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Showing 25–48 of 24 matching trials from the live ClinicalTrials.gov search.
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Filters: Intervention: Praluent Clear all
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 6, 2020 · Synced Sep 25, 2026, 1:05 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 1, 2017 · Synced Sep 25, 2026, 1:05 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 21, 2015 · Synced Sep 25, 2026, 1:05 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 16, 2025 · Synced Sep 25, 2026, 1:05 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 20, 2017 · Synced Sep 25, 2026, 1:05 AM 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 25, 2026, 1:05 AM 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 25, 2026, 1:05 AM 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 14, 2021 · Synced Sep 25, 2026, 1:05 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 5, 2015 · Synced Sep 25, 2026, 1:05 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 23, 2015 · Synced Sep 25, 2026, 1:05 AM EDT
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
420 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 Jul 21, 2026 · Synced Sep 25, 2026, 1:05 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 5, 2023 · Synced Sep 25, 2026, 1:05 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 26, 2015 · Synced Sep 25, 2026, 1:05 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 21, 2015 · Synced Sep 25, 2026, 1:05 AM 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 3, 2026 · Synced Sep 25, 2026, 1:05 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 3, 2016 · Synced Sep 25, 2026, 1:05 AM EDT
Completed Phase 3 Interventional Results available

Efficacy and Safety of Alirocumab (SAR236553/REGN727) Versus Ezetimibe on Top of Statin in High Cardiovascular Risk Patients With Hypercholesterolemia (ODYSSEY COMBO II)

NCT01644188
View directory record Official record
Conditions
Hypercholesterolemia
Interventions
Alirocumab, Placebo (for alirocumab), Ezetimibe, Placebo (for ezetimibe), Lipid Modifying Therapy (LMT)
Drug
Lead sponsor
Sanofi
Industry
Eligibility
18 Years and older
Enrollment
720 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2012 – 2015
U.S. locations
58
States / cities
Birmingham, Alabama • Phoenix, Arizona • Tucson, Arizona + 51 more
Source: ClinicalTrials.gov public record
Updated Aug 3, 2016 · Synced Sep 25, 2026, 1:05 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 23, 2026 · Synced Sep 25, 2026, 1:05 AM EDT
Completed Phase 3 Interventional Results available

Phase III Study To Evaluate Alirocumab in Patients With Hypercholesterolemia Not Treated With a Statin (ODYSSEY CHOICE II)

NCT02023879
View directory record Official record
Conditions
Hypercholesterolemia
Interventions
Alirocumab, Placebo (for Alirocumab), Non-statin LMT, Diet Alone
Drug · Other
Lead sponsor
Sanofi
Industry
Eligibility
18 Years and older
Enrollment
233 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2013 – 2017
U.S. locations
8
States / cities
Beverly Hills, California • Atlantis, Florida • Jacksonville, Florida + 5 more
Source: ClinicalTrials.gov public record
Updated Jul 26, 2018 · Synced Sep 25, 2026, 1:05 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 5, 2015 · Synced Sep 25, 2026, 1:05 AM EDT
Terminated No phase listed Observational Accepts healthy volunteers

Praluent® (Alirocumab) Pregnancy Exposure Registry: An OTIS Pregnancy Surveillance Study

NCT03379558
View directory record Official record
Conditions
Hypercholesterolemia
Interventions
ALIROCUMAB SAR236553 (REGN727)
Drug
Lead sponsor
Regeneron Pharmaceuticals
Industry
Eligibility
Female only
Enrollment
37 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2017 – 2020
U.S. locations
1
States / cities
San Diego, California
Source: ClinicalTrials.gov public record
Updated Nov 22, 2020 · Synced Sep 25, 2026, 1:05 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 20, 2020 · Synced Sep 25, 2026, 1:05 AM 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 8, 2019 · Synced Sep 25, 2026, 1:05 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 Apr 30, 2018 · Synced Sep 25, 2026, 1:05 AM EDT