xml: <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/NCT05979428</url>
    </required_header>
    <id_info>
      <org_study_id>NN6491-4973</org_study_id>
      <secondary_id>U1111-1285-1575</secondary_id>
      <nct_id>NCT05979428</nct_id>
    </id_info>
    <brief_title>A Study to Look at How Safe a New Medicine (NNC0491-6075) is in Healthy People and in Participants With High Levels of Fat in the Blood</brief_title>
    <official_title>A Phase I, Randomised, Placebo-controlled Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of NNC0491-6075 Following Single Dose Administration to Healthy Participants and Multiple Doses to Participants With Dyslipidaemia</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 study is testing a new study medicine to treat people with high levels of fat in the&#xD;
        blood. The main aim of the study is to see if the new study medicine is safe and how it works&#xD;
        in the body. Participants will either get NNC0491-6075 (the new study medicine) or placebo (a&#xD;
        &quot;dummy medicine&quot; without active ingredients). Which treatment participants get is decided by&#xD;
        chance. NNC0491-6075 is a new medicine which cannot be prescribed by doctors. The study has 3&#xD;
        parts (Part A, Part B and Part C). In Part A, investigators look at the effect of the study&#xD;
        medicine after a single dose in healthy participants. Participants will get the study&#xD;
        medicine either as injection(s) under the skin or as an infusion into a vein by the study&#xD;
        staff. In Part B, investigators look at the effect of receiving the study medicine once&#xD;
        weekly for four weeks in participants with high levels of fat in the blood but who are&#xD;
        otherwise healthy. Participants will get the study medicine as injections under the skin by&#xD;
        the study staff. In Part C, investigators look at the effect of the study medicine after a&#xD;
        single dose in healthy participants of Japanese origin. Participants will get the study&#xD;
        medicine either as injection(s) under the skin or as an infusion into a vein by the study&#xD;
        staff. The study will last for about 18 months in total for Part A, Part B and Part C.&#xD;
        Participants in Part A and Part C will be in the study for about 139 days each, from&#xD;
        screening to the final visit while in Part B they will be in the study for about 160 days&#xD;
        from screening to the final visit.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">August 7, 2023</start_date>
    <completion_date type="Anticipated">March 10, 2025</completion_date>
    <primary_completion_date type="Anticipated">February 3, 2025</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>Sequential Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Part A (SAD): Number of treatment emergent adverse events (TEAEs)</measure>
      <time_frame>From pre-dose (Day 1) to end of study (Day 110)</time_frame>
      <description>Measured as count of events. An adverse event (AE) is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom or disease temporally associated with the use of a product, whether or not considered related to the product. A TEAE is defined as an AE that either has onset time after first trial product administration and no later than the end of study visit or Is present before first trial product administration and increases in severity during the treatment period and no later than the end of study visit.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Part B (MAD): Number of treatment emergent adverse events (TEAEs)</measure>
      <time_frame>From pre-dose (Day 1) to end of study (Day 131)</time_frame>
      <description>Measured as count of events. An adverse event (AE) is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom or disease temporally associated with the use of a product, whether or not considered related to the product. A TEAE is defined as an AE that either has onset time after first trial product administration and no later than the end of study visit or Is present before first trial product administration and increases in severity during the treatment period and no later than the end of study visit.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Part C (SAD): Number of treatment emergent adverse events (TEAEs)</measure>
      <time_frame>From pre-dose (Day 1) to end of study (Day 110)</time_frame>
      <description>Measured as count of events. An adverse event (AE) is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom or disease temporally associated with the use of a product, whether or not considered related to the product. A TEAE is defined as an AE that either has onset time after first trial product administration and no later than the end of study visit or Is present before first trial product administration and increases in severity during the treatment period and no later than the end of study visit.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Part A (SAD): AUC0-∞, SD; the area under the NNC0491-6075 serum concentration-time curve from 0 to infinity after a single dose</measure>
      <time_frame>From pre-dose (Day 1) to end of study (Day 110)</time_frame>
      <description>Measured as hours*nanomoles per liter (h*nmol/L)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Part A (SAD): Cmax, SD; the maximum serum concentration of NNC0491-6075 after a single dose</measure>
      <time_frame>From pre-dose (Day 1) to end of study (Day 110)</time_frame>
      <description>Measured as nanomoles per liter (nmol/L)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Part A (SAD): t½, SD; the terminal half-life of NNC0491-6075 after a single dose</measure>
      <time_frame>From pre-dose (Day 1) to end of study (Day 110)</time_frame>
      <description>Measured as hours (h)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Part A (SAD): tmax, SD; The time to maximum concentration of NNC0491-6075 after a single-dose (only from subcutaneous administration)</measure>
      <time_frame>From pre-dose (Day 1) to end of study (Day 110)</time_frame>
      <description>Measured as hours</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Part B (MAD): AUC0-168h, MD; the area under the NNC0491-6075 serum concentration-time curve from time 0 to 168 hours after last dose</measure>
      <time_frame>From pre-dose (Day 22) to 168 hours after last dose (Day 29)</time_frame>
      <description>Measured as h*nmol/L</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Part B (MAD): Cmax, MD; the maximum serum concentration of NNC0491-6075 after last dose</measure>
      <time_frame>From pre-dose (Day 22) to end of study (Day 131)</time_frame>
      <description>Measured as nmol/L</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Part B (MAD): t½, MD; the terminal half-life of NNC0491-6075 after last dose</measure>
      <time_frame>From pre-dose (Day 22) to end of study (Day 131)</time_frame>
      <description>Measured as hours</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Part B (MAD): tmax, MD; The time to maximum concentration of NNC0491-6075 after last dose</measure>
      <time_frame>From pre-dose (Day 22) to end of study (Day 131)</time_frame>
      <description>Measured as hours</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Part C (SAD): AUC0-∞, SD; the area under the NNC0491-6075 serum concentration-time curve from 0 to infinity after a single dose</measure>
      <time_frame>From pre-dose (Day 1) to end of study (Day 110)</time_frame>
      <description>Measured as h*nmol/L</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Part C (SAD): Cmax, SD; the maximum serum concentration of NNC0491-6075 after a single dose</measure>
      <time_frame>From pre-dose (Day 1) to end of study (Day 110)</time_frame>
      <description>Measured as nmol/L</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Part C (SAD): t½, SD; the terminal half-life of NNC0491-6075 after a single dose</measure>
      <time_frame>From pre-dose (Day 1) to end of study (Day 110)</time_frame>
      <description>Measured as hours</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Part C (SAD): tmax, SD; The time to maximum concentration of NNC0491-6075 after a single-dose (only from subcutaneous administration)</measure>
      <time_frame>From pre-dose (Day 1) to end of study (Day 110)</time_frame>
      <description>Measured as hours</description>
    </secondary_outcome>
    <number_of_arms>3</number_of_arms>
    <enrollment type="Anticipated">106</enrollment>
    <condition>Healthy Volunteers</condition>
    <condition>Dyslipidaemia</condition>
    <arm_group>
      <arm_group_label>Part A Single ascending dose (SAD) cohorts in healthy participants:</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Healthy participants, randomized in 3:1 ratio in each of the cohorts will receive single ascending dose of either NNC0491-6075 or placebo in 5 cohorts (Cohort A1, A2, A3, A4 and A5). In cohorts A1, A2 and A3, the participants will receive subcutaneous injection, whereas in cohorts A4 and A5 the administration will be performed intravenously.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Part B Multiple ascending dose (MAD) cohorts in dyslipidemia participants</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants with dyslipidemia, randomized in the ratio 2:1 in each of the cohorts will receive multiple ascending dose of either NNC0491-6075 or placebo in 3 cohorts (Cohort B1,B2 and B3). Participants will receive subcutaneous injections of either NNC0491-6075 or placebo once weekly for 4 weeks.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Part C: Single ascending dose (SAD) cohorts in healthy Japanese participants:</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Healthy Japanese participants, randomized in the ratio 3:1 in each of the cohorts will receive single ascending dose of either NNC0491-6075 or placebo in 3 cohorts (Cohort C1,C2 and C3). The route of administration will be subcutaneous or intravenous.</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>NNC0491-6075</intervention_name>
      <description>NNC0491-6075 will be administered as a subcutaneous injection in a skinfold in the abdomen or intravenously into a vein in the wrist, elbow, or the back of the hand.</description>
      <arm_group_label>Part A Single ascending dose (SAD) cohorts in healthy participants:</arm_group_label>
      <arm_group_label>Part B Multiple ascending dose (MAD) cohorts in dyslipidemia participants</arm_group_label>
      <arm_group_label>Part C: Single ascending dose (SAD) cohorts in healthy Japanese participants:</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Placebo</intervention_name>
      <description>Placebo matched to NNC0491-6075 will be administered as a subcutaneous injection in a skinfold in the abdomen or intravenously into a vein in the wrist, elbow, or the back of the hand.</description>
      <arm_group_label>Part A Single ascending dose (SAD) cohorts in healthy participants:</arm_group_label>
      <arm_group_label>Part B Multiple ascending dose (MAD) cohorts in dyslipidemia participants</arm_group_label>
      <arm_group_label>Part C: Single ascending dose (SAD) cohorts in healthy Japanese participants:</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
          Part A:&#xD;
  &#xD;
            -  Men or women of non-childbearing potential&#xD;
  &#xD;
            -  Aged 18-55 years (both inclusive) at the time of signing informed consent&#xD;
  &#xD;
            -  Considered to be generally healthy based on the medical history, physical examination,&#xD;
               and the results of vital signs, electrocardiogram and clinical laboratory tests&#xD;
               (presence of dyslipidaemia [example hypertriglyceridemia] is allowed) performed during&#xD;
               the screening visit, as judged by the investigator&#xD;
  &#xD;
            -  Body mass index (BMI) between 18.5 and 34.9 kilograms per square meter (kg/m^2) (both&#xD;
               inclusive) at screening&#xD;
  &#xD;
            -  Non-Japanese defined as not meeting inclusion criteria for Part C&#xD;
  &#xD;
          Part B:&#xD;
  &#xD;
            -  Men or women of non-childbearing potential&#xD;
  &#xD;
            -  Aged 18-64 years (both inclusive) at the time of signing informed consent&#xD;
  &#xD;
            -  Dyslipidaemia at screening defined as all the below: Fasting serum triglycerides (TGs)&#xD;
               greater than or equal to 150 milligrams per deciliter (mg/dL) and less than or equal&#xD;
               to 500 mg/dL. Participants must have two measurements performed for eligibility. Both&#xD;
               measurements must be greater than or equal to 135 mg/dL and at least one must be&#xD;
               greater than or equal to 150 mg/dL. One of the measurements may be based on medical&#xD;
               records or pre-screening results if the test is no more than 90 days old. If TGs are&#xD;
               measured twice during the screening period, the tests must be performed with at least&#xD;
               4 days apart. TGs measured in the screening period must be after a 10 hour fast&#xD;
  &#xD;
            -  Fasting low-density lipoprotein cholesterol (LDL-C) greater than or equal to 50 mg/dL&#xD;
               and less than 190 mg/dL&#xD;
  &#xD;
            -  Considered to be generally healthy based on the medical history, physical examination,&#xD;
               and the results of vital signs, electrocardiogram and clinical laboratory tests&#xD;
               performed during the screening visit, as judged by the investigator&#xD;
  &#xD;
            -  BMI between 18.5 and 34.9 kg/m^2 (both inclusive) at screening&#xD;
  &#xD;
            -  If on statin therapy the dose must have been stable for at least 8 weeks before&#xD;
               screening and must be intended to remain stable throughout the study&#xD;
  &#xD;
          Part C:&#xD;
  &#xD;
            -  Men or women of non-childbearing potential&#xD;
  &#xD;
            -  Aged 18-55 years (both inclusive) at the time of signing informed consent&#xD;
  &#xD;
            -  Considered to be generally healthy based on the medical history, physical examination,&#xD;
               and the results of vital signs, electrocardiogram and clinical laboratory tests&#xD;
               (presence of dyslipidaemia [example, hypertriglyceridemia] is allowed) performed&#xD;
               during the screening visit, as judged by the investigator&#xD;
  &#xD;
            -  BMI between 18.5 and 34.9 kg/m^2 (both inclusive) at screening&#xD;
  &#xD;
            -  Japanese defined as both biological parents of Japanese descent&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          Part A,B and C:&#xD;
  &#xD;
            -  Known or suspected hypersensitivity to study intervention(s) or related products&#xD;
  &#xD;
            -  Any disorder, which in the investigator's opinion might jeopardise participant's&#xD;
               safety or compliance with the protocol&#xD;
  &#xD;
            -  Use of prescription or non-prescription medicinal products within 14 days before&#xD;
               screening. Exceptions are: Topical medications; occasional use of over-the-counter&#xD;
               acetaminophen or Non-steroidal anti-inflammatory drugs (NSAIDs) at their labelled&#xD;
               doses for mild pain; and statin therapy in Part B only if the dose has been stable for&#xD;
               at least 8 weeks prior to screening and is intended to remain stable throughout the&#xD;
               trial&#xD;
  &#xD;
            -  Any laboratory safety parameters at screening outside the below laboratory ranges, see&#xD;
               designated reference range documents for specific values: Alanine aminotransferase&#xD;
               greater than upper limit of normal (ULN) +50 percentage (%), Aspartate&#xD;
               aminotransferase greater than ULN +50%, Total Bilirubin greater than ULN +20%,&#xD;
               Creatine kinase greater than ULN +50%.&#xD;
        </textblock>
      </criteria>
      <gender>All</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>Clinical Transparency dept. 2834</last_name>
      <role>Study Director</role>
      <affiliation>Novo Nordisk A/S</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Novo Nordisk</last_name>
      <phone>(+1) 866-867-7178</phone>
      <email>clinicaltrials@novonordisk.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Novo Nordisk Investigational Site</name>
        <address>
          <city>Cypress</city>
          <state>California</state>
          <zip>90630</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 31, 2023</study_first_submitted>
    <study_first_submitted_qc>July 31, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 7, 2023</study_first_posted>
    <last_update_submitted>August 8, 2023</last_update_submitted>
    <last_update_submitted_qc>August 8, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 9, 2023</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>Dyslipidemias</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>According to the Novo Nordisk disclosure commitment on novonordisk-trials.com.</ipd_description>
      <ipd_url>http://novonordisk-trials.com</ipd_url>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05979428
  org study id: NN6491-4973
  secondary id: U1111-1285-1575
  nct id: NCT05979428
  lead sponsor: 
  has dmc: No
  is fda regulated drug: Yes
  is fda regulated device: No
  The study is testing a new study medicine to treat people with high levels of fat in the
        blood. The main aim of the study is to see if the new study medicine is safe and how it works
        in the body. Participants will either get NNC0491-6075 (the new study medicine) or placebo (a
        "dummy medicine" without active ingredients). Which treatment participants get is decided by
        chance. NNC0491-6075 is a new medicine which cannot be prescribed by doctors. The study has 3
        parts (Part A, Part B and Part C). In Part A, investigators look at the effect of the study
        medicine after a single dose in healthy participants. Participants will get the study
        medicine either as injection(s) under the skin or as an infusion into a vein by the study
        staff. In Part B, investigators look at the effect of receiving the study medicine once
        weekly for four weeks in participants with high levels of fat in the blood but who are
        otherwise healthy. Participants will get the study medicine as injections under the skin by
        the study staff. In Part C, investigators look at the effect of the study medicine after a
        single dose in healthy participants of Japanese origin. Participants will get the study
        medicine either as injection(s) under the skin or as an infusion into a vein by the study
        staff. The study will last for about 18 months in total for Part A, Part B and Part C.
        Participants in Part A and Part C will be in the study for about 139 days each, from
        screening to the final visit while in Part B they will be in the study for about 160 days
        from screening to the final visit.
  allocation: Randomized
  intervention model: Sequential Assignment
  primary purpose: Treatment
  masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  measure: Part A (SAD): Number of treatment emergent adverse events (TEAEs)
  time frame: From pre-dose (Day 1) to end of study (Day 110)
  description: Measured as count of events. An adverse event (AE) is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom or disease temporally associated with the use of a product, whether or not considered related to the product. A TEAE is defined as an AE that either has onset time after first trial product administration and no later than the end of study visit or Is present before first trial product administration and increases in severity during the treatment period and no later than the end of study visit.
  measure: Part B (MAD): Number of treatment emergent adverse events (TEAEs)
  time frame: From pre-dose (Day 1) to end of study (Day 131)
  description: Measured as count of events. An adverse event (AE) is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom or disease temporally associated with the use of a product, whether or not considered related to the product. A TEAE is defined as an AE that either has onset time after first trial product administration and no later than the end of study visit or Is present before first trial product administration and increases in severity during the treatment period and no later than the end of study visit.
  measure: Part C (SAD): Number of treatment emergent adverse events (TEAEs)
  time frame: From pre-dose (Day 1) to end of study (Day 110)
  description: Measured as count of events. An adverse event (AE) is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom or disease temporally associated with the use of a product, whether or not considered related to the product. A TEAE is defined as an AE that either has onset time after first trial product administration and no later than the end of study visit or Is present before first trial product administration and increases in severity during the treatment period and no later than the end of study visit.
  measure: Part A (SAD): AUC0-∞, SD; the area under the NNC0491-6075 serum concentration-time curve from 0 to infinity after a single dose
  time frame: From pre-dose (Day 1) to end of study (Day 110)
  description: Measured as hours*nanomoles per liter (h*nmol/L)
  measure: Part A (SAD): Cmax, SD; the maximum serum concentration of NNC0491-6075 after a single dose
  time frame: From pre-dose (Day 1) to end of study (Day 110)
  description: Measured as nanomoles per liter (nmol/L)
  measure: Part A (SAD): t½, SD; the terminal half-life of NNC0491-6075 after a single dose
  time frame: From pre-dose (Day 1) to end of study (Day 110)
  description: Measured as hours (h)
  measure: Part A (SAD): tmax, SD; The time to maximum concentration of NNC0491-6075 after a single-dose (only from subcutaneous administration)
  time frame: From pre-dose (Day 1) to end of study (Day 110)
  description: Measured as hours
  measure: Part B (MAD): AUC0-168h, MD; the area under the NNC0491-6075 serum concentration-time curve from time 0 to 168 hours after last dose
  time frame: From pre-dose (Day 22) to 168 hours after last dose (Day 29)
  description: Measured as h*nmol/L
  measure: Part B (MAD): Cmax, MD; the maximum serum concentration of NNC0491-6075 after last dose
  time frame: From pre-dose (Day 22) to end of study (Day 131)
  description: Measured as nmol/L
  measure: Part B (MAD): t½, MD; the terminal half-life of NNC0491-6075 after last dose
  time frame: From pre-dose (Day 22) to end of study (Day 131)
  description: Measured as hours
  measure: Part B (MAD): tmax, MD; The time to maximum concentration of NNC0491-6075 after last dose
  time frame: From pre-dose (Day 22) to end of study (Day 131)
  description: Measured as hours
  measure: Part C (SAD): AUC0-∞, SD; the area under the NNC0491-6075 serum concentration-time curve from 0 to infinity after a single dose
  time frame: From pre-dose (Day 1) to end of study (Day 110)
  description: Measured as h*nmol/L
  measure: Part C (SAD): Cmax, SD; the maximum serum concentration of NNC0491-6075 after a single dose
  time frame: From pre-dose (Day 1) to end of study (Day 110)
  description: Measured as nmol/L
  measure: Part C (SAD): t½, SD; the terminal half-life of NNC0491-6075 after a single dose
  time frame: From pre-dose (Day 1) to end of study (Day 110)
  description: Measured as hours
  measure: Part C (SAD): tmax, SD; The time to maximum concentration of NNC0491-6075 after a single-dose (only from subcutaneous administration)
  time frame: From pre-dose (Day 1) to end of study (Day 110)
  description: Measured as hours
  arm group label: Part A Single ascending dose (SAD) cohorts in healthy participants:
  arm group type: Experimental
  description: Healthy participants, randomized in 3:1 ratio in each of the cohorts will receive single ascending dose of either NNC0491-6075 or placebo in 5 cohorts (Cohort A1, A2, A3, A4 and A5). In cohorts A1, A2 and A3, the participants will receive subcutaneous injection, whereas in cohorts A4 and A5 the administration will be performed intravenously.
  arm group label: Part B Multiple ascending dose (MAD) cohorts in dyslipidemia participants
  arm group type: Experimental
  description: Participants with dyslipidemia, randomized in the ratio 2:1 in each of the cohorts will receive multiple ascending dose of either NNC0491-6075 or placebo in 3 cohorts (Cohort B1,B2 and B3). Participants will receive subcutaneous injections of either NNC0491-6075 or placebo once weekly for 4 weeks.
  arm group label: Part C: Single ascending dose (SAD) cohorts in healthy Japanese participants:
  arm group type: Experimental
  description: Healthy Japanese participants, randomized in the ratio 3:1 in each of the cohorts will receive single ascending dose of either NNC0491-6075 or placebo in 3 cohorts (Cohort C1,C2 and C3). The route of administration will be subcutaneous or intravenous.
  intervention type: Drug
  intervention name: NNC0491-6075
  description: NNC0491-6075 will be administered as a subcutaneous injection in a skinfold in the abdomen or intravenously into a vein in the wrist, elbow, or the back of the hand.
  arm group label: Part A Single ascending dose (SAD) cohorts in healthy participants:
  arm group label: Part B Multiple ascending dose (MAD) cohorts in dyslipidemia participants
  arm group label: Part C: Single ascending dose (SAD) cohorts in healthy Japanese participants:
  intervention type: Drug
  intervention name: Placebo
  description: Placebo matched to NNC0491-6075 will be administered as a subcutaneous injection in a skinfold in the abdomen or intravenously into a vein in the wrist, elbow, or the back of the hand.
  arm group label: Part A Single ascending dose (SAD) cohorts in healthy participants:
  arm group label: Part B Multiple ascending dose (MAD) cohorts in dyslipidemia participants
  arm group label: Part C: Single ascending dose (SAD) cohorts in healthy Japanese participants:
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 55 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Clinical Transparency dept. 2834
  role: Study Director
  affiliation: Novo Nordisk A/S
  last name: Novo Nordisk
  phone: (+1) 866-867-7178
  email: clinicaltrials@novonordisk.com
  facility: 
  status: Recruiting
  country: United States
  responsible party type: Sponsor
  mesh term: Dyslipidemias
  sharing ipd: Yes
  ipd description: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com.
  ipd url: http://novonordisk-trials.com