<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/NCT03787225</url>
  </required_header>
  <id_info>
    <org_study_id>NN9838-4483</org_study_id>
    <secondary_id>U1111-1219-7303</secondary_id>
    <nct_id>NCT03787225</nct_id>
  </id_info>
  <brief_title>A Research Study of How NNC0174-0833 Behaves in Japanese and Caucasian Volunteers Who Are Normal Weight, Overweight or With Obesity</brief_title>
  <official_title>Investigation of Pharmacokinetic Properties, Safety and Tolerability of Single Subcutaneous Doses of NNC0174-0833 in Male Japanese and Caucasian Subjects Being Normal Weight, Overweight or With 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>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this study is to look at how the study medicine behaves in the participant's body&#xD;
      and how it is removed from the participant's body. The study compares Japanese and Caucasian&#xD;
      people who are normal weight, overweight or with obesity. The participants will either get&#xD;
      NNC0174-0833 (a potential new medicine) or placebo (a &quot;dummy&quot; medicine similar to the study&#xD;
      medicine but without active ingredients) - which treatment any participant gets is decided by&#xD;
      chance. Participants will get 1 injection by a study nurse at the clinic. The injection will&#xD;
      be with a needle in a skin fold in the participant's stomach area. The study will last for&#xD;
      about 4 months, but duration of participation for any participant will last up to about 2&#xD;
      months. The participants will have 8 clinic visits with the study staff.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 7, 2019</start_date>
  <completion_date type="Actual">June 4, 2019</completion_date>
  <primary_completion_date type="Actual">June 4, 2019</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>
    <intervention_model_description>Participants will be randomised to 1 of 6 treatment arms, in 3 receiving active NNC0174-0833 and 3 receiving placebo. For statistical analysis and reporting of results, data from the 3 placebo arms will be pooled.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
    <masking_description>Sponsor staff involved in the clinical trial is masked according to company standard procedures.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>AUC0-∞,AM833: the area under the NNC0174-0833 plasma concentration-time curve from time 0 to infinity after single dose</measure>
    <time_frame>From Day 1 (pre-dose) until completion of the post-treatment follow-up visit (Day 36)</time_frame>
    <description>Measured in h*nmol/L</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Cmax,AM833: the maximum concentration of NNC0174-0833 in plasma</measure>
    <time_frame>From Day 1 (pre-dose) until completion of the post-treatment follow-up visit (Day 36)</time_frame>
    <description>Measured in nmol/L</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of treatment emergent adverse events (TEAEs)</measure>
    <time_frame>From time of first dosing (Day 1) until completion of the post-treatment follow-up visit (Day 36)</time_frame>
    <description>Count of events</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">66</enrollment>
  <condition>Obesity</condition>
  <condition>Overweight</condition>
  <arm_group>
    <arm_group_label>NNC0174-0833 (0.3 mg)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive single dose of NNC0174-0833</description>
  </arm_group>
  <arm_group>
    <arm_group_label>NNC0174-0833 (0.9 mg)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive single dose of NNC0174-0833</description>
  </arm_group>
  <arm_group>
    <arm_group_label>NNC0174-0833 (1.8 mg)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive single dose of NNC0174-0833</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo (NNC0174-0833)</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Participants will receive placebo (NNC0174-0833)</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>NNC0174-0833</intervention_name>
    <description>Participants will receive dose levels of 0.3, 0.9 or 1.8 mg of NNC0174-0833 subcutaneously. Each participant will receive only one dose.</description>
    <arm_group_label>NNC0174-0833 (0.3 mg)</arm_group_label>
    <arm_group_label>NNC0174-0833 (0.9 mg)</arm_group_label>
    <arm_group_label>NNC0174-0833 (1.8 mg)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo (NNC0174-0833)</intervention_name>
    <description>Participants will receive NNC0174-0833 matched placebo subcutaneously.</description>
    <arm_group_label>Placebo (NNC0174-0833)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male, aged 18-55 years (both inclusive) at the time of signing informed consent.&#xD;
&#xD;
          -  For Japanese subjects, both parents of Japanese descent and both paternal and maternal&#xD;
             grandparents of Japanese descent.&#xD;
&#xD;
          -  For Caucasian subjects, self-reported European descent or white Latin-American&#xD;
             descent.&#xD;
&#xD;
          -  Body mass index (BMI) between 20.0 and 39.9 kg/m^2 (both inclusive) at screening.&#xD;
             Overweight should be due to excess adipose tissue, as judged by the investigator.&#xD;
&#xD;
          -  Body weight between 60 and 110 kg (both inclusive) at screening&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Male subject who is not surgically sterilised (vasectomy) and is sexually active (with&#xD;
             female partner[s] of childbearing potential), who is 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 less than 1%), or intend to donate sperm in the period from screening until 3&#xD;
             months following administration of the investigational medical product.&#xD;
&#xD;
          -  Any disorder which in the investigator's opinion might jeopardise subject's safety or&#xD;
             compliance with the protocol.&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Clinical Reporting Anchor and Disclosure 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>Glendale</city>
        <state>California</state>
        <zip>91206</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2019</verification_date>
  <study_first_submitted>December 21, 2018</study_first_submitted>
  <study_first_submitted_qc>December 21, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 26, 2018</study_first_posted>
  <last_update_submitted>June 21, 2019</last_update_submitted>
  <last_update_submitted_qc>June 21, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">June 24, 2019</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>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>According to the Novo Nordisk disclosure commitment on novonordisktrials.com</ipd_description>
    <ipd_url>http://novonordisk-trials.com</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/NCT03787225
org study id: NN9838-4483
secondary id: U1111-1219-7303
nct id: NCT03787225
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
The aim of this study is to look at how the study medicine behaves in the participant's body
      and how it is removed from the participant's body. The study compares Japanese and Caucasian
      people who are normal weight, overweight or with obesity. The participants will either get
      NNC0174-0833 (a potential new medicine) or placebo (a "dummy" medicine similar to the study
      medicine but without active ingredients) - which treatment any participant gets is decided by
      chance. Participants will get 1 injection by a study nurse at the clinic. The injection will
      be with a needle in a skin fold in the participant's stomach area. The study will last for
      about 4 months, but duration of participation for any participant will last up to about 2
      months. The participants will have 8 clinic visits with the study staff.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Participants will be randomised to 1 of 6 treatment arms, in 3 receiving active NNC0174-0833 and 3 receiving placebo. For statistical analysis and reporting of results, data from the 3 placebo arms will be pooled.
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
masking description: Sponsor staff involved in the clinical trial is masked according to company standard procedures.
measure: AUC0-∞,AM833: the area under the NNC0174-0833 plasma concentration-time curve from time 0 to infinity after single dose
time frame: From Day 1 (pre-dose) until completion of the post-treatment follow-up visit (Day 36)
description: Measured in h*nmol/L
measure: Cmax,AM833: the maximum concentration of NNC0174-0833 in plasma
time frame: From Day 1 (pre-dose) until completion of the post-treatment follow-up visit (Day 36)
description: Measured in nmol/L
measure: Number of treatment emergent adverse events (TEAEs)
time frame: From time of first dosing (Day 1) until completion of the post-treatment follow-up visit (Day 36)
description: Count of events
arm group label: NNC0174-0833 (0.3 mg)
arm group type: Experimental
description: Participants will receive single dose of NNC0174-0833
arm group label: NNC0174-0833 (0.9 mg)
arm group type: Experimental
description: Participants will receive single dose of NNC0174-0833
arm group label: NNC0174-0833 (1.8 mg)
arm group type: Experimental
description: Participants will receive single dose of NNC0174-0833
arm group label: Placebo (NNC0174-0833)
arm group type: Placebo Comparator
description: Participants will receive placebo (NNC0174-0833)
intervention type: Drug
intervention name: NNC0174-0833
description: Participants will receive dose levels of 0.3, 0.9 or 1.8 mg of NNC0174-0833 subcutaneously. Each participant will receive only one dose.
arm group label: NNC0174-0833 (0.3 mg)
arm group label: NNC0174-0833 (0.9 mg)
arm group label: NNC0174-0833 (1.8 mg)
intervention type: Drug
intervention name: Placebo (NNC0174-0833)
description: Participants will receive NNC0174-0833 matched placebo subcutaneously.
arm group label: Placebo (NNC0174-0833)
criteria: 
gender: Male
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Clinical Reporting Anchor and Disclosure 1452
role: Study Director
affiliation: Novo Nordisk A/S
facility: 
country: United States
responsible party type: Sponsor
mesh term: Obesity
mesh term: Overweight
sharing ipd: Yes
ipd description: According to the Novo Nordisk disclosure commitment on novonordisktrials.com
ipd url: http://novonordisk-trials.com