<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/NCT02235961</url>
  </required_header>
  <id_info>
    <org_study_id>NN9030-4111</org_study_id>
    <secondary_id>U1111-1151-0761</secondary_id>
    <nct_id>NCT02235961</nct_id>
  </id_info>
  <brief_title>Investigate Safety, Tolerability and Pharmacokinetics for Single Doses of NNC9204-0530 Alone and in Combination With Liraglutide in Overweight to Obese But Otherwise Healthy Male Subjects</brief_title>
  <official_title>A First Human Dose Trial Investigating Safety, Tolerability and Pharmacokinetics for Single Doses of NNC9204-0530 Alone and in Combination With Liraglutide in Overweight to Obese But Otherwise Healthy Male Subjects.</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 the United States of America (USA). The aim of the trial is to&#xD;
      investigate safety, tolerability and pharmacokinetics (the exposure of the trial drug in the&#xD;
      body) for single doses of NNC9204-0530 alone and in combination with liraglutide in&#xD;
      overweight to obese but otherwise healthy male subjects.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 4, 2014</start_date>
  <completion_date type="Actual">July 6, 2016</completion_date>
  <primary_completion_date type="Actual">July 6, 2016</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>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of treatment emergent adverse events recorded</measure>
    <time_frame>From time of dosing of NNC9204-0530 (Day 1) until completion of the follow-up visit (Day 21-27)</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Area under the NNC9204-0530 serum concentration-time curve</measure>
    <time_frame>From dosing visit to infinity calculated on 0-24 days NNC9204-0530 serum concentration-curve based on 21 sampling points</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maximum concentration of NNC9204-0530 in serum</measure>
    <time_frame>From dosing visit to infinity calculated on 0-24 days NNC9204-0530 serum concentration-curve based on 21 sampling points</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The time to maximum concentration of NNC9204-0530 in serum</measure>
    <time_frame>From dosing visit to infinity calculated on 0-24 days NNC9204-0530 serum concentration-curve based on 21 sampling points</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The terminal half-life of NNC9204-0530</measure>
    <time_frame>From dosing visit to infinity calculated on 0-24 days NNC9204-0530 serum concentration-curve based on 21 sampling points</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">163</enrollment>
  <condition>Metabolism and Nutrition Disorder</condition>
  <condition>Obesity</condition>
  <arm_group>
    <arm_group_label>Part 1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Part 2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>NNC9204-0530</intervention_name>
    <description>Administered as single subcutaneous (s.c., under the skin) injections.</description>
    <arm_group_label>Part 1</arm_group_label>
    <arm_group_label>Part 2</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>liraglutide</intervention_name>
    <description>Administered as subcutaneous (s.c., under the skin) injections of 1.8 or 3.0 mg.</description>
    <arm_group_label>Part 2</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>placebo</intervention_name>
    <description>Administered as single subcutaneous (s.c., under the skin) injections.</description>
    <arm_group_label>Part 1</arm_group_label>
    <arm_group_label>Part 2</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male, age between (both inclusive) 18 and 55 years at the time of signing inform&#xD;
             consent&#xD;
&#xD;
          -  Overweight or obese but otherwise healthy male subjects; BMI of between or equal to&#xD;
             27.0 and 35.0 kg/m^2&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Thyroid stimulating hormone values outside 0.4-6.0 mIU/l&#xD;
&#xD;
          -  HbA1c (glycated hemoglobin) above or equal to 6.5%&#xD;
&#xD;
          -  Any clinically relevant ECG (electrocardiogram) findings (e.g. 2nd or 3rd degree&#xD;
             AV-block), in particular subjects with repeated demonstration of a QTcF (QT interval&#xD;
             corrected by Fridericia formula) interval above 430 ms&#xD;
&#xD;
          -  A history of additional risk factors for Torsades de pointes (e.g., heart failure,&#xD;
             hypokalemia, family history of Long QT Syndrome)&#xD;
&#xD;
          -  The use of concomitant medications that prolong the QT/QTc interval&#xD;
&#xD;
          -  Obesity caused by endocrinology disorders (e.g. Cushing's Syndrome)&#xD;
&#xD;
          -  Personal or family history of medullary thyroid carcinoma or multiple endocrine&#xD;
             neoplasia syndrome type 2&#xD;
&#xD;
          -  Calcitonin above 50 ng/L&#xD;
&#xD;
          -  History of pancreatitis (acute or chronic)&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</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>Overland Park</city>
        <state>Kansas</state>
        <zip>66212</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://novonordisk-trials.com</url>
    <description>Clinical Trials at Novo Nordisk</description>
  </link>
  <verification_date>July 2017</verification_date>
  <study_first_submitted>September 2, 2014</study_first_submitted>
  <study_first_submitted_qc>September 5, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 10, 2014</study_first_posted>
  <last_update_submitted>July 25, 2017</last_update_submitted>
  <last_update_submitted_qc>July 25, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">July 27, 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>Overweight</mesh_term>
    <mesh_term>Nutrition Disorders</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Liraglutide</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/NCT02235961
org study id: NN9030-4111
secondary id: U1111-1151-0761
nct id: NCT02235961
lead sponsor: 
has dmc: No
This trial is conducted in the United States of America (USA). The aim of the trial is to
      investigate safety, tolerability and pharmacokinetics (the exposure of the trial drug in the
      body) for single doses of NNC9204-0530 alone and in combination with liraglutide in
      overweight to obese but otherwise healthy male subjects.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Number of treatment emergent adverse events recorded
time frame: From time of dosing of NNC9204-0530 (Day 1) until completion of the follow-up visit (Day 21-27)
measure: Area under the NNC9204-0530 serum concentration-time curve
time frame: From dosing visit to infinity calculated on 0-24 days NNC9204-0530 serum concentration-curve based on 21 sampling points
measure: Maximum concentration of NNC9204-0530 in serum
time frame: From dosing visit to infinity calculated on 0-24 days NNC9204-0530 serum concentration-curve based on 21 sampling points
measure: The time to maximum concentration of NNC9204-0530 in serum
time frame: From dosing visit to infinity calculated on 0-24 days NNC9204-0530 serum concentration-curve based on 21 sampling points
measure: The terminal half-life of NNC9204-0530
time frame: From dosing visit to infinity calculated on 0-24 days NNC9204-0530 serum concentration-curve based on 21 sampling points
arm group label: Part 1
arm group type: Experimental
arm group label: Part 2
arm group type: Experimental
intervention type: Drug
intervention name: NNC9204-0530
description: Administered as single subcutaneous (s.c., under the skin) injections.
arm group label: Part 1
arm group label: Part 2
intervention type: Drug
intervention name: liraglutide
description: Administered as subcutaneous (s.c., under the skin) injections of 1.8 or 3.0 mg.
arm group label: Part 2
intervention type: Drug
intervention name: placebo
description: Administered as single subcutaneous (s.c., under the skin) injections.
arm group label: Part 1
arm group label: Part 2
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 55 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Global Clinical Registry (GCR, 1452)
role: Study Director
affiliation: Novo Nordisk A/S
facility: 
country: United States
url: http://novonordisk-trials.com
description: Clinical Trials at Novo Nordisk
responsible party type: Sponsor
mesh term: Overweight
mesh term: Nutrition Disorders
mesh term: Liraglutide