Alirocumab Clinical Trials (2026): 86 Studies for Hypercholesterolemia & Hypercholesterolaemia
Hipa.ai Research · Source: ClinicalTrials.gov / AACT
Synced daily from ClinicalTrials.gov via AACT. Last sync: .
86 Alirocumab clinical trials are catalogued on Hipa.ai from the AACT mirror of ClinicalTrials.gov, spanning 33 indications (including Hypercholesterolemia & Hypercholesterolaemia) and 55,861 total planned enrollment. 31 Phase 3 Alirocumab trials and 14 Phase 2, 16 Phase 4 are listed. 11 Alirocumab clinical trials are actively recruiting at 8 U.S. sites across 7 states. Most recent activity: NCT05430828 (Mar 2030).
Where to Participate: All Alirocumab Trial Sites in the U.S. (8 sites across 7 states)
Every actively recruiting Alirocumabtrial site, sorted by state then city. Each row links to the trial detail page (eligibility, contacts, full study record). Sites no longer enrolling at the location level are excluded. ClinicalTrials.gov / AACT does not provide street-level addresses; the map link uses the facility's geocoded coordinates where available.
| State | Facility | City | Trial | Map |
|---|---|---|---|---|
| FL | Precision Clinical Research | Sunrise33351 | NCT07477704 | Map |
| GA | Balanced Life Health Care Solutions | Lawrenceville30046 | NCT07477704 | Map |
| MD | National Institutes of Health Clinical Center | Bethesda20892 | NCT04781322 | Map |
| MT | Mercury Street Medical Group, PLLC | Butte59701 | NCT07477704 | Map |
| NC | Velocity Clinical Research - Durham | Durham27701 | NCT07477704 | Map |
| OR | Velocity Clinical Research, Medford | Medford97504 | NCT07477704 | Map |
| TX | Baylor Soltero CV Research | Dallas75226 | NCT03480568 | Map |
| TX | Velocity Clinical Research Dallas | Dallas75230 | NCT07477704 | Map |
Alirocumab clinical trials at a glance: phase × recruitment status
| Phase | recruiting | active not recruiting | completed | terminated | withdrawn | suspended | not yet recruiting | unknown | Total |
|---|---|---|---|---|---|---|---|---|---|
| Early P1 | 1 | 1 | |||||||
| P1 | 1 | 12 | 13 | ||||||
| P2 | 1 | 2 | 9 | 1 | 1 | 14 | |||
| P2/P3 | 1 | 1 | |||||||
| P3 | 1 | 29 | 1 | 31 | |||||
| P4 | 2 | 6 | 1 | 2 | 1 | 4 | 16 | ||
| N/A | 4 | 1 | 1 | 4 | 10 |
Recruiting Alirocumab clinical trials (11)
Studies currently enrolling participants. Click any NCT ID to view the trial detail page (eligibility, sites, contacts).
| NCT ID | Title | Phase | Indication | Enrollment | Started |
|---|---|---|---|---|---|
| NCT05430828 | AT-TARGET-ITEvaluation of Adherence, Persistence and Efficacy of Treatment With PCSK9 Inhibitors in Italy | — | Hypercholesterolemia | 5,000 | Mar 2020 |
| NCT07375225 | ALINETEvaluation of Adherence, Persistence and Efficacy of Treatment With Alirocumab 300mg in Italy | — | Hypercholesterolaemia | 1,500 | Dec 2024 |
| NCT06858332 | STaRTLipoprotein(a) Levels in Patients With Atherosclerotic Cardiovascular Diseases in Russia | — | Atherosclerotic Cardiovascular Disease | 2,382 | Apr 2025 |
| NCT07477704 | ASCEND-QWA Study to See How Safe and Effective Alirocumab is When Given Weekly to Adult Participants Who Have Hypercholesterolemia | P2 | Hypercholesterolemia | 420 | Jun 2026 |
| NCT05587621 | GoTIntensive Lipid-lowering in Patients With STEMI and NSTEMI (Germany on Target) | N/A | ST Elevation Myocardial Infarction | 300 | Apr 2024 |
| NCT05292404 | Impact of Early PCSK9 Inhibitor Treatment on Heart After Acute Myocardium Infarction | P4 | Acute Myocardial Infarction | 160 | Oct 2022 |
| NCT04781322 | Safety, Tolerability, and Bioeffects of Alirocumab in Non-treatment Seeking Heavy Drinkers | P1 | Alcohol Associated Liver Disease | 100 | Oct 2021 |
| NCT06083961 | The Effect of Early Administration of PCSK9 Inhibitor to Acute Ischemic Stroke Patients Associated With Atherosclerosis on the Stroke Prognosis and Lipid Profile | P4 | Stroke, Acute Ischemic | 200 | Oct 2023 |
| NCT04731155 | PERFECT-AMIImpact of Early PCSK9 Inhibitor on Heart After Acute Myocardium Infarction | P4 | Early PCSK9 Inhibitor on Ventricular Remodling | 20 | Apr 2021 |
| NCT06567418 | Retrospective Analysis of the Effect of In-hospital Initiation of PCSK9i on Clinical Outcomes in Chinese ACS Patients | — | Acute Coronary Syndrome | 10,000 | Aug 2024 |
| NCT03480568 | Alirocumab in Patients on a Stable Dialysis Regimen | P3 | Hemodialysis | 20 | May 2018 |
Alirocumab clinical trials by indication
Hypercholesterolemia (38)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT05430828 | AT-TARGET-IT | N/A | recruiting | Evaluation of Adherence, Persistence and Efficacy of Treatment With PCSK9 Inhibitors in Italy |
| NCT07477704 | ASCEND-QW | P2 | recruiting | A Study to See How Safe and Effective Alirocumab is When Given Weekly to Adult Participants Who Have Hypercholesterolemia |
| NCT04790513 | LIBerate-H2H | P3 | completed | Trial to Evaluate Efficacy and Safety of LIB003, Evolocumab and Alirocumab in High-risk CVD Patients |
| NCT03379558 | — | N/A | terminated | Praluent® (Alirocumab) Pregnancy Exposure Registry: An OTIS Pregnancy Surveillance Study |
| NCT02957682 | — | P4 | completed | Evaluating Effect of the Study Drug Praluent (Alirocumab) on Neurocognitive Function When Compared to Placebo |
| NCT03510715 | — | P3 | completed | An Efficacy and Safety Study of Alirocumab in Children and Adolescents With Homozygous Familial Hypercholesterolemia |
| NCT02476006 | ODYSSEY APPRISE | P3 | completed | Safety, Tolerability, and Effect of Alirocumab in High Cardiovascular Risk Patients With Severe Hypercholesterolemia Not Adequately Controlled With Conventional Lipid-modifying Therapies (ODYSSEY APPRISE) |
| NCT02715726 | ODYSSEY EAST | P3 | completed | Evaluation of Alirocumab Versus Ezetimibe on Top of Statin in Asia in High Cardiovascular Risk Patients With Hypercholesterolemia |
| + 30 more, see All trials below. | ||||
Hypercholesterolaemia (6)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT07375225 | ALINET | N/A | recruiting | Evaluation of Adherence, Persistence and Efficacy of Treatment With Alirocumab 300mg in Italy |
| NCT03510884 | — | P3 | completed | An Efficacy and Safety Study of Alirocumab in Children and Adolescents With Heterozygous Familial Hypercholesterolemia |
| NCT02890992 | ODYSSEY KIDS | P2 | completed | An 8-Week Dose-Finding Study to Evaluate the Efficacy and Safety of Alirocumab in Children and Adolescents With Heterozygous Familial Hypercholesterolemia |
| NCT03415178 | SYDNEY | P3 | completed | 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 |
| NCT02585778 | — | P3 | completed | 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) |
| NCT01617655 | ODYSSEY HIGH FH | P3 | completed | Efficacy and Safety of Alirocumab (SAR236553/REGN727) Versus Placebo on Top of Lipid-Modifying Therapy in Patients With Heterozygous Familial Hypercholesterolemia (ODYSSEY HIGH FH) |
Atherosclerosis (3)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT03355027 | INTENSITY-HIGH | N/A | unknown | Investigating the Lowest Threshold of Vascular Benefits From LDL Cholesterol Lowering in Patients With Stable CV Disease |
| NCT02992301 | — | P4 | unknown | Assessment of Atherosclerotic Plaque Characteristics Change by DCE-MRI With Alirocumab |
| NCT03014830 | — | P1 | completed | Alirocumab and Reverse Cholesterol Transport |
Atherosclerotic Cardiovascular Disease (2)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT06858332 | STaRT | N/A | recruiting | Lipoprotein(a) Levels in Patients With Atherosclerotic Cardiovascular Diseases in Russia |
| NCT01663402 | — | P3 | completed | ODYSSEY Outcomes: Evaluation of Cardiovascular Outcomes After an Acute Coronary Syndrome During Treatment With Alirocumab |
Acute Coronary Syndrome (2)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT06567418 | — | N/A | recruiting | Retrospective Analysis of the Effect of In-hospital Initiation of PCSK9i on Clinical Outcomes in Chinese ACS Patients |
| NCT04613167 | GEBI | N/A | unknown | Markers of Cardiovascular Risk in Patients With Premature Coronary Artery Disease and Treatment |
ST Elevation Myocardial Infarction (2)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT05587621 | GoT | N/A | not yet recruiting | Intensive Lipid-lowering in Patients With STEMI and NSTEMI (Germany on Target) |
| NCT03718286 | EPIC STEMI | P2 | completed | Effects of Acute, Rapid Lowering of LDL Cholesterol With Alirocumab in Patients With STEMI Undergoing Primary PCI |
Intracranial Atherosclerosis (2)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT05001984 | TOPICAL-MRI | P2 | active not recruiting | Trial of PCSK9 Inhibition in Patients with Acute Stroke and Symptomatic Intracranial Atherosclerosis |
| NCT06080256 | EAST-aICAS | P3 | unknown | Extra Alirocumab in Addition to Statin Therapy in Asymptomatic Intracranial Atherosclerotic Stenosis (EAST-aICAS) |
Stroke (2)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT06052020 | EAST-sICAS | N/A | unknown | Extra Alirocumab in Addition to Statin Therapy in Symptomatic IntraCranial Atherosclerotic Stenosis ----a Pilot Study |
| NCT03507374 | PINNACLE | Early P1 | terminated | PCSK9 Inhibition in Patients With Symptomatic Intracranial Atherosclerosis |
Sepsis (2)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT05469347 | PALMS | P1 | completed | Alirocumab in Patients with Sepsis |
| NCT03634293 | — | P2/P3 | unknown | Treatment of Severe Infection With Antihyperlipidemia Drug |
Myocardial Infarction (2)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT03750760 | EARLY | P4 | withdrawn | Early Alirocumab to Reduce LDL-C in Myocardial Infarction |
| NCT02938949 | — | P4 | completed | Alirocumab in Patients With Acute Myocardial Infarction |
Coronary Artery Disease (2)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT03552432 | ALTAIR | P4 | unknown | The Efficacy of Alirocumab for Thin-cap fIbroatheroma in Patients With Coronary Artery Disease Estimated by Optical Coherence Tomography |
| NCT03529253 | ANTARES | P4 | unknown | Effect of Alirocumab(Proprotein Convertase Subtilisin/Kexin type9 Inhibitor) and Rosuvastatin or Rosuvastatin Alone on Lipid Core Plaques in Coronary Artery Disease Evaluated by Near-infrared Spectroscopy Intravascular Ultrasound |
Heterozygous Familial Hypercholesterolemia (2)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT02326220 | ODYSSEY ESCAPE | P3 | completed | Study of Alirocumab (REGN727/SAR236553) in Patients With Heterozygous Familial Hypercholesterolemia (HeFH) Undergoing Low-density Lipoprotein (LDL) Apheresis Therapy |
| NCT01709500 | ODYSSEY FH II | P3 | completed | Study of Alirocumab (REGN727/SAR236553) in Patients With heFH (Heterozygous Familial Hypercholesterolemia) Who Are Not Adequately Controlled With Their LMT (Lipid-Modifying Therapy) |
Non Small Cell Lung Cancer (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT06385262 | TOP 2301 | P2 | suspended | TOP 2301: Neoadjuvant Chemo for NSCLC |
Stroke, Acute Ischemic (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT06083961 | — | P4 | not yet recruiting | The Effect of Early Administration of PCSK9 Inhibitor to Acute Ischemic Stroke Patients Associated With Atherosclerosis on the Stroke Prognosis and Lipid Profile |
Non-small Cell Lung Cancer (NSCLC) (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT05553834 | — | P2 | active not recruiting | PCSK9 Inhibitor and PD-1 Inhibitor in Patients With Metastatic, Refractory To Prior Anti PD-1 Non-small Cell Lung |
Acute Myocardial Infarction (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT05292404 | — | P4 | recruiting | Impact of Early PCSK9 Inhibitor Treatment on Heart After Acute Myocardium Infarction |
Alcohol Associated Liver Disease (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT04781322 | — | P1 | recruiting | Safety, Tolerability, and Bioeffects of Alirocumab in Non-treatment Seeking Heavy Drinkers |
Early PCSK9 Inhibitor on Ventricular Remodling (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT04731155 | PERFECT-AMI | P4 | recruiting | Impact of Early PCSK9 Inhibitor on Heart After Acute Myocardium Infarction |
Healthy Subjects (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT04189484 | — | P1 | completed | Pharmacodynamic Biomarkers to Support Biosimilar Development: PCSK9 Inhibitors |
Cardiac Allograft Vasculopathy (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT04193306 | ACAV | P4 | unknown | Efficacy and Safety Of Alirocumab to Prevent Early Cardiac Allograft Vasculopathy in Recent Heart Transplant Recipients |
Vasculopathy (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT03537742 | CAVIAR | P2 | completed | Cardiac Allograft Vasculopathy Inhibition With Alirocumab |
Type2 Diabetes (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT03344692 | EUTERPE | P3 | completed | Effect of Alirocumab on Postprandial Hyperlipemia in Patients With Type 2 Diabetes |
Saphenous Vein Graft Atherosclerosis (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT03542110 | ASAP-SVG | P4 | terminated | The Alirocumab for Stopping Atherosclerosis Progression in Saphenous Vein Grafts (ASAP-SVG) Pilot Trial |
Familial Hypercholesterolemia (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT05465278 | ARCHITECT | P4 | completed | Alirocumab and Plaque Burden In Familial Hypercholesterolaemia |
Hemodialysis (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT03480568 | — | P3 | recruiting | Alirocumab in Patients on a Stable Dialysis Regimen |
Dyslipidemias (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT03207945 | EPIC-HIV | P3 | completed | Effect of PCSK9 Inhibition on Cardiovascular Risk in Treated HIV Infection (EPIC-HIV Study) |
Coronary Artery Disease Progression (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT03533959 | POLARIS | N/A | unknown | To Evaluate the Efficacy of Alirocumab for Neoatherosclerosis by Using OCT, in Comparison With Standard Statin Therapy |
Homozygous Familial Hypercholesterolemia (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT03156621 | ODYSSEY HoFH | P3 | completed | Study in Participants With Homozygous Familial Hypercholesterolemia (HoFH) |
Peripheral Arterial Disease (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT02959047 | — | P4 | completed | A Trial of Alirocumab and Plaque Regression in Peripheral Arterial Disease |
Coronary Vessel (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT03067844 | PACMAN-AMI | P3 | completed | Vascular Effects of Alirocumab in Acute MI-Patients |
Nephrotic Syndrome (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT03004001 | — | P2 | terminated | Effect of PCSK9-Antibody (Alirocumab) on Dyslipidemia Secondary to Nephrotic Syndrome |
Lipid Lowering, Vascular Inflammation (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT02941016 | — | P4 | withdrawn | Vascular Inflammation and Cholesterol Lowering Therapy |
Dyslipidemia (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT02642159 | — | P4 | completed | 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) |
Alirocumab pivotal trial highlights (Phase 2/3/4)
Phase-2/3/4 studies with named acronyms — the registration-grade trials most cited in label discussions and Wikipedia.
| Acronym | NCT | Phase | Status | Indication | Enrollment | PubMed |
|---|---|---|---|---|---|---|
| PERFECT-AMI | NCT04731155 | P4 | recruiting | Early PCSK9 Inhibitor on Ventricular Remodling | 20 | — |
| ACAV | NCT04193306 | P4 | unknown | Cardiac Allograft Vasculopathy | 126 | PMID 29706574 |
| ARCHITECT | NCT05465278 | P4 | completed | Familial Hypercholesterolemia | 104 | PMID 37009731 |
| EARLY | NCT03750760 | P4 | withdrawn | Myocardial Infarction | 0 | — |
| ALTAIR | NCT03552432 | P4 | unknown | Coronary Artery Disease | 24 | PMID 30579806 |
| ANTARES | NCT03529253 | P4 | unknown | Coronary Artery Disease | 30 | — |
| ASAP-SVG | NCT03542110 | P4 | terminated | Saphenous Vein Graft Atherosclerosis | 46 | PMID 19890125 |
| ODYSSEY J-IVUS | NCT02984982 | P4 | completed | Hypercholesterolemia | 206 | PMID 31434809 |
| EPIC-HIV | NCT03207945 | P3 | completed | Dyslipidemias | 118 | PMID 41771366 |
| EAST-aICAS | NCT06080256 | P3 | unknown | Intracranial Atherosclerosis | 80 | PMID 39182330 |
| LIBerate-H2H | NCT04790513 | P3 | completed | Hypercholesterolemia | 204 | — |
| EUTERPE | NCT03344692 | P3 | completed | Type2 Diabetes | 22 | — |
| PACMAN-AMI | NCT03067844 | P3 | completed | Coronary Vessel | 294 | PMID 22421299 |
| ODYSSEY HoFH | NCT03156621 | P3 | completed | Homozygous Familial Hypercholesterolemia | 69 | PMID 32646561 |
| ODYSSEY APPRISE | NCT02476006 | P3 | completed | Hypercholesterolemia | 998 | PMID 36064689 |
| SYDNEY | NCT03415178 | P3 | completed | Hypercholesterolaemia | 69 | PMID 31879033 |
| ODYSSEY EAST | NCT02715726 | P3 | completed | Hypercholesterolemia | 615 | PMID 31882376 |
| ODYSSEY-NIPPON | NCT02584504 | P3 | completed | Hypercholesterolemia | 163 | PMID 30509509 |
| ODYSSEY OLE | NCT01954394 | P3 | completed | Hypercholesterolemia | 986 | PMID 30287210 |
| ODYSSEY CHOICE II | NCT02023879 | P3 | completed | Hypercholesterolemia | 233 | PMID 27625344 |
| CV | NCT01709513 | P3 | completed | Hypercholesterolemia | 314 | PMID 26687696 |
| ODYSSEY ESCAPE | NCT02326220 | P3 | completed | Heterozygous Familial Hypercholesterolemia | 62 | PMID 27206951 |
| ODYSSEY JAPAN | NCT02107898 | P3 | completed | Hypercholesterolemia | 216 | PMID 27452202 |
| ODYSSEY COMBO II | NCT01644188 | P3 | completed | Hypercholesterolemia | 720 | PMID 25687353 |
| ODYSSEY CHOICE 1 | NCT01926782 | P3 | completed | Hypercholesterolemia | 803 | PMID 27639753 |
| ODYSSEY FH II | NCT01709500 | P3 | completed | Heterozygous Familial Hypercholesterolemia | 249 | PMID 24842558 |
| ODYSSEY HIGH FH | NCT01617655 | P3 | completed | Hypercholesterolaemia | 107 | PMID 27618825 |
| ODYSSEY FH I | NCT01623115 | P3 | completed | Hypercholesterolemia | 486 | — |
| LMT | NCT01730053 | P3 | completed | Hypercholesterolemia | 305 | PMID 30183102 |
| LMT | NCT01730040 | P3 | completed | Hypercholesterolemia | 355 | PMID 25269777 |
| ODYSSEY COMBO I | NCT01644175 | P3 | completed | Hypercholesterolemia | 316 | PMID 26027630 |
| ODYSSEY MONO | NCT01644474 | P3 | completed | Hypercholesterolemia | 103 | PMID 25037695 |
| TOP 2301 | NCT06385262 | P2 | suspended | Non Small Cell Lung Cancer | 126 | — |
| ASCEND-QW | NCT07477704 | P2 | recruiting | Hypercholesterolemia | 420 | — |
| CAVIAR | NCT03537742 | P2 | completed | Vasculopathy | 114 | PMID 41212178 |
| TOPICAL-MRI | NCT05001984 | P2 | active not recruiting | Intracranial Atherosclerosis | 60 | PMID 35487727 |
| EPIC STEMI | NCT03718286 | P2 | completed | ST Elevation Myocardial Infarction | 97 | PMID 36349701 |
| ODYSSEY KIDS | NCT02890992 | P2 | completed | Hypercholesterolaemia | 42 | PMID 32331936 |
| ADH | NCT01604824 | P2 | completed | Hypercholesterolemia | 23 | PMID 31767518 |
| NCT01266876 | NCT01576484 | P2 | completed | Hypercholesterolemia | 58 | PMID 27886619 |
Terminated and withdrawn Alirocumab trials (7)
Studies that ended before completion. Reasons are filed in each trial's ClinicalTrials.gov entry.
- NCT06385262suspendedTOP 2301: Neoadjuvant Chemo for NSCLC
- NCT03750760withdrawnEarly Alirocumab to Reduce LDL-C in Myocardial Infarction
- NCT02941016withdrawnVascular Inflammation and Cholesterol Lowering Therapy
- NCT03379558terminatedPraluent® (Alirocumab) Pregnancy Exposure Registry: An OTIS Pregnancy Surveillance Study
- NCT03542110terminatedThe Alirocumab for Stopping Atherosclerosis Progression in Saphenous Vein Grafts (ASAP-SVG) Pilot Trial
- NCT03507374terminatedPCSK9 Inhibition in Patients With Symptomatic Intracranial Atherosclerosis
- NCT03004001terminatedEffect of PCSK9-Antibody (Alirocumab) on Dyslipidemia Secondary to Nephrotic Syndrome
All Alirocumab trials (86)
Sorted by most recent activity (completion → start → posted date). Each row links to the trial detail page on Hipa.ai.
| NCT ID | Acronym | Title | Phase | Status | Enrollment | Sponsor | Started |
|---|---|---|---|---|---|---|---|
| NCT05430828 | AT-TARGET-IT | Evaluation of Adherence, Persistence and Efficacy of Treatment With PCSK9 Inhibitors in Italy | — | recruiting | 5,000 | Federico II University | Mar 2020 |
| NCT06385262 | TOP 2301 | TOP 2301: Neoadjuvant Chemo for NSCLC | P2 | suspended | 126 | Duke University | Mar 2025 |
| NCT07375225 | ALINET | Evaluation of Adherence, Persistence and Efficacy of Treatment With Alirocumab 300mg in Italy | — | recruiting | 1,500 | Federico II University | Dec 2024 |
| NCT06858332 | STaRT | Lipoprotein(a) Levels in Patients With Atherosclerotic Cardiovascular Diseases in Russia | — | recruiting | 2,382 | Novartis Pharmaceuticals | Apr 2025 |
| NCT07477704 | ASCEND-QW | A Study to See How Safe and Effective Alirocumab is When Given Weekly to Adult Participants Who Have Hypercholesterolemia | P2 | recruiting | 420 | Regeneron Pharmaceuticals | Jun 2026 |
| NCT05587621 | GoT | Intensive Lipid-lowering in Patients With STEMI and NSTEMI (Germany on Target) | N/A | not yet recruiting | 300 | Jena University Hospital | Apr 2024 |
| NCT05292404 | Impact of Early PCSK9 Inhibitor Treatment on Heart After Acute Myocardium Infarction | P4 | recruiting | 160 | Shanghai Tong Ren Hospital | Oct 2022 | |
| NCT04781322 | Safety, Tolerability, and Bioeffects of Alirocumab in Non-treatment Seeking Heavy Drinkers | P1 | recruiting | 100 | National Institute on Alcohol Abuse and Alcoholism (NIAAA) | Oct 2021 | |
| NCT06083961 | The Effect of Early Administration of PCSK9 Inhibitor to Acute Ischemic Stroke Patients Associated With Atherosclerosis on the Stroke Prognosis and Lipid Profile | P4 | not yet recruiting | 200 | Sun U. Kwon | Oct 2023 | |
| NCT05553834 | PCSK9 Inhibitor and PD-1 Inhibitor in Patients With Metastatic, Refractory To Prior Anti PD-1 Non-small Cell Lung | P2 | active not recruiting | 60 | Duke University | May 2023 | |
| NCT03533959 | POLARIS | To Evaluate the Efficacy of Alirocumab for Neoatherosclerosis by Using OCT, in Comparison With Standard Statin Therapy | — | unknown | 31 | Kobe University | Dec 2017 |
| NCT04731155 | PERFECT-AMI | Impact of Early PCSK9 Inhibitor on Heart After Acute Myocardium Infarction | P4 | recruiting | 20 | Shanghai Tong Ren Hospital | Apr 2021 |
| NCT03207945 | EPIC-HIV | Effect of PCSK9 Inhibition on Cardiovascular Risk in Treated HIV Infection (EPIC-HIV Study) | P3 | completed | 118 | University of California, San Francisco | Apr 2018 |
| NCT04193306 | ACAV | Efficacy and Safety Of Alirocumab to Prevent Early Cardiac Allograft Vasculopathy in Recent Heart Transplant Recipients | P4 | unknown | 126 | Institute for Clinical and Experimental Medicine | Nov 2019 |
| NCT03537742 | CAVIAR | Cardiac Allograft Vasculopathy Inhibition With Alirocumab | P2 | completed | 114 | Stanford University | May 2019 |
| NCT05001984 | TOPICAL-MRI | Trial of PCSK9 Inhibition in Patients with Acute Stroke and Symptomatic Intracranial Atherosclerosis | P2 | active not recruiting | 60 | Chang Gung Memorial Hospital | Aug 2021 |
| NCT05469347 | PALMS | Alirocumab in Patients with Sepsis | P1 | completed | 50 | Jonathan Sevransky | Jan 2023 |
| NCT06567418 | Retrospective Analysis of the Effect of In-hospital Initiation of PCSK9i on Clinical Outcomes in Chinese ACS Patients | — | recruiting | 10,000 | Yun Dai Chen | Aug 2024 | |
| NCT06080256 | EAST-aICAS | Extra Alirocumab in Addition to Statin Therapy in Asymptomatic Intracranial Atherosclerotic Stenosis (EAST-aICAS) | P3 | unknown | 80 | The First Affiliated Hospital with Nanjing Medical University | Dec 2023 |
| NCT06052020 | EAST-sICAS | Extra Alirocumab in Addition to Statin Therapy in Symptomatic IntraCranial Atherosclerotic Stenosis ----a Pilot Study | — | unknown | 50 | The First Affiliated Hospital with Nanjing Medical University | Sep 2023 |
| NCT03355027 | INTENSITY-HIGH | Investigating the Lowest Threshold of Vascular Benefits From LDL Cholesterol Lowering in Patients With Stable CV Disease | N/A | unknown | 60 | Cambridge University Hospitals NHS Foundation Trust | Nov 2017 |
| NCT02959047 | A Trial of Alirocumab and Plaque Regression in Peripheral Arterial Disease | P4 | completed | 40 | University of Virginia | Jul 2017 | |
| NCT04790513 | LIBerate-H2H | Trial to Evaluate Efficacy and Safety of LIB003, Evolocumab and Alirocumab in High-risk CVD Patients | P3 | completed | 204 | LIB Therapeutics LLC | Apr 2021 |
| NCT03510884 | An Efficacy and Safety Study of Alirocumab in Children and Adolescents With Heterozygous Familial Hypercholesterolemia | P3 | completed | 153 | Sanofi | May 2018 | |
| NCT03344692 | EUTERPE | Effect of Alirocumab on Postprandial Hyperlipemia in Patients With Type 2 Diabetes | P3 | completed | 22 | Nantes University Hospital | Feb 2019 |
| NCT05465278 | ARCHITECT | Alirocumab and Plaque Burden In Familial Hypercholesterolaemia | P4 | completed | 104 | Fundación Hipercolesterolemia Familiar | May 2018 |
| NCT03750760 | EARLY | Early Alirocumab to Reduce LDL-C in Myocardial Infarction | P4 | withdrawn | 0 | Imperial College London | Jan 2020 |
| NCT03067844 | PACMAN-AMI | Vascular Effects of Alirocumab in Acute MI-Patients | P3 | completed | 294 | Insel Gruppe AG, University Hospital Bern | Apr 2017 |
| NCT03718286 | EPIC STEMI | Effects of Acute, Rapid Lowering of LDL Cholesterol With Alirocumab in Patients With STEMI Undergoing Primary PCI | P2 | completed | 97 | Population Health Research Institute | Mar 2019 |
| NCT04613167 | GEBI | Markers of Cardiovascular Risk in Patients With Premature Coronary Artery Disease and Treatment | N/A | unknown | 70 | University Medical Centre Ljubljana | Nov 2020 |
| NCT03552432 | ALTAIR | The Efficacy of Alirocumab for Thin-cap fIbroatheroma in Patients With Coronary Artery Disease Estimated by Optical Coherence Tomography | P4 | unknown | 24 | Kobe University | Aug 2017 |
| NCT04189484 | Pharmacodynamic Biomarkers to Support Biosimilar Development: PCSK9 Inhibitors | P1 | completed | 72 | Food and Drug Administration (FDA) | Jan 2020 | |
| NCT03634293 | Treatment of Severe Infection With Antihyperlipidemia Drug | P2/P3 | unknown | 712 | Wolfson Medical Center | Jan 2019 | |
| NCT03480568 | Alirocumab in Patients on a Stable Dialysis Regimen | P3 | recruiting | 20 | Baylor Research Institute | May 2018 | |
| NCT02941016 | Vascular Inflammation and Cholesterol Lowering Therapy | P4 | withdrawn | 0 | Rigshospitalet, Denmark | Oct 2016 | |
| NCT03529253 | ANTARES | Effect of Alirocumab(Proprotein Convertase Subtilisin/Kexin type9 Inhibitor) and Rosuvastatin or Rosuvastatin Alone on Lipid Core Plaques in Coronary Artery Disease Evaluated by Near-infrared Spectroscopy Intravascular Ultrasound | P4 | unknown | 30 | Kobe University | Apr 2018 |
| NCT03379558 | Praluent® (Alirocumab) Pregnancy Exposure Registry: An OTIS Pregnancy Surveillance Study | — | terminated | 37 | Regeneron Pharmaceuticals | Dec 2017 | |
| NCT03542110 | ASAP-SVG | The Alirocumab for Stopping Atherosclerosis Progression in Saphenous Vein Grafts (ASAP-SVG) Pilot Trial | P4 | terminated | 46 | Minneapolis Heart Institute Foundation | Aug 2018 |
| NCT03507374 | PINNACLE | PCSK9 Inhibition in Patients With Symptomatic Intracranial Atherosclerosis | Early P1 | terminated | 20 | University of Utah | Oct 2018 |
| NCT02957682 | Evaluating Effect of the Study Drug Praluent (Alirocumab) on Neurocognitive Function When Compared to Placebo | P4 | completed | 2,176 | Regeneron Pharmaceuticals | Nov 2016 | |
| NCT03510715 | An Efficacy and Safety Study of Alirocumab in Children and Adolescents With Homozygous Familial Hypercholesterolemia | P3 | completed | 18 | Sanofi | Aug 2018 | |
| NCT03156621 | ODYSSEY HoFH | Study in Participants With Homozygous Familial Hypercholesterolemia (HoFH) | P3 | completed | 69 | Regeneron Pharmaceuticals | Oct 2017 |
| NCT03004001 | Effect of PCSK9-Antibody (Alirocumab) on Dyslipidemia Secondary to Nephrotic Syndrome | P2 | terminated | 3 | Gloria Vega | Jan 2017 | |
| NCT02992301 | Assessment of Atherosclerotic Plaque Characteristics Change by DCE-MRI With Alirocumab | P4 | unknown | 35 | Westside Medical Associates of Los Angeles | Nov 2016 | |
| 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) | P3 | completed | 998 | Sanofi | Jun 2015 |
| NCT02890992 | ODYSSEY KIDS | An 8-Week Dose-Finding Study to Evaluate the Efficacy and Safety of Alirocumab in Children and Adolescents With Heterozygous Familial Hypercholesterolemia | P2 | completed | 42 | Sanofi | Sep 2016 |
| NCT02938949 | Alirocumab in Patients With Acute Myocardial Infarction | P4 | completed | 20 | Virginia Commonwealth University | Jan 2017 | |
| NCT03415178 | SYDNEY | 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 | P3 | completed | 69 | Sanofi | Mar 2018 |
| NCT02715726 | ODYSSEY EAST | Evaluation of Alirocumab Versus Ezetimibe on Top of Statin in Asia in High Cardiovascular Risk Patients With Hypercholesterolemia | P3 | completed | 615 | Sanofi | Jul 2016 |
| NCT03014830 | Alirocumab and Reverse Cholesterol Transport | P1 | completed | 28 | Washington University School of Medicine | Jun 2017 | |
| NCT02984982 | ODYSSEY J-IVUS | Evaluation of Effect of Alirocumab on Coronary Atheroma Volume in Japanese Patients Hospitalized for Acute Coronary Syndrome With Hypercholesterolemia | P4 | completed | 206 | Sanofi | Nov 2016 |
| NCT01663402 | ODYSSEY Outcomes: Evaluation of Cardiovascular Outcomes After an Acute Coronary Syndrome During Treatment With Alirocumab | P3 | completed | 18,924 | Sanofi | Oct 2012 | |
| 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 | P3 | completed | 163 | Sanofi | Nov 2015 |
| NCT02979015 | SC | A Study of Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Subcutaneous (SC) Administered Alirocumab in Healthy Chinese Subjects | P1 | completed | 35 | Sanofi | Nov 2016 |
| NCT01604824 | ADH | A Study of Alirocumab in Participants With Autosomal Dominant Hypercholesterolemia (ADH) and Gain-of-Function Mutations (GOFm) of the Proprotein Convertase Subtilisin Kexin 9 (PCSK9) Gene or Loss-of-Function Mutations (LOFm) of the Apolipoprotein (Apo) B Gene | P2 | completed | 23 | Regeneron Pharmaceuticals | Feb 2012 |
| NCT01954394 | ODYSSEY OLE | Open Label Study of Long Term Safety Evaluation of Alirocumab | P3 | completed | 986 | Sanofi | Dec 2013 |
| NCT02023879 | ODYSSEY CHOICE II | Phase III Study To Evaluate Alirocumab in Patients With Hypercholesterolemia Not Treated With a Statin (ODYSSEY CHOICE II) | P3 | completed | 233 | Sanofi | Dec 2013 |
| NCT01709513 | CV | 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) | P3 | completed | 314 | Regeneron Pharmaceuticals | Sep 2012 |
| NCT02642159 | 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) | P4 | completed | 413 | Sanofi | Mar 2016 | |
| NCT02585778 | 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) | P3 | completed | 517 | Sanofi | Oct 2015 | |
| NCT01576484 | NCT01266876 | Open-Label Extension of Study R727-CL-1003 (NCT01266876) to Evaluate the Long-Term Safety and Efficacy of Alirocumab (REGN727) in Participants With Heterozygous Familial Hypercholesterolemia (HeFH) | P2 | completed | 58 | Regeneron Pharmaceuticals | Feb 2012 |
| NCT02326220 | ODYSSEY ESCAPE | Study of Alirocumab (REGN727/SAR236553) in Patients With Heterozygous Familial Hypercholesterolemia (HeFH) Undergoing Low-density Lipoprotein (LDL) Apheresis Therapy | P3 | completed | 62 | Regeneron Pharmaceuticals | Mar 2015 |
| NCT02289963 | Evaluation of Alirocumab in Addition to Lipid-Modifying Therapy in Patients With High Cardiovascular Risk and Hypercholesterolemia in South Korea and Taiwan | P3 | completed | 199 | Sanofi | Jan 2015 | |
| 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) | P3 | completed | 216 | Sanofi | Mar 2014 |
| 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) | P3 | completed | 720 | Sanofi | Aug 2012 |
| NCT01959971 | Effect of Alirocumab on Lipid Metabolism in Adults With Elevated LDL-Cholesterol | P1 | completed | 20 | Sanofi | Dec 2013 | |
| 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) | P3 | completed | 803 | Regeneron Pharmaceuticals | Sep 2013 |
| 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) | P3 | completed | 249 | Regeneron Pharmaceuticals | Dec 2012 |
| 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) | P3 | completed | 107 | Sanofi | Jun 2012 |
| 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 | P3 | completed | 486 | Sanofi | Jul 2012 |
| NCT01507831 | 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) | P3 | completed | 2,341 | Sanofi | Jan 2012 | |
| NCT01730053 | LMT | Study of Alirocumab (REGN727/SAR236553) added-on to Rosuvastatin Versus Other Lipid Modifying Treatments (LMT) (ODYSSEY OPTIONS II) | P3 | completed | 305 | Regeneron Pharmaceuticals | Nov 2012 |
| NCT01730040 | LMT | Study of the Efficacy and Safety of Alirocumab (REGN727/SAR236553) in Combination With Other Lipid-modifying Treatment (LMT) (ODYSSEY OPTIONS I) | P3 | completed | 355 | Regeneron Pharmaceuticals | Oct 2012 |
| 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) | P3 | completed | 316 | Sanofi | Jul 2012 |
| NCT01812707 | Efficacy and Safety Evaluation of Alirocumab (SAR236553/REGN727) in Patients With Primary Hypercholesterolemia on Stable Atorvastatin Therapy in Japan | P2 | completed | 100 | Sanofi | Mar 2013 | |
| NCT01785329 | REGN727 | Pharmacokinetic of Alirocumab SAR236553 (REGN727) Administered Subcutaneously at 3 Different Injection Sites in Healthy Subjects | P1 | completed | 60 | Sanofi | Feb 2013 |
| NCT01723735 | Effect of Alirocumab (SAR236553/REGN727) Administered on Top of Ezetimibe or Fenofibrate on Lipid Profiles in Healthy Subjects | P1 | completed | 79 | Sanofi | Nov 2012 | |
| NCT01644474 | ODYSSEY MONO | Efficacy and Safety of Alirocumab (SAR236553/REGN727) Versus Ezetimibe in Patients With Hypercholesterolemia | P3 | completed | 103 | Sanofi | Jul 2012 |
| NCT01670734 | REGN727 | Pharmacokinetic and Tolerability of Alirocumab SAR236553 (REGN727) in Patients With Hepatic Impairment and in Healthy Subjects | P1 | completed | 25 | Sanofi | Sep 2012 |
| NCT01448317 | Ascending Dose Study of the Safety and Tolerability of Alirocumab (SAR236553/REGN727) in Japanese Healthy Volunteers | P1 | completed | 32 | Sanofi | May 2011 | |
| NCT01288443 | Efficacy and Safety Evaluation of Alirocumab (SAR236553/REGN727) in Patients With Primary Hypercholesterolemia on Stable Atorvastatin Therapy | P2 | completed | 183 | Sanofi | Jan 2011 | |
| NCT01443650 | REGN727 | Injection Site Tolerability, Safety, Pharmacokinetics, Pharmacodynamics in Different Single-Dose Treatments of Alirocumab SAR236553 (REGN727) in Healthy Subjects | P1 | completed | 36 | Sanofi | Jul 2011 |
| NCT01266876 | Study of the Safety and Efficacy of REGN727/SAR236553 in Patients With HeFH Hypercholesterolemia | P2 | completed | 77 | Regeneron Pharmaceuticals | Jan 2011 | |
| NCT01448304 | REGN727 | Study of the Tolerability, Safety, Pharmacokinetics and Pharmacodynamics of Alirocumab SAR236553 (REGN727) | P1 | completed | 24 | Sanofi | Jun 2011 |
| NCT01288469 | Efficacy and Safety Evaluation of Alirocumab (SAR236553/REGN727) When Co-administered With High Dose of Atorvastatin in Patients With Primary Hypercholesterolemia | P2 | completed | 92 | Sanofi | Jan 2011 | |
| NCT01448239 | REGN727 | Injection Site Tolerability, Safety, Pharmacokinetics and Pharmacodynamics Study After a Single Dose Subcutaneous Treatment of Alirocumab SAR236553 (REGN727) | P1 | completed | 24 | Sanofi | Feb 2011 |
Alirocumab clinical trials: frequently asked questions
- How many Alirocumab clinical trials are there?
- 86 Alirocumab clinical trials are catalogued on Hipa.ai, sourced from the AACT mirror of ClinicalTrials.gov. 9 are actively recruiting participants. 56 are marked completed.
- Are Alirocumab clinical trials recruiting in 2026?
- Yes — 9 Alirocumab trials are actively recruiting in 2026, with 8 U.S. sites across 7 states. See the recruiting trials and the per-state site list further down this page.
- What conditions is Alirocumab being studied for?
- Alirocumab is being studied for Hypercholesterolemia, Hypercholesterolaemia, Acute Coronary Syndrome, Dyslipidemias, Atherosclerosis and 57 more. The trials are grouped by indication on this page.
- What phase is Alirocumab in?
- Alirocumab clinical trials span 16 Phase 4, 31 Phase 3, 14 Phase 2, 13 Phase 1. The phase × status matrix at the top of this page breaks down counts by phase and recruitment status.
- Who sponsors Alirocumab clinical trials?
- The lead sponsor across the most Alirocumab trials is Sanofi, with 35 additional lead sponsors listed in the data. Each trial row links to the full study detail page including sponsor information.
Sources and methodology
Trial inventory derived from the AACT mirror of ClinicalTrials.gov. Trials are filtered to those naming Alirocumabas an intervention. Phase, status, enrollment, sponsor, and dates are taken from the source `studies` table; primary indication is the first listed condition. Acronyms are extracted from each trial's brief title where present. PubMed links are populated for trials whose published primary outcomes have been indexed in our evidence cache.
Last refreshed .
Related pages on Hipa.ai: