<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/NCT02210871</url>
  </required_header>
  <id_info>
    <org_study_id>NN9535-3651</org_study_id>
    <secondary_id>U1111-1149-3924</secondary_id>
    <secondary_id>2009-011673-33</secondary_id>
    <nct_id>NCT02210871</nct_id>
  </id_info>
  <brief_title>Investigating the Pharmacokinetics, Safety and Tolerability After a Single Subcutaneous Injection of Semaglutide in Subjects With Mild, Moderate or Severe Hepatic Impairment Compared to Subjects With Normal Hepatic Function</brief_title>
  <official_title>A Multi-centre, Open-label, Parallel-group Trial Investigating the Pharmacokinetics, Safety and Tolerability After a Single Subcutaneous Injection of Semaglutide in Subjects With Mild, Moderate or Severe Hepatic Impairment Compared to Subjects With Normal Hepatic Function</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Novo Nordisk A/S</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Novo Nordisk A/S</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This trial is conducted in Europe. The aim of this trial is to investigate the&#xD;
      pharmacokinetics (the exposure of the trial drug in the body), safety and tolerability after&#xD;
      a single injection of semaglutide in subjects with mild, moderate or severe hepatic&#xD;
      impairment compared to subjects with normal hepatic function.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 7, 2014</start_date>
  <completion_date type="Actual">June 3, 2015</completion_date>
  <primary_completion_date type="Actual">June 3, 2015</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Area under the semaglutide plasma concentration-time curve</measure>
    <time_frame>Day 1 - day 36</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Maximum observed semaglutide plasma concentration</measure>
    <time_frame>Day 1 - day 36</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of treatment emergent adverse events (TEAEs)</measure>
    <time_frame>Day 1 - day 36</time_frame>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">44</enrollment>
  <condition>Diabetes</condition>
  <condition>Diabetes Mellitus, Type 2</condition>
  <condition>Hepatic Impaired</condition>
  <arm_group>
    <arm_group_label>Normal hepatic function</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Mild hepatic impairment</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Moderate hepatic impairment</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Severe hepatic impairment</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>semaglutide</intervention_name>
    <description>All subjects will be treated with a single subcutane (s.c., under the skin) injection of 0.5 mg semaglutide.</description>
    <arm_group_label>Mild hepatic impairment</arm_group_label>
    <arm_group_label>Moderate hepatic impairment</arm_group_label>
    <arm_group_label>Normal hepatic function</arm_group_label>
    <arm_group_label>Severe hepatic impairment</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male or female, age at least 18 years at the time of signing informed consent&#xD;
&#xD;
          -  Body mass index (BMI) 18.5-40.0 kg/m^2 (both inclusive)&#xD;
&#xD;
          -  Only for subjects with hepatic impairment (mild, moderate and severe): A diagnosis of&#xD;
             cirrhosis due to parenchymal liver disease, classified as Child-Pugh grade A,B or C as&#xD;
             assessed by investigator and which is confirmed and documented by medical history,&#xD;
             physical examination and at least one of the following: hepatic&#xD;
             ultrasound,computerised axial tomography (CT) scan, magnetic resonance imaging (MRI),&#xD;
             and/or liver biopsy&#xD;
&#xD;
          -  Only for subjects with normal hepatic function: Subjects who are judged to be in good&#xD;
             general health based on physical examination, medical history, ECG, vital signs, and&#xD;
             the results of biochemistry, coagulation, haematology tests and urinalysis performed&#xD;
             during the screening visit, as judged by the investigator&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Female who is pregnant, breast-feeding or intends to become pregnant or is of&#xD;
             child-bearing potential not using an adequate contraceptive method throughout the&#xD;
             trial including the follow-up period (adequate contraceptive measures as required by&#xD;
             local regulation or practice)&#xD;
&#xD;
          -  Uncontrolled hypertension (defined as systolic blood pressure above or equal to 180&#xD;
             mmHg and/or diastolic blood pressure above or equal to 100 mmHg). If white-coat&#xD;
             hypertension is suspected at the screening visit a repeated measurement at the&#xD;
             screening visit is allowed&#xD;
&#xD;
          -  Mental inability, unwillingness or language barrier precluding adequate understanding&#xD;
             of or compliance with trial procedures&#xD;
&#xD;
          -  Donation of any blood or plasma in the past month or in excess of 400 mL within the 3&#xD;
             months preceding screening, or surgery or trauma with more than 400 mL blood loss&#xD;
             within the 3 months preceding screening&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Global Clinical Registry GCR, 1452</last_name>
    <role>Study Director</role>
    <affiliation>Novo Nordisk A/S</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Warszawa</city>
        <zip>02-507</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Wolomin</city>
        <zip>05-200</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Bratislava</city>
        <zip>83101</zip>
        <country>Slovakia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Bratislava</city>
        <zip>833 05</zip>
        <country>Slovakia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Poland</country>
    <country>Slovakia</country>
  </location_countries>
  <link>
    <url>http://novonordisk-trials.com</url>
    <description>Clinical Trials at Novo Nordisk</description>
  </link>
  <results_reference>
    <citation>Jensen L, Kupcova V, Arold G, Pettersson J, Hjerpsted JB. Pharmacokinetics and tolerability of semaglutide in people with hepatic impairment. Diabetes Obes Metab. 2018 Apr;20(4):998-1005. doi: 10.1111/dom.13186. Epub 2018 Jan 17.</citation>
    <PMID>29205786</PMID>
  </results_reference>
  <verification_date>December 2017</verification_date>
  <study_first_submitted>August 6, 2014</study_first_submitted>
  <study_first_submitted_qc>August 6, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 7, 2014</study_first_posted>
  <last_update_submitted>December 20, 2017</last_update_submitted>
  <last_update_submitted_qc>December 20, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">December 21, 2017</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>Diabetes Mellitus</mesh_term>
    <mesh_term>Diabetes Mellitus, Type 2</mesh_term>
  </condition_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/NCT02210871
org study id: NN9535-3651
secondary id: U1111-1149-3924
secondary id: 2009-011673-33
nct id: NCT02210871
lead sponsor: 
has dmc: No
This trial is conducted in Europe. The aim of this trial is to investigate the
      pharmacokinetics (the exposure of the trial drug in the body), safety and tolerability after
      a single injection of semaglutide in subjects with mild, moderate or severe hepatic
      impairment compared to subjects with normal hepatic function.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Area under the semaglutide plasma concentration-time curve
time frame: Day 1 - day 36
measure: Maximum observed semaglutide plasma concentration
time frame: Day 1 - day 36
measure: Number of treatment emergent adverse events (TEAEs)
time frame: Day 1 - day 36
arm group label: Normal hepatic function
arm group type: Experimental
arm group label: Mild hepatic impairment
arm group type: Experimental
arm group label: Moderate hepatic impairment
arm group type: Experimental
arm group label: Severe hepatic impairment
arm group type: Experimental
intervention type: Drug
intervention name: semaglutide
description: All subjects will be treated with a single subcutane (s.c., under the skin) injection of 0.5 mg semaglutide.
arm group label: Mild hepatic impairment
arm group label: Moderate hepatic impairment
arm group label: Normal hepatic function
arm group label: Severe hepatic impairment
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Global Clinical Registry GCR, 1452
role: Study Director
affiliation: Novo Nordisk A/S
facility: 
facility: 
facility: 
facility: 
country: Poland
country: Slovakia
url: http://novonordisk-trials.com
description: Clinical Trials at Novo Nordisk
citation: Jensen L, Kupcova V, Arold G, Pettersson J, Hjerpsted JB. Pharmacokinetics and tolerability of semaglutide in people with hepatic impairment. Diabetes Obes Metab. 2018 Apr;20(4):998-1005. doi: 10.1111/dom.13186. Epub 2018 Jan 17.
PMID: 29205786
responsible party type: Sponsor
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 2