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NCT05682378 · ClinicalTrials.gov registry record · Phase 3
Long-term Safety and Tolerability of Inclisiran in Participants With HeFH or HoFH Who Have Completed the Adolescent ORION-16 or ORION-13 Studies
A Phase 3 study of Heterozygous or Homozygous Familial Hypercholesterolemia, sponsored by Novartis Pharmaceuticals.
- Active
- Registry status
- Phase 3
- Development phase
- 131
- Enrollment target
- 20
- Study locations
NCT05682378: Active Phase 3 study of Heterozygous or Homozygous Familial Hypercholesterolemia, sponsored by Novartis Pharmaceuticals.
NCT05682378 is a Phase 3 study of Heterozygous or Homozygous Familial Hypercholesterolemia that is active but no longer recruiting, run by Novartis Pharmaceuticals. The registered enrollment target is 131 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (83% lower). The trial reports 20 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05682378, a Phase 3 study of Heterozygous or Homozygous Familial Hypercholesterolemia, is active but no longer recruiting, sponsored by Novartis Pharmaceuticals.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 131 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this open-label, single arm, multicenter extension study is to evaluate the long-term safety and tolerability of inclisiran in participants with HeFH or HoFH who have completed the ORION-16 or ORION-13 studies.
Primary Outcome
Safety and tolerability: TEAEs, TESAEs (incidence, severity, relationship to study drug and discontinuation due to TEAEs)
Conditions Studied
Interventions
- DRUG Inclisiran
Study Locations (20)
Other
- Novartis Investigative Site - Prague
- Novartis Investigative Site - Prague
- Novartis Investigative Site - Besançon
- Novartis Investigative Site - Toulouse
- Novartis Investigative Site - Freiburg im Breisgau
- Novartis Investigative Site - Athens
- Novartis Investigative Site - Athens
- Novartis Investigative Site - Jerusalem
São Paulo
- Novartis Investigative Site - São Paulo
- Novartis Investigative Site - São Paulo
Florida
- Excel Medical Clinical Trials LLC - Boca Raton
New York
- Icahn School of Med at Mt Sinai - New York
Ohio
- Cincinnati Childrens Hospital MC - Cincinnati
Pennsylvania
- Childrens Hosp Pittsburgh UPMC - Pittsburgh
Utah
- Primary Childrens Medical Center - Salt Lake City
Formosa Province
- Novartis Investigative Site - Formosa
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 131 participants |
| Start Date | 2023-02-10 |
| Est. Completion | 2028-03-02 |
| Phase | Phase 3 |
What the registry record for NCT05682378 still lists
NCT05682378 is an interventional study that assigns participants to a tested intervention. The registered 131 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (83% lower).
The record links to 1 condition, with Heterozygous or Homozygous Familial Hypercholesterolemia appearing as the primary indexed condition, and to 1 intervention - of which Inclisiran is the first listed.
NCT05682378 names 20 study sites across 12 states, led by Other, São Paulo, Florida.
Frequently Asked Questions
What is clinical trial NCT05682378 about?
NCT05682378 is a clinical study titled "Long-term Safety and Tolerability of Inclisiran in Participants With HeFH or HoFH Who Have Completed the Adolescent ORION-16 or ORION-13 Studies". The purpose of this open-label, single arm, multicenter extension study is to evaluate the long-term safety and tolerability of inclisiran in participants with HeFH or HoFH who have completed the ORION-16 or ORION-13 studies.
What is the current status of trial NCT05682378?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 131 participants. The study started on 2023-02-10. Estimated completion is 2028-03-02.
What conditions does trial NCT05682378 study?
This clinical trial studies the following conditions: Heterozygous or Homozygous Familial Hypercholesterolemia.
What interventions are being tested in trial NCT05682378?
The interventions under investigation include: Inclisiran (DRUG).
Who is sponsoring clinical trial NCT05682378?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05682378 being conducted?
This trial has 20 study locations across Florida, New York, Ohio, Pennsylvania, 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 NCT05682378's enrollment target sits among peer trials
131 1594th of 2000 higher than 407 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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