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ClinicalTrials.gov public records Last synced Oct 1, 2026, 10:36 PM EDT

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Showing 1–24 of 57 matching trials from the live ClinicalTrials.gov search.
Filters: Intervention: Praluent (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 1, 2026, 10:36 PM 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 9, 2019 · Synced Oct 1, 2026, 10:36 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 24, 2025 · Synced Oct 1, 2026, 10:36 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 21, 2020 · Synced Oct 1, 2026, 10:36 PM 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 1, 2026, 10:36 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 and older
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 Sep 4, 2026 · Synced Oct 1, 2026, 10:36 PM EDT
Not listed Phase 4 Interventional Accepts healthy volunteers

Assessment of Atherosclerotic Plaque Characteristics Change by DCE-MRI With Alirocumab

NCT02992301
View directory record Official record
Conditions
Atherosclerosis, Hyperlipidemia
Interventions
Alirocumab
Drug
Lead sponsor
Westside Medical Associates of Los Angeles
Other
Eligibility
18 Years and older
Enrollment
35 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2016 – 2019
U.S. locations
1
States / cities
Beverly Hills, California
Source: ClinicalTrials.gov public record
Updated Apr 26, 2019 · Synced Oct 1, 2026, 10:36 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 24, 2026 · Synced Oct 1, 2026, 10:36 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 27, 2015 · Synced Oct 1, 2026, 10:36 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 May 1, 2018 · Synced Oct 1, 2026, 10:36 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 2, 2017 · Synced Oct 1, 2026, 10:36 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 22, 2024 · Synced Oct 1, 2026, 10:36 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 17, 2025 · Synced Oct 1, 2026, 10:36 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 6, 2023 · Synced Oct 1, 2026, 10:36 PM 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 1, 2026, 10:36 PM 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 1, 2026, 10:36 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 8, 2016 · Synced Oct 1, 2026, 10:36 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 27, 2015 · Synced Oct 1, 2026, 10:36 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 6, 2019 · Synced Oct 1, 2026, 10:36 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 4, 2016 · Synced Oct 1, 2026, 10:36 PM 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 15, 2021 · Synced Oct 1, 2026, 10:36 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 23, 2020 · Synced Oct 1, 2026, 10:36 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 10, 2023 · Synced Oct 1, 2026, 10:36 PM 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 1, 2026, 10:36 PM EDT