<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01723735</url>
  </required_header>
  <id_info>
    <org_study_id>PKD12910</org_study_id>
    <secondary_id>U1111-1131-3203</secondary_id>
    <secondary_id>2012-003049-13</secondary_id>
    <nct_id>NCT01723735</nct_id>
  </id_info>
  <brief_title>Effect of Alirocumab (SAR236553/REGN727) Administered on Top of Ezetimibe or Fenofibrate on Lipid Profiles in Healthy Subjects</brief_title>
  <official_title>A Randomized, Partial Blind, 3 Parallel Groups Study of the Pharmacodynamic Profile of SAR236553 (REGN727) Administered as Multiple Subcutaneous Doses, Either Alone or on Top of Ezetimibe or Fenofibrate Administered as Multiple Oral Doses in Healthy Subjects</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sanofi</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Regeneron Pharmaceuticals</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Sanofi</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Primary Objective:&#xD;
&#xD;
      To assess the pharmacodynamic profile of alirocumab (SAR236553/REGN727) administered either&#xD;
      alone or on top of ezetimibe or fenofibrate, based on low-density lipoprotein -cholesterol&#xD;
      (LDL-C).&#xD;
&#xD;
      Secondary Objectives:&#xD;
&#xD;
        -  To assess the pharmacodynamic profile of alirocumab administered either alone or on top&#xD;
           of ezetimibe or fenofibrate, based on other lipid parameters.&#xD;
&#xD;
        -  To assess the pharmacokinetic profile of alirocumab administered either alone or on top&#xD;
           of ezetimibe or fenofibrate.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Total duration of the study per subject (excluding screening) is about 22 weeks.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>November 2012</start_date>
  <completion_date type="Actual">July 2013</completion_date>
  <primary_completion_date type="Actual">July 2013</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Assessment of the effect of alirocumab on LDL-C</measure>
    <time_frame>Up to 18 weeks</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Assessment of the pharmacodynamic profile of alirocumab</measure>
    <time_frame>Up to 18 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pharmacokinetics: Assessment of serum concentrations of alirocumab</measure>
    <time_frame>Up to 18 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pharmacokinetics: Assessment of serum concentrations of proprotein convertase subtilisin kexin type 9 (PCSK9)</measure>
    <time_frame>Up to 18 weeks</time_frame>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">79</enrollment>
  <condition>Hypercholesterolemia</condition>
  <arm_group>
    <arm_group_label>Alirocumab + Ezetimibe Placebo</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subcutaneous (SC) injections of alirocumab added to oral administration of ezetimibe placebo</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Alirocumab + Ezetimibe</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subcutaneous (SC) injections of alirocumab added to oral administration of ezetimibe</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Alirocumab + Fenofibrate</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subcutaneous (SC) injections of alirocumab added to oral administration of fenofibrate</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Alirocumab</intervention_name>
    <description>Pharmaceutical form: solution for injection&#xD;
Route of administration: subcutaneous</description>
    <arm_group_label>Alirocumab + Ezetimibe</arm_group_label>
    <arm_group_label>Alirocumab + Ezetimibe Placebo</arm_group_label>
    <arm_group_label>Alirocumab + Fenofibrate</arm_group_label>
    <other_name>SAR236553</other_name>
    <other_name>REGN727</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ezetimibe</intervention_name>
    <description>Pharmaceutical form: overencapsulated tablet&#xD;
Route of administration: oral</description>
    <arm_group_label>Alirocumab + Ezetimibe</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ezetimibe Placebo</intervention_name>
    <description>Pharmaceutical form: capsule&#xD;
Route of administration: oral</description>
    <arm_group_label>Alirocumab + Ezetimibe Placebo</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Fenofibrate</intervention_name>
    <description>Pharmaceutical form: tablet&#xD;
Route of administration: oral</description>
    <arm_group_label>Alirocumab + Fenofibrate</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion criteria :&#xD;
&#xD;
          -  Healthy male /or female subjects,&#xD;
&#xD;
          -  aged 18 to 65 years old,&#xD;
&#xD;
          -  with LDL-C &gt; 130 mg/dL&#xD;
&#xD;
          -  not receiving lipid lowering therapy.&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
          -  Healthy subjects with history or presence of clinically relevant illness.&#xD;
&#xD;
          -  Subjects currently taking statins, ezetimibe or fenofibrate.&#xD;
&#xD;
          -  The above information is not intended to contain all considerations relevant to a&#xD;
             patient's potential participation in a clinical trial.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Clinical Sciences &amp; Operations</last_name>
    <role>Study Director</role>
    <affiliation>Sanofi</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Investigational Site Number 250001</name>
      <address>
        <city>Rennes</city>
        <zip>35000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 250002</name>
      <address>
        <city>Rueil Malmaison</city>
        <zip>92502</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <results_reference>
    <citation>Rey J, Poitiers F, Paehler T, Brunet A, DiCioccio AT, Cannon CP, Surks HK, Pinquier JL, Hanotin C, Sasiela WJ. Relationship Between Low-Density Lipoprotein Cholesterol, Free Proprotein Convertase Subtilisin/Kexin Type 9, and Alirocumab Levels After Different Lipid-Lowering Strategies. J Am Heart Assoc. 2016 Jun 10;5(6):e003323. doi: 10.1161/JAHA.116.003323.</citation>
    <PMID>27287699</PMID>
  </results_reference>
  <verification_date>September 2016</verification_date>
  <study_first_submitted>November 6, 2012</study_first_submitted>
  <study_first_submitted_qc>November 7, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 8, 2012</study_first_posted>
  <last_update_submitted>September 27, 2016</last_update_submitted>
  <last_update_submitted_qc>September 27, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 28, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypercholesterolemia</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ezetimibe</mesh_term>
    <mesh_term>Alirocumab</mesh_term>
    <mesh_term>Fenofibrate</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01723735
org study id: PKD12910
secondary id: U1111-1131-3203
secondary id: 2012-003049-13
nct id: NCT01723735
lead sponsor: 
collaborator: 
has dmc: No
Primary Objective:

      To assess the pharmacodynamic profile of alirocumab (SAR236553/REGN727) administered either
      alone or on top of ezetimibe or fenofibrate, based on low-density lipoprotein -cholesterol
      (LDL-C).

      Secondary Objectives:

        -  To assess the pharmacodynamic profile of alirocumab administered either alone or on top
           of ezetimibe or fenofibrate, based on other lipid parameters.

        -  To assess the pharmacokinetic profile of alirocumab administered either alone or on top
           of ezetimibe or fenofibrate.
Total duration of the study per subject (excluding screening) is about 22 weeks.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Assessment of the effect of alirocumab on LDL-C
time frame: Up to 18 weeks
measure: Assessment of the pharmacodynamic profile of alirocumab
time frame: Up to 18 weeks
measure: Pharmacokinetics: Assessment of serum concentrations of alirocumab
time frame: Up to 18 weeks
measure: Pharmacokinetics: Assessment of serum concentrations of proprotein convertase subtilisin kexin type 9 (PCSK9)
time frame: Up to 18 weeks
arm group label: Alirocumab + Ezetimibe Placebo
arm group type: Experimental
description: Subcutaneous (SC) injections of alirocumab added to oral administration of ezetimibe placebo
arm group label: Alirocumab + Ezetimibe
arm group type: Experimental
description: Subcutaneous (SC) injections of alirocumab added to oral administration of ezetimibe
arm group label: Alirocumab + Fenofibrate
arm group type: Experimental
description: Subcutaneous (SC) injections of alirocumab added to oral administration of fenofibrate
intervention type: Drug
intervention name: Alirocumab
description: Pharmaceutical form: solution for injection
Route of administration: subcutaneous
arm group label: Alirocumab + Ezetimibe
arm group label: Alirocumab + Ezetimibe Placebo
arm group label: Alirocumab + Fenofibrate
other name: SAR236553
other name: REGN727
intervention type: Drug
intervention name: Ezetimibe
description: Pharmaceutical form: overencapsulated tablet
Route of administration: oral
arm group label: Alirocumab + Ezetimibe
intervention type: Drug
intervention name: Ezetimibe Placebo
description: Pharmaceutical form: capsule
Route of administration: oral
arm group label: Alirocumab + Ezetimibe Placebo
intervention type: Drug
intervention name: Fenofibrate
description: Pharmaceutical form: tablet
Route of administration: oral
arm group label: Alirocumab + Fenofibrate
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Clinical Sciences & Operations
role: Study Director
affiliation: Sanofi
facility: 
facility: 
country: France
citation: Rey J, Poitiers F, Paehler T, Brunet A, DiCioccio AT, Cannon CP, Surks HK, Pinquier JL, Hanotin C, Sasiela WJ. Relationship Between Low-Density Lipoprotein Cholesterol, Free Proprotein Convertase Subtilisin/Kexin Type 9, and Alirocumab Levels After Different Lipid-Lowering Strategies. J Am Heart Assoc. 2016 Jun 10;5(6):e003323. doi: 10.1161/JAHA.116.003323.
PMID: 27287699
responsible party type: Sponsor
mesh term: Hypercholesterolemia
mesh term: Ezetimibe
mesh term: Alirocumab
mesh term: Fenofibrate