<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/NCT02188303</url>
  </required_header>
  <id_info>
    <org_study_id>15247</org_study_id>
    <secondary_id>I7I-EW-XNAB</secondary_id>
    <nct_id>NCT02188303</nct_id>
  </id_info>
  <brief_title>A Study of LY2944876 in Healthy Japanese and Non-Japanese Participants</brief_title>
  <official_title>A Single and Multiple Ascending Dose Study to Evaluate Safety, Tolerability, and Pharmacokinetics of the Oxyntomodulin Analog, LY2944876, in Healthy Japanese Subjects and Healthy Non-Japanese Subjects</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>OPKO Health, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>OPKO Health, Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      LY2944876 is an investigative drug for the treatment of Type 2 Diabetes Mellitus. Part A of&#xD;
      the study will assess the safety and tolerability of single doses of LY2944876 in Japanese&#xD;
      participants. Participation is expected to last up to about 7 weeks, not including screening.&#xD;
&#xD;
      Part B of the study will investigate the safety and tolerability of multiple doses of&#xD;
      LY2944876 in non Japanese participants. Participation is expected to last up to about 8&#xD;
      weeks, not including screening.&#xD;
&#xD;
      All doses will be administered as injections into the fatty layer just beneath the skin.&#xD;
&#xD;
      Screening is required within 28 days prior to the start of the study. All participants will&#xD;
      attend a post study safety assessment approximately 6 weeks after their final dose.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    The termination criteria of the protocol was met during dose escalation.&#xD;
  </why_stopped>
  <start_date>July 2014</start_date>
  <completion_date type="Actual">December 2014</completion_date>
  <primary_completion_date type="Actual">December 2014</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>Basic Science</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to Be Related to Study Drug Administration</measure>
    <time_frame>Pre-dose (PRD) through Study Completion (Up to Day 40)</time_frame>
    <description>An SAE is any adverse event that results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. The number of participants with 1 or more SAEs considered by the investigator to be related to study drug administration is reported. A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, were reported in the Reported Adverse Events module.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Pharmacokinetics: Area Under the Concentration Versus Time Curve - Time Zero to 168 Hours Post-dose [AUC(0-168h)] of LY2944876</measure>
    <time_frame>Cohorts1-3:Day1 PRD,8,12,24,32,48,56,72,96,168Hrs;Days15,28,42:Cohort4:Day1 PRD,12 Hrs;Days2,3,4,5,6 PRD;Day7 PRD,12,24,36,48,56,72,96,168 Hrs;Days21,34,49: Cohort 5:Day1 PRD,12,24,48 Hrs;Days4,6,8,10 PRD;Day12 PRD,12,24,36,48,56,72,96,168 Hrs;Day26,39,53</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pharmacokinetics: Maximum Concentration (Cmax) of LY2944876</measure>
    <time_frame>Cohorts1-3:Day1 PRD,8,12,24,32,48,56,72,96,168Hrs;Days15,28,42:Cohort4:Day1 PRD,12 Hrs;Days2,3,4,5,6 PRD;Day7 PRD,12,24,36,48,56,72,96,168 Hrs;Days21,34,49: Cohort 5:Day1 PRD,12,24,48 Hrs;Days4,6,8,10 PRD;Day12 PRD,12,24,36,48,56,72,96,168 Hrs;Day26,39,53</time_frame>
  </secondary_outcome>
  <number_of_arms>6</number_of_arms>
  <enrollment type="Actual">48</enrollment>
  <condition>Healthy Volunteers</condition>
  <arm_group>
    <arm_group_label>Placebo (Single Dose, Cohorts 1-3)</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Single dose of placebo matching LY2944876 administered subcutaneous (SC) on Day 1</description>
  </arm_group>
  <arm_group>
    <arm_group_label>LY2944876 (Single Dose, Cohorts 1-3)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Single dose of 10 milligrams (mg) of LY2944876 administered SC on Day 1</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo (Multiple Dose, Cohort 4)</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo matching LY2944876 administered once daily SC on Days 1-7</description>
  </arm_group>
  <arm_group>
    <arm_group_label>LY2944876 (Multiple Dose, Cohort 4)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>40 mg LY2944876 administered once daily SC on Days 1-7</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo (Multiple, Cohort 5)</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo matching LY2944876 administered once daily SC on Days 1, 4, 6, 8, 10 and 12</description>
  </arm_group>
  <arm_group>
    <arm_group_label>LY2944876 (Multiple Dose, Cohort 5, Titrated)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>LY2944876 in titrated doses of 15 mg on Day 1, 30 mg on Day 4, up to 60 mg on Day 6, and up to 80 mg on Days 8, 10 and 12 administered once daily SC</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>LY2944876</intervention_name>
    <description>Administered SC</description>
    <arm_group_label>LY2944876 (Multiple Dose, Cohort 4)</arm_group_label>
    <arm_group_label>LY2944876 (Multiple Dose, Cohort 5, Titrated)</arm_group_label>
    <arm_group_label>LY2944876 (Single Dose, Cohorts 1-3)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Administered SC</description>
    <arm_group_label>Placebo (Multiple Dose, Cohort 4)</arm_group_label>
    <arm_group_label>Placebo (Multiple, Cohort 5)</arm_group_label>
    <arm_group_label>Placebo (Single Dose, Cohorts 1-3)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy males or female participants&#xD;
&#xD;
          -  Are first generation Japanese participants (Part A) or non-Japanese participants (Part&#xD;
             B)&#xD;
&#xD;
          -  Have a body mass index (BMI) of 18.5 to 30 kilogram per meter square (kg/m^2),&#xD;
             inclusive, for Part A and a BMI of 25 to 40 kg/m^2, inclusive, for Part B at screening&#xD;
&#xD;
          -  Have normal blood pressure and heart rate (after approximately 5 minutes supine and&#xD;
             approximately 2 minutes standing) as determined by the investigator at screening&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Have known allergies to LY2944876, related compounds or any components of the&#xD;
             formulation, or history of significant atopy&#xD;
&#xD;
          -  Have an abnormality in the 12-lead electrocardiogram (ECG) at screening and/or&#xD;
             baseline that, in the opinion of the investigator, increases the risks associated with&#xD;
             participating in the study&#xD;
&#xD;
          -  Have significant history of or current cardiovascular, respiratory, hepatic, renal,&#xD;
             gastrointestinal (GI), endocrine, hematological, or neurological disorders capable of&#xD;
             significantly altering the absorption, metabolism, or elimination of drugs; of&#xD;
             constituting a risk when taking the study medication; or of interfering with the&#xD;
             interpretation of data&#xD;
&#xD;
          -  Have a history of acute or chronic pancreatitis or elevation in serum lipase and/or&#xD;
             amylase greater than 2 times the upper limit of normal (ULN) at screening and/or&#xD;
             baseline&#xD;
&#xD;
          -  Have known or ongoing psychiatric disorders considered clinically significant in the&#xD;
             opinion of the investigator&#xD;
&#xD;
          -  Have undergone any form of bariatric surgery&#xD;
&#xD;
          -  Have fasting blood glucose levels greater than or equal to (≥) 7 millimoles per liter&#xD;
             (mmol/L) [≥126 milligrams per deciliter (mg/dL)] at screening&#xD;
&#xD;
          -  Have fasting triglycerides levels ≥300 mg/dL (3.4 mmol/L) at screening&#xD;
&#xD;
          -  Have obvious clinical signs or symptoms of liver disease, acute or chronic hepatitis,&#xD;
             or an alanine transaminase (ALT) or aspartate aminotransferase (AST) levels greater&#xD;
             than (&gt;) 2.5 times the ULN at screening and/or baseline&#xD;
&#xD;
          -  Have used or intend to use medications that promote weight loss, within 3 months prior&#xD;
             to screening, for the duration of the study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)</last_name>
    <role>Study Director</role>
    <affiliation>Eli Lilly and Company</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Leeds</city>
        <state>West Yorkshire</state>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>May 2021</verification_date>
  <study_first_submitted>July 10, 2014</study_first_submitted>
  <study_first_submitted_qc>July 10, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 11, 2014</study_first_posted>
  <results_first_submitted>October 17, 2019</results_first_submitted>
  <results_first_submitted_qc>March 19, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">April 14, 2021</results_first_posted>
  <last_update_submitted>May 25, 2021</last_update_submitted>
  <last_update_submitted_qc>May 25, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">May 27, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Part A / Cohorts 1-3 - Placebo</title>
          <description>Placebo, Single Dose Administered Subcutaneously (SC) on Day 1</description>
        </group>
        <group group_id="P2">
          <title>Part A / Cohort 1 - 10 mg LY2944876</title>
          <description>10 milligram (mg) LY2944876, Single Dose Administered SC on Day 1</description>
        </group>
        <group group_id="P3">
          <title>Part A / Cohort 2 - 30 mg LY2944876</title>
          <description>30 mg LY2944876, Single Dose Administered SC on Day 1</description>
        </group>
        <group group_id="P4">
          <title>Part A / Cohort 3 - 50 mg LY2944876</title>
          <description>50 mg LY2944876, Single Dose Administered SC on Day 1</description>
        </group>
        <group group_id="P5">
          <title>Part B / Cohort 4 - Placebo</title>
          <description>Placebo Administered Once Daily (QD) SC, Days 1-7</description>
        </group>
        <group group_id="P6">
          <title>Part B / Cohort 4 - 40 mg LY2944876</title>
          <description>40 mg LY2944876 Administered QD SC, Days 1-7</description>
        </group>
        <group group_id="P7">
          <title>Part B / Cohort 5 - Placebo</title>
          <description>Placebo Administered QD SC, Day 1, 4 and 6.</description>
        </group>
        <group group_id="P8">
          <title>Part B / Cohort 5 - 15-60 mg Titrated LY2944876</title>
          <description>LY2944876 Administered QD SC 15 mg on Day 1, 30 mg on Day 4 and up to 60 mg on Day 6.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
                <participants group_id="P2" count="6"/>
                <participants group_id="P3" count="6"/>
                <participants group_id="P4" count="6"/>
                <participants group_id="P5" count="4"/>
                <participants group_id="P6" count="12"/>
                <participants group_id="P7" count="2"/>
                <participants group_id="P8" count="6"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
                <participants group_id="P2" count="6"/>
                <participants group_id="P3" count="6"/>
                <participants group_id="P4" count="6"/>
                <participants group_id="P5" count="4"/>
                <participants group_id="P6" count="10"/>
                <participants group_id="P7" count="0">Protocol-defined dose termination criteria met, dosing stopped on Day 5 and study was terminated.</participants>
                <participants group_id="P8" count="0">Protocol-defined dose termination criteria met, dosing stopped on Day 5 and study was terminated.</participants>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="2"/>
                <participants group_id="P7" count="2"/>
                <participants group_id="P8" count="6"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="2"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Dose Termination Criteria Met</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="2"/>
                <participants group_id="P8" count="4"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Part A / Cohorts 1-3 - Placebo</title>
          <description>Placebo, Single Dose Administered SC</description>
        </group>
        <group group_id="B2">
          <title>Part A / Cohort 1 - 10 mg LY2944876</title>
          <description>LY2944876 10 mg, Single Dose Administered SC</description>
        </group>
        <group group_id="B3">
          <title>Part A / Cohort 2 - 30 mg LY2944876</title>
          <description>LY2944876 30 mg, Single Dose Administered SC</description>
        </group>
        <group group_id="B4">
          <title>Part A / Cohort 3 - 50 mg LY2944876</title>
          <description>LY2944876 50 mg, Single Dose Administered SC</description>
        </group>
        <group group_id="B5">
          <title>Part B / Cohort 4 - Placebo</title>
          <description>Placebo Administered QD SC, Days 1-7</description>
        </group>
        <group group_id="B6">
          <title>Part B / Cohort 4 - 40 mg LY2944876</title>
          <description>LY2944876 40 mg, Administered QD SC, Days 1-7</description>
        </group>
        <group group_id="B7">
          <title>Part B / Cohort 5 - Placebo</title>
          <description>Placebo, Administered QD SC, Days 1, 4 and 6.</description>
        </group>
        <group group_id="B8">
          <title>Part B / Cohort 5 - 15-60 mg Titrated LY2944876</title>
          <description>LY2944876 Administered QD SC 15 mg on Day 1, 30 mg on Day 4 and up to 60 mg on Day 6.</description>
        </group>
        <group group_id="B9">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="6"/>
            <count group_id="B2" value="6"/>
            <count group_id="B3" value="6"/>
            <count group_id="B4" value="6"/>
            <count group_id="B5" value="4"/>
            <count group_id="B6" value="12"/>
            <count group_id="B7" value="2"/>
            <count group_id="B8" value="6"/>
            <count group_id="B9" value="48"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <population>Age data was presented per Cohort (Part A and Part B).</population>
          <units>Years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <title>Cohorts 1-3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="6"/>
                    <count group_id="B2" value="6"/>
                    <count group_id="B3" value="6"/>
                    <count group_id="B4" value="6"/>
                    <count group_id="B5" value="0"/>
                    <count group_id="B6" value="0"/>
                    <count group_id="B7" value="0"/>
                    <count group_id="B8" value="0"/>
                    <count group_id="B9" value="24"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="29.2" spread="5.4"/>
                    <measurement group_id="B2" value="33.2" spread="5.8"/>
                    <measurement group_id="B3" value="29.5" spread="3.9"/>
                    <measurement group_id="B4" value="29.2" spread="3.5"/>
                    <measurement group_id="B9" value="30.3" spread="4.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cohorts 4-5</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                    <count group_id="B2" value="0"/>
                    <count group_id="B3" value="0"/>
                    <count group_id="B4" value="0"/>
                    <count group_id="B5" value="4"/>
                    <count group_id="B6" value="12"/>
                    <count group_id="B7" value="2"/>
                    <count group_id="B8" value="6"/>
                    <count group_id="B9" value="24"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B5" value="47.5" spread="18.2"/>
                    <measurement group_id="B6" value="46.3" spread="16.4"/>
                    <measurement group_id="B7" value="56.5" spread="7.8"/>
                    <measurement group_id="B8" value="46.3" spread="16.6"/>
                    <measurement group_id="B9" value="47.3" spread="15.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="6"/>
                    <count group_id="B2" value="6"/>
                    <count group_id="B3" value="6"/>
                    <count group_id="B4" value="6"/>
                    <count group_id="B5" value="4"/>
                    <count group_id="B6" value="12"/>
                    <count group_id="B7" value="2"/>
                    <count group_id="B8" value="6"/>
                    <count group_id="B9" value="48"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="2"/>
                    <measurement group_id="B6" value="3"/>
                    <measurement group_id="B7" value="1"/>
                    <measurement group_id="B8" value="2"/>
                    <measurement group_id="B9" value="8"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="6"/>
                    <measurement group_id="B4" value="6"/>
                    <measurement group_id="B5" value="2"/>
                    <measurement group_id="B6" value="9"/>
                    <measurement group_id="B7" value="1"/>
                    <measurement group_id="B8" value="4"/>
                    <measurement group_id="B9" value="40"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Asian</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="6"/>
                    <count group_id="B2" value="6"/>
                    <count group_id="B3" value="6"/>
                    <count group_id="B4" value="6"/>
                    <count group_id="B5" value="4"/>
                    <count group_id="B6" value="12"/>
                    <count group_id="B7" value="2"/>
                    <count group_id="B8" value="6"/>
                    <count group_id="B9" value="48"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="6"/>
                    <measurement group_id="B4" value="6"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="1"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="0"/>
                    <measurement group_id="B9" value="25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>White</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="6"/>
                    <count group_id="B2" value="6"/>
                    <count group_id="B3" value="6"/>
                    <count group_id="B4" value="6"/>
                    <count group_id="B5" value="4"/>
                    <count group_id="B6" value="12"/>
                    <count group_id="B7" value="2"/>
                    <count group_id="B8" value="6"/>
                    <count group_id="B9" value="48"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="4"/>
                    <measurement group_id="B6" value="11"/>
                    <measurement group_id="B7" value="2"/>
                    <measurement group_id="B8" value="6"/>
                    <measurement group_id="B9" value="23"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>Participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United Kingdom</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="6"/>
                    <count group_id="B2" value="6"/>
                    <count group_id="B3" value="6"/>
                    <count group_id="B4" value="6"/>
                    <count group_id="B5" value="4"/>
                    <count group_id="B6" value="12"/>
                    <count group_id="B7" value="2"/>
                    <count group_id="B8" value="6"/>
                    <count group_id="B9" value="48"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="6"/>
                    <measurement group_id="B4" value="6"/>
                    <measurement group_id="B5" value="4"/>
                    <measurement group_id="B6" value="12"/>
                    <measurement group_id="B7" value="2"/>
                    <measurement group_id="B8" value="6"/>
                    <measurement group_id="B9" value="48"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to Be Related to Study Drug Administration</title>
        <description>An SAE is any adverse event that results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. The number of participants with 1 or more SAEs considered by the investigator to be related to study drug administration is reported. A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, were reported in the Reported Adverse Events module.</description>
        <time_frame>Pre-dose (PRD) through Study Completion (Up to Day 40)</time_frame>
        <population>All enrolled participants, whether or not they completed all protocol requirements.</population>
        <group_list>
          <group group_id="O1">
            <title>Cohorts 1-3 - Placebo</title>
            <description>Placebo, Single Dose Administered SC</description>
          </group>
          <group group_id="O2">
            <title>Cohort 1 - 10 mg LY2944876</title>
            <description>10 mg LY2944876, Single Dose Administered SC</description>
          </group>
          <group group_id="O3">
            <title>Cohort 2 - 30 mg LY2944876</title>
            <description>30 mg LY2944876, Single Dose Administered SC</description>
          </group>
          <group group_id="O4">
            <title>Cohort 3 - 50 mg LY2944876</title>
            <description>50 mg LY2944876, Single Dose Administered SC</description>
          </group>
          <group group_id="O5">
            <title>Cohort 4 - Placebo</title>
            <description>Placebo Administered QD SC, Days 1-7</description>
          </group>
          <group group_id="O6">
            <title>Cohort 4 - 40 mg LY2944876</title>
            <description>40 mg LY2944876 Administered QD SC, Days 1-7</description>
          </group>
          <group group_id="O7">
            <title>Cohort 5 - Placebo</title>
            <description>Placebo Administered QD SC, Day 1, Day 4 and Day 6.</description>
          </group>
          <group group_id="O8">
            <title>Cohort 5 - 15-60 mg Titrated LY2944876</title>
            <description>LY2944876 Administered QD SC 15 mg on Day 1, 30 mg on Day 4 and up to 60 mg on Day 6.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to Be Related to Study Drug Administration</title>
          <description>An SAE is any adverse event that results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. The number of participants with 1 or more SAEs considered by the investigator to be related to study drug administration is reported. A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, were reported in the Reported Adverse Events module.</description>
          <population>All enrolled participants, whether or not they completed all protocol requirements.</population>
          <units>Participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="6"/>
                <count group_id="O3" value="6"/>
                <count group_id="O4" value="6"/>
                <count group_id="O5" value="4"/>
                <count group_id="O6" value="12"/>
                <count group_id="O7" value="2"/>
                <count group_id="O8" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Pharmacokinetics: Area Under the Concentration Versus Time Curve - Time Zero to 168 Hours Post-dose [AUC(0-168h)] of LY2944876</title>
        <time_frame>Cohorts1-3:Day1 PRD,8,12,24,32,48,56,72,96,168Hrs;Days15,28,42:Cohort4:Day1 PRD,12 Hrs;Days2,3,4,5,6 PRD;Day7 PRD,12,24,36,48,56,72,96,168 Hrs;Days21,34,49: Cohort 5:Day1 PRD,12,24,48 Hrs;Days4,6,8,10 PRD;Day12 PRD,12,24,36,48,56,72,96,168 Hrs;Day26,39,53</time_frame>
        <population>All randomized participants receiving at least one dose of the investigational product and had evaluable AUC data.</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort 1 - 10 mg LY2944876</title>
            <description>10 mg LY2944876, Single Dose Administered SC</description>
          </group>
          <group group_id="O2">
            <title>Cohort 2 - 30 mg LY2944876</title>
            <description>30 mg LY2944876, Single Dose Administered SC</description>
          </group>
          <group group_id="O3">
            <title>Cohort 3 - 50 mg LY2944876</title>
            <description>50 mg LY2944876, Single Dose Administered SC</description>
          </group>
          <group group_id="O4">
            <title>Cohort 4 - 40 mg LY2944876</title>
            <description>40 mg LY2944876 Administered QD SC, Day 7</description>
          </group>
          <group group_id="O5">
            <title>Cohort 5 - 15-60 mg Titrated LY2944876</title>
            <description>LY2944876 Administered QD SC, titrated up to 60 mg on Day 6</description>
          </group>
        </group_list>
        <measure>
          <title>Pharmacokinetics: Area Under the Concentration Versus Time Curve - Time Zero to 168 Hours Post-dose [AUC(0-168h)] of LY2944876</title>
          <population>All randomized participants receiving at least one dose of the investigational product and had evaluable AUC data.</population>
          <units>nanograms∙hours/milliliters (ng∙h/mL)</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="6"/>
                <count group_id="O3" value="6"/>
                <count group_id="O4" value="10"/>
                <count group_id="O5" value="5"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="105000" spread="32"/>
                    <measurement group_id="O2" value="307000" spread="38"/>
                    <measurement group_id="O3" value="495000" spread="34"/>
                    <measurement group_id="O4" value="1789000" spread="15"/>
                    <measurement group_id="O5" value="803000" spread="24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Pharmacokinetics: Maximum Concentration (Cmax) of LY2944876</title>
        <time_frame>Cohorts1-3:Day1 PRD,8,12,24,32,48,56,72,96,168Hrs;Days15,28,42:Cohort4:Day1 PRD,12 Hrs;Days2,3,4,5,6 PRD;Day7 PRD,12,24,36,48,56,72,96,168 Hrs;Days21,34,49: Cohort 5:Day1 PRD,12,24,48 Hrs;Days4,6,8,10 PRD;Day12 PRD,12,24,36,48,56,72,96,168 Hrs;Day26,39,53</time_frame>
        <population>All randomized participants receiving at least one dose of the investigational product and had evaluable Cmax data.</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort 1 - 10 mg LY2944876</title>
            <description>10 mg LY2944876, Single Dose Administered SC</description>
          </group>
          <group group_id="O2">
            <title>Cohort 2 - 30 mg LY2944876</title>
            <description>30 mg LY2944876, Single Dose Administered SC</description>
          </group>
          <group group_id="O3">
            <title>Cohort 3 - LY2944876 50 mg</title>
            <description>50 mg LY2944876, Single Dose Administered SC</description>
          </group>
          <group group_id="O4">
            <title>Cohort 4 - 40 mg LY2944876</title>
            <description>40 mg LY2944876 Administered QD SC, Day 7</description>
          </group>
          <group group_id="O5">
            <title>Cohort 5 - 15-60 mg Titrated LY2944876</title>
            <description>LY2944876 Administered QD SC, titrated up to 60 mg on Day 6</description>
          </group>
        </group_list>
        <measure>
          <title>Pharmacokinetics: Maximum Concentration (Cmax) of LY2944876</title>
          <population>All randomized participants receiving at least one dose of the investigational product and had evaluable Cmax data.</population>
          <units>nanograms/milliliter (ng/mL)</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="6"/>
                <count group_id="O3" value="6"/>
                <count group_id="O4" value="10"/>
                <count group_id="O5" value="5"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="790" spread="33"/>
                    <measurement group_id="O2" value="2360" spread="36"/>
                    <measurement group_id="O3" value="3640" spread="35"/>
                    <measurement group_id="O4" value="11700" spread="26"/>
                    <measurement group_id="O5" value="5470" spread="22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <group_list>
        <group group_id="E1">
          <title>Cohorts 1-3 - Placebo</title>
          <description>Placebo, Single Dose Administered Subcutaneously (SC)</description>
        </group>
        <group group_id="E2">
          <title>Cohort 1 - LY2944876 10 mg</title>
          <description>LY2944876 10 mg, Single Dose Administered SC</description>
        </group>
        <group group_id="E3">
          <title>Cohort 2 - LY2944876 30 mg</title>
          <description>LY2944876 30 mg, Single Dose Administered SC</description>
        </group>
        <group group_id="E4">
          <title>Cohort 3 - LY2944876 50 mg</title>
          <description>LY2944876 50 mg, Single Dose Administered SC</description>
        </group>
        <group group_id="E5">
          <title>Cohort 4 - Placebo</title>
          <description>Placebo Administered QD SC, Days 1-7</description>
        </group>
        <group group_id="E6">
          <title>Cohort 4 - LY2944876 40 mg</title>
          <description>LY2944876 40 mg Administered QD SC, Days 1-7</description>
        </group>
        <group group_id="E7">
          <title>Cohort 5 - Placebo</title>
          <description>Placebo Administered QD SC, Day 1, Day 4, and Day 6.</description>
        </group>
        <group group_id="E8">
          <title>Cohort 5 - 15-80 mg Titrated LY2944876</title>
          <description>LY2944876 Administered QD SC 15 mg on Day 1, 30 mg on Day 4 and up to 60 mg on Day 6.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA 17.0</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="6" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="4" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="12" subjects_at_risk="12"/>
                <counts group_id="E7" subjects_affected="2" subjects_at_risk="2"/>
                <counts group_id="E8" subjects_affected="6" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Palpitations</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal discomfort</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Abdominal distension</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="6" subjects_affected="5" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="2" subjects_affected="1" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Abdominal pain lower</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="2"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Abdominal pain upper</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" events="3" subjects_affected="3" subjects_at_risk="12"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="2" subjects_affected="2" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="4" subjects_affected="4" subjects_at_risk="6"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" events="6" subjects_affected="6" subjects_at_risk="12"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" events="2" subjects_affected="2" subjects_at_risk="12"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="3" subjects_affected="2" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Dyspepsia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" events="3" subjects_affected="3" subjects_at_risk="12"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="3" subjects_affected="3" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Epigastric discomfort</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Eructation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="2"/>
                <counts group_id="E8" events="2" subjects_affected="2" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Flatulence</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Gastrooesophageal reflux disease</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" events="6" subjects_affected="6" subjects_at_risk="12"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Lip dry</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E4" events="3" subjects_affected="3" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" events="6" subjects_affected="6" subjects_at_risk="12"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="2"/>
                <counts group_id="E8" events="5" subjects_affected="5" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Rectal tenesmus</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" events="8" subjects_affected="8" subjects_at_risk="12"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="3" subjects_affected="3" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Feeling hot</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="2" subjects_affected="2" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Injection site bruising</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E6" events="2" subjects_affected="2" subjects_at_risk="12"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="2" subjects_affected="1" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Injection site pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Malaise</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Labyrinthitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="2"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Viral upper respiratory tract infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Procedural site reaction</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="2" subjects_affected="2" subjects_at_risk="4"/>
                <counts group_id="E6" events="2" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Decreased appetite</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="6"/>
                <counts group_id="E4" events="3" subjects_affected="3" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" events="9" subjects_affected="9" subjects_at_risk="12"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="3" subjects_affected="3" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E6" events="2" subjects_affected="2" subjects_at_risk="12"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Joint lock</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="2" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Pain in extremity</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="2" subjects_affected="2" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Ageusia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E6" events="3" subjects_affected="3" subjects_at_risk="12"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="3" subjects_affected="3" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Dysarthria</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" events="7" subjects_affected="6" subjects_at_risk="12"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="2"/>
                <counts group_id="E8" events="2" subjects_affected="2" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Lethargy</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Paraesthesia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="2" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Oropharyngeal pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" events="2" subjects_affected="2" subjects_at_risk="12"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Rhinorrhoea</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Alopecia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Dry skin</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Erythema</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Rash</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Rash erythematous</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Rash macular</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Skin lesion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Chief Medical Officer</name_or_title>
      <organization>Eli Lilly and Company</organization>
      <phone>800-545-5979</phone>
      <email>ClinicalTrials.gov@lilly.com</email>
    </point_of_contact>
  </clinical_results>
</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/NCT02188303
org study id: 15247
secondary id: I7I-EW-XNAB
nct id: NCT02188303
lead sponsor: 
has dmc: No
LY2944876 is an investigative drug for the treatment of Type 2 Diabetes Mellitus. Part A of
      the study will assess the safety and tolerability of single doses of LY2944876 in Japanese
      participants. Participation is expected to last up to about 7 weeks, not including screening.

      Part B of the study will investigate the safety and tolerability of multiple doses of
      LY2944876 in non Japanese participants. Participation is expected to last up to about 8
      weeks, not including screening.

      All doses will be administered as injections into the fatty layer just beneath the skin.

      Screening is required within 28 days prior to the start of the study. All participants will
      attend a post study safety assessment approximately 6 weeks after their final dose.
allocation: Randomized
intervention model: Sequential Assignment
primary purpose: Basic Science
masking: Double (Participant, Investigator)
measure: Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to Be Related to Study Drug Administration
time frame: Pre-dose (PRD) through Study Completion (Up to Day 40)
description: An SAE is any adverse event that results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. The number of participants with 1 or more SAEs considered by the investigator to be related to study drug administration is reported. A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, were reported in the Reported Adverse Events module.
measure: Pharmacokinetics: Area Under the Concentration Versus Time Curve - Time Zero to 168 Hours Post-dose [AUC(0-168h)] of LY2944876
time frame: Cohorts1-3:Day1 PRD,8,12,24,32,48,56,72,96,168Hrs;Days15,28,42:Cohort4:Day1 PRD,12 Hrs;Days2,3,4,5,6 PRD;Day7 PRD,12,24,36,48,56,72,96,168 Hrs;Days21,34,49: Cohort 5:Day1 PRD,12,24,48 Hrs;Days4,6,8,10 PRD;Day12 PRD,12,24,36,48,56,72,96,168 Hrs;Day26,39,53
measure: Pharmacokinetics: Maximum Concentration (Cmax) of LY2944876
time frame: Cohorts1-3:Day1 PRD,8,12,24,32,48,56,72,96,168Hrs;Days15,28,42:Cohort4:Day1 PRD,12 Hrs;Days2,3,4,5,6 PRD;Day7 PRD,12,24,36,48,56,72,96,168 Hrs;Days21,34,49: Cohort 5:Day1 PRD,12,24,48 Hrs;Days4,6,8,10 PRD;Day12 PRD,12,24,36,48,56,72,96,168 Hrs;Day26,39,53
arm group label: Placebo (Single Dose, Cohorts 1-3)
arm group type: Placebo Comparator
description: Single dose of placebo matching LY2944876 administered subcutaneous (SC) on Day 1
arm group label: LY2944876 (Single Dose, Cohorts 1-3)
arm group type: Experimental
description: Single dose of 10 milligrams (mg) of LY2944876 administered SC on Day 1
arm group label: Placebo (Multiple Dose, Cohort 4)
arm group type: Placebo Comparator
description: Placebo matching LY2944876 administered once daily SC on Days 1-7
arm group label: LY2944876 (Multiple Dose, Cohort 4)
arm group type: Experimental
description: 40 mg LY2944876 administered once daily SC on Days 1-7
arm group label: Placebo (Multiple, Cohort 5)
arm group type: Placebo Comparator
description: Placebo matching LY2944876 administered once daily SC on Days 1, 4, 6, 8, 10 and 12
arm group label: LY2944876 (Multiple Dose, Cohort 5, Titrated)
arm group type: Experimental
description: LY2944876 in titrated doses of 15 mg on Day 1, 30 mg on Day 4, up to 60 mg on Day 6, and up to 80 mg on Days 8, 10 and 12 administered once daily SC
intervention type: Drug
intervention name: LY2944876
description: Administered SC
arm group label: LY2944876 (Multiple Dose, Cohort 4)
arm group label: LY2944876 (Multiple Dose, Cohort 5, Titrated)
arm group label: LY2944876 (Single Dose, Cohorts 1-3)
intervention type: Drug
intervention name: Placebo
description: Administered SC
arm group label: Placebo (Multiple Dose, Cohort 4)
arm group label: Placebo (Multiple, Cohort 5)
arm group label: Placebo (Single Dose, Cohorts 1-3)
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: Study Director
affiliation: Eli Lilly and Company
facility: 
country: United Kingdom
responsible party type: Sponsor
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 