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Showing 1–24 of 38 matching trials from the live ClinicalTrials.gov search.
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Filters: Intervention: Alirocumab placebo Clear all
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 23, 2026, 8:16 PM EDT
Completed Phase 2 Interventional Results available

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

NCT01288469
View directory record Official record
Conditions
Hypercholesterolemia
Interventions
Alirocumab, Placebo (for alirocumab), Atorvastatin, Placebo (for atorvastatin)
Drug
Lead sponsor
Sanofi
Industry
Eligibility
18 Years to 75 Years
Enrollment
92 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2011
U.S. locations
20
States / cities
Mesa, Arizona • Tucson, Arizona • Los Angeles, California + 14 more
Source: ClinicalTrials.gov public record
Updated Sep 23, 2015 · Synced Sep 23, 2026, 8:16 PM EDT
Completed Phase 1 Interventional Accepts healthy volunteers Results available

Pharmacodynamic Biomarkers to Support Biosimilar Development: PCSK9 Inhibitors

NCT04189484
View directory record Official record
Conditions
Healthy Subjects, Pharmacokinetics, Pharmacodynamics
Interventions
Evolocumab, Alirocumab, Placebo
Biological
Lead sponsor
Food and Drug Administration (FDA)
Federal
Eligibility
18 Years to 55 Years
Enrollment
72 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2020 – 2021
U.S. locations
1
States / cities
West Bend, Wisconsin
Source: ClinicalTrials.gov public record
Updated Apr 21, 2024 · Synced Sep 23, 2026, 8:16 PM 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 23, 2026, 8:16 PM EDT
Completed Phase 3 Interventional Results available

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

NCT01730040
View directory record Official record
Conditions
Hypercholesterolemia
Interventions
Alirocumab, Atorvastatin, Ezetimibe, Rosuvastatin, Placebo
Drug
Lead sponsor
Regeneron Pharmaceuticals
Industry
Eligibility
18 Years and older
Enrollment
355 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2012 – 2014
U.S. locations
56
States / cities
Mobile, Alabama • Chandler, Arizona • Tucson, Arizona + 53 more
Source: ClinicalTrials.gov public record
Updated Aug 30, 2015 · Synced Sep 23, 2026, 8:16 PM 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 23, 2026, 8:16 PM 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 23, 2026, 8:16 PM 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 23, 2026, 8:16 PM 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 Not Adequately Controlled With Their Lipid-Modifying Therapy

NCT01623115
View directory record Official record
Conditions
Hypercholesterolemia
Interventions
Alirocumab, Placebo (for alirocumab), Lipid Modifying Therapy (LMT)
Drug
Lead sponsor
Sanofi
Industry
Eligibility
18 Years and older
Enrollment
486 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2012 – 2014
U.S. locations
26
States / cities
Bell Gardens, California • Long Beach, California • Los Angeles, California + 21 more
Source: ClinicalTrials.gov public record
Updated Feb 7, 2016 · Synced Sep 23, 2026, 8:16 PM 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 23, 2026, 8:16 PM EDT
Completed Phase 4 Interventional Results available

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

NCT02957682
View directory record Official record
Conditions
Hypercholesterolemia
Interventions
Praluent (Alirocumab), Placebo
Drug
Lead sponsor
Regeneron Pharmaceuticals
Industry
Eligibility
40 Years to 85 Years
Enrollment
2,176 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2016 – 2020
U.S. locations
73
States / cities
Auburn, Alabama • Birmingham, Alabama • Mobile, Alabama + 63 more
Source: ClinicalTrials.gov public record
Updated May 6, 2021 · Synced Sep 23, 2026, 8:16 PM EDT
Completed Phase 1 Interventional Accepts healthy volunteers

Alirocumab and Reverse Cholesterol Transport

NCT03014830
View directory record Official record
Conditions
Atherosclerosis, Coronary Heart Disease
Interventions
Alirocumab, Placebos
Drug
Lead sponsor
Washington University School of Medicine
Other
Eligibility
18 Years to 80 Years
Enrollment
28 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2017 – 2018
U.S. locations
1
States / cities
St Louis, Missouri
Source: ClinicalTrials.gov public record
Updated Nov 6, 2018 · Synced Sep 23, 2026, 8:16 PM 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 23, 2026, 8:16 PM EDT
Completed Phase 3 Interventional Results available

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)

NCT01926782
View directory record Official record
Conditions
Hypercholesterolemia
Interventions
Placebo (for alirocumab), Alirocumab, Statin
Drug
Lead sponsor
Regeneron Pharmaceuticals
Industry
Eligibility
18 Years and older
Enrollment
803 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2013 – 2015
U.S. locations
49
States / cities
Chandler, Arizona • Goodyear, Arizona • Carmichael, California + 46 more
Source: ClinicalTrials.gov public record
Updated Mar 20, 2017 · Synced Sep 23, 2026, 8:16 PM EDT
Terminated Phase 4 Interventional

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

NCT03542110
View directory record Official record
Conditions
Saphenous Vein Graft Atherosclerosis
Interventions
Alirocumab 150 MG/ML subcutaneous injection, Matching Placebo subcutaneous injection
Drug
Lead sponsor
Minneapolis Heart Institute Foundation
Other
Eligibility
18 Years and older
Enrollment
46 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2018 – 2020
U.S. locations
4
States / cities
San Francisco, California • Atlanta, Georgia • Minneapolis, Minnesota + 1 more
Source: ClinicalTrials.gov public record
Updated Sep 15, 2021 · Synced Sep 23, 2026, 8:16 PM 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 23, 2026, 8:16 PM EDT
Completed Phase 3 Interventional

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

NCT03207945
View directory record Official record
Conditions
Dyslipidemias, Cardiovascular Diseases, HIV Infections
Interventions
Alirocumab, Placebo
Drug · Other
Lead sponsor
University of California, San Francisco
Other
Eligibility
40 Years and older
Enrollment
118 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2018 – 2025
U.S. locations
1
States / cities
San Francisco, California
Source: ClinicalTrials.gov public record
Updated Aug 23, 2026 · Synced Sep 23, 2026, 8:16 PM 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 23, 2026, 8:16 PM 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 23, 2026, 8:16 PM EDT
Recruiting Phase 1 Interventional Accepts healthy volunteers

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

NCT04781322
View directory record Official record
Conditions
Alcohol Associated Liver Disease, Heavy Drinking Behavior
Interventions
Alirocumab, Placebo
Drug · Other
Lead sponsor
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
NIH
Eligibility
21 Years to 65 Years
Enrollment
100 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2021 – 2026
U.S. locations
1
States / cities
Bethesda, Maryland
Source: ClinicalTrials.gov public record
Updated Jul 19, 2026 · Synced Sep 23, 2026, 8:16 PM EDT
Completed Phase 2 Interventional Results available

Study of Evinacumab (REGN1500) in Participants With Persistent Hypercholesterolemia

NCT03175367
View directory record Official record
Conditions
Hypercholesterolemia
Interventions
Evinacumab, Matching placebo, Background Lipid Modifying Therapy (LMT)
Drug · Other
Lead sponsor
Regeneron Pharmaceuticals
Industry
Eligibility
18 Years to 80 Years
Enrollment
272 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2017 – 2020
U.S. locations
23
States / cities
Los Angeles, California • Newport Beach, California • Boca Raton, Florida + 19 more
Source: ClinicalTrials.gov public record
Updated Feb 9, 2023 · Synced Sep 23, 2026, 8:16 PM EDT
Completed Phase 1 Interventional

Alirocumab in Patients with Sepsis

NCT05469347
View directory record Official record
Conditions
Sepsis
Interventions
Alirocumab, Placebo
Drug
Lead sponsor
Jonathan Sevransky
Other
Eligibility
18 Years to 90 Years
Enrollment
50 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2023 – 2025
U.S. locations
2
States / cities
Atlanta, Georgia
Source: ClinicalTrials.gov public record
Updated Mar 23, 2025 · Synced Sep 23, 2026, 8:16 PM 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 23, 2026, 8:16 PM 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 23, 2026, 8:16 PM EDT