Reimagining Medicine
Company overview
Innovation: Pipeline overview
Cardiovascular
Financial review
Immunology
LeqvioⓇ - siRNA (regulation of LDL-C)
NCT04652726 ORION-16 (CKJX839C12301)
2023 priorities
Innovation: Clinical trials
Neuroscience
Oncology
Appendix
Abbreviations
Other
Leqvio® - siRNA (regulation of LDL-C)
NCT04659863 ORION-13 (CKJX839C12302)
Hyperlipidemia, pediatrics
Indication
Hyperlipidemia, pediatrics
Indication
Phase
Phase 3
Phase
Phase 3
Patients
150
Patients
12
Primary
Outcome
Measures
Percentage (%) change in low-density lipoprotein cholesterol (LDL-C) from
baseline to Day 330
Primary
Outcome
Measures
Arms
Intervention
Group 1: Inclisiran sodium 300mg on Days 1, 90, 270, placebo on Day 360,
inclisiran sodium 300mg on Days 450 and 630
Group 2: Placebo on Days 1, 90, 270, inclisiran sodium 300mg on Days 360,
450 and 630.
Adolescents (12 to less than 18 years) with heterozygous familial
hypercholesterolemia (HeFH) and elevated low density lipoprotein cholesterol
Arms
Intervention
Target
Patients
Target
Patients
(LDL-C)
Readout
Milestone(s)
2025
Publication
Design publication (O-16/-13) in Eur. J. Prev. Cardiol. Vol. 29, Feb. 2022
(actual)
Readout
Milestone(s)
Publication
Presentation at EAS May-2022 on O-13/-16 study design (actual)
64 Investor Relations | Q4 2022 Results
Percentage (%) change in low-density lipoprotein cholesterol (LDL-C) from
baseline to day 330
Group 1: Inclisiran sodium 300mg on Days 1, 90, 270, placebo on Day 360,
inclisiran sodium 300mg on Days 450 and 630.
Group 2: Placebo on Days 1, 90, 270, inclisiran sodium 300mg on Days 360, 450
and 630.
Adolescents (12 to less than 18 years) with homozygous familial
hypercholesterolemia (HoFH) and elevated low density lipoprotein cholesterol
(LDL-C)
2025
Design publication (O-16/-13) in Eur. J. Prev. Cardiol. Vol. 29, Feb. 2022 (actual)
Presentation at EAS May-2022 on O-13/-16 study design (actual)
NOVARTIS | Reimagining MedicineView entire presentation