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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 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. The trial reports 18 study locations across 11 states.
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).
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06597006
The ClinicalTrials.gov registry entry for NCT06597006 describes a study currently listed as recruiting, categorized as Phase 3. The registered enrollment target is 9 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Novartis Pharmaceuticals, which has 1,375 total studies on file at ClinicalTrials.gov.
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 reports 18 study locations spanning 11 distinct geographic areas - top geographies include 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.
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