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ClinicalTrials.gov public records Last synced Oct 23, 2026, 9:26 PM EDT

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Showing 1–24 of 57 matching trials from the live ClinicalTrials.gov search.
Filters: Intervention: Praluent Clear all
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 23, 2026, 9:26 PM 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 23, 2026, 9:26 PM EDT
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 28, 2013 · Synced Oct 23, 2026, 9:26 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 23, 2026, 9:26 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 23, 2026, 9:26 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 12, 2020 · Synced Oct 23, 2026, 9:26 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 23, 2026, 9:26 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 23, 2026, 9:26 PM 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 Oct 22, 2026 · Synced Oct 23, 2026, 9:26 PM 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 23, 2026, 9:26 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 23, 2026, 9:26 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 23, 2026, 9:26 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 29, 2021 · Synced Oct 23, 2026, 9:26 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 23, 2026, 9:26 PM EDT
Completed Phase 4 Interventional Results available

Evaluating Effect of the Study Drug Praluent (Alirocumab) on Neurocognitive Function When Compared to Placebo

NCT02957682
View directory record Official record
Conditions
Hypercholesterolemia
Interventions
Praluent (Alirocumab), Placebo
Drug
Lead sponsor
Regeneron Pharmaceuticals
Industry
Eligibility
40 Years to 85 Years
Enrollment
2,176 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2016 – 2020
U.S. locations
73
States / cities
Auburn, Alabama • Birmingham, Alabama • Mobile, Alabama + 63 more
Source: ClinicalTrials.gov public record
Updated May 7, 2021 · Synced Oct 23, 2026, 9:26 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 23, 2026, 9:26 PM 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 23, 2026, 9:26 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 5, 2020 · Synced Oct 23, 2026, 9:26 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 24, 2015 · Synced Oct 23, 2026, 9:26 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 23, 2026, 9:26 PM EDT
Recruiting 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 Oct 16, 2026 · Synced Oct 23, 2026, 9:26 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 6, 2015 · Synced Oct 23, 2026, 9:26 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 23, 2026, 9:26 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 24, 2018 · Synced Oct 23, 2026, 9:26 PM EDT