About this data Sourced primarily from ClinicalTrials.gov — a listing isn't proof of safety or FDA approval.

Pipeline and clinical trial information here comes primarily from ClinicalTrials.gov. A listing on ClinicalTrials.gov means a study has been registered — not that a treatment is proven safe, effective, or FDA-approved. Investigational treatments may never be approved. Who can join a trial is decided only by that trial's own study team.

Not yet reported

Alirocumab

Company: Regeneron Pharmaceuticals
Mechanism: Mechanism not yet reported
Route: Route not yet reported
Recruiting trials: 13 recruiting

Efficacy results: Not yet reported

Find a Clinical Trial Near Me

13 recruiting studies currently listed on ClinicalTrials.gov.

Data source: ClinicalTrials.gov · trial data as of Oct 16, 2026

Trial details

Recruiting NCT NCT03480568

Alirocumab in Patients on a Stable Dialysis Regimen

Not yet reported Baylor Research Institute 20 participants Est. completion 2020-12-31 1 site Stand-alone

Other conditions: Hemodialysis, Peritoneal Dialysis, Hypercholesterolemia, Atherosclerotic Disease
View official trial listing →
Recruiting NCT NCT04731155

Impact of Early PCSK9 Inhibitor on Heart After Acute Myocardium Infarction

Not yet reported Shanghai Tong Ren Hospital 20 participants Est. completion 2025-10 2 sites Stand-alone

Other conditions: Early PCSK9 Inhibitor on Ventricular Remodling
View official trial listing →
Recruiting NCT NCT04781322

Safety, Tolerability, and Bioeffects of Alirocumab in Non-treatment Seeking Heavy Drinkers

Not yet reported National Institute on Alcohol Abuse and Alcoholism (NIAAA) 100 participants Est. completion 2026-12-31 1 site Stand-alone

Other conditions: Alcohol Associated Liver Disease, Heavy Drinking Behavior
View official trial listing →
Recruiting NCT NCT04847752

Study of Predictive Factors Related to Prognosis of Patients With Ischemic Stroke Due to Large-artery Atherosclerosis

Tongji Hospital 1000 participants Est. completion 2028-12-31 1 site

Cardiovascular disease Other conditions: Large-Artery Atherosclerosis (Embolus/Thrombosis)
View official trial listing →
Recruiting NCT NCT04968509

Effect of PCSK9 Inhibitors on Calcific Aortic Valve Stenosis

Not yet reported Beijing Anzhen Hospital 160 participants Est. completion 2028-01 1 site Stand-alone

Other conditions: Aortic Stenosis
View official trial listing →
Recruiting NCT NCT05292404

Impact of Early PCSK9 Inhibitor Treatment on Heart After Acute Myocardium Infarction

Not yet reported Shanghai Tong Ren Hospital 160 participants Est. completion 2026-12 5 sites Stand-alone

Cardiovascular disease
View official trial listing →
Recruiting NCT NCT05430828

Evaluation of Adherence, Persistence and Efficacy of Treatment With PCSK9 Inhibitors in Italy

Federico II University 5000 participants Est. completion 2030-03-31 27 sites

Other conditions: Hypercholesterolemia
View official trial listing →
Recruiting NCT NCT06738758

Multicenter Real-World Cohort Study Evaluating the Impact of Early Intensive Lipid-Lowering Therapy on the Prognosis of Acute Coronary Syndrome Patients(ELITE-ACS)

Yun Dai Chen 6000 participants Est. completion 2027-12-31 1 site

Other conditions: Acute Coronary Syndromes
View official trial listing →
Recruiting NCT NCT06858332

Lipoprotein(a) Levels in Patients With Atherosclerotic Cardiovascular Diseases in Russia

Novartis Pharmaceuticals 2382 participants Est. completion 2027-09-30 20 sites

Cardiovascular disease
View official trial listing →
Recruiting NCT NCT07375225

Evaluation of Adherence, Persistence and Efficacy of Treatment With Alirocumab 300mg in Italy

Federico II University 1500 participants Est. completion 2027-12-01 1 site

Other conditions: Hypercholesterolaemia
View official trial listing →
Recruiting NCT NCT07543731

A Real-World Study of Long-Term Adherence and Persistence to Inclisiran, Evolocumab, and Alirocumab

Novartis Pharmaceuticals 5995 participants Est. completion 2026-10-30 1 site

Cardiovascular disease Other conditions: Hypercholesterolemia, Familial
View official trial listing →
Recruiting NCT NCT07581808

Dual PCSK9 Inhibition With Inclisiran and Alirocumab in Secondary Prevention

Not yet reported University Medical Centre Ljubljana 60 participants Est. completion 2027-06 1 site Stand-alone

Cardiovascular disease Other conditions: Hypercholesterolemia
View official trial listing →
Recruiting NCT NCT07704918

Aggressive Lipid Lowering Therapy in ICI-Treated Melanoma

Not yet reported University of Colorado, Denver 40 participants Est. completion 2028-12 1 site Stand-alone

Other conditions: Melanoma
View official trial listing →
Completed NCT NCT01026597

Ascending Dose Study of the Safety and Tolerability of REGN727(SAR236553) in Healthy Volunteers

Not yet reported Regeneron Pharmaceuticals 40 participants Est. completion 2010-10 1 site Stand-alone

Other conditions: Healthy
View official trial listing →
Completed NCT NCT01074372

Ascending Dose Study of the Safety and Tolerability of REGN727 (SAR236553) in Healthy Volunteers

Not yet reported Regeneron Pharmaceuticals 32 participants Est. completion 2010-11 1 site Stand-alone

Other conditions: Healthy Volunteers
View official trial listing →
Completed NCT NCT01161082

Ascending Multi-dose Study of REGN727(SAR236553) With and Without Concomitant Atorvastatin

Not yet reported Regeneron Pharmaceuticals 72 participants Est. completion 2011-05 2 sites Stand-alone

Other conditions: Hypercholesterolemia
View official trial listing →
Completed NCT NCT01266876

Study of the Safety and Efficacy of REGN727/SAR236553 in Patients With HeFH Hypercholesterolemia

Not yet reported Regeneron Pharmaceuticals 77 participants Est. completion 2011-11 22 sites Stand-alone

Other conditions: Hypercholesterolemia
View official trial listing →
Completed NCT NCT01288443

Efficacy and Safety Evaluation of Alirocumab (SAR236553/REGN727) in Patients With Primary Hypercholesterolemia on Stable Atorvastatin Therapy

Not yet reported Sanofi 183 participants Est. completion 2011-12 38 sites Stand-alone

Other conditions: Hypercholesterolemia
View official trial listing →
Completed NCT NCT01288469

Efficacy and Safety Evaluation of Alirocumab (SAR236553/REGN727) When Co-administered With High Dose of Atorvastatin in Patients With Primary Hypercholesterolemia

Not yet reported Sanofi 92 participants Est. completion 2011-09 20 sites Stand-alone

Other conditions: Hypercholesterolemia
View official trial listing →
Completed NCT NCT01443650

Injection Site Tolerability, Safety, Pharmacokinetics, Pharmacodynamics in Different Single-Dose Treatments of Alirocumab SAR236553 (REGN727) in Healthy Subjects

Not yet reported Sanofi 36 participants Est. completion 2011-11 1 site Stand-alone

Other conditions: Hypercholesterolemia
View official trial listing →
Completed NCT NCT01448239

Injection Site Tolerability, Safety, Pharmacokinetics and Pharmacodynamics Study After a Single Dose Subcutaneous Treatment of Alirocumab SAR236553 (REGN727)

Not yet reported Sanofi 24 participants Est. completion 2011-05 1 site Stand-alone

Other conditions: Hypercholesterolemia
View official trial listing →
Completed NCT NCT01448304

Study of the Tolerability, Safety, Pharmacokinetics and Pharmacodynamics of Alirocumab SAR236553 (REGN727)

Not yet reported Sanofi 24 participants Est. completion 2011-09 1 site Stand-alone

Other conditions: Hypercholesterolemia
View official trial listing →
Completed NCT NCT01448317

Ascending Dose Study of the Safety and Tolerability of Alirocumab (SAR236553/REGN727) in Japanese Healthy Volunteers

Not yet reported Sanofi 32 participants Est. completion 2012-01 1 site Stand-alone

Other conditions: Hypercholesterolemia
View official trial listing →
Completed NCT 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)

Not yet reported Sanofi 2341 participants Est. completion 2014-11 320 sites Stand-alone

Other conditions: Hypercholesterolemia
View official trial listing →
Completed NCT NCT01576484

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)

Not yet reported Regeneron Pharmaceuticals 58 participants Est. completion 2016-12-22 14 sites Stand-alone

Other conditions: Hypercholesterolemia, Heterozygous Familial Hypercholesterolemia
View official trial listing →
Completed NCT NCT01604824

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

Not yet reported Regeneron Pharmaceuticals 23 participants Est. completion 2017-07-28 4 sites Stand-alone

Other conditions: Hypercholesterolemia
View official trial listing →
Completed NCT NCT01617655

Efficacy and Safety of Alirocumab (SAR236553/REGN727) Versus Placebo on Top of Lipid-Modifying Therapy in Patients With Heterozygous Familial Hypercholesterolemia (ODYSSEY HIGH FH)

Not yet reported Sanofi 107 participants Est. completion 2015-01 35 sites Stand-alone

Other conditions: Hypercholesterolaemia
View official trial listing →
Completed NCT NCT01623115

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

Not yet reported Sanofi 486 participants Est. completion 2014-12 91 sites Stand-alone

Other conditions: Hypercholesterolemia
View official trial listing →
Completed NCT NCT01644175

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)

Not yet reported Sanofi 316 participants Est. completion 2014-04 76 sites Stand-alone

Other conditions: Hypercholesterolemia
View official trial listing →
Completed NCT NCT01644188

Efficacy and Safety of Alirocumab (SAR236553/REGN727) Versus Ezetimibe on Top of Statin in High Cardiovascular Risk Patients With Hypercholesterolemia (ODYSSEY COMBO II)

Not yet reported Sanofi 720 participants Est. completion 2015-07 126 sites Stand-alone

Other conditions: Hypercholesterolemia
View official trial listing →
Completed NCT NCT01644474

Efficacy and Safety of Alirocumab (SAR236553/REGN727) Versus Ezetimibe in Patients With Hypercholesterolemia

Not yet reported Sanofi 103 participants Est. completion 2013-07 8 sites Stand-alone

Other conditions: Hypercholesterolemia
View official trial listing →
Completed NCT NCT01663402

ODYSSEY Outcomes: Evaluation of Cardiovascular Outcomes After an Acute Coronary Syndrome During Treatment With Alirocumab

Not yet reported Sanofi 18924 participants Est. completion 2018-01-23 1388 sites Stand-alone

Cardiovascular disease
View official trial listing →
Completed NCT NCT01670734

Pharmacokinetic and Tolerability of Alirocumab SAR236553 (REGN727) in Patients With Hepatic Impairment and in Healthy Subjects

Not yet reported Sanofi 25 participants Est. completion 2013-05 2 sites Stand-alone

Other conditions: Hypercholesterolemia
View official trial listing →
Completed NCT NCT01709500

Study of Alirocumab (REGN727/SAR236553) in Patients With heFH (Heterozygous Familial Hypercholesterolemia) Who Are Not Adequately Controlled With Their LMT (Lipid-Modifying Therapy)

Not yet reported Regeneron Pharmaceuticals 249 participants Est. completion 2015-01 24 sites Stand-alone

Other conditions: Heterozygous Familial Hypercholesterolemia
View official trial listing →
Completed NCT NCT01709513

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)

Not yet reported Regeneron Pharmaceuticals 314 participants Est. completion 2017-05-31 70 sites Stand-alone

Other conditions: Hypercholesterolemia
View official trial listing →
Completed NCT NCT01723735

Effect of Alirocumab (SAR236553/REGN727) Administered on Top of Ezetimibe or Fenofibrate on Lipid Profiles in Healthy Subjects

Not yet reported Sanofi 79 participants Est. completion 2013-07 2 sites Stand-alone

Other conditions: Hypercholesterolemia
View official trial listing →
Completed NCT NCT01730040

Study of the Efficacy and Safety of Alirocumab (REGN727/SAR236553) in Combination With Other Lipid-modifying Treatment (LMT) (ODYSSEY OPTIONS I)

Not yet reported Regeneron Pharmaceuticals 355 participants Est. completion 2014-05 97 sites Stand-alone

Other conditions: Hypercholesterolemia
View official trial listing →
Completed NCT NCT01730053

Study of Alirocumab (REGN727/SAR236553) added-on to Rosuvastatin Versus Other Lipid Modifying Treatments (LMT) (ODYSSEY OPTIONS II)

Not yet reported Regeneron Pharmaceuticals 305 participants Est. completion 2014-05-31 93 sites Stand-alone

Other conditions: Hypercholesterolemia
View official trial listing →
Completed NCT NCT01785329

Pharmacokinetic of Alirocumab SAR236553 (REGN727) Administered Subcutaneously at 3 Different Injection Sites in Healthy Subjects

Not yet reported Sanofi 60 participants Est. completion 2013-07 1 site Stand-alone

Other conditions: Hypercholesterolemia
View official trial listing →
Completed NCT NCT01812707

Efficacy and Safety Evaluation of Alirocumab (SAR236553/REGN727) in Patients With Primary Hypercholesterolemia on Stable Atorvastatin Therapy in Japan

Not yet reported Sanofi 100 participants Est. completion 2014-01 4 sites Stand-alone

Other conditions: Hypercholesterolemia
View official trial listing →
Completed NCT NCT01926782

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)

Not yet reported Regeneron Pharmaceuticals 803 participants Est. completion 2015-04 83 sites Stand-alone

Other conditions: Hypercholesterolemia
View official trial listing →
Completed NCT NCT01954394

Open Label Study of Long Term Safety Evaluation of Alirocumab

Not yet reported Sanofi 986 participants Est. completion 2017-06-30 177 sites Stand-alone

Other conditions: Hypercholesterolemia
View official trial listing →
Completed NCT NCT01959971

Effect of Alirocumab on Lipid Metabolism in Adults With Elevated LDL-Cholesterol

Not yet reported Sanofi 20 participants Est. completion 2015-05 1 site Stand-alone

Other conditions: Hypercholesterolemia
View official trial listing →
Completed NCT NCT02023879

Phase III Study To Evaluate Alirocumab in Patients With Hypercholesterolemia Not Treated With a Statin (ODYSSEY CHOICE II)

Not yet reported Sanofi 233 participants Est. completion 2017-06-30 43 sites Stand-alone

Other conditions: Hypercholesterolemia
View official trial listing →
Completed NCT NCT02107898

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)

Not yet reported Sanofi 216 participants Est. completion 2015-09 32 sites Stand-alone

Other conditions: Hypercholesterolemia
View official trial listing →
Completed NCT NCT02289963

Evaluation of Alirocumab in Addition to Lipid-Modifying Therapy in Patients With High Cardiovascular Risk and Hypercholesterolemia in South Korea and Taiwan

Not yet reported Sanofi 199 participants Est. completion 2016-04 27 sites

Other conditions: Hypercholesterolemia
View official trial listing →
Completed NCT NCT02326220

Study of Alirocumab (REGN727/SAR236553) in Patients With Heterozygous Familial Hypercholesterolemia (HeFH) Undergoing Low-density Lipoprotein (LDL) Apheresis Therapy

Not yet reported Regeneron Pharmaceuticals 62 participants Est. completion 2016-04-30 13 sites Stand-alone

Other conditions: Heterozygous Familial Hypercholesterolemia
View official trial listing →
Completed NCT NCT02476006

Safety, Tolerability, and Effect of Alirocumab in High Cardiovascular Risk Patients With Severe Hypercholesterolemia Not Adequately Controlled With Conventional Lipid-modifying Therapies (ODYSSEY APPRISE)

Not yet reported Sanofi 998 participants Est. completion 2019-04-12 153 sites Stand-alone

Other conditions: Hypercholesterolemia
View official trial listing →
Completed NCT NCT02584504

Efficacy and Safety of Alirocumab in Patients With Hypercholesterolemia Not Adequately Controlled With Non-statin Lipid Modifying Therapy or the Lowest Strength of Statin

Not yet reported Sanofi 163 participants Est. completion 2018-01-09 30 sites Stand-alone

Other conditions: Hypercholesterolemia
View official trial listing →
Completed NCT 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)

Not yet reported Sanofi 517 participants Est. completion 2017-04-03 110 sites Stand-alone

Other conditions: Hypercholesterolaemia
View official trial listing →
Completed NCT 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)

Not yet reported Sanofi 413 participants Est. completion 2017-05-15 119 sites Stand-alone

Other conditions: Dyslipidemia
View official trial listing →
Completed NCT NCT02715726

Evaluation of Alirocumab Versus Ezetimibe on Top of Statin in Asia in High Cardiovascular Risk Patients With Hypercholesterolemia

Not yet reported Sanofi 615 participants Est. completion 2018-08-06 62 sites Stand-alone

Other conditions: Hypercholesterolemia
View official trial listing →
Completed NCT NCT02890992

An 8-Week Dose-Finding Study to Evaluate the Efficacy and Safety of Alirocumab in Children and Adolescents With Heterozygous Familial Hypercholesterolemia

Not yet reported Sanofi 42 participants Est. completion 2019-02-22 16 sites Stand-alone

Other conditions: Hypercholesterolaemia
View official trial listing →
Completed NCT NCT02938949

Alirocumab in Patients With Acute Myocardial Infarction

Not yet reported Virginia Commonwealth University 20 participants Est. completion 2018-08-16 1 site

Cardiovascular disease Other conditions: Hypercholesterolemia
View official trial listing →
Withdrawn NCT NCT02941016

Vascular Inflammation and Cholesterol Lowering Therapy

Not yet reported Copenhagen University Hospital, Rigshospitalet Est. completion 2020-10-01 1 site Stand-alone

Other conditions: Lipid Lowering, Vascular Inflammation
View official trial listing →
Completed NCT NCT02957682

Evaluating Effect of the Study Drug Praluent (Alirocumab) on Neurocognitive Function When Compared to Placebo

Not yet reported Regeneron Pharmaceuticals 2176 participants Est. completion 2020-03-05 188 sites Stand-alone

Other conditions: Hypercholesterolemia
View official trial listing →
Completed NCT NCT02959047

A Trial of Alirocumab and Plaque Regression in Peripheral Arterial Disease

Not yet reported University of Virginia 40 participants Est. completion 2023-05-08 2 sites Stand-alone

Other conditions: Peripheral Arterial Disease
View official trial listing →
Completed NCT NCT02979015

A Study of Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Subcutaneous (SC) Administered Alirocumab in Healthy Chinese Subjects

Not yet reported Sanofi 35 participants Est. completion 2017-11-27 1 site Stand-alone

Other conditions: Hypercholesterolemia
View official trial listing →
Completed NCT NCT02984982

Evaluation of Effect of Alirocumab on Coronary Atheroma Volume in Japanese Patients Hospitalized for Acute Coronary Syndrome With Hypercholesterolemia

Not yet reported Sanofi 206 participants Est. completion 2018-07-27 39 sites Stand-alone

Other conditions: Hypercholesterolemia, Acute Coronary Syndrome
View official trial listing →
Status unknown NCT NCT02992301

Assessment of Atherosclerotic Plaque Characteristics Change by DCE-MRI With Alirocumab

Not yet reported Westside Medical Associates of Los Angeles 35 participants Est. completion 2019-11 1 site Stand-alone

Other conditions: Atherosclerosis, Hyperlipidemia
View official trial listing →
Terminated NCT NCT03004001

Effect of PCSK9-Antibody (Alirocumab) on Dyslipidemia Secondary to Nephrotic Syndrome

Not yet reported Gloria Vega 3 participants Est. completion 2019-12 1 site Stand-alone

Other conditions: Nephrotic Syndrome
View official trial listing →
Completed NCT NCT03014830

Alirocumab and Reverse Cholesterol Transport

Not yet reported Washington University School of Medicine 28 participants Est. completion 2018-07-30 1 site

Other conditions: Atherosclerosis, Coronary Heart Disease
View official trial listing →
Completed NCT NCT03067844

Vascular Effects of Alirocumab in Acute MI-Patients

Not yet reported Insel Gruppe AG, University Hospital Bern 294 participants Est. completion 2021-10-13 9 sites Stand-alone

Other conditions: Coronary Vessel, Coronary Circulation, Atheroma; Myocardial
View official trial listing →
Completed NCT NCT03110432

Prospective German Very High Cardiovascular Risk Patients Dyslipidemia Treatment Indication Registry

GWT-TUD GmbH 1695 participants Est. completion 2024-04-17 3 sites

Other conditions: Dyslipoproteinemias, Hypercholesterolemia, Familial, Familial Hypercholesterolemia - Homozygous, Familial Combined Hyperlipidemia
View official trial listing →
Completed NCT NCT03156621

Study in Participants With Homozygous Familial Hypercholesterolemia (HoFH)

Not yet reported Regeneron Pharmaceuticals 69 participants Est. completion 2020-02-13 28 sites Stand-alone

Other conditions: Homozygous Familial Hypercholesterolemia
View official trial listing →
Completed NCT NCT03175367

Study of Evinacumab (REGN1500) in Participants With Persistent Hypercholesterolemia

Not yet reported Regeneron Pharmaceuticals 272 participants Est. completion 2020-12-14 95 sites Stand-alone

Other conditions: Hypercholesterolemia
View official trial listing →
Completed NCT NCT03207945

Effect of PCSK9 Inhibition on Cardiovascular Risk in Treated HIV Infection (EPIC-HIV Study)

Not yet reported University of California, San Francisco 118 participants Est. completion 2025-09-24 1 site Stand-alone

Cardiovascular disease Other conditions: Dyslipidemias, HIV Infections
View official trial listing →
Completed NCT NCT03273972

INvestigating the Lowest Threshold of Vascular bENefits From LDL Lowering With a PCSK9 InhibiTor in healthY Volunteers

Not yet reported Cambridge University Hospitals NHS Foundation Trust 30 participants Est. completion 2018-10-10 1 site Stand-alone

Cardiovascular disease Other conditions: Atherosclerosis
View official trial listing →
Completed NCT NCT03344692

Effect of Alirocumab on Postprandial Hyperlipemia in Patients With Type 2 Diabetes

Not yet reported Nantes University Hospital 22 participants Est. completion 2022-04-28 1 site Stand-alone

Type 2 diabetes
View official trial listing →
Status unknown NCT NCT03355027

Investigating the Lowest Threshold of Vascular Benefits From LDL Cholesterol Lowering in Patients With Stable CV Disease

Not yet reported Cambridge University Hospitals NHS Foundation Trust 60 participants Est. completion 2023-11-30 1 site Stand-alone

Cardiovascular disease Other conditions: Atherosclerosis
View official trial listing →
Terminated NCT NCT03379558

Praluent® (Alirocumab) Pregnancy Exposure Registry: An OTIS Pregnancy Surveillance Study

Regeneron Pharmaceuticals 37 participants Est. completion 2020-09-04 1 site

Other conditions: Hypercholesterolemia
View official trial listing →
Completed NCT NCT03415178

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

Not yet reported Sanofi 69 participants Est. completion 2018-08-09 13 sites Stand-alone

Other conditions: Hypercholesterolaemia
View official trial listing →
Terminated NCT NCT03507374

PCSK9 Inhibition in Patients With Symptomatic Intracranial Atherosclerosis

Not yet reported University of Utah 20 participants Est. completion 2020-04-17 1 site

Cardiovascular disease Other conditions: Intracranial Atherosclerosis, Intraplaque Hemorrhage
View official trial listing →
Completed NCT NCT03510715

An Efficacy and Safety Study of Alirocumab in Children and Adolescents With Homozygous Familial Hypercholesterolemia

Not yet reported Sanofi 18 participants Est. completion 2020-02-17 10 sites Stand-alone

Other conditions: Hypercholesterolemia
View official trial listing →
Completed NCT NCT03510884

An Efficacy and Safety Study of Alirocumab in Children and Adolescents With Heterozygous Familial Hypercholesterolemia

Not yet reported Sanofi 153 participants Est. completion 2022-08-05 43 sites Stand-alone

Other conditions: Hypercholesterolaemia
View official trial listing →
Status unknown NCT NCT03529253

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

Not yet reported Kobe University 30 participants Est. completion 2020-09-30 1 site Stand-alone

Cardiovascular disease Other conditions: Angina Pectoris
View official trial listing →
Status unknown NCT NCT03533959

To Evaluate the Efficacy of Alirocumab for Neoatherosclerosis by Using OCT, in Comparison With Standard Statin Therapy

Kobe University 31 participants Est. completion 2025-12 1 site

Cardiovascular disease
View official trial listing →
Completed NCT NCT03537742

Cardiac Allograft Vasculopathy Inhibition With Alirocumab

Not yet reported Stanford University 114 participants Est. completion 2025-07-11 1 site Stand-alone

Other conditions: Vasculopathy
View official trial listing →
Terminated NCT NCT03542110

The Alirocumab for Stopping Atherosclerosis Progression in Saphenous Vein Grafts (ASAP-SVG) Pilot Trial

Not yet reported Minneapolis Heart Institute Foundation 46 participants Est. completion 2020-07-31 4 sites

Other conditions: Saphenous Vein Graft Atherosclerosis
View official trial listing →
Status unknown NCT NCT03552432

The Efficacy of Alirocumab for Thin-cap fIbroatheroma in Patients With Coronary Artery Disease Estimated by Optical Coherence Tomography

Not yet reported Kobe University 24 participants Est. completion 2021-09-30 1 site Stand-alone

Cardiovascular disease Other conditions: Thin-cap fIbroatheroma
View official trial listing →
Terminated NCT NCT03559309

Investigating the Effects of Lipid-therapy Intensification With Alirocumab on Endothelial Function, Carotid Arteries, Lipoprotein Particle Subfractions, Inflammation and Post-prandial Lipemia

Not yet reported Medical University of Graz 24 participants Est. completion 2020-02-05 1 site

Cardiovascular disease Other conditions: Atherosclerosis, Hypercholesterolemia, Post Prandial Lipemia
View official trial listing →
Status unknown NCT NCT03634293

Treatment of Severe Infection With Antihyperlipidemia Drug

Not yet reported, Not yet reported Wolfson Medical Center 712 participants Est. completion 2021-02 1 site

Other conditions: Sepsis, Septic Shock
View official trial listing →
Terminated NCT NCT03694197

Long Term Safety Study of PRALUENT

Not yet reported Regeneron Pharmaceuticals 1389 participants Est. completion 2020-04-08 123 sites Stand-alone

Other conditions: Heterozygous Familial Hypercholesterolemia, Non-familial Hypercholesterolemia
View official trial listing →
Completed NCT NCT03718286

Effects of Acute, Rapid Lowering of LDL Cholesterol With Alirocumab in Patients With STEMI Undergoing Primary PCI

Not yet reported Population Health Research Institute 97 participants Est. completion 2021-10-08 1 site Stand-alone

Cardiovascular disease Other conditions: Acute Coronary Syndrome, Hypercholesterolemia, Hyperlipidemias, Dyslipidemias, Physiological Effects of Drugs
View official trial listing →
Withdrawn NCT NCT03750760

Early Alirocumab to Reduce LDL-C in Myocardial Infarction

Not yet reported Imperial College London Est. completion 2021-12 17 sites

Cardiovascular disease Other conditions: Dyslipidemias
View official trial listing →
Completed NCT NCT04189484

Pharmacodynamic Biomarkers to Support Biosimilar Development: PCSK9 Inhibitors

Not yet reported Food and Drug Administration (FDA) 72 participants Est. completion 2021-04-07 1 site Stand-alone

Other conditions: Healthy Subjects, Pharmacokinetics, Pharmacodynamics
View official trial listing →
Status unknown NCT NCT04193306

Efficacy and Safety Of Alirocumab to Prevent Early Cardiac Allograft Vasculopathy in Recent Heart Transplant Recipients

Not yet reported Institute for Clinical and Experimental Medicine 126 participants Est. completion 2025-07 1 site Stand-alone

Other conditions: Cardiac Allograft Vasculopathy
View official trial listing →
Completed NCT NCT04319081

Study to Evaluate Changes in Cognitive Function in Patients Treated With PCSK9 Inhibitors

Jose Seijas Amigo 180 participants Est. completion 2023-01-13 12 sites

Other conditions: Cognitive Function, Hypercholesterolemia, Quality of Life
View official trial listing →
Status unknown NCT NCT04613167

Markers of Cardiovascular Risk in Patients With Premature Coronary Artery Disease and Treatment

Not yet reported University Medical Centre Ljubljana 70 participants Est. completion 2021-10-01 1 site Stand-alone

Other conditions: Acute Coronary Syndrome, Premature Coronary Heart Disease, Lipoproteinemia, Inflammation, Genetic Polymorphisms
View official trial listing →
Active, not recruiting NCT NCT04656028

Genetic Testing and Motivational Counseling for FH

Not yet reported National Medical Research Center for Therapy and Preventive Medicine 180 participants Est. completion 2025-03-30 1 site Stand-alone

Other conditions: Hypercholesterolemia, Familial, Hypercholesterolemia, Familial, 1, Hypercholesterolemia, Familial, 2, Hypercholesterolemia, Familial, 3, Hypercholesterolemia, Familial, 4, Hypercholesterolemia, Familial, 4, Autosomal Recessive, Familial Hypercholesterolemia With Hyperlipemia, Hypercholesterolemia, Autosomal Dominant, Type B, Hypercholesterolemia, Autosomal Dominant, Hypercholesterolemia, Autosomal Dominant, 3, Apolipoprotein B-100, Familial Defective, Genetic Testing, Motivational Interviewing, Therapeutic Adherence, Therapeutic Adherence and Compliance, Treatment Adherence, Medication Adherence, Treatment Adherence and Compliance, Patient Adherence, Compliance, Patient Compliance, Familial Hypercholesterolemia, Familial Hypercholesterolemia - Heterozygous, Adherence, Patient, Adherence, Medication, Adherence
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Completed NCT NCT04790513

Trial to Evaluate Efficacy and Safety of LIB003, Evolocumab and Alirocumab in High-risk CVD Patients

Not yet reported LIB Therapeutics LLC 204 participants Est. completion 2022-12-31 3 sites

Cardiovascular disease Other conditions: Hypercholesterolemia
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Completed NCT NCT04851769

Impact of PCSK9 Inhibitors on Coronary Plaque Composition and Vulnerability Assessed by Optical Coherence Tomography

Not yet reported Beijing Anzhen Hospital 60 participants Est. completion 2021-03-01 1 site Stand-alone

Other conditions: Randomized Controlled Trials
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Active, not recruiting NCT NCT04862260

Cholesterol Disruption in Combination With the Standard of Care in Patients With Advanced Pancreatic Adenocarcinoma

Not yet reported CHU de Quebec-Universite Laval 3 participants Est. completion 2026-12-31 2 sites

Other conditions: Pancreatic Ductal Adenocarcinoma, Pancreatic Cancer, Pancreas Cancer, Metastatic Cancer
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Active, not recruiting NCT NCT05001984

Trial of PCSK9 Inhibition in Patients with Acute Stroke and Symptomatic Intracranial Atherosclerosis

Not yet reported Chang Gung Memorial Hospital 60 participants Est. completion 2025-04-15 1 site

Cardiovascular disease Other conditions: Intracranial Atherosclerosis, ICAS - Intracranial Atherosclerosis
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Status unknown NCT NCT05043740

PCSK9 Inhibitor on ACS Patients With Multivessel Disease and Relatively Low LDL-C Level in Chinese Population

Not yet reported Second Xiangya Hospital of Central South University 1360 participants Est. completion 2023-10-01 Stand-alone

Other conditions: Acute Coronary Syndrome
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Status unknown NCT NCT05081336

Low-density Lipoprotein Cholesterol Reduction With State-of-the-art Therapy in Secondary Prevention and Major Cardiovascular Adverse Events: Republic of Srpska Registry

University Clinical Centre of Republic of Srpska 500 participants Est. completion 2023-03 1 site

Other conditions: Acute Coronary Syndrome, Dyslipidemias
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Completed NCT NCT05129241

Non-interventional Study on the Monthly Administration of 300 mg AliRocumab (PRALUENT®) With the 2 ml SYDNEY Auto-injector

Sanofi 163 participants Est. completion 2023-02-16 1 site

Cardiovascular disease Other conditions: Primary Hypercholesterolaemia and Mixed Dyslipidaemia
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Completed NCT NCT05465278

Alirocumab and Plaque Burden In Familial Hypercholesterolaemia

Not yet reported Fundación Hipercolesterolemia Familiar 104 participants Est. completion 2022-03-30 1 site Stand-alone

Other conditions: Familial Hypercholesterolemia
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Completed NCT NCT05469347

Alirocumab in Patients with Sepsis

Not yet reported Jonathan Sevransky 50 participants Est. completion 2025-02-23 2 sites Stand-alone

Other conditions: Sepsis
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Active, not recruiting NCT NCT05537948

Efficacy and Safety of Pitavastatin and PCSK9 Inhibitors in Liver Transplant Patients

Not yet reported National Medical Research Center for Therapy and Preventive Medicine 59 participants Est. completion 2025-01-31 1 site

Other conditions: Dyslipidemias, Hyperlipidemias, Liver Transplant Disorder, Immunosuppression, Hydroxymethylglutaryl-CoA Reductase Inhibitors, Statins
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Active, not recruiting NCT NCT05553834

PCSK9 Inhibitor and PD-1 Inhibitor in Patients With Metastatic, Refractory To Prior Anti PD-1 Non-small Cell Lung

Not yet reported Duke University 60 participants Est. completion 2026-11-01 2 sites Stand-alone

Other conditions: Non-small Cell Lung Cancer (NSCLC)
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Not yet recruiting NCT NCT05587621

Intensive Lipid-lowering in Patients With STEMI and NSTEMI (Germany on Target)

Not yet reported Jena University Hospital 300 participants Est. completion 2026-12-31 10 sites

Cardiovascular disease Other conditions: LDL-cholesterol
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Status unknown NCT NCT05624658

Effect of Combined Lipid-lowering Therapy on Atherosclerotic Plaque Vulnerability in Patients With ACS

Not yet reported Samara Regional Cardiology Dispensary 200 participants Est. completion 2024-05 1 site

Other conditions: Dyslipidemias
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Status unknown NCT NCT06052020

Extra Alirocumab in Addition to Statin Therapy in Symptomatic IntraCranial Atherosclerotic Stenosis ----a Pilot Study

The First Affiliated Hospital with Nanjing Medical University 50 participants Est. completion 2024-09-30 1 site

Cardiovascular disease Other conditions: Intracranial Atherosclerotic Stenosis
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Status unknown NCT NCT06080256

Extra Alirocumab in Addition to Statin Therapy in Asymptomatic Intracranial Atherosclerotic Stenosis (EAST-aICAS)

Not yet reported The First Affiliated Hospital with Nanjing Medical University 80 participants Est. completion 2024-12-31 1 site Stand-alone

Other conditions: Intracranial Atherosclerosis, Atherosclerotic Plaque, Stenosis
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Not yet recruiting NCT NCT06083961

The Effect of Early Administration of PCSK9 Inhibitor to Acute Ischemic Stroke Patients Associated With Atherosclerosis on the Stroke Prognosis and Lipid Profile

Not yet reported Sun U. Kwon 200 participants Est. completion 2026-11-15 1 site Stand-alone

Cardiovascular disease Other conditions: PCSK9 Inhibitor
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Status unknown NCT NCT06381947

Efficacy and Safety of Bempedoic Acid in Association With Anti-PCSK9 and Ezetimibe in Statin-intolerant Patients

Not yet reported University of Salerno 130 participants Est. completion 2025-06-30

Cardiovascular disease Other conditions: Dyslipidemias, Statin Adverse Reaction, Lipid Metabolism Disorders
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Suspended NCT NCT06385262

TOP 2301: Neoadjuvant Chemo for NSCLC

Not yet reported Duke University 63 participants Est. completion 2029-10-30 1 site Stand-alone

Other conditions: Non Small Cell Lung Cancer
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Status unknown NCT NCT06567418

Retrospective Analysis of the Effect of In-hospital Initiation of PCSK9i on Clinical Outcomes in Chinese ACS Patients

Yun Dai Chen 10000 participants Est. completion 2025-01-31 1 site

Other conditions: Acute Coronary Syndrome
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Not yet recruiting NCT NCT06791031

PCSK9 inhibitoRs for Early Passivation of coRonary athEroSclerotic plaqueS in Acute Coronary Syndromes (REPRESS)

Not yet reported West China Hospital 212 participants Est. completion 2028-06 Stand-alone

Cardiovascular disease
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Completed NCT NCT07023445

Patterns of Inclisiran Use in the Real World: An Analysis of US Databases

Novartis Pharmaceuticals 37688 participants Est. completion 2024-06-28 1 site

Cardiovascular disease Other conditions: Familial Hypercholesterolemia
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Not yet recruiting NCT NCT07174375

PCSK9 Inhibitors in Acute Ischemic Stroke Patients Undergoing Endovascular Therapy

Not yet reported, Not yet reported Nanfang Hospital, Southern Medical University 478 participants Est. completion 2027-12-15 12 sites Stand-alone

Cardiovascular disease
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Active, not recruiting NCT NCT07477704

A Study to See How Safe and Effective Alirocumab is When Given Weekly to Adult Participants Who Have Hypercholesterolemia

Not yet reported Regeneron Pharmaceuticals 438 participants Est. completion 2027-02-23 34 sites Stand-alone

Other conditions: Hypercholesterolemia
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Not yet recruiting NCT NCT07586540

Alirocumab for Stabilisation of Symptomatic Vulnerable Carotid Plaque

Not yet reported Middle East North Africa Stroke and Interventional Neurotherapies Organization 280 participants Est. completion 2030-09 14 sites Stand-alone

Other conditions: Carotid Stenosis
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Completed NCT NCT07615166

Low-Density Lipoprotein Cholesterol Reduction With Alirocumab 150 mg Versus Inclisiran in Individuals Initiating Therapy in Routine Clinical Practice

Sanofi 996 participants Est. completion 2026-06-30 1 site

Cardiovascular disease
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Completed NCT NCT07615179

Alirocumab and Ischemic Risk in Atherosclerotic Cardiovascular Disease (ASCVD)

Sanofi 4545 participants Est. completion 2026-05-30 1 site

Cardiovascular disease
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Completed NCT NCT07734753

Impact of Alirocumab on Cardiovascular Events in Participants With Atherosclerotic Cardiovascular Disease But Without Prior Ischemic Events

Sanofi 4006 participants Est. completion 2026-08-15 1 site

Cardiovascular disease
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Not yet recruiting NCT NCT07819643

RESCUE: PCSK9 Inhibitors for Carotid Vulnerable Plaque Remodeling

Not yet reported Keqiang Zhao 120 participants Est. completion 2029-12-01 Stand-alone

Other conditions: Atherosclerosis Cerebral, Carotid Plaque, Vulnerable Plaque, Carotid Stenosis
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Efficacy history

Not yet reported.

Safety

Not yet reported.

Sources

ClinicalTrials.gov — NCT07477704

Also known as: Alirocumab, Praluent, REGN727, SAR236553

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