<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/NCT04494360</url>
  </required_header>
  <id_info>
    <org_study_id>CR108830</org_study_id>
    <secondary_id>NOPRODNAS0001</secondary_id>
    <nct_id>NCT04494360</nct_id>
  </id_info>
  <brief_title>Study to Estimate How Common it is to Have Genetic Variants Associated With NAFLD</brief_title>
  <official_title>Study for the Identification of Participants With Liver Steatosis Who Carry Genetic Variants Associated With Nonalcoholic Fatty Liver Disease (NAFLD)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Janssen Research &amp; Development, LLC</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Janssen Research &amp; Development, LLC</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to estimate the prevalence of genetic variants associated with&#xD;
      liver disease in participants who are known, or are likely to have NAFLD.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 7, 2020</start_date>
  <completion_date type="Actual">October 10, 2022</completion_date>
  <primary_completion_date type="Actual">October 10, 2022</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Prevalence of Genetic Variants Associated with NAFLD</measure>
    <time_frame>Up to 8 weeks</time_frame>
    <description>Genotyping for known mutations associated with NAFLD will be conducted and the prevalence in the overall population enrolled will be calculated.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Liver Fat Content Estimated with Fibroscan</measure>
    <time_frame>Up to 8 weeks</time_frame>
    <description>Fibroscan will be performed to obtain the controlled attenuation parameter (CAP) score to estimate liver fat content. Number of participants with a CAP score greater or equal to (&gt;=) 310 decibels per minute (dB/m) (that is, liver fat &gt;= 10 percent [%]) will be estimated.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Liver Fibrosis Estimated with Fibroscan</measure>
    <time_frame>Up to 8 weeks</time_frame>
    <description>Fibroscan will be conducted to obtain liver stiffness measurement to estimate liver fibrosis. Number of participants with absent, low or moderate fibrosis (that is, less than or equal to (&lt;=) 9 kilopascals [kPa]) will be estimated.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hepatic Fat Fraction</measure>
    <time_frame>Up to 8 weeks</time_frame>
    <description>The liver fat fraction will be obtained by magnetic resonance imaging-proton density fat fraction (MRI-PDFF) to estimate the inter-participant variability in liver fat measurement.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">830</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>Healthy Participants</arm_group_label>
    <description>Healthy participants (men and women) who have, or are likely to have, NAFLD will be enrolled in the study.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>No intervention</intervention_name>
    <description>No investigational medicinal product will be administered as a part of this study.</description>
    <arm_group_label>Healthy Participants</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Participants, who are known to have, or are likely to have, NAFLD.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  No clinically significant abnormality based on medical history, physical exam, and&#xD;
             12-lead electrocardiogram (ECG) collected during Visit 1&#xD;
&#xD;
          -  Women must be of non-childbearing potential, defined as either: a.) Postmenopausal or&#xD;
             b.) Permanently sterile&#xD;
&#xD;
          -  Must be willing to provide a deoxyribonucleic acid (DNA) sample for assessment of&#xD;
             genetic variants associated with NAFLD&#xD;
&#xD;
          -  Must sign an informed consent form (ICF) indicating that he or she understands the&#xD;
             purpose of, and procedures required for, the study and is willing to participate in&#xD;
             the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History or presence of drug abuse within the 2 years prior to Visit 1&#xD;
&#xD;
          -  Excessive use of alcohol within 2 years prior to the study&#xD;
&#xD;
          -  Body mass index greater than (&gt;) 40 kilogram per meter square (kg/m^2)&#xD;
&#xD;
          -  Evidence of other active (acute or chronic) liver disease other than NAFLD/&#xD;
             Nonalcoholic steatohepatitis (NASH)&#xD;
&#xD;
          -  History of bariatric surgery or planning to undergo bariatric surgery within the next&#xD;
             year&#xD;
&#xD;
          -  Inability to undergo magnetic resonance imaging (MRI)&#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>Janssen Research &amp; Development, LLC Clinical Trial</last_name>
    <role>Study Director</role>
    <affiliation>Janssen Research &amp; Development, LLC</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Research Centers of America, LLC</name>
      <address>
        <city>Hollywood</city>
        <state>Florida</state>
        <zip>33024</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>PRA Health Sciences</name>
      <address>
        <city>Lenexa</city>
        <state>Kansas</state>
        <zip>66219</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Endeavor Clinical Trials, LLC</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78240</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <removed_countries>
    <country>Puerto Rico</country>
  </removed_countries>
  <verification_date>February 2023</verification_date>
  <study_first_submitted>July 28, 2020</study_first_submitted>
  <study_first_submitted_qc>July 28, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 31, 2020</study_first_posted>
  <last_update_submitted>February 28, 2023</last_update_submitted>
  <last_update_submitted_qc>February 28, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 1, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>The data sharing policy of the Janssen Pharmaceutical Companies of Johnson &amp; Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu</ipd_description>
    <ipd_url>https://www.janssen.com/clinical-trials/transparency</ipd_url>
  </patient_data>
  <!-- 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/NCT04494360
org study id: CR108830
secondary id: NOPRODNAS0001
nct id: NCT04494360
lead sponsor: 
has dmc: No
is fda regulated device: No
The purpose of this study is to estimate the prevalence of genetic variants associated with
      liver disease in participants who are known, or are likely to have NAFLD.
observational model: Other
time perspective: Cross-Sectional
measure: Prevalence of Genetic Variants Associated with NAFLD
time frame: Up to 8 weeks
description: Genotyping for known mutations associated with NAFLD will be conducted and the prevalence in the overall population enrolled will be calculated.
measure: Liver Fat Content Estimated with Fibroscan
time frame: Up to 8 weeks
description: Fibroscan will be performed to obtain the controlled attenuation parameter (CAP) score to estimate liver fat content. Number of participants with a CAP score greater or equal to (>=) 310 decibels per minute (dB/m) (that is, liver fat >= 10 percent [%]) will be estimated.
measure: Liver Fibrosis Estimated with Fibroscan
time frame: Up to 8 weeks
description: Fibroscan will be conducted to obtain liver stiffness measurement to estimate liver fibrosis. Number of participants with absent, low or moderate fibrosis (that is, less than or equal to (<=) 9 kilopascals [kPa]) will be estimated.
measure: Hepatic Fat Fraction
time frame: Up to 8 weeks
description: The liver fat fraction will be obtained by magnetic resonance imaging-proton density fat fraction (MRI-PDFF) to estimate the inter-participant variability in liver fat measurement.
arm group label: Healthy Participants
description: Healthy participants (men and women) who have, or are likely to have, NAFLD will be enrolled in the study.
intervention type: Other
intervention name: No intervention
description: No investigational medicinal product will be administered as a part of this study.
arm group label: Healthy Participants
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Janssen Research & Development, LLC Clinical Trial
role: Study Director
affiliation: Janssen Research & Development, LLC
facility: 
facility: 
facility: 
country: United States
country: Puerto Rico
responsible party type: Sponsor
sharing ipd: Yes
ipd description: The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
ipd url: https://www.janssen.com/clinical-trials/transparency