Alirocumab

Generic Name: Alirocumab

Brand Names: Praluent

Drug Type: Biotech

CAS Number: 1245916-14-6

Unique Ingredient Identifier: PP0SHH6V16

Background: Alirocumab is a biopharmaceutical that obtained FDA approval in July 2015 as a second line treatment for high cholesterol in adults whose LDL-cholesterol (LDL-C) is not controlled by the combination of diet and statin treatment. It is a human monoclonal antibody part of the family of the PCSK9 inhibitors which are a novel class of anticholesterol therapeutics. From this family, it was the first agent to receive FDA approval. The FDA approval was contingent on the completion of further clinical trials to better determine efficacy and safety. PCSK9 inhibition facilitates more LDL-C clearance from the blood.

Indication: Alirocumab is an antibody eliciting proprotein convertase subtilisin kexin type 9 (PCSK9) inhibitor activity that is indicated for:

(i) use in reducing the risk of myocardial infarction, stroke, and unstable angina requiring hospitalization in adults with established cardiovascular disease , and/or

(ii) use as an adjunct to diet or use alone or in combination with other lipid-lowering therapies (statins, ezetimibe, for example) for the treatment of adults with primary hyperlipidemia (including heterozygous familial hypercholesterolemia) to reduce low-density lipoprotein cholesterol (LDL-C) levels in the body .

Associated Conditions: Heterozygous Familial Hypercholesterolemia (HeFH), Homozygous Familial Hypercholesterolaemia (HoFH), Myocardial Infarction, Stroke, Unstable Angina Pectoris, Primary Hyperlipidemia

Clinical Trials

Alirocumab in Patients With Acute Myocardial Infarction

Phase 4

Completed

Conditions: Myocardial Infarction
Hypercholesterolemia

Interventions: Drug: alirocumab
Drug: placebo

First Posted Date: 2016-10-19

Last Posted Date: 2019-09-06

Lead Sponsor: Virginia Commonwealth University

Target Recruit Count: 20

Registration Number: NCT02938949

Locations: 🇺🇸
Virginia Commonwealth University, Richmond, Virginia, United States

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

Phase 2

Completed

Conditions: Hypercholesterolaemia

Interventions: Drug: alirocumab SAR236553 (REGN727)
Drug: statins
Drug: ezetimibe
Drug: cholestyramine
Drug: fenofibrate
Drug: omega-3 fatty acids
Drug: nicotinic acid

First Posted Date: 2016-09-07

Last Posted Date: 2019-09-06

Lead Sponsor: Sanofi

Target Recruit Count: 42

Registration Number: NCT02890992

Locations: 🇨🇿
Investigational Site Number 2030002, Zlin, Czechia
🇺🇸
Investigational Site Number 8400005, Charlotte, North Carolina, United States
🇺🇸
Investigational Site Number 8400001, Cincinnati, Ohio, United States

and more 13 locations

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

Phase 3

Completed

Conditions: Hypercholesterolemia

Interventions: Drug: Placebo for alirocumab
Drug: Alirocumab
Drug: placebo for ezetimibe
Drug: ezetimibe
Drug: atorvastatin
Drug: rosuvastatin
Drug: simvastatin

First Posted Date: 2016-03-22

Last Posted Date: 2019-09-30

Lead Sponsor: Sanofi

Target Recruit Count: 615

Registration Number: NCT02715726

Locations: 🇨🇳
Investigational Site Number 1560018, Beijing, China
🇨🇳
Investigational Site Number 1560008, Hangzhou, China
🇨🇳
Investigational Site Number 1560009, Shenyang, China

and more 59 locations

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)

Phase 4

Completed

Conditions: Dyslipidemia

Interventions: Drug: Alirocumab
Drug: Statins
Drug: Ezetimibe
Drug: Antihyperglycemic Drug
Drug: Fenofibrate
Drug: Nicotinic acid
Drug: Omega-3 fatty acids

First Posted Date: 2015-12-30

Last Posted Date: 2018-05-01

Lead Sponsor: Sanofi

Target Recruit Count: 413

Registration Number: NCT02642159

Locations: 🇺🇸
Investigational Site Number 840-156, Tustin, California, United States
🇫🇮
Investigational Site Number 246101, Oulu, Finland
🇺🇸
Investigational Site Number 840-118, Los Angeles, California, United States

and more 116 locations

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)

Phase 3

Completed

Conditions: Hypercholesterolaemia

Interventions: Drug: Placebo
Drug: Alirocumab
Drug: Lipid-Modifying Therapy (LMT)
Drug: Antihyperglycemic Drug

First Posted Date: 2015-10-23

Last Posted Date: 2018-05-17

Lead Sponsor: Sanofi

Target Recruit Count: 517

Registration Number: NCT02585778

Locations: 🇺🇸
Investigational Site Number 840020, Encino, California, United States
🇺🇸
Investigational Site Number 840027, Loveland, Colorado, United States
🇺🇸
Investigational Site Number 840029, Oakland, California, United States

and more 107 locations

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

Phase 3

Completed

Conditions: Hypercholesterolemia

Interventions: Drug: Placebo
Drug: Alirocumab
Drug: Non-statin Lipid-Modifying Therapy
Drug: Atorvastatin
Other: Diet Alone

First Posted Date: 2015-10-22

Last Posted Date: 2019-01-23

Lead Sponsor: Sanofi

Target Recruit Count: 163

Registration Number: NCT02584504

Locations: 🇯🇵
Investigational Site Number 392004, Kawanishi-Shi, Japan
🇯🇵
Investigational Site Number 392016, Shinagawa-Ku, Japan
🇯🇵
Investigational Site Number 392029, Chuo-Ku, Japan

and more 27 locations

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

Phase 3

Completed

Conditions: Hypercholesterolemia

Interventions: Drug: ALIROCUMAB SAR236553 (REGN727)
Drug: placebo (for injection training only)
Drug: ezetimibe
Drug: atorvastatin
Drug: rosuvastatin
Drug: simvastatin

First Posted Date: 2015-06-19

Last Posted Date: 2022-03-28

Lead Sponsor: Sanofi

Target Recruit Count: 998

Registration Number: NCT02476006

Locations: 🇦🇹
Investigational Site Number 040001, Graz, Austria
🇦🇹
Investigational Site Number 040002, Wien, Austria
🇦🇹
Investigational Site Number 040010, Wien, Austria

and more 150 locations

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

Phase 3

Completed

Conditions: Heterozygous Familial Hypercholesterolemia

Interventions: Drug: Placebo
Drug: Alirocumab

First Posted Date: 2014-12-29

Last Posted Date: 2020-05-01

Lead Sponsor: Regeneron Pharmaceuticals

Target Recruit Count: 62

Registration Number: NCT02326220

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

Phase 3

Completed

Conditions: Hypercholesterolemia

Interventions: Drug: Placebo (for Alirocumab)
Drug: Alirocumab
Drug: Lipid-Modifying Therapy (LMT)

First Posted Date: 2014-11-13

Last Posted Date: 2017-06-26

Lead Sponsor: Sanofi

Target Recruit Count: 199

Registration Number: NCT02289963

Locations: 🇰🇷
Investigational Site Number 410017, Busan, Korea, Republic of
🇰🇷
Investigational Site Number 410018, Jeonju-Si, Korea, Republic of
🇰🇷
Investigational Site Number 410009, Anyang-Si, Korea, Republic of

and more 24 locations

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)

Phase 3

Completed

Conditions: Hypercholesterolemia

Interventions: Drug: Placebo (for alirocumab)
Drug: Alirocumab
Drug: Lipid-Modifying Therapy (LMT)

First Posted Date: 2014-04-08

Last Posted Date: 2016-10-04

Lead Sponsor: Sanofi

Target Recruit Count: 216

Registration Number: NCT02107898

Locations: 🇯🇵
Investigational Site Number 392016, Adachi-Ku, Japan
🇯🇵
Investigational Site Number 392012, Chuo-Ku, Japan
🇯🇵
Investigational Site Number 392024, Aki-Gun, Japan

and more 29 locations

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