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ClinicalTrials.gov public records Last synced Oct 17, 2026, 8:24 AM EDT

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Showing 1–24 of 28 matching trials from the live ClinicalTrials.gov search.
Filters: Intervention: Placebo (for alirocumab) Clear all
Completed Phase 2 Interventional Results available

Cardiac Allograft Vasculopathy Inhibition With Alirocumab

NCT03537742
View directory record Official record
Conditions
Vasculopathy
Interventions
alirocumab, placebo
Biological
Lead sponsor
Stanford University
Other
Eligibility
18 Years and older
Enrollment
114 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2019 – 2025
U.S. locations
1
States / cities
Stanford, California
Source: ClinicalTrials.gov public record
Updated Aug 18, 2026 · Synced Oct 17, 2026, 8:24 AM EDT
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 18, 2019 · Synced Oct 17, 2026, 8:24 AM 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 7, 2018 · Synced Oct 17, 2026, 8:24 AM 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 31, 2015 · Synced Oct 17, 2026, 8:24 AM EDT
Terminated Early Phase 1 Interventional

PCSK9 Inhibition in Patients With Symptomatic Intracranial Atherosclerosis

NCT03507374
View directory record Official record
Conditions
Stroke, Intracranial Atherosclerosis, Intraplaque Hemorrhage
Interventions
Alirocumab, Placebo
Drug
Lead sponsor
University of Utah
Other
Eligibility
18 Years and older
Enrollment
20 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2018 – 2020
U.S. locations
1
States / cities
Salt Lake City, Utah
Source: ClinicalTrials.gov public record
Updated Apr 21, 2020 · Synced Oct 17, 2026, 8:24 AM EDT
Completed Phase 2 Interventional Results available

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

NCT01266876
View directory record Official record
Conditions
Hypercholesterolemia
Interventions
Alirocumab, Placebo
Drug
Lead sponsor
Regeneron Pharmaceuticals
Industry
Eligibility
18 Years to 75 Years
Enrollment
77 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2011
U.S. locations
17
States / cities
Huntsville, Alabama • Mission Viejo, California • Newport Beach, California + 14 more
Source: ClinicalTrials.gov public record
Updated Sep 22, 2015 · Synced Oct 17, 2026, 8:24 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 22, 2015 · Synced Oct 17, 2026, 8:24 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 6, 2015 · Synced Oct 17, 2026, 8:24 AM EDT
Completed Phase 3 Interventional Results available

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)

NCT02585778
View directory record Official record
Conditions
Hypercholesterolaemia
Interventions
Alirocumab, Placebo, Lipid-Modifying Therapy (LMT), Antihyperglycemic Drug
Drug
Lead sponsor
Sanofi
Industry
Eligibility
18 Years and older
Enrollment
517 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2015 – 2017
U.S. locations
29
States / cities
Encino, California • Fresno, California • Oakland, California + 25 more
Source: ClinicalTrials.gov public record
Updated May 17, 2018 · Synced Oct 17, 2026, 8:24 AM 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 21, 2017 · Synced Oct 17, 2026, 8:24 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 24, 2015 · Synced Oct 17, 2026, 8:24 AM 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 10, 2023 · Synced Oct 17, 2026, 8:24 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 2, 2017 · Synced Oct 17, 2026, 8:24 AM EDT
Completed Phase 3 Interventional Results available

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

NCT01730053
View directory record Official record
Conditions
Hypercholesterolemia
Interventions
Alirocumab, Rosuvastatin, Ezetimibe, Placebo
Drug
Lead sponsor
Regeneron Pharmaceuticals
Industry
Eligibility
18 Years and older
Enrollment
305 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2012 – 2014
U.S. locations
54
States / cities
Chandler, Arizona • Tucson, Arizona • Anaheim, California + 51 more
Source: ClinicalTrials.gov public record
Updated Apr 7, 2020 · Synced Oct 17, 2026, 8:24 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 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 8, 2016 · Synced Oct 17, 2026, 8:24 AM 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 24, 2026 · Synced Oct 17, 2026, 8:24 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 6, 2015 · Synced Oct 17, 2026, 8:24 AM 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 24, 2015 · Synced Oct 17, 2026, 8:24 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 6, 2023 · Synced Oct 17, 2026, 8:24 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 23, 2020 · Synced Oct 17, 2026, 8:24 AM 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 16, 2021 · Synced Oct 17, 2026, 8:24 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 4, 2016 · Synced Oct 17, 2026, 8:24 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 17, 2020 · Synced Oct 17, 2026, 8:24 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 5, 2020 · Synced Oct 17, 2026, 8:24 AM EDT