<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/NCT03015207</url>
  </required_header>
  <id_info>
    <org_study_id>NN9499-4277</org_study_id>
    <secondary_id>U1111-1181-9045</secondary_id>
    <nct_id>NCT03015207</nct_id>
  </id_info>
  <brief_title>First Human Dose Trial Investigating Safety, Tolerability and Pharmacokinetics of NNC0194-0499 in Male Subjects With Overweight or Obesity</brief_title>
  <official_title>A Randomised, Double-blinded, Single-dose, Dose-escalation, First Human Dose Trial Investigating Safety, Tolerability and Pharmacokinetics of NNC0194-0499 in Male Subjects With Overweight or Obesity</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. The aim of this trial is to&#xD;
      investigate Safety, Tolerability and Pharmacokinetics (the exposure of the trial drug in the&#xD;
      body) of NNC0194-0499 in Male Subjects with Overweight or Obesity.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 6, 2017</start_date>
  <completion_date type="Actual">October 26, 2017</completion_date>
  <primary_completion_date type="Actual">October 26, 2017</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>Single Group 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 (TEAEs)</measure>
    <time_frame>From time of administration of NNC0194-0499 (day 1) to completion of the post-treatment period at follow-up (day 36)</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>The area under the NNC0194-0499 serum concentration-time curve after a single subcutaneous administration</measure>
    <time_frame>From pre-dose (day 1) until the followup (day 36)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The maximum concentration of NNC0194-0499 in serum after a single subcutaneous administration</measure>
    <time_frame>From pre-dose (day 1) until the followup (day 36)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The time to maximum concentration of NNC0194-0499 in serum after a single subcutaneous administration</measure>
    <time_frame>From pre-dose (day 1) until the followup (day 36)</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">56</enrollment>
  <condition>Metabolism and Nutrition Disorder</condition>
  <condition>Obesity</condition>
  <arm_group>
    <arm_group_label>NNC0194-0499</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Injected s.c. /subcutaneously (under the skin)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Injected s.c. /subcutaneously (under the skin)</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>NNC0194-0499</intervention_name>
    <arm_group_label>NNC0194-0499</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male, aged 22-55 years (both inclusive) at the time of signing informed consent&#xD;
&#xD;
          -  Body mass index (BMI) between 25.0 and 34.9 kg/m^2 (both inclusive). Overweight should&#xD;
             be due to excess adipose tissue, as judged by the investigator&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any concomitant illness or disorder, which in the investigator's opinion might&#xD;
             jeopardise the subject's safety or compliance with the protocol&#xD;
&#xD;
          -  Subjects aged above or equal to 40 years with an estimated 10-year atherosclerotic&#xD;
             cardiovascular disease (ASCVD according to ACC/AHA (American College of Cardiology&#xD;
             /American Heart Association) guideline) risk above or equal to 5%&#xD;
&#xD;
          -  Male subjects who are not sexually abstinent or surgically sterilised (vasectomy) and&#xD;
             are sexually active with female partner(s) and who are not using a highly effective&#xD;
             method of contraception (such as condom with spermicide) combined with a highly&#xD;
             effective method of contraception for their non-pregnant female partner(s) (Pearl&#xD;
             Index below 1%, such as implants, injectables, oral contraceptives, intrauterine&#xD;
             devices, diaphragm or cervical cap+spermicide), and/or intend to donate sperm in the&#xD;
             period from screening (visit 1) until 3 months following administration of the&#xD;
             investigational medical product&#xD;
&#xD;
          -  Use of prescription or non-prescription medicinal products including herbal products&#xD;
             and non-routine vitamins, within 2 weeks prior to screening, with the exception of&#xD;
             occasional use of acetaminophen, ibuprofen or acetylsalicylic acid&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>22 Years</minimum_age>
    <maximum_age>55 Years</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>San Antonio</city>
        <state>Texas</state>
        <zip>78209</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2018</verification_date>
  <study_first_submitted>January 6, 2017</study_first_submitted>
  <study_first_submitted_qc>January 6, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 9, 2017</study_first_posted>
  <last_update_submitted>September 3, 2018</last_update_submitted>
  <last_update_submitted_qc>September 3, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">September 5, 2018</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>Obesity</mesh_term>
    <mesh_term>Overweight</mesh_term>
    <mesh_term>Nutrition Disorders</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/NCT03015207
org study id: NN9499-4277
secondary id: U1111-1181-9045
nct id: NCT03015207
lead sponsor: 
has dmc: No
This trial is conducted in The United States of America. The aim of this trial is to
      investigate Safety, Tolerability and Pharmacokinetics (the exposure of the trial drug in the
      body) of NNC0194-0499 in Male Subjects with Overweight or Obesity.
allocation: Randomized
intervention model: Single Group Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Number of treatment-emergent adverse events (TEAEs)
time frame: From time of administration of NNC0194-0499 (day 1) to completion of the post-treatment period at follow-up (day 36)
measure: The area under the NNC0194-0499 serum concentration-time curve after a single subcutaneous administration
time frame: From pre-dose (day 1) until the followup (day 36)
measure: The maximum concentration of NNC0194-0499 in serum after a single subcutaneous administration
time frame: From pre-dose (day 1) until the followup (day 36)
measure: The time to maximum concentration of NNC0194-0499 in serum after a single subcutaneous administration
time frame: From pre-dose (day 1) until the followup (day 36)
arm group label: NNC0194-0499
arm group type: Experimental
description: Injected s.c. /subcutaneously (under the skin)
arm group label: Placebo
arm group type: Placebo Comparator
description: Injected s.c. /subcutaneously (under the skin)
intervention type: Drug
intervention name: NNC0194-0499
arm group label: NNC0194-0499
intervention type: Drug
intervention name: Placebo
arm group label: Placebo
criteria: 
gender: Male
minimum age: 22 Years
maximum age: 55 Years
healthy volunteers: No
last name: Global Clinical Registry (GCR,1452)
role: Study Director
affiliation: Novo Nordisk A/S
facility: 
country: United States
responsible party type: Sponsor
mesh term: Obesity
mesh term: Overweight
mesh term: Nutrition Disorders