| Leqvio (inclisiran) / Novartis |
2017-005066-22: A research study to find out whether inclisiran sodium, given as injection under the skin every 6 months for about 5 years, helps to prevent heart attacks, strokes or the need for urgent procedures to unblock the arteries supplying the heart, in people who already have vascular disease. |
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| Not yet recruiting | 3 | 15000 | Europe | Inclisiran for Injection, Inclisiran for Injection, Solution for injection | University of Oxford, The Medicines Company, , The Medicines Company | Atherosclerotic cardiovascular disease, Circulatory problems (such as heart attacks and strokes) caused by narrowing of the vessels supplying blood to the brain, heart and other organs, Diseases [C] - Cardiovascular Diseases [C14] | | | | |
| Completed | 3 | 1617 | Europe, RoW | Inclisiran Sodium, Placebo, Saline Solution | The Medicines Company | ASCVD, Risk Factor, Cardiovascular, Elevated Cholesterol | 07/19 | 08/19 | | |
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ORION-9, NCT03397121 / 2017-002472-30: Trial to Evaluate the Effect of Inclisiran Treatment on Low Density Lipoprotein Cholesterol (LDL-C) in Subjects With Heterozygous Familial Hypercholesterolemia (HeFH) |
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| Completed | 3 | 482 | Europe, Canada, US, RoW | Inclisiran, Placebo, Saline Solution | The Medicines Company | Heterozygous Familial Hypercholesterolemia, Elevated Cholesterol | 08/19 | 09/19 | | |
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ORION-10, NCT03399370: Inclisiran for Participants With Atherosclerotic Cardiovascular Disease and Elevated Low-density Lipoprotein Cholesterol |
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| Completed | 3 | 1561 | US | Inclisiran Sodium, Placebo, Saline Solution | The Medicines Company | ASCVD, Elevated Cholesterol | 09/19 | 09/19 | | |
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ORION-5, NCT03851705: A Study of Inclisiran in Participants With Homozygous Familial Hypercholesterolemia (HoFH) |
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| Completed | 3 | 56 | RoW | Inclisiran Sodium for injection, ALN-PCSSC; KJX839, ALN-PCSSC, Placebo, Placebos | Novartis Pharmaceuticals | Homozygous Familial Hypercholesterolemia | 03/20 | 09/21 | | |
2021-002006-27: A research study to find out whether a medicine called inclisiran helps to prevent cardiovascular death, heart attacks or strokes in people who already have vascular disease. Une étude de recherche visant à déterminer si un médicament appelé inclisiran aide à prévenir les décès cardiovasculaires, les crises cardiaques ou les accidents vasculaires cérébraux chez les personnes qui souffrent déjà d'une maladie vasculaire. |
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| Ongoing | 3 | 15000 | Europe, RoW | Inclisiran sodium, KJX839, Solution for injection in pre-filled syringe, Leqvio 284 mg solution for injection in pre-filled syringe | Novartis Pharma AG, NOVARTIS PHARMA AG, Novartis Pharma AG | Atherosclerotic cardiovascular disease (ASCVD) Maladie cardiovasculaire athéroscléreuse, Circulatory problems (such as heart attacks and strokes) caused by narrowing of the vessels supplying blood to the brain, heart and other organs Problèmes circulatoires (tels que les crises cardiaques et les accidents vasculaires cérébraux) causés par le rétrécissement des vaisseaux alimentant en sang le cerveau, le cœur et d'autres organes, Diseases [C] - Cardiovascular Diseases [C14] | | | | |
2021-005602-10: Study which will investigate, if the treatment with Inclisiran, Bempedoic acid and monoclonal antibodies Alirocumab or Evolocumab has other than lipid-lowering effects such as change in platelet activity and inflammation markers. |
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| Not yet recruiting | 3 | 60 | Europe | Inclisiran, Nilemdo, Repatha, Rosuvastatin, Atorvastatin, Solution for injection in pre-filled syringe, Film-coated tablet, Leqvio, Nilemdo, Repatha, Rosuvastatin, Atorvastatin | Verein zur Förderung der Forschung auf dem Gebiet der Arteriosklerose, Thrombose und vaskulären Biologie (ATVB), Verein zur Fördferung der Forschung auf dem Gebiet der Arteriosklerose, Thrombose und vaskulären Biologie (ATVB) | platelet activity and inflammation markers in patients with coronary artery disease, platelet activity and inflammation markers in patients with coronary artery disease, Diseases [C] - Cardiovascular Diseases [C14] | | | | |
2021-004601-47: Coronary computed tomography study to assess the effect of inclisiran on atherosclerotic plaque progression in participants with a diagnosis of nonobstructivecoronary artery disease without previous cardiovascular events --- |
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| Not yet recruiting | 3 | 600 | Europe | Inclisiran, [KJX839], Solution for injection in pre-filled syringe, Leqvio 284 mg solution for injection in pre-filled syringe | NOVARTIS PHARMA AG, Novartis Pharma AG, Novartis Farmacéutica, S.A., Novartis Pharma AG | Non-obstructive coronary artery disease -, atherosclerotic plaque (fatty deposits that can lead to heart disease) in the heart with less than 50% obstruction of blood flow -, Diseases [C] - Cardiovascular Diseases [C14] | | | | |
NCT04765657: Study of Efficacy and Safety of Inclisiran in Asian Participants With Atherosclerotic Cardiovascular Disease (ASCVD) or ASCVD High Risk and Elevated Low Density Lipoprotein Cholesterol (LDL-C) |
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| Active, not recruiting | 3 | 345 | RoW | inclisiran sodium, KJX839, Placebo | Novartis Pharmaceuticals | Hypercholesterolemia | 06/22 | 12/26 | | |
2022-001109-29: Efficacy and safety of inclisiran as monotherapy in patients with primary hypercholesterolemia not receiving lipid-lowering therapy. |
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| Ongoing | 3 | 300 | Europe | inclisiran sodium, KJX839, Solution for injection in pre-filled syringe, Capsule, hard + tablet, Leqvio 284 mg solution for injection in pre-filled syringe, EZETIMIBE tablets, USP, 10 mg | Novartis Pharma AG, Novartis Pharma AG | Primary Hypercholesterolemia, Primary Hypercholesterolemia, Diseases [C] - Cardiovascular Diseases [C14] | | | | |
SPIRIT, NCT04807400: Study in Primary Care Evaluating Inclisiran Delivery Implementation + Enhanced Support |
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| Completed | 3 | 892 | Europe | Inclisiran, Behavioural Support, Background lipid lowering therapy | Novartis Pharmaceuticals | Atherosclerotic Cardiovascular Disease, Atherosclerotic Cardiovascular Disease Risk Equivelents, Elevated Low Density Lipoprotein Cholesterol | 01/23 | 01/23 | | |
2022-002316-23: Long-term safety and tolerability of inclisiran in participants withheterozygous familial hypercholesterolaemia or homozygous familialhypercholesterolaemia who have completed the adolescent ORION-16 or ORION-13 studies Seguridad y tolerabilidad a largo plazo de inclisirán en participantes con hipercolesterolemia familiar heterocigótica o hipercolesterolemia familiar homocigótica que hayan finalizado los estudios para adolescentes ORION-16 u ORION-13. |
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| Ongoing | 3 | 165 | Europe | inclisiran sodium, KJX839, Solution for injection in pre-filled syringe, Leqvio 284 mg solution for injection in pre-filled syringe | Novartis Farmacéutica, S.A., Novartis Pharma AG, Novartis Pharma AG | Familial Hypercholesterolemia Hipercolesterolemia familiar, Familial Hypercholesterolemia Hipercolesterolemia familiar, Diseases [C] - Cardiovascular Diseases [C14] | | | | |
| Completed | 3 | 3275 | Europe, Canada, US, RoW | Inclisiran Sodium | Novartis Pharmaceuticals | ASCVD, Elevated Cholesterol, Heterozygous Familial Hypercholesterolemia, Homozygous Familial Hypercholesterolemia | 02/23 | 02/23 | | |
V-INITIATE, NCT04929249: A Randomized Study to Evaluate the Effect of an "Inclisiran First" Implementation Strategy Compared to Usual Care in Patients With Atherosclerotic Cardiovascular Disease and Elevated LDL-C Despite Receiving Maximally Tolerated Statin Therapy (VICTORION-INITIATE) |
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| Completed | 3 | 450 | US | Inclisiran, Inclisiran First | Novartis Pharmaceuticals | Atherosclerotic Cardiovascular Disease | 09/23 | 09/23 | | |
| Active, not recruiting | 3 | 13 | Europe, Canada, US, RoW | Inclisiran, KJX839, Placebo, Saline solution | Novartis Pharmaceuticals, Novartis Pharma AG | Familial Hypercholesterolemia - Homozygous | 10/23 | 12/24 | | |
| Active, not recruiting | 3 | 160 | Europe | lerodalcibep, LIB003, Inclisiran, Leqvio | LIB Therapeutics LLC, Medpace, Inc. | Hypercholesterolemia, Atherosclerotic Ischemic Disease | 05/24 | 07/24 | | |
| Active, not recruiting | 3 | 141 | Europe, Canada, US, RoW | Inclisiran, KJX839, Placebo, Saline solution | Novartis Pharmaceuticals | Familial Hypercholesterolemia - Heterozygous | 11/23 | 12/24 | | |
V-Mono, NCT05763875: Efficacy and Safety of Inclisiran as Monotherapy in Patients With Primary Hypercholesterolemia Not Receiving Lipid-lowering Therapy. |
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| Active, not recruiting | 3 | 350 | Europe, US, RoW | Inclisiran, KJX839, Ezetimibe, Sandoz ezetimibe, Matching Placebo for Inclisiran, Placebo s.c., Matching Placebo for Ezetimibe, Placebo p.o. | Novartis Pharmaceuticals | Hypercholesterolemia | 06/24 | 06/24 | | |
V-Mono China, NCT05888103: Efficacy and Safety of Inclisiran as Monotherapy in Chinese Adults With Low or Moderate ASCVD Risk and Elevated Low-density Lipoprotein Cholesterol. |
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| Active, not recruiting | 3 | 207 | RoW | Inclisiran, KJX839, Matching Placebo for Inclisiran, Placebo s.c. | Novartis Pharmaceuticals | Primary Hypercholesterolemia or Mixed Dyslipidemia | 04/24 | 10/24 | | |
VICTORION-INCEPTION, NCT04873934: Management of LDL-cholesterol With Inclisiran + Usual Care Compared to Usual Care Alone in Participants With a Recent Acute Coronary Syndrome |
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| Active, not recruiting | 3 | 400 | US | Inclisiran, KJX839 | Novartis Pharmaceuticals | Acute Coronary Syndrome | 08/24 | 08/24 | | |
V-PLAQUE, NCT05360446: Coronary Computed Tomography Study to Assess the Effect of Inclisiran in Addition to Maximally Tolerated Statin Therapy on Atherosclerotic Plaque Progression in Participants With a Diagnosis of Non-obstructive Coronary Artery Disease Without Previous Cardiovascular Events |
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| Recruiting | 3 | 600 | Europe, Canada, Japan, US, RoW | Inclisiran sodium 300 mg, Placebo | Novartis Pharmaceuticals | Coronary Artery Disease | 01/27 | 01/27 | | |
ORION-4, NCT03705234: A Randomized Trial Assessing the Effects of Inclisiran on Clinical Outcomes Among People With Cardiovascular Disease |
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| Active, not recruiting | 3 | 16124 | Europe, US | Inclisiran, Placebo, Saline solution | University of Oxford, The TIMI Study Group, Novartis Pharmaceuticals | Atherosclerotic Cardiovascular Disease | 07/26 | 12/49 | | |
VICTORION-2P, NCT05030428: Study of Inclisiran to Prevent Cardiovascular (CV) Events in Participants With Established Cardiovascular Disease |
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| Active, not recruiting | 3 | 17006 | Europe, Canada, Japan, US, RoW | Inclisiran sodium 300 mg, Placebo | Novartis Pharmaceuticals | Atherosclerotic Cardiovascular Disease | 10/27 | 10/27 | | |
| Recruiting | 3 | 165 | Europe, Canada, US, RoW | Inclisiran, KJX839 | Novartis Pharmaceuticals, Novartis Pharma AG | Heterozygous or Homozygous Familial Hypercholesterolemia | 12/27 | 12/27 | | |
| Recruiting | 3 | 14000 | Europe, Canada, US, RoW | Inclisiran sodium 300 mg (equivalent to 284 mg inclisiran) in 1.5 mL, KJX839, Placebo in 1.5ml | Novartis Pharmaceuticals | Primary Prevention of Atherosclerotic Cardiovascular Disease | 04/29 | 04/29 | | |
