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About this data Sourced primarily from ClinicalTrials.gov — a listing isn't proof of safety or FDA approval.

Pipeline and clinical trial information here comes primarily from ClinicalTrials.gov. A listing on ClinicalTrials.gov means a study has been registered — not that a treatment is proven safe, effective, or FDA-approved. Investigational treatments may never be approved. Who can join a trial is decided only by that trial's own study team.

Not yet reported

alirocumab SAR236553

Company
Sanofi
Mechanism
Mechanism not yet reported
Route
Route not yet reported
Recruiting trials
None currently listed

Efficacy results: Not yet reported

No recruiting studies currently listed

See all studies for this drug

Data source: ClinicalTrials.gov · trial data as of Sep 11, 2026

Trial details
  • Completed NCT NCT01288443

    Efficacy and Safety Evaluation of Alirocumab (SAR236553/REGN727) in Patients With Primary Hypercholesterolemia on Stable Atorvastatin Therapy

    Not yet reported Sanofi 183 participants Est. completion 2011-12 38 sites
    Other conditions: Hypercholesterolemia
    View official trial listing →
  • Completed NCT NCT01288469

    Efficacy and Safety Evaluation of Alirocumab (SAR236553/REGN727) When Co-administered With High Dose of Atorvastatin in Patients With Primary Hypercholesterolemia

    Not yet reported Sanofi 92 participants Est. completion 2011-09 20 sites
    Other conditions: Hypercholesterolemia
    View official trial listing →
  • Completed NCT NCT01443650

    Injection Site Tolerability, Safety, Pharmacokinetics, Pharmacodynamics in Different Single-Dose Treatments of Alirocumab SAR236553 (REGN727) in Healthy Subjects

    Not yet reported Sanofi 36 participants Est. completion 2011-11 1 site Stand-alone
    Other conditions: Hypercholesterolemia
    View official trial listing →
  • Completed NCT NCT01448239

    Injection Site Tolerability, Safety, Pharmacokinetics and Pharmacodynamics Study After a Single Dose Subcutaneous Treatment of Alirocumab SAR236553 (REGN727)

    Not yet reported Sanofi 24 participants Est. completion 2011-05 1 site Stand-alone
    Other conditions: Hypercholesterolemia
    View official trial listing →
  • Completed NCT NCT01448304

    Study of the Tolerability, Safety, Pharmacokinetics and Pharmacodynamics of Alirocumab SAR236553 (REGN727)

    Not yet reported Sanofi 24 participants Est. completion 2011-09 1 site Stand-alone
    Other conditions: Hypercholesterolemia
    View official trial listing →
  • Completed NCT NCT01448317

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

    Not yet reported Sanofi 32 participants Est. completion 2012-01 1 site
    Other conditions: Hypercholesterolemia
    View official trial listing →
  • Completed NCT NCT01507831

    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)

    Not yet reported Sanofi 2341 participants Est. completion 2014-11 320 sites
    Other conditions: Hypercholesterolemia
    View official trial listing →
  • Completed NCT NCT01617655

    Efficacy and Safety of Alirocumab (SAR236553/REGN727) Versus Placebo on Top of Lipid-Modifying Therapy in Patients With Heterozygous Familial Hypercholesterolemia (ODYSSEY HIGH FH)

    Not yet reported Sanofi 107 participants Est. completion 2015-01 35 sites
    Other conditions: Hypercholesterolaemia
    View official trial listing →
  • Completed NCT NCT01623115

    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

    Not yet reported Sanofi 486 participants Est. completion 2014-12 91 sites
    Other conditions: Hypercholesterolemia
    View official trial listing →
  • Completed NCT NCT01644175

    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)

    Not yet reported Sanofi 316 participants Est. completion 2014-04 76 sites
    Other conditions: Hypercholesterolemia
    View official trial listing →
  • Completed NCT NCT01644188

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

    Not yet reported Sanofi 720 participants Est. completion 2015-07 126 sites
    Other conditions: Hypercholesterolemia
    View official trial listing →
  • Completed NCT NCT01644474

    Efficacy and Safety of Alirocumab (SAR236553/REGN727) Versus Ezetimibe in Patients With Hypercholesterolemia

    Not yet reported Sanofi 103 participants Est. completion 2013-07 8 sites
    Other conditions: Hypercholesterolemia
    View official trial listing →
  • Completed NCT NCT01663402

    ODYSSEY Outcomes: Evaluation of Cardiovascular Outcomes After an Acute Coronary Syndrome During Treatment With Alirocumab

    Not yet reported Sanofi 18924 participants Est. completion 2018-01-23 1388 sites
    Cardiovascular disease
    View official trial listing →
  • Completed NCT NCT01670734

    Pharmacokinetic and Tolerability of Alirocumab SAR236553 (REGN727) in Patients With Hepatic Impairment and in Healthy Subjects

    Not yet reported Sanofi 25 participants Est. completion 2013-05 2 sites Stand-alone
    Other conditions: Hypercholesterolemia
    View official trial listing →
  • Completed NCT NCT01723735

    Effect of Alirocumab (SAR236553/REGN727) Administered on Top of Ezetimibe or Fenofibrate on Lipid Profiles in Healthy Subjects

    Not yet reported Sanofi 79 participants Est. completion 2013-07 2 sites
    Other conditions: Hypercholesterolemia
    View official trial listing →
  • Completed NCT NCT01785329

    Pharmacokinetic of Alirocumab SAR236553 (REGN727) Administered Subcutaneously at 3 Different Injection Sites in Healthy Subjects

    Not yet reported Sanofi 60 participants Est. completion 2013-07 1 site Stand-alone
    Other conditions: Hypercholesterolemia
    View official trial listing →
  • Completed NCT NCT01812707

    Efficacy and Safety Evaluation of Alirocumab (SAR236553/REGN727) in Patients With Primary Hypercholesterolemia on Stable Atorvastatin Therapy in Japan

    Not yet reported Sanofi 100 participants Est. completion 2014-01 4 sites
    Other conditions: Hypercholesterolemia
    View official trial listing →
  • Completed NCT NCT02476006

    Safety, Tolerability, and Effect of Alirocumab in High Cardiovascular Risk Patients With Severe Hypercholesterolemia Not Adequately Controlled With Conventional Lipid-modifying Therapies (ODYSSEY APPRISE)

    Not yet reported Sanofi 998 participants Est. completion 2019-04-12 153 sites Stand-alone
    Other conditions: Hypercholesterolemia
    View official trial listing →
  • Completed NCT NCT02715726

    Evaluation of Alirocumab Versus Ezetimibe on Top of Statin in Asia in High Cardiovascular Risk Patients With Hypercholesterolemia

    Not yet reported Sanofi 615 participants Est. completion 2018-08-06 62 sites
    Other conditions: Hypercholesterolemia
    View official trial listing →
  • Completed NCT NCT02890992

    An 8-Week Dose-Finding Study to Evaluate the Efficacy and Safety of Alirocumab in Children and Adolescents With Heterozygous Familial Hypercholesterolemia

    Not yet reported Sanofi 42 participants Est. completion 2019-02-22 16 sites Stand-alone
    Other conditions: Hypercholesterolaemia
    View official trial listing →
  • Completed NCT NCT02979015

    A Study of Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Subcutaneous (SC) Administered Alirocumab in Healthy Chinese Subjects

    Not yet reported Sanofi 35 participants Est. completion 2017-11-27 1 site Stand-alone
    Other conditions: Hypercholesterolemia
    View official trial listing →
  • Completed NCT NCT02984982

    Evaluation of Effect of Alirocumab on Coronary Atheroma Volume in Japanese Patients Hospitalized for Acute Coronary Syndrome With Hypercholesterolemia

    Not yet reported Sanofi 206 participants Est. completion 2018-07-27 39 sites Stand-alone
    Other conditions: Hypercholesterolemia, Acute Coronary Syndrome
    View official trial listing →
  • Completed NCT NCT03207945

    Effect of PCSK9 Inhibition on Cardiovascular Risk in Treated HIV Infection (EPIC-HIV Study)

    Not yet reported University of California, San Francisco 118 participants Est. completion 2025-09-24 1 site
    Cardiovascular disease Other conditions: Dyslipidemias, HIV Infections
    View official trial listing →
  • Terminated NCT NCT03379558

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

    Regeneron Pharmaceuticals 37 participants Est. completion 2020-09-04 1 site
    Other conditions: Hypercholesterolemia
    View official trial listing →
  • Completed NCT NCT03415178

    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

    Not yet reported Sanofi 69 participants Est. completion 2018-08-09 13 sites Stand-alone
    Other conditions: Hypercholesterolaemia
    View official trial listing →
  • Completed NCT NCT03510715

    An Efficacy and Safety Study of Alirocumab in Children and Adolescents With Homozygous Familial Hypercholesterolemia

    Not yet reported Sanofi 18 participants Est. completion 2020-02-17 10 sites Stand-alone
    Other conditions: Hypercholesterolemia
    View official trial listing →
  • Completed NCT NCT03510884

    An Efficacy and Safety Study of Alirocumab in Children and Adolescents With Heterozygous Familial Hypercholesterolemia

    Not yet reported Sanofi 153 participants Est. completion 2022-08-05 43 sites Stand-alone
    Other conditions: Hypercholesterolaemia
    View official trial listing →
Efficacy history

Not yet reported.

Safety

Not yet reported.

Sources

Also known as: alirocumab SAR236553, alirocumab SAR236553 (REGN727)

Related On The Pen coverage

No related coverage yet.

This drug may be investigational and not yet approved for any use. Whether someone can join a clinical trial is determined only by that trial's own study team — On The Pen does not determine eligibility. Information here can change; always confirm current details on the official ClinicalTrials.gov listing or with the sponsor.