Table 3 Important clinical trials for the development of PCSK9-iTs
From: Targeting proprotein convertase subtilisin/kexin type 9 (PCSK9): from bench to bedside
PCSK9-iT for CVD | NCT Number | Study Name | Study Title | Phases | Study Status | Conditions | Interventions | Sponsor | Start Date | Primary Completion Date |
|---|---|---|---|---|---|---|---|---|---|---|
Evolocumab Anti-PCSK9 mAb Approved by EMA and the US FDA in 2015 | NCT01516879 | DESCARTES | Durable Effect of PCSK9 Antibody CompARed wiTh placEbo Study | 3 | COMPLETED | Hypercholesterolemia | BIOLOGICAL: Evolocumab BIOLOGICAL: Placebo DRUG: Atorvastatin DRUG: Ezetimibe OTHER: Diet Only | Amgen | Jan-12 | Oct-13 |
NCT01588496 | TESLA | Trial Evaluating PCSK9 Antibody in Subjects With LDL Receptor Abnormalities | 2/3 | COMPLETED | Homozygous Familial Hypercholesterolemia | BIOLOGICAL: Evolocumab DRUG: Placebo | Amgen | Apr-12 | Jan-14 | |
NCT01624142 | TAUSSIG | Trial Assessing Long Term USe of PCSK9 Inhibition in Subjects With Genetic LDL Disorders | 2/3 | COMPLETED | Severe Familial Hypercholesterolemia | BIOLOGICAL: Evolocumab | Amgen | Jun-12 | May-18 | |
NCT01763827 | MENDEL-2 | Monoclonal Antibody Against PCSK9 to Reduce Elevated LDL-C in Subjects Currently Not Receiving Drug Therapy for Easing Lipid Levels-2 | 3 | COMPLETED | Hyperlipidemia | BIOLOGICAL: Evolocumab DRUG: Ezetimibe BIOLOGICAL: Placebo to Evolocumab OTHER: Placebo to Ezetimibe | Amgen | Jan-13 | Oct-13 | |
NCT01763866 | LAPLACE-2 | LDL-C Assessment With PCSK9 Monoclonal Antibody Inhibition Combined With Statin Therapy-2 | 3 | COMPLETED | Hyperlipidemia | BIOLOGICAL: Evolocumab DRUG: Ezetimibe DRUG: Placebo to Evolocumab DRUG: Placebo to Ezetimibe DRUG: Atorvastatin DRUG: Rosuvastatin DRUG: Simvastatin | Amgen | Jan-13 | Nov-13 | |
NCT01763905 | GAUSS-2 | Goal Achievement After Utilizing an Anti-PCSK9 Antibody in Statin Intolerant Subjects -2 | 3 | COMPLETED | Hyperlipidemia | BIOLOGICAL: Evolocumab DRUG: Placebo to Evolocumab DRUG: Ezetimibe DRUG: Placebo to Ezetimibe | Amgen | Jan-13 | Nov-13 | |
NCT01763918 | RUTHERFORD-2 | Reduction of LDL-C With PCSK9 Inhibition in Heterozygous Familial Hypercholesterolemia Disorder Study-2 | 3 | COMPLETED | Hyperlipidemia | BIOLOGICAL: Evolocumab DRUG: Placebo | Amgen | Feb-13 | Nov-13 | |
NCT01764633 | FOURIER | Further Cardiovascular Outcomes Research With PCSK9 Inhibition in Subjects With Elevated Risk | 3 | COMPLETED | Dyslipidemia | BIOLOGICAL: Evolocumab DRUG: Placebo | Amgen | Feb-13 | Nov-16 | |
NCT01813422 | GLAGOV | GLobal Assessment of Plaque reGression With a PCSK9 antibOdy as Measured by intraVascular Ultrasound | 3 | COMPLETED | Hypercholesterolemia | BIOLOGICAL: Evolocumab DRUG: Placebo | Amgen | Apr-13 | July-16 | |
NCT01849497 | n/a | Study to Assess In-home Use of Evolocumab (AMG 145) Using a Prefilled Syringe or a Prefilled Autoinjector/Pen | 3 | COMPLETED | Primary Hypercholesterolemia|Mixed Dyslipidemia | BIOLOGICAL: Evolocumab Pre-filled Syringe BIOLOGICAL: Evolocumab AI/pen | Amgen | Apr-13 | Sep-13 | |
NCT01854918 | OSLER-2 | Open-label Extension Study of Evolocumab (AMG 145) in Adults With Hyperlipidemia and Mixed Dyslipidemia | 3 | COMPLETED | Hyperlipidemia and Mixed Dyslipidemia | BIOLOGICAL: Evolocumab DRUG: Standard of Care | Amgen | Apr-13 | May-18 | |
NCT01879319 | n/a | Study to Assess in Home Use of Evolocumab (AMG 145) Administration Using Either an Automated Mini-doser or a Prefilled Autoinjector/Pen | 3 | COMPLETED | Primary Hypercholesterolemia|Mixed Dyslipidemia | BIOLOGICAL: Evolocumab AMD BIOLOGICAL: Evolocumab AI/pen | Amgen | Jul-13 | Nov-13 | |
NCT01953328 | AMG145 | Study of Low-Density Lipoprotein Cholesterol (LDL-C) Reduction Using Evolocumab (AMG 145) in Japanese Patients With Advanced Cardiovascular Risk | 3 | COMPLETED | Hyperlipidemia or Mixed Dyslipidemia at High Risk for Cardiovascular Events | DRUG: Atorvastatin BIOLOGICAL: Evolocumab OTHER: Placebo to Evolocumab | Amgen | Oct-13 | Jun-14 | |
NCT01984424 | GAUSS-3 | Goal Achievement After Utilizing an Anti-PCSK9 Antibody in Statin Intolerant Subjects-3 | 3 | COMPLETED | Hyperlipidemia | DRUG: Atorvastatin DRUG: Placebo to Atorvastatin OTHER: Placebo to Ezetimibe DRUG: Ezetimibe OTHER: Placebo to Evolocumab DRUG: Evolocumab | Amgen | Dec-13 | Nov-15 | |
NCT02189837 | FLOREY | Effects on Lipoprotein Metabolism From PCSK9 Inhibition Utilizing a Monoclonal Antibody | 3 | COMPLETED | Primary Hyperlipidemia and Mixed Dyslipidemia | BIOLOGICAL: Evolocumab DRUG: Atorvastatin DRUG: Placebo to Evolocumab DRUG: Placebo to Atorvastatin | Amgen | Jul-14 | Feb-15 | |
NCT02207634 | EBBINGHAUS | Evaluating PCSK9 Binding antiBody Influence oN coGnitive HeAlth in High cardiovascUlar Risk Subjects | 3 | COMPLETED | Dyslipidemia | BIOLOGICAL: Evolocumab DRUG: Placebo DRUG: Background Statin Therapy | Amgen | Sep-14 | Nov-16 | |
NCT02304484 | n/a | Open-label Extension (OLE) Study to Assess Safety and Efficacy of Evolocumab | 3 | COMPLETED | Hypercholesterolemia | BIOLOGICAL: Evolocumab | Amgen | Nov-14 | Mar-18 | |
NCT02392559 | HAUSER-RCT | Trial Assessing Efficacy, Safety and Tolerability of Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9) Inhibition in Pediatric Subjects With Genetic Low-Density Lipoprotein (LDL) Disorders | 3 | COMPLETED | Heterozygous Familial Hypercholesterolemia | DRUG: Evolocumab DRUG: Placebo | Amgen | Mar-16 | Nov-19 | |
NCT02585895 | n/a | Evolocumab Compared to LDL-C Apheresis in Patients Receiving LDL-C Apheresis Prior to Study Enrollment | 3 | COMPLETED | Hypercholesterolemia | BIOLOGICAL: Evolocumab PROCEDURE: Low-density Lipoprotein Cholesterol (LDL-C) Apheresis | Amgen | Dec-15 | Sep-16 | |
NCT02624869 | HAUSER-OLE | Safety, Tolerability and Efficacy of Evolocumab (AMG 145) in Children With Inherited Elevated Low-density Lipoprotein Cholesterol (Familial Hypercholesterolemia) | 3 | COMPLETED | Familial Hypercholesterolemia | BIOLOGICAL: Evolocumab | Amgen | Sep-16 | Jun-21 | |
NCT02634580 | GAUSS-4 | Goal Achievement After Utilizing an Anti-PCSK9 Antibody in Statin Intolerant Subjects-4 | 3 | COMPLETED | Hypercholesterolemia | BIOLOGICAL: Evolocumab DRUG: Ezetimibe DRUG: Placebo to Evolocumab DRUG: Placebo Ezetimibe | Amgen | Feb-16 | Aug-17 | |
NCT02662569 | BERSON | Safety and Efficacy of Evolocumab in Combination With Statin Therapy in Adults With Diabetes and Hyperlipidemia or Mixed Dyslipidemia | 3 | COMPLETED | Diabetes, Hyperlipidemia, Mixed Dyslipidemia | BIOLOGICAL: Evolocumab DRUG: Atorvastatin OTHER: Placebo | Amgen | Apr-16 | Dec-17 | |
NCT02729025 | ANITSCHKOW | Effects of Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9) Inhibition on Arterial Wall Inflammation in Patients With Elevated Lipoprotein(a) (Lp(a)) | 3 | COMPLETED | Subjects With Hyperlipidemia, Dyslipidemia | DRUG: Evolocumab DRUG: Placebo | Amgen | Apr-16 | Apr-18 | |
NCT02739984 | BANTING | Evaluation of Evolocumab (AMG 145) Efficacy in Diabetic Adults With Hypercholesterolemia/Mixed Dyslipidemia | 3 | COMPLETED | Hypercholesterolemia Mixed Dyslipidemia Type 2 Diabetes | BIOLOGICAL: Evolocumab DRUG: Placebo to Evolocumab | Amgen | May-16 | Aug-17 | |
NCT02833844 | n/a | Safety, Tolerability and Efficacy on Low Density Lipoprotein Cholesterol (LDL-C) of Evolocumab in Participants With Human Immunodeficiency Virus (HIV) and Hyperlipidemia/Mixed Dyslipidemia | 3 | COMPLETED | Subjects With Hyperlipidemia, Dyslipidemia and HIV Infection | DRUG: Evolocumab DRUG: Placebo | Amgen | May-17 | Jul-19 | |
NCT02867813 | FOURIER OLE | Further Cardiovascular Outcomes Research With PCSK9 Inhibition in Subjects With Elevated Risk Open-label Extension | 3 | COMPLETED | Dyslipidemia | BIOLOGICAL: Evolocumab | Amgen | Sep-16 | Mar-22 | |
NCT03403374 | RAMAN | Safety and Tolerability of Repatha®(Evolocumab) in Indian Participants With Homozygous Familial Hypercholesterolemia | 4 | COMPLETED | Homozygous Familial Hypercholesterolemia HoFH | DRUG: evolocumab | Amgen | Aug-18 | Nov-19 | |
NCT03570697 | n/a | Imaging of Coronary Plaques in Participants Treated With Evolocumab | 3 | COMPLETED | Coronary Artery Disease (CAD) | DRUG: Evolocumab DRUG: Placebo DRUG: Statin therapy | Amgen | Nov-18 | Dec-20 | |
NCT03872401 | VESALIUS-CV | Effect of Evolocumab in Patients at High Cardiovascular Risk Without Prior Myocardial Infarction or Stroke | 3 | ACTIVE_NOT_RECRUITING | Coronary Heart Disease (CHD) | DRUG: Evolocumab DRUG: Placebo | Amgen | Jun-19 | Jul-25 | |
NCT05284747 | EVOLVE-MI | EVOLVE-MI: EVOLocumab Very Early After Myocardial Infarction | 4 | RECRUITING | Cardiovascular Disease Myocardial Infarction Stroke Coronary Revascularization | DRUG: Evolocumab DRUG: Routine Lipid Management | Amgen | Oct-22 | Jun-27 | |
Alirocumab Anti-PCSK9 mAb Approved by EMA and the US FDA in 2015 | NCT01507831 | ODYSSEY Long Term | Long-term Safety and Tolerability of Alirocumab (SAR236553/REGN727) Versus Placebo on Top of Lipid-Modifying Therapy in High Cardiovascular Risk Patients With Hypercholesterolemia (ODYSSEY Long Term) | 3 | COMPLETED | Hypercholesterolemia | DRUG: Placebo (for alirocumab) DRUG: Alirocumab DRUG: Lipid-Modifying Therapy (LMT) | Sanofi/Regeneron | Jan-12 | Nov-14 |
NCT01617655 | ODYSSEY HIGH FH | Efficacy and Safety of Alirocumab (SAR236553/REGN727) Versus Placebo on Top of Lipid-Modifying Therapy in Patients With Heterozygous Familial Hypercholesterolemia (ODYSSEY HIGH FH) | 3 | COMPLETED | Hypercholesterolemia | DRUG: Alirocumab DRUG: Placebo (for alirocumab) DRUG: Lipid Modifying Therapy (LMT) | Sanofi/Regeneron | Jun-12 | May-14 | |
NCT01623115 | ODYSSEY FH I | Efficacy and Safety of Alirocumab (SAR236553/REGN727) Versus Placebo on Top of Lipid-Modifying Therapy in Patients With Heterozygous Familial Hypercholesterolemia Not Adequately Controlled With Their Lipid-Modifying Therapy | 3 | COMPLETED | Hypercholesterolemia | DRUG: Alirocumab DRUG: Placebo (for alirocumab) DRUG: Lipid Modifying Therapy (LMT) | Sanofi/Regeneron | Jul-12 | Apr-14 | |
NCT01644175 | ODYSSEY COMBO I | Efficacy and Safety of Alirocumab (SAR236553/REGN727) Versus Placebo on Top of Lipid-Modifying Therapy in Patients With High Cardiovascular Risk and Hypercholesterolemia (ODYSSEY COMBO I) | 3 | COMPLETED | Hypercholesterolemia | DRUG: Placebo (for alirocumab) DRUG: Alirocumab DRUG: Lipid-Modifying Therapy (LMT) | Sanofi/Regeneron | Jul-12 | Apr-14 | |
NCT01644188 | ODYSSEY COMBO II | Efficacy and Safety of Alirocumab (SAR236553/REGN727) Versus Ezetimibe on Top of Statin in High Cardiovascular Risk Patients With Hypercholesterolemia (ODYSSEY COMBO II) | 3 | COMPLETED | Hypercholesterolemia | DRUG: Alirocumab DRUG: Placebo (for alirocumab) DRUG: Ezetimibe DRUG: Placebo (for ezetimibe) DRUG: Lipid Modifying Therapy (LMT) | Sanofi/Regeneron | Aug-12 | May-14 | |
NCT01644474 | ODYSSEY MONO | Efficacy and Safety of Alirocumab (SAR236553/REGN727) Versus Ezetimibe in Patients With Hypercholesterolemia | 3 | COMPLETED | Hypercholesterolemia | DRUG: Alirocumab DRUG: Ezetimibe DRUG: Placebo (for Alirocumab) DRUG: Placebo (for Ezetimibe) | Sanofi/Regeneron | Jul-12 | Jul-13 | |
NCT01663402 | ODYSSEY Outcomes | ODYSSEY Outcomes: Evaluation of Cardiovascular Outcomes After an Acute Coronary Syndrome During Treatment With Alirocumab | 3 | COMPLETED | Atherosclerotic Cardiovascular Disease | DRUG: Alirocumab DRUG: Placebo DRUG: LMT | Sanofi/Regeneron | Oct-12 | Jan-18 | |
NCT01709500 | ODYSSEY FH II | Study of Alirocumab (REGN727/SAR236553) in Patients With heFH (Heterozygous Familial Hypercholesterolemia) Who Are Not Adequately Controlled With Their LMT (Lipid-Modifying Therapy) | 3 | COMPLETED | Heterozygous Familial Hypercholesterolemia | DRUG: LMT (atorvastatin, simvastatin, or rosuvastatin) DRUG: alirocumab DRUG: Placebo | Regeneron/Sanofi | ######### | May-14 | |
NCT01709513 | ODYSSEY ALTERNATIVE | Study of Alirocumab (REGN727/SAR236553) in Patients With Primary Hypercholesterolemia and Moderate, High, or Very High Cardiovascular (CV) Risk, Who Are Intolerant to Statins (ODYSSEY ALTERNATIVE) | 3 | COMPLETED | Hypercholesterolemia | DRUG: Atorvastatin DRUG: Ezetimibe DRUG: Alirocumab DRUG: Placebo | Regeneron/Sanofi | Sep-12 | May-14 | |
NCT01730040 | ODYSSEY OPTIONS I | Study of the Efficacy and Safety of Alirocumab (REGN727/SAR236553) in Combination With Other Lipid-modifying Treatment (LMT) (ODYSSEY OPTIONS I) | 3 | COMPLETED | Hypercholesterolemia | DRUG: Alirocumab DRUG: Atorvastatin DRUG: Ezetimibe DRUG: Rosuvastatin DRUG: Placebo | Regeneron/Sanofi | Oct-12 | Apr-14 | |
NCT01730053 | ODYSSEY OPTIONS II | Study of Alirocumab (REGN727/SAR236553) added-on to Rosuvastatin Versus Other Lipid Modifying Treatments (LMT) (ODYSSEY OPTIONS II) | 3 | COMPLETED | Hypercholesterolemia | DRUG: Alirocumab DRUG: Rosuvastatin DRUG: Ezetimibe DRUG: Placebo | Regeneron/Sanofi | Nov-12 | Apr-14 | |
NCT01926782 | ODYSSEY CHOICE 1 | Study to Evaluate the Efficacy and Safety of an Every Four Weeks Treatment Regimen of Alirocumab (REGN727/ SAR236553) in Patients With Primary Hypercholesterolemia (ODYSSEY CHOICE 1) | 3 | COMPLETED | Hypercholesterolemia | DRUG: Placebo (for alirocumab) DRUG: Alirocumab DRUG: Statin | Regeneron/Sanofi | Sep-13 | Sep-14 | |
NCT01954394 | ODYSSEY OLE | Open Label Study of Long Term Safety Evaluation of Alirocumab | 3 | COMPLETED | Hypercholesterolemia | DRUG: Alirocumab DRUG: Lipid-Modifying Therapy (LMT) | Sanofi/Regeneron | Dec-13 | Jun-17 | |
NCT02023879 | ODYSSEY CHOICE II | Phase III Study To Evaluate Alirocumab in Patients With Hypercholesterolemia Not Treated With a Statin (ODYSSEY CHOICE II) | 3 | COMPLETED | Hypercholesterolemia | DRUG: Alirocumab DRUG: Placebo (for Alirocumab) DRUG: Non-statin LMT OTHER: Diet Alone | Sanofi/Regeneron | Dec-13 | Oct-14 | |
NCT02107898 | ODYSSEY JAPAN | Efficacy and Safety Evaluation of Alirocumab in Patients With Heterozygous Familial Hypercholesterolemia or High Cardiovascular Risk Patients With Hypercholesterolemia on Lipid Modifying Therapy (ODYSSEY JAPAN) | 3 | COMPLETED | Hypercholesterolemia | DRUG: Placebo (for alirocumab) DRUG: Alirocumab DRUG: Lipid-Modifying Therapy (LMT) | Sanofi/Regeneron | Mar-14 | Jan-15 | |
NCT02289963 | n/a | Evaluation of Alirocumab in Addition to Lipid-Modifying Therapy in Patients With High Cardiovascular Risk and Hypercholesterolemia in South Korea and Taiwan | 3 | COMPLETED | Hypercholesterolemia | DRUG: Placebo (for Alirocumab) DRUG: Alirocumab DRUG: Lipid-Modifying Therapy (LMT) | Sanofi/Regeneron | Jan-15 | Apr-16 | |
NCT02326220 | ODYSSEY ESCAPE | Study of Alirocumab (REGN727/SAR236553) in Patients With Heterozygous Familial Hypercholesterolemia (HeFH) Undergoing Low-density Lipoprotein (LDL) Apheresis Therapy | 3 | COMPLETED | Heterozygous Familial Hypercholesterolemia | DRUG: Placebo DRUG: Alirocumab | Regeneron/Sanofi | Mar-15 | Jan-16 | |
NCT02476006 | ODYSSEY APPRISE | Safety, Tolerability, and Effect of Alirocumab in High Cardiovascular Risk Patients With Severe Hypercholesterolemia Not Adequately Controlled With Conventional Lipid-modifying Therapies (ODYSSEY APPRISE) | 3 | COMPLETED | Hypercholesterolemia | DRUG: ALIROCUMAB SAR236553 (REGN727) DRUG: placebo (for injection training only) DRUG: ezetimibe DRUG: atorvastatin DRUG: rosuvastatin DRUG: simvastatin | Sanofi/Regeneron | Jun-15 | Apr-19 | |
NCT02584504 | ODYSSEY-NIPPON | Efficacy and Safety of Alirocumab in Patients With Hypercholesterolemia Not Adequately Controlled With Non-statin Lipid Modifying Therapy or the Lowest Strength of Statin | 3 | COMPLETED | Hypercholesterolemia | DRUG: Alirocumab DRUG: Placebo DRUG: Atorvastatin DRUG: Non-statin Lipid-Modifying Therapy OTHER: Diet Alone | Sanofi/Regeneron | Nov-15 | Apr-17 | |
NCT02585778 | ODYSSEY DM - Insulin | Efficacy and Safety of Alirocumab Versus Placebo on Top of Maximally Tolerated Lipid Lowering Therapy in Patients With Hypercholesterolemia Who Have Type 1 or Type 2 Diabetes and Are Treated With Insulin (ODYSSEY DM - Insulin) | 3 | COMPLETED | Hypercholesterolemia | DRUG: Alirocumab DRUG: Placebo DRUG: Lipid-Modifying Therapy (LMT) DRUG: Antihyperglycemic Drug | Sanofi/Regeneron | Oct-15 | Apr-17 | |
NCT02642159 | ODYSSEY DM-Dyslipidemia | Efficacy and Safety of Alirocumab Versus Usual Care on Top of Maximally Tolerated Statin Therapy in Patients With Type 2 Diabetes and Mixed Dyslipidemia (ODYSSEY DM-Dyslipidemia) | 4 | COMPLETED | Dyslipidemia | DRUG: Alirocumab DRUG: Statins DRUG: Ezetimibe DRUG: Fenofibrate DRUG: Nicotinic acid DRUG: Omega-3 fatty acids DRUG: Antihyperglycemic Drug | Sanofi/Regeneron | Mar-16 | Mar-17 | |
NCT02715726 | ODYSSEY EAST | Evaluation of Alirocumab Versus Ezetimibe on Top of Statin in Asia in High Cardiovascular Risk Patients With Hypercholesterolemia | 3 | COMPLETED | Hypercholesterolemia | DRUG: Alirocumab DRUG: Placebo for alirocumab DRUG: ezetimibe DRUG: placebo for ezetimibe DRUG: atorvastatin DRUG: rosuvastatin DRUG: simvastatin | Sanofi/Regeneron | Jul-16 | Aug-18 | |
NCT02957682 | n/a | Evaluating Effect of the Study Drug Praluent (Alirocumab) on Neurocognitive Function When Compared to Placebo | 4 | COMPLETED | Hypercholesterolemia | DRUG: Praluent (Alirocumab) DRUG: Placebo | Regeneron/Sanofi | Nov-16 | Mar-20 | |
NCT02984982 | ODYSSEY J-IVUS | Evaluation of Effect of Alirocumab on Coronary Atheroma Volume in Japanese Patients Hospitalized for Acute Coronary Syndrome With Hypercholesterolemia | 4 | COMPLETED | Hypercholesterolemia Acute Coronary Syndrome | DRUG: Alirocumab SAR236553 DRUG: Atorvastatin DRUG: Rosuvastatin DRUG: Fenofibrate DRUG: Bezafibrate DRUG: Ezetimibe DRUG: Antiplatelets DRUG: Anticoagulants | Sanofi/Regeneron | Nov-16 | Jul-18 | |
NCT03156621 | ODYSSEY HoFH | Study in Participants With Homozygous Familial Hypercholesterolemia (HoFH) | 3 | COMPLETED | Homozygous Familial Hypercholesterolemia | DRUG: Alirocumab DRUG: Placebo | Regeneron/Sanofi | Oct-17 | Sep-19 | |
NCT03415178 | n/a | Usability Study of the Commercial Auto-injector Device and the New Auto-injector Device (SYDNEY) in Patients With High or Very High CV Risk With Hypercholesterolemia Not Adequately Controlled With Their Lipid-Modifying Therapy | 3 | COMPLETED | Hypercholesterolemia | DRUG: Alirocumab SAR236553 DEVICE: Current auto-injector device (AI) DEVICE: New auto-injector device (SYDNEY) DRUG: Atorvastatin DRUG: Rosuvastatin | Sanofi/Regeneron | Mar-18 | Aug-18 | |
NCT03510715 | n/a | An Efficacy and Safety Study of Alirocumab in Children and Adolescents With Homozygous Familial Hypercholesterolemia | 3 | COMPLETED | Hypercholesterolemia | DRUG: Alirocumab SAR236553 (REGN727) DRUG: Atorvastatin DRUG: Simvastatin DRUG: Fluvastatin DRUG: Pravastatin DRUG: Lovastatin DRUG: Rosuvastatin DRUG: Ezetimibe DRUG: Cholestyramine DRUG: Nicotinic acid DRUG: Fenofibrate DRUG: Omega-3 fatty acids | Sanofi/Regeneron | Aug-18 | Feb-20 | |
NCT03510884 | n/a | An Efficacy and Safety Study of Alirocumab in Children and Adolescents With Heterozygous Familial Hypercholesterolemia | 3 | COMPLETED | Hypercholesterolemia | DRUG: Alirocumab SAR236553 (REGN727) DRUG: Rosuvastatin DRUG: Atorvastatin DRUG: Simvastatin DRUG: Pravastatin DRUG: Lovastatin DRUG: Fluvastatin DRUG: Ezetimibe DRUG: Cholestyramine DRUG: Nicotinic acid DRUG: Fenofibrate DRUG: Omega-3 fatty acids DRUG: Placebo | Sanofi/Regeneron | May-18 | Jan-21 | |
Inclisiran A PCSK9-specific siRNA approved by EMA in 2020, and the US FDA in 2021 | NCT02314442 | n/a | A Phase 1 Study of an Investigational Drug, ALN-PCSSC, in Subjects With Elevated Low Density Lipoprotein Cholesterol (LDL-C) | 1 | COMPLETED | Hypercholesterolemia | DRUG: ALN-PCSSC DRUG: Sterile Normal Saline (0.9% NaCl) | Alnylam Pharmaceuticals | Dec-14 | May-15 |
NCT02597127 | ORION-1 | Trial to Evaluate the Effect of ALN-PCSSC Treatment on Low Density Lipoprotein Cholesterol (LDL-C) | 2 | COMPLETED | Atherosclerotic Cardiovascular Disease Familial Hypercholesterolemia Diabetes | DRUG: ALN-PCSSC DRUG: Normal Saline | The Medicines Company | Jan-16 | Jun-17 | |
NCT02963311 | ORION-2 | A Study of ALN-PCSSC in Participants With Homozygous Familial Hypercholesterolemia (HoFH) | 2 | COMPLETED | Homozygous Familial Hypercholesterolemia | DRUG: ALN-PCSSC DRUG: Standard of Care | The Medicines Company | Dec-16 | Oct-18 | |
NCT03060577 | ORION-3 | An Extension Trial of Inclisiran in Participants With Cardiovascular Disease and High Cholesterol | 2 | COMPLETED | Atherosclerotic Cardiovascular Disease Symptomatic Atherosclerosis Type2 Diabetes Familial Hypercholesterolemia | DRUG: Inclisiran DRUG: Evolocumab | Novartis Pharmaceuticals | Apr-17 | Dec-21 | |
NCT03159416 | ORION-7 | A Study of Inclisiran in Participants With Renal Impairment Compared to Participants With Normal Renal Function (ORION-7) | 1 | COMPLETED | Renal Impairment | DRUG: Inclisiran | The Medicines Company | Jun-17 | Mar-18 | |
NCT03397121 | ORION-9 | Trial to Evaluate the Effect of Inclisiran Treatment on Low Density Lipoprotein Cholesterol (LDL-C) in Subjects With Heterozygous Familial Hypercholesterolemia (HeFH) | 3 | COMPLETED | Heterozygous Familial Hypercholesterolemia Elevated Cholesterol | DRUG: Inclisiran DRUG: Placebo | The Medicines Company | Nov-17 | Aug-19 | |
NCT03399370 | ORION-10 | Inclisiran for Participants With Atherosclerotic Cardiovascular Disease and Elevated Low-density Lipoprotein Cholesterol | 3 | COMPLETED | ASCVD Elevated Cholesterol | DRUG: Inclisiran Sodium DRUG: Placebo | The Medicines Company | Dec-17 | Sep-19 | |
NCT03400800 | ORION-11 | Inclisiran for Subjects With ASCVD or ASCVD-Risk Equivalents and Elevated Low-density Lipoprotein Cholesterol | 3 | COMPLETED | ASCVD Risk Factor, Cardiovascular Elevated Cholesterol | DRUG: Inclisiran Sodium DRUG: Placebo | The Medicines Company | Nov-17 | Jul-19 | |
NCT03705234 | ORION-4 | A Randomized Trial Assessing the Effects of Inclisiran on Clinical Outcomes Among People With Cardiovascular Disease | 3 | ACTIVE_NOT_RECRUITING | Atherosclerotic Cardiovascular Disease | DRUG: Inclisiran DRUG: Placebo | University of Oxford | Oct-18 | Jul-26 | |
NCT03814187 | ORION-8 | Trial to Assess the Effect of Long Term Dosing of Inclisiran in Subjects With High CV Risk and Elevated LDL-C | 3 | COMPLETED | ASCVD Elevated Cholesterol Heterozygous Familial Hypercholesterolemia Homozygous Familial Hypercholesterolemia | DRUG: Inclisiran Sodium | Novartis Pharmaceuticals | Apr-19 | Feb-23 | |
NCT03851705 | ORION-5 | A Study of Inclisiran in Participants With Homozygous Familial Hypercholesterolemia (HoFH) | 3 | COMPLETED | Homozygous Familial Hypercholesterolemia | DRUG: Inclisiran Sodium for injection DRUG: Placebo DRUG: Placebos | Novartis Pharmaceuticals | Feb-19 | Mar-20 | |
NCT04652726 | ORION-16 | Study to Evaluate Efficacy and Safety of Inclisiran in Adolescents With Heterozygous Familial Hypercholesterolemia | 3 | ACTIVE_NOT_RECRUITING | Familial Hypercholesterolemia - Heterozygous | DRUG: Inclisiran DRUG: Placebo | Novartis Pharmaceuticals | Jan-21 | Nov-23 | |
NCT04659863 | ORION-13 | Study to Evaluate Efficacy and Safety of Inclisiran in Adolescents With Homozygous Familial Hypercholesterolemia | 3 | ACTIVE_NOT_RECRUITING | Familial Hypercholesterolemia - Homozygous | DRUG: Inclisiran DRUG: Placebo | Novartis Pharmaceuticals | Feb-21 | Nov-23 | |
NCT04666298 | ORION-15 | Study of Efficacy and Safety of Inclisiran in Japanese Participants With High Cardiovascular Risk and Elevated LDL-C | 2 | COMPLETED | Hypercholesterolemia Heterozygous Familial Hypercholesterolemia | DRUG: Inclisiran sodium DRUG: Placebo | Novartis Pharmaceuticals | Jan-21 | Apr-22 | |
NCT04765657 | n/a | 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) | 3 | ACTIVE_NOT_RECRUITING | Hypercholesterolemia | DRUG: inclisiran sodium DRUG: Placebo | Novartis Pharmaceuticals | Mar-21 | Jun-22 | |
NCT04774003 | ORION-14 | Study of Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Inclisiran in Chinese Participants With Elevated Serum LDL-C | 1 | COMPLETED | Hyperlipidemia | DRUG: 100 mg inclisiran sodium (equivalent to 94.5 mg inclisiran) DRUG: Placebo DRUG: 300 mg inclisiran sodium (equivalent to 284 mg inclisiran) | Novartis Pharmaceuticals | Feb-21 | Oct-21 | |
NCT04807400 | SPIRIT | Study in Primary Care Evaluating Inclisiran Delivery Implementation + Enhanced Support | 3 | COMPLETED | Atherosclerotic Cardiovascular Disease Atherosclerotic Cardiovascular Disease Risk Equivelents Elevated Low Density Lipoprotein Cholesterol | DRUG: Inclisiran BEHAVIORAL: Behavioral Support | Novartis Pharmaceuticals | Jul-21 | Jan-23 | |
NCT04873934 | VICTORION-INCEPTION | Management of LDL-cholesterol With Inclisiran + Usual Care Compared to Usual Care Alone in Participants With a Recent Acute Coronary Syndrome | 3 | RECRUITING | Acute Coronary Syndrome | DRUG: Inclisiran | Novartis Pharmaceuticals | Jun-21 | Aug-24 | |
NCT04929249 | VICTORION-INITIATE | 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) | 3 | ACTIVE_NOT_RECRUITING | Atherosclerotic Cardiovascular Disease | DRUG: Inclisiran | Novartis Pharmaceuticals | Jun-21 | Sep-23 | |
NCT05030428 | VICTORION-2PREVENT | Study of Inclisiran to Prevent Cardiovascular (CV) Events in Participants With Established Cardiovascular Disease | 3 | RECRUITING | Atherosclerotic Cardiovascular Disease | DRUG: Inclisiran sodium 300 mg DRUG: Placebo | Novartis Pharmaceuticals | Nov-21 | Oct-27 | |
NCT05192941 | VICTORION-DIFFERENCE | Study of Efficacy, Safety, Tolerability and Quality of Life of Inclisiran (KJX839) vs Placebo, on Top of Ongoing Individually Optimized Lipid-lowering Therapy, in Participants With Hypercholesterolemia | 4 | RECRUITING | Hypercholesterolemia | DRUG: Inclisiran Sodium DRUG: Placebo | Novartis Pharmaceuticals | Apr-22 | Feb-25 | |
NCT05360446 | VICTORION-PLAQUE | 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 | 3 | RECRUITING | Coronary Artery Disease | DRUG: Inclisiran sodium 300 mg DRUG: Placebo | Novartis Pharmaceuticals | Jul-22 | Jan-26 | |
NCT05399992 | VICTORION-REAL | Study Evaluating Effectiveness and Adherence of Inclisiran Plus Standard of Care (SoC) Lipid-lowering Therapy Compared to SoC in ASCVD | n/a | RECRUITING | Primary Hypercholesterolemia Mixed Dyslipidemia | OTHER: Inclisiran | Novartis Pharmaceuticals | Sep-22 | Apr-27 | |
NCT05682378 | VICTORION-PEDS-OLE | Long-term Safety and Tolerability of Inclisiran in Participants With HeFH or HoFH Who Have Completed the Adolescent ORION-16 or ORION-13 Studies | 3 | RECRUITING | Heterozygous or Homozygous Familial Hypercholesterolemia | DRUG: Inclisiran | Novartis Pharmaceuticals | Feb-23 | Dec-27 | |
NCT05739383 | n/a | A Study of Inclisiran to Prevent Cardiovascular Events in High-risk Primary Prevention Patients. | 3 | RECRUITING | Primary Prevention of Atherosclerotic Cardiovascular Disease | DRUG: Inclisiran sodium 300 mg (equivalent to 284 mg inclisiran) in 1.5 mL DRUG: Placebo in 1.5 ml | Novartis Pharmaceuticals | Mar-23 | Apr-29 | |
NCT05763875 | VICTORION-Mono | Efficacy and Safety of Inclisiran as Monotherapy in Patients With Primary Hypercholesterolemia Not Receiving Lipid-lowering Therapy. | 3 | RECRUITING | Hypercholesterolemia | DRUG: Inclisiran DRUG: Ezetimibe DRUG: Matching Placebo for Inclisiran DRUG: Matching Placebo for Ezetimibe | Novartis Pharmaceuticals | Mar-23 | Aug-24 | |
NCT05888103 | VICTORION-Mono China | Efficacy and Safety of Inclisiran as Monotherapy in Chinese Adults With Low or Moderate ASCVD Risk and Elevated Low-density Lipoprotein Cholesterol. | 3 | NOT_YET_RECRUITING | Primary Hypercholesterolemia or Mixed Dyslipidemia | DRUG: Inclisiran DRUG: Matching Placebo for Inclisiran | Novartis Pharmaceuticals | Jul-23 | Apr-24 | |
Tafolecimab (IBI306) Anti-PCSK9 mAb Approved by China’s NMPA in 2023 | NCT03366688 | n/a | Single Ascending Dose Study of PCSK-9 Inhibitor (IBI306) in Healthy Subjects. | 1 | COMPLETED | Hypercholesterolemia | DRUG: IBI306 | DRUG: placebo | Innovent Biologics (Suzhou) Co. Ltd. | Nov-17 | Nov-18 |
NCT03815812 | n/a | Multiple Ascending Dose Study of PCSK-9 Inhibitor (IBI306) in Chinese Patients With Hypercholesterolemia | 2 | COMPLETED | Hypercholesterolemia | DRUG: IBI306 | DRUG: placebo | Innovent Biologics (Suzhou) Co. Ltd. | Mar-19 | Dec-19 | |
NCT04031742 | n/a | A Study to Evaluate Safety and Efficacy of IBI306, a PCSK9 Monoclonal Antibody in Chinese Subjects With Homozygous Familial Hypercholesterolemia | 2/3 | COMPLETED | Homozygous Familial Hypercholesterolemia | BIOLOGICAL: IBI306 | BIOLOGICAL: IBI306 | Innovent Biologics (Suzhou) Co. Ltd. | Sep-19 | Dec-21 | |
NCT04179669 | CREDIT-2 | Safety and Efficacy of IBI306 in HeFH Patients | 3 | COMPLETED | Heterozygous Familial Hypercholesterolemia | DRUG: IBI306 | DRUG: placebo | Innovent Biologics (Suzhou) Co. Ltd. | Dec-19 | Jun-21 | |
NCT04289285 | CREDIT-1 | Safety and Efficacy of IBI306 in Chinese Subjects With Non-familial Hypercholesterolemia | 3 | COMPLETED | Hypercholesterolemia | DRUG: IBI306 450 mg SC Q4W | DRUG: Placebo SC Q4W | DRUG: IBI306 600 mg SC Q6W | OTHER: Placebo SC Q6W | Innovent Biologics (Suzhou) Co. Ltd. | Apr-20 | Feb-22 | |
NCT04709536 | CREDIT-4 | A Study of IBI306 in Participants With Hypercholesterolemia | 3 | UNKNOWN | Hypercholesterolemia | DRUG: IBI306 | DRUG: Placebo | Innovent Biologics (Suzhou) Co. Ltd. | Feb-21 | May-21 | |
NCT04759534 | n/a | Application of PCSK9 Inhibitors in Patients With Heterozygous Familial Hypercholesterolemia | 3 | UNKNOWN | Efficacy and Safety|Heterozygous Familial Hypercholesterolemia|PCSK9 | BIOLOGICAL: protein convertase subtilisin/kexin type 9 inhibitor | Shenzhen People’s Hospital | Sep-20 | Oct-21 | |
NCT04948008 | n/a | Evaluate the Efficacy and Safety of IBI306 in Subjects With Homozygous Familial Hypercholesterolemia | 2/3 | UNKNOWN | Familial Hypercholesterolemia - Homozygous|Lipid Metabolism Disorders|Proprotein Convertase Subtilisin/Kexin 9 | BIOLOGICAL: IBI306 | Shenzhen People’s Hospital | Nov-19 | Jul-20 | |
NCT05792917 | n/a | Bioequivalence Study of Tafolecimab Injections in Chinese Healthy Male Volunteers | 1 | COMPLETED | Healthy Male Subjects | DRUG: tafolecimab (a modified manufacturing process)|DRUG: tafolecimab (a original manufacturing process) | Innovent Biologics (Suzhou) Co. Ltd. | Mar-23 | Mar-23 | |
PCSK9-iT for other disorders | NCT Number | Study Title | Phases | Study Status | Conditions | Interventions | Sponsor | Start Date | Primary Completion Date | |
Infection | NCT02833844 | Safety, Tolerability and Efficacy on Low Density Lipoprotein Cholesterol (LDL-C) of Evolocumab in Participants With Human Immunodeficiency Virus (HIV) and Hyperlipidemia/Mixed Dyslipidemia | 3 | COMPLETED | Subjects With Hyperlipidemia, Dyslipidemia and HIV Infection | DRUG: Evolocumab DRUG: Placebo | Amgen | May-17 | Jul-19 | |
NCT03139630 | COPANA - A09 PCSK 9 Substudy: Impact of Protease Inhibitors on PCSK9 Levels in Naive HIV-Infected Patients | n/a | COMPLETED | HIV Seropositivity Dyslipidemias PCSK9 | n/a | Franck Boccara | Mar-16 | Sep-16 | ||
NCT03207945 | Effect of PCSK9 Inhibition on Cardiovascular Risk in Treated HIV Infection (EPIC-HIV Study) | 3 | RECRUITING | Dyslipidemias Cardiovascular Diseases HIV Infections | DRUG: Alirocumab OTHER: Placebo | University of California, San Francisco | Apr-18 | Jul-24 | ||
NCT03500302 | Effect of Evolocumab on Coronary Endothelial Function | 2 | COMPLETED | Human Immunodeficiency Virus Coronary Artery Disease | DRUG: Evolocumab | Johns Hopkins University | May-18 | Nov-19 | ||
NCT03634293 | Treatment of Severe Infection With Antihyperlipidemia Drug | 2/3 | UNKNOWN | Sepsis Septic Shock | DRUG: Alirocumab Injectable Product DRUG: Saline Solution | Wolfson Medical Center | Jan-19 | Jan-21 | ||
NCT03869073 | Evolocumab for PCSK9 Lowering in Early Acute Sepsis (The PLEASe Study) | 2 | UNKNOWN | Sepsis | DRUG: Evolocumab DRUG: Placebo | University of British Columbia | Feb-19 | Feb-21 | ||
NCT04941105 | Impact of PCSK9 Inhibition on Clinical Outcome in Patients During the Inflammatory Stage of the COVID-19 | 3 | COMPLETED | Sars-CoV-2 Infection | DRUG: Evolocumab DRUG: Saline solution | Collegium Medicum w Bydgoszczy | Jun-21 | May-22 | ||
NCT05469347 | Alirocumab in Patients With Sepsis | 1 | RECRUITING | Sepsis | DRUG: Alirocumab DRUG: Placebo | Jonathan Sevransky | Jan-23 | Apr-24 | ||
Autoimmune disorder | NCT05191342 | Proprotein Convertase Subtilisin Kexin 9 in Rheumatoid Arthritis | n/a | RECRUITING | PCSK9 | DIAGNOSTIC_TEST: Enzyme-linked immunosorbent assay for PCSK9 | First Affiliated Hospital of Harbin Medical University | Nov-21 | Nov-22 | |
Alcohol use disorder (AUD) | NCT04781322 | Safety, Tolerability, and Bioeffects of Alirocumab in Non-treatment Seeking Heavy Drinkers | 1 | RECRUITING | Alcohol Associated Liver Disease Heavy Drinking Behavior | DRUG: Alirocumab OTHER: Placebo | National Institute on Alcohol Abuse and Alcoholism (NIAAA) | Oct-21 | Dec-23 | |
Cancer | NCT03337698 | A Study Of Multiple Immunotherapy-Based Treatment Combinations In Participants With Metastatic Non-Small Cell Lung Cancer (Morpheus- Non-Small Cell Lung Cancer) | 1/2 | RECRUITING | Carcinoma, Non-Small-Cell Lung | DRUG: Atezolizumab DRUG: Cobimetinib DRUG: RO6958688 DRUG: Docetaxel DRUG: CPI-444 DRUG: Pemetrexed DRUG: Carboplatin DRUG: Gemcitabine DRUG: Linagliptin DRUG: Tocilizumab DRUG: Ipatasertib DRUG: Bevacizumab DRUG: Sacituzumab Govitecan OTHER: Radiation DRUG: Evolocumab DRUG: Tiragolumab DRUG: XL092 DRUG: Camonsertib | Hoffmann-La Roche | Jan-18 | Aug-25 | |
NCT04862260 | Cholesterol Disruption in Combination With FOLFIRINOX in Patients With Advanced Pancreatic Adenocarcinoma | early 1 | RECRUITING | Pancreatic Ductal Adenocarcinoma Pancreatic Cancer Pancreas Cancer Metastatic Cancer | DRUG: Cholesterol metabolism disruption | CHU de Quebec-Universite Laval | Oct-21 | Jan-25 | ||
NCT04937413 | The PCSK9i Inhibitor Evolocumab - a Surgical Trial of Pharamcodynamics and Kinetics Evaluation | early 1 | RECRUITING | Malignant Glioma Glioblastoma | DRUG: Evolocumab | Duke University | Oct-21 | Jun-25 | ||
NCT05128539 | A Study Explore JS001 + JS002 in Patients With Advanced Cancer | 1 | RECRUITING | Advanced Cancer | DRUG: JS001(Toripalimab)+JS002 | Shanghai Junshi Bioscience Co., Ltd. | Dec-21 | Feb-24 | ||
NCT05144529 | A Randomized Pilot Study of Evolocumab Plus Nivolumab/Ipilimumab in Treatment-Na??ve Patients With Metastatic NSCLC | 2 | RECRUITING | Lung Cancer Metastatic | DRUG: Nivolumab DRUG: Ipilimumab DRUG: Evolocumab | Scott Antonia | Mar-22 | Dec-23 | ||
NCT05553834 | PCSK9 Inhibitor and PD-1 Inhibitor in Patients With Metastatic, Refractory To Prior Anti PD-1 Non-small Cell Lung | 2 | RECRUITING | Non-small Cell Lung Cancer (NSCLC) | COMBINATION_PRODUCT: Alirocumab and Cemiplimab | Duke University | May-23 | Jan-27 | ||
NCT05976893 | Study on the Composite Endpoint Event of PCSK9 Inhibitor in Patients With Very High Risk of ASCVD and Cancer | 4 | NOT_YET_RECRUITING | ASCVD|Cancer | DRUG: Evolocumab DRUG: Statin | Xiang Xie | Aug-23 | Dec-25 | ||
