Novartis Q4 Results
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LeqvioⓇ - siRNA (regulation of LDL-C)
LeqvioⓇ - siRNA (regulation of LDL-C)
Company overview
Financial review
Conclusions
Appendix
Innovation: Pipeline overview
Financial performance
Innovation: Clinical trials
> Cardiovascular, Renal
and Metabolic
Immunology
Neuroscience
Oncology
Other
Global Health
Abbreviations
References
NCT05739383 VICTORION-1P (CKJX839D12302)
CVRR (Primary prevention)
Phase 3
Indication
Phase
Patients
14000
Primary
Outcome
Measures
Arms
Intervention
Target Patients
NCT05763875 V-Mono (CKJX839D12304)
Indication
Phase
CVRR (Primary prevention)
Phase 3
Patients
300
Time to the first occurrence of 4P-MACE
4-Point-Major Adverse Cardiovascular Events (4P-MACE): composite of
cardiovascular death, non-fatal myocardial infarction, non-fatal ischemic stroke,
and urgent coronary revascularization
Arm 1 Experimental: Inclisiran Sodium 300mg, subcutaneous injection in
pre-filled syringe
Arm 2 Placebo
High-risk primary prevention patients
2029
Primary
Outcome
Measures
Arms
Intervention
Target Patients
1.Percentage change in Low-density Lipoprotein Cholesterol (LDL-C) from
baseline to day 150 compared with placebo [ Time Frame: Baseline, Day 150 ]
2. Percentage change in LDL-C from baseline to day 150 compared with
ezetimibe [ Time Frame: Baseline, Day 150 ]
Arm 1 Experimental: Inclisiran s.c and Placebo p.o.
Arm 2 Active Comparator: Placebo s.c. and Ezetimibe p.o.
Arm 3 Placebo Comparator: Placebo s.c. and Placebo p.o.
Adult patients with primary hypercholesterolemia not receiving any lipid-lowering
therapy (LLT), with a 10-year Atherosclerotic Cardiovascular Disease (ASCVD)
risk of less than 7.
Readout
Milestone(s)
Publication
TBD
□ NOVARTIS Reimagining Medicine
Readout
Milestone(s)
2024
Publication
TBD
Novartis Q4 Results | January 31, 2024
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