Long-term Safety and Tolerability of Inclisiran in Participants With HeFH or HoFH Who Have Completed the Pediatric ORION-16, ORION-13, ORION-20, or ORION-19 Studies
Recruiting now Phase 3 NCT05682378
Run by Novartis Pharmaceuticals · for 12 to 100 · All sexes
What this study is about
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 (CKJX839C12301), ORION-13 (CKJX839C12302), ORION-20 (CKJX839C12303) or ORION-19 (CKJX839C12304) studies.
Who can join (things the study team will check)
Key inclusion: * Male and female participants with a diagnosis of HeFH or HoFH who completed the ORION-16, ORION-13, ORION-20 or ORION-19 studies * Per investigator's clinical judgment, participant derived benefit from treatment with inclisiran in the ORION-16, ORION-13, ORION-20 or ORION-19 studies Key exclusion: * Participants who in the feeder ORION-16, ORION-13, ORION-20, or ORION-19 studies either screen failed or permanently discontinued from the treatment/study for any reason or had serious safety or tolerability issues related to inclisiran treatment * Any uncontrolled or serious disease, or any medical, physical, or surgical condition, that may either interfere with participation in the clinical study or interpretation of clinical study results, and/or put the participant at significant risk…
Where this trial is running
- Excel Medical Clinical Trials LLC, Boca Raton, Florida, United States
- Icahn School of Med at Mt Sinai, New York, New York, United States
- Cincinnati Childrens Hospital MC, Cincinnati, Ohio, United States
- Childrens Hosp Pittsburgh UPMC, Pittsburgh, Pennsylvania, United States
- Primary Childrens Medical Center, Salt Lake City, Utah, United States
- Novartis Investigative Site, Formosa, Formosa Province, Argentina
- Novartis Investigative Site, Fortaleza, Ceará, Brazil
- Novartis Investigative Site, São Paulo, São Paulo, Brazil
- Novartis Investigative Site, São Paulo, São Paulo, Brazil
- Novartis Investigative Site, Québec, Quebec, Canada
- Novartis Investigative Site, Prague, Czechia
- Novartis Investigative Site, Prague, Czechia
+ 40 more sites.
Who to contact
Novartis Pharmaceuticals · 1-888-669-6682 · novartis.email@novartis.com
It's completely normal to call and ask questions before deciding anything. Mention the study ID: NCT05682378.
Verify everything on the official ClinicalTrials.gov record. Page updated July 2026.