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NCT04659863 · ClinicalTrials.gov registry record · Phase 3
Study to Evaluate Efficacy and Safety of Inclisiran in Adolescents With Homozygous Familial Hypercholesterolemia
A Phase 3 study of Familial Hypercholesterolemia - Homozygous, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 13
- Enrollment target
- 11
- Study locations
NCT04659863: Completed Phase 3 study of Familial Hypercholesterolemia - Homozygous, sponsored by Novartis Pharmaceuticals.
NCT04659863 is a Phase 3 study of Familial Hypercholesterolemia - Homozygous that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 13 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (98% lower). The trial reports 11 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04659863, a Phase 3 study of Familial Hypercholesterolemia - Homozygous, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 13 participants
- Enrollment target
- 11
- Study locations
Study Summary
This was a pivotal phase III study designed to evaluate safety, tolerability, and efficacy of inclisiran in adolescents with homozygous familial hypercholesterolemia (HoFH) and elevated low density lipoprotein cholesterol (LDL-C).
Primary Outcome
Percentage change in low-density lipoprotein cholesterol (LDL-C) from baseline to Day 330 (Year 1)
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Inclisiran
Study Locations (11)
Other
- Novartis Investigative Site - Bron
- Metropolitan Hospital - Athens
- American University of Beirut Medical Center - Beirut
- Hotel Dieu de France Hospital - El Achrafiyé
- Novartis Investigative Site - Kuala Lumpur
- Novartis Investigative Site - Amsterdam
- Novartis Investigative Site - Izmir
Florida
- Excel Medical Clinical Trials LLC - Boca Raton
Quebec
- Novartis Investigative Site - Québec
GR
- University General Hospital of Ioannina - Ioannina
TUR
- Novartis Investigative Site - Istanbul
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 13 participants |
| Start Date | 2021-02-16 |
| Est. Completion | 2024-11-18 |
| Phase | Phase 3 |
What the finished NCT04659863 record still lists
NCT04659863 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 13 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (98% 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.
NCT04659863 lists 11 locations in 5 states (Other, Florida, Quebec).
Frequently Asked Questions
What is clinical trial NCT04659863 about?
NCT04659863 is a clinical study titled "Study to Evaluate Efficacy and Safety of Inclisiran in Adolescents With Homozygous Familial Hypercholesterolemia". This was a pivotal phase III study designed to evaluate safety, tolerability, and efficacy of inclisiran in adolescents with homozygous familial hypercholesterolemia (HoFH) and elevated low density lipoprotein cholesterol (LDL-C).
What is the current status of trial NCT04659863?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 13 participants. The study started on 2021-02-16. Estimated completion is 2024-11-18.
What conditions does trial NCT04659863 study?
This clinical trial studies the following conditions: Familial Hypercholesterolemia - Homozygous.
What interventions are being tested in trial NCT04659863?
The interventions under investigation include: Placebo (DRUG), Inclisiran (DRUG).
Who is sponsoring clinical trial NCT04659863?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04659863 being conducted?
This trial has 11 study locations across Florida, Quebec, GR, TUR. 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 NCT04659863's enrollment target sits among peer trials
13 1984th of 2000 higher than 17 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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