Q1 2023 Results
Company overview
Financial review
Conclusions
Innovation: Pipeline overview
Financial performance
Cardiovascular
Immunology
LeqvioⓇ - siRNA (regulation of LDL-C)
NCT04652726 ORION-16 (CKJX839C12301)
Appendix
Innovation: Clinical trials
Neuroscience
Oncology
References
Leqvio® - siRNA (regulation of LDL-C)
NCT04659863 ORION-13 (CKJX839C12302)
Hyperlipidemia, pediatrics
Indication
Hyperlipidemia, pediatrics
Indication
Phase
Phase 3
Phase
Phase 3
Patients
141
Patients
13
Primary
Outcome
Percentage (%) change in low-density lipoprotein cholesterol (LDL-C) from
baseline to Day 330
Measures
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
Arms
Intervention
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
Target
Patients
(LDL-C)
Readout
Milestone(s)
2025
Abbreviations
Other
Target
Patients
Readout
Milestone(s)
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)
Publication
Design publication (O-16/-13) in Eur. J. Prev. Cardiol. Vol. 29, Feb. 2022
(actual)
Publication
Presentation at EAS May-2022 on O-13/-16 study design (actual)
49 Investor Relations | Q1 2023 Results
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