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Showing 1–24 of 36 matching trials from the live ClinicalTrials.gov search.
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Filters: Intervention: Alirocumab SAR236553 Clear all
Completed Phase 3 Interventional Results available

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

NCT01663402
View directory record Official record
Conditions
Atherosclerotic Cardiovascular Disease
Interventions
Alirocumab, Placebo, LMT
Drug
Lead sponsor
Sanofi
Industry
Eligibility
40 Years and older
Enrollment
18,924 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2012 – 2018
U.S. locations
273
States / cities
Birmingham, Alabama • Huntsville, Alabama • Mobile, Alabama + 218 more
Source: ClinicalTrials.gov public record
Updated Mar 17, 2019 · Synced Sep 28, 2026, 7:32 AM EDT
Completed Phase 2 Interventional Results available

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)

NCT01576484
View directory record Official record
Conditions
Hypercholesterolemia, Heterozygous Familial Hypercholesterolemia
Interventions
Alirocumab, Placebo Matched to Alirocumab
Drug
Lead sponsor
Regeneron Pharmaceuticals
Industry
Eligibility
18 Years to 75 Years
Enrollment
58 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2012 – 2016
U.S. locations
11
States / cities
Mission Viejo, California • Newport Beach, California • Thousand Oaks, California + 8 more
Source: ClinicalTrials.gov public record
Updated Aug 4, 2020 · Synced Sep 28, 2026, 7:32 AM EDT
Completed Phase 1 Interventional

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

NCT01161082
View directory record Official record
Conditions
Hypercholesterolemia
Interventions
REGN727(SAR236553)
Drug
Lead sponsor
Regeneron Pharmaceuticals
Industry
Eligibility
18 Years to 65 Years
Enrollment
72 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2010 – 2011
U.S. locations
2
States / cities
Cincinnati, Ohio • Knoxville, Tennessee
Source: ClinicalTrials.gov public record
Updated Jan 26, 2015 · Synced Sep 28, 2026, 7:32 AM EDT
Completed Phase 2 Interventional Results available

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

NCT01604824
View directory record Official record
Conditions
Hypercholesterolemia
Interventions
Alirocumab, Placebo
Drug
Lead sponsor
Regeneron Pharmaceuticals
Industry
Eligibility
18 Years to 70 Years
Enrollment
23 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2012 – 2017
U.S. locations
1
States / cities
Salt Lake City, Utah
Source: ClinicalTrials.gov public record
Updated Jun 16, 2020 · Synced Sep 28, 2026, 7:32 AM EDT
Terminated No phase listed Observational Accepts healthy volunteers

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

NCT03379558
View directory record Official record
Conditions
Hypercholesterolemia
Interventions
ALIROCUMAB SAR236553 (REGN727)
Drug
Lead sponsor
Regeneron Pharmaceuticals
Industry
Eligibility
Female only
Enrollment
37 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2017 – 2020
U.S. locations
1
States / cities
San Diego, California
Source: ClinicalTrials.gov public record
Updated Nov 22, 2020 · Synced Sep 28, 2026, 7:32 AM EDT
Completed Phase 1 Interventional Accepts healthy volunteers

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

NCT01959971
View directory record Official record
Conditions
Hypercholesterolemia
Interventions
alirocumab, Placebo
Drug
Lead sponsor
Sanofi
Industry
Eligibility
18 Years to 65 Years
Enrollment
20 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2013 – 2015
U.S. locations
1
States / cities
New York, New York
Source: ClinicalTrials.gov public record
Updated May 1, 2017 · Synced Sep 28, 2026, 7:32 AM EDT
Completed Phase 2 Interventional Results available

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

NCT02890992
View directory record Official record
Conditions
Hypercholesterolaemia
Interventions
alirocumab SAR236553 (REGN727), statins, ezetimibe, cholestyramine, fenofibrate, omega-3 fatty acids, nicotinic acid
Drug
Lead sponsor
Sanofi
Industry
Eligibility
8 Years to 17 Years
Enrollment
42 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2016 – 2019
U.S. locations
3
States / cities
St Louis, Missouri • Charlotte, North Carolina • Cincinnati, Ohio
Source: ClinicalTrials.gov public record
Updated Sep 5, 2019 · Synced Sep 28, 2026, 7:32 AM EDT
Completed Phase 1 Interventional Accepts healthy volunteers

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

NCT01448304
View directory record Official record
Conditions
Hypercholesterolemia
Interventions
alirocumab SAR236553 (REGN727)
Drug
Lead sponsor
Sanofi
Industry
Eligibility
18 Years to 65 Years
Enrollment
24 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2011
U.S. locations
1
States / cities
Bridgewater, New Jersey
Source: ClinicalTrials.gov public record
Updated Jun 27, 2013 · Synced Sep 28, 2026, 7:32 AM EDT
Completed Phase 3 Interventional Results available

Study in Participants With Homozygous Familial Hypercholesterolemia (HoFH)

NCT03156621
View directory record Official record
Conditions
Homozygous Familial Hypercholesterolemia
Interventions
Alirocumab, Placebo
Drug
Lead sponsor
Regeneron Pharmaceuticals
Industry
Eligibility
18 Years and older
Enrollment
69 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2017 – 2020
U.S. locations
4
States / cities
Boca Raton, Florida • New York, New York • Cincinnati, Ohio + 1 more
Source: ClinicalTrials.gov public record
Updated Jun 28, 2021 · Synced Sep 28, 2026, 7:32 AM EDT
Completed Phase 3 Interventional Results available

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

NCT01644474
View directory record Official record
Conditions
Hypercholesterolemia
Interventions
Alirocumab, Ezetimibe, Placebo (for Alirocumab), Placebo (for Ezetimibe)
Drug
Lead sponsor
Sanofi
Industry
Eligibility
18 Years and older
Enrollment
103 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2012 – 2013
U.S. locations
3
States / cities
Overland Park, Kansas • Cincinnati, Ohio • Richmond, Virginia
Source: ClinicalTrials.gov public record
Updated Nov 5, 2015 · Synced Sep 28, 2026, 7:32 AM EDT
Completed Phase 1 Interventional Accepts healthy volunteers

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

NCT01026597
View directory record Official record
Conditions
Healthy
Interventions
REGN727, Placebo
Drug
Lead sponsor
Regeneron Pharmaceuticals
Industry
Eligibility
18 Years to 65 Years
Enrollment
40 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2009 – 2010
U.S. locations
1
States / cities
Overland Park, Kansas
Source: ClinicalTrials.gov public record
Updated Jan 26, 2015 · Synced Sep 28, 2026, 7:32 AM EDT
Completed Phase 3 Interventional Results available

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)

NCT01644175
View directory record Official record
Conditions
Hypercholesterolemia
Interventions
Placebo (for alirocumab), Alirocumab, Lipid-Modifying Therapy (LMT)
Drug
Lead sponsor
Sanofi
Industry
Eligibility
18 Years and older
Enrollment
316 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2012 – 2014
U.S. locations
76
States / cities
Birmingham, Alabama • Mobile, Alabama • Montgomery, Alabama + 68 more
Source: ClinicalTrials.gov public record
Updated Nov 5, 2015 · Synced Sep 28, 2026, 7:32 AM EDT
Completed Phase 1 Interventional Accepts healthy volunteers

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

NCT01443650
View directory record Official record
Conditions
Hypercholesterolemia
Interventions
alirocumab SAR236553 (REGN727)
Drug
Lead sponsor
Sanofi
Industry
Eligibility
18 Years to 65 Years
Enrollment
36 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2011
U.S. locations
1
States / cities
Bridgewater, New Jersey
Source: ClinicalTrials.gov public record
Updated Jun 27, 2013 · Synced Sep 28, 2026, 7:32 AM EDT
Completed Phase 4 Interventional Results available

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)

NCT02642159
View directory record Official record
Conditions
Dyslipidemia
Interventions
Alirocumab, Statins, Ezetimibe, Fenofibrate, Nicotinic acid, Omega-3 fatty acids, Antihyperglycemic Drug
Drug
Lead sponsor
Sanofi
Industry
Eligibility
18 Years and older
Enrollment
413 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2016 – 2017
U.S. locations
57
States / cities
Little Rock, Arkansas • Fresno, California • Huntington Beach, California + 51 more
Source: ClinicalTrials.gov public record
Updated Apr 30, 2018 · Synced Sep 28, 2026, 7:32 AM EDT
Terminated Phase 4 Interventional Results available

Long Term Safety Study of PRALUENT

NCT03694197
View directory record Official record
Conditions
Heterozygous Familial Hypercholesterolemia, Non-familial Hypercholesterolemia
Interventions
Praluent
Drug
Lead sponsor
Regeneron Pharmaceuticals
Industry
Eligibility
40 Years to 85 Years
Enrollment
1,389 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2018 – 2020
U.S. locations
57
States / cities
Auburn, Alabama • Mobile, Alabama • Beverly Hills, California + 50 more
Source: ClinicalTrials.gov public record
Updated Jun 14, 2021 · Synced Sep 28, 2026, 7:32 AM EDT
Completed Phase 3 Interventional Results available

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)

NCT01507831
View directory record Official record
Conditions
Hypercholesterolemia
Interventions
Placebo (for alirocumab), Alirocumab, Lipid-Modifying Therapy (LMT)
Drug
Lead sponsor
Sanofi
Industry
Eligibility
18 Years and older
Enrollment
2,341 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2012 – 2014
U.S. locations
115
States / cities
Huntsville, Alabama • Gilbert, Arizona • Sierra Vista, Arizona + 90 more
Source: ClinicalTrials.gov public record
Updated Dec 21, 2015 · Synced Sep 28, 2026, 7:32 AM EDT
Completed Phase 3 Interventional Results available

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

NCT02023879
View directory record Official record
Conditions
Hypercholesterolemia
Interventions
Alirocumab, Placebo (for Alirocumab), Non-statin LMT, Diet Alone
Drug · Other
Lead sponsor
Sanofi
Industry
Eligibility
18 Years and older
Enrollment
233 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2013 – 2017
U.S. locations
8
States / cities
Beverly Hills, California • Atlantis, Florida • Jacksonville, Florida + 5 more
Source: ClinicalTrials.gov public record
Updated Jul 26, 2018 · Synced Sep 28, 2026, 7:32 AM EDT
Completed Phase 3 Interventional Results available

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

NCT03415178
View directory record Official record
Conditions
Hypercholesterolaemia
Interventions
Alirocumab SAR236553, Current auto-injector device (AI), New auto-injector device (SYDNEY), Atorvastatin, Rosuvastatin
Drug · Device
Lead sponsor
Sanofi
Industry
Eligibility
18 Years and older
Enrollment
69 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2018
U.S. locations
13
States / cities
Los Angeles, California • Jacksonville, Florida • Ponte Vedra, Florida + 8 more
Source: ClinicalTrials.gov public record
Updated Sep 8, 2019 · Synced Sep 28, 2026, 7:32 AM EDT
Completed Phase 3 Interventional Results available

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

NCT01617655
View directory record Official record
Conditions
Hypercholesterolaemia
Interventions
Alirocumab, Placebo (for alirocumab), Lipid Modifying Therapy (LMT)
Drug
Lead sponsor
Sanofi
Industry
Eligibility
18 Years and older
Enrollment
107 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2012 – 2015
U.S. locations
14
States / cities
Bell Gardens, California • Newport Beach, California • Northridge, California + 8 more
Source: ClinicalTrials.gov public record
Updated Oct 3, 2016 · Synced Sep 28, 2026, 7:32 AM EDT
Completed Phase 3 Interventional Results available

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)

NCT01709513
View directory record Official record
Conditions
Hypercholesterolemia
Interventions
Atorvastatin, Ezetimibe, Alirocumab, Placebo
Drug
Lead sponsor
Regeneron Pharmaceuticals
Industry
Eligibility
18 Years and older
Enrollment
314 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2012 – 2017
U.S. locations
41
States / cities
Anaheim, California • Beverly Hills, California • Mission Viejo, California + 38 more
Source: ClinicalTrials.gov public record
Updated Jun 22, 2020 · Synced Sep 28, 2026, 7:32 AM EDT
Completed Phase 2 Interventional Results available

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

NCT01288443
View directory record Official record
Conditions
Hypercholesterolemia
Interventions
Alirocumab, Placebo (for alirocumab), Atorvastatin
Drug
Lead sponsor
Sanofi
Industry
Eligibility
18 Years to 75 Years
Enrollment
183 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2011
U.S. locations
38
States / cities
Tempe, Arizona • Los Angeles, California • Mission Viejo, California + 33 more
Source: ClinicalTrials.gov public record
Updated Sep 23, 2015 · Synced Sep 28, 2026, 7:32 AM EDT
Completed Phase 3 Interventional Results available

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

NCT03510884
View directory record Official record
Conditions
Hypercholesterolaemia
Interventions
Alirocumab SAR236553 (REGN727), Rosuvastatin, Atorvastatin, Simvastatin, Pravastatin, Lovastatin, Fluvastatin, Ezetimibe, Cholestyramine, Nicotinic acid, Fenofibrate, Omega-3 fatty acids, Placebo
Drug
Lead sponsor
Sanofi
Industry
Eligibility
8 Years to 17 Years
Enrollment
153 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2018 – 2022
U.S. locations
5
States / cities
Boca Raton, Florida • St Louis, Missouri • Charlotte, North Carolina + 2 more
Source: ClinicalTrials.gov public record
Updated May 5, 2023 · Synced Sep 28, 2026, 7:32 AM EDT
Completed Phase 3 Interventional Results available

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

NCT02326220
View directory record Official record
Conditions
Heterozygous Familial Hypercholesterolemia
Interventions
Placebo, Alirocumab
Drug
Lead sponsor
Regeneron Pharmaceuticals
Industry
Eligibility
18 Years and older
Enrollment
62 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2015 – 2016
U.S. locations
7
States / cities
Aurora, Colorado • Hartford, Connecticut • Kansas City, Kansas + 4 more
Source: ClinicalTrials.gov public record
Updated Apr 30, 2020 · Synced Sep 28, 2026, 7:32 AM EDT
Completed Phase 3 Interventional Results available

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

NCT01644188
View directory record Official record
Conditions
Hypercholesterolemia
Interventions
Alirocumab, Placebo (for alirocumab), Ezetimibe, Placebo (for ezetimibe), Lipid Modifying Therapy (LMT)
Drug
Lead sponsor
Sanofi
Industry
Eligibility
18 Years and older
Enrollment
720 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2012 – 2015
U.S. locations
58
States / cities
Birmingham, Alabama • Phoenix, Arizona • Tucson, Arizona + 51 more
Source: ClinicalTrials.gov public record
Updated Aug 3, 2016 · Synced Sep 28, 2026, 7:32 AM EDT