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ClinicalTrials.gov public records Last synced Oct 17, 2026, 9:55 AM EDT

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Showing 1–24 of 57 matching trials from the live ClinicalTrials.gov search.
Filters: Intervention: Alirocumab Clear all
Completed Phase 1 Interventional Accepts healthy volunteers

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

NCT01074372
View directory record Official record
Conditions
Healthy Volunteers
Interventions
REGN727, Placebo
Drug
Lead sponsor
Regeneron Pharmaceuticals
Industry
Eligibility
18 Years to 65 Years
Enrollment
32 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2010
U.S. locations
1
States / cities
Overland Park, Kansas
Source: ClinicalTrials.gov public record
Updated Jan 27, 2015 · Synced Oct 17, 2026, 9:55 AM EDT
Active, not recruiting Phase 2 Interventional

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

NCT07477704
View directory record Official record
Conditions
Hypercholesterolemia
Interventions
Alirocumab
Drug
Lead sponsor
Regeneron Pharmaceuticals
Industry
Eligibility
18 Years to 80 Years
Enrollment
438 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2026 – 2027
U.S. locations
34
States / cities
Anniston, Alabama • Cullman, Alabama • Anaheim, California + 30 more
Source: ClinicalTrials.gov public record
Updated Oct 15, 2026 · Synced Oct 17, 2026, 9:55 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 May 1, 2018 · Synced Oct 17, 2026, 9:55 AM EDT
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, 9:55 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, 9:55 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 27, 2015 · Synced Oct 17, 2026, 9:55 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, 9:55 AM EDT
Recruiting Not applicable Interventional

Aggressive Lipid Lowering Therapy in ICI-Treated Melanoma

NCT07704918
View directory record Official record
Conditions
Melanoma
Interventions
Statins (atorvastatin, rosuvastatin, simvastatin, or pravastatin), +/- ezetimibe, +/- PCSK9 inhibitor (alirocumab, evolocumab, inclisiran)
Drug
Lead sponsor
University of Colorado, Denver
Other
Eligibility
55 Years and older
Enrollment
40 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2026 – 2028
U.S. locations
1
States / cities
Aurora, Colorado
Source: ClinicalTrials.gov public record
Updated Aug 7, 2026 · Synced Oct 17, 2026, 9:55 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, 9:55 AM EDT
Completed No phase listed Observational

Alirocumab and Ischemic Risk in Atherosclerotic Cardiovascular Disease (ASCVD)

NCT07615179
View directory record Official record
Conditions
Atherosclerotic Cardiovascular Disease Without Prior Ischemic Events
Interventions
Alirocumab, Comparator: No PCSK9i Therapy (either mAb or siRNA)
Drug
Lead sponsor
Sanofi
Industry
Eligibility
18 Years and older
Enrollment
4,545 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2025 – 2026
U.S. locations
1
States / cities
Bridgewater, New Jersey
Source: ClinicalTrials.gov public record
Updated Sep 8, 2026 · Synced Oct 17, 2026, 9:55 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, 9:55 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 27, 2015 · Synced Oct 17, 2026, 9:55 AM EDT
Completed No phase listed Observational

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

NCT07023445
View directory record Official record
Conditions
Atherosclerotic Cardiovascular Disease, Familial Hypercholesterolemia
Interventions
Not listed
Lead sponsor
Novartis Pharmaceuticals
Industry
Eligibility
18 Years and older
Enrollment
37,688 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2023 – 2024
U.S. locations
1
States / cities
East Hanover, New Jersey
Source: ClinicalTrials.gov public record
Updated Jun 17, 2025 · Synced Oct 17, 2026, 9:55 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 6, 2019 · Synced Oct 17, 2026, 9:55 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 29, 2021 · Synced Oct 17, 2026, 9:55 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, 9:55 AM EDT
Active, not recruiting Phase 2 Interventional

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

NCT05553834
View directory record Official record
Conditions
Non-small Cell Lung Cancer (NSCLC)
Interventions
Alirocumab and Cemiplimab
Combination Product
Lead sponsor
Duke University
Other
Eligibility
18 Years and older
Enrollment
60 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2023 – 2026
U.S. locations
2
States / cities
Tampa, Florida • Durham, North Carolina
Source: ClinicalTrials.gov public record
Updated Apr 13, 2026 · Synced Oct 17, 2026, 9:55 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, 9:55 AM 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 20, 2026 · Synced Oct 17, 2026, 9:55 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, 9:55 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, 9:55 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, 9:55 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, 9:55 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 28, 2013 · Synced Oct 17, 2026, 9:55 AM EDT