evaluate safety, tolerability, and efficacy of inclisiran in children (aged 2 to \<12 years) with homozygous familial hypercholesterolemia (HoFH) and elevated low density lipoprotein cholesterol (LDLC).
What is the current status of trial NCT06597006?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 9 participants. The study started on 2025-02-28. Estimated completion is 2029-04-15.
What conditions does trial NCT06597006 study?
This clinical trial studies the following conditions: Familial Hypercholesterolemia - Homozygous.
What interventions are being tested in trial NCT06597006?
The interventions under investigation include: Placebo (DRUG), Inclisiran (DRUG).
Who is sponsoring clinical trial NCT06597006?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06597006 being conducted?
This trial has 18 study locations across California, District of Columbia, Missouri, Beijing Municipality, Hesse. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Familial Hypercholesterolemia - Homozygous
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06597006's enrollment target sits among peer trials
9 1993rd of 2000 higher than 8 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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