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Showing 1–24 of 57 matching trials from the live ClinicalTrials.gov search.
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Filters: Intervention: alirocumab Clear all
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 2, 2026, 7:01 PM 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 20, 2020 · Synced Sep 2, 2026, 7:01 PM EDT
Completed No phase listed Observational

Low-Density Lipoprotein Cholesterol Reduction With Alirocumab 150 mg Versus Inclisiran in Individuals Initiating Therapy in Routine Clinical Practice

NCT07615166
View directory record Official record
Conditions
Atherosclerotic Cardiovascular Disease
Interventions
Alirocumab 150 mg, Inclisiran
Drug
Lead sponsor
Sanofi
Industry
Eligibility
18 Years to 65 Years · Male only
Enrollment
996 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 Jul 8, 2026 · Synced Sep 2, 2026, 7:01 PM EDT
Terminated Phase 2 Interventional

Effect of PCSK9-Antibody (Alirocumab) on Dyslipidemia Secondary to Nephrotic Syndrome

NCT03004001
View directory record Official record
Conditions
Nephrotic Syndrome
Interventions
Alirocumab, Alirocumab placebo, Atorvastatin
Drug
Lead sponsor
Gloria Vega
Federal
Eligibility
18 Years to 75 Years
Enrollment
3 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2017 – 2019
U.S. locations
1
States / cities
Dallas, Texas
Source: ClinicalTrials.gov public record
Updated Aug 18, 2022 · Synced Sep 2, 2026, 7:01 PM 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 2, 2026, 7:01 PM 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 2, 2026, 7:01 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 2, 2026, 7:01 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 2, 2026, 7:01 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 2, 2026, 7:01 PM EDT
Recruiting Phase 3 Interventional

Alirocumab in Patients on a Stable Dialysis Regimen

NCT03480568
View directory record Official record
Conditions
Hemodialysis, Peritoneal Dialysis, Hypercholesterolemia, Atherosclerotic Disease
Interventions
Alirocumab 150 MG/ML [Praluent]
Drug
Lead sponsor
Baylor Research Institute
Other
Eligibility
18 Years to 80 Years
Enrollment
20 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2018 – 2020
U.S. locations
1
States / cities
Dallas, Texas
Source: ClinicalTrials.gov public record
Updated Feb 11, 2020 · Synced Sep 2, 2026, 7:01 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 2, 2026, 7:01 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 2, 2026, 7:01 PM 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 2, 2026, 7:01 PM EDT
Suspended Phase 2 Interventional

TOP 2301: Neoadjuvant Chemo for NSCLC

NCT06385262
View directory record Official record
Conditions
Non Small Cell Lung Cancer
Interventions
Alirocumab, Cemiplimab, Chemotherapy
Drug
Lead sponsor
Duke University
Other
Eligibility
18 Years and older
Enrollment
63 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2025 – 2029
U.S. locations
1
States / cities
Durham, North Carolina
Source: ClinicalTrials.gov public record
Updated Aug 23, 2026 · Synced Sep 2, 2026, 7:01 PM EDT
Completed Phase 4 Interventional Results available

Alirocumab in Patients With Acute Myocardial Infarction

NCT02938949
View directory record Official record
Conditions
Myocardial Infarction, Hypercholesterolemia
Interventions
alirocumab, placebo
Drug
Lead sponsor
Virginia Commonwealth University
Other
Eligibility
21 Years and older
Enrollment
20 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2017 – 2018
U.S. locations
1
States / cities
Richmond, Virginia
Source: ClinicalTrials.gov public record
Updated Sep 5, 2019 · Synced Sep 2, 2026, 7:01 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 2, 2026, 7:01 PM 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 17, 2026 · Synced Sep 2, 2026, 7:01 PM 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 16, 2025 · Synced Sep 2, 2026, 7:01 PM EDT
Completed Phase 3 Interventional Results available

Open Label Study of Long Term Safety Evaluation of Alirocumab

NCT01954394
View directory record Official record
Conditions
Hypercholesterolemia
Interventions
Alirocumab, Lipid-Modifying Therapy (LMT)
Drug
Lead sponsor
Sanofi
Industry
Eligibility
18 Years and older
Enrollment
986 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2013 – 2017
U.S. locations
44
States / cities
Huntsville, Alabama • Tempe, Arizona • Bell Gardens, California + 39 more
Source: ClinicalTrials.gov public record
Updated Jul 23, 2018 · Synced Sep 2, 2026, 7:01 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 2, 2026, 7:01 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 2, 2026, 7:01 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 2, 2026, 7:01 PM 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 2, 2026, 7:01 PM 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 12, 2026 · Synced Sep 2, 2026, 7:01 PM EDT