<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/NCT04472676</url>
  </required_header>
  <id_info>
    <org_study_id>17611</org_study_id>
    <secondary_id>J2O-MC-EKBA</secondary_id>
    <secondary_id>2020-002522-91</secondary_id>
    <nct_id>NCT04472676</nct_id>
  </id_info>
  <brief_title>A Study of LY3473329 in Healthy Participants</brief_title>
  <official_title>A Safety, Tolerability, and Pharmacokinetic Study of Single-and Multiple-Ascending Doses of LY3473329 in Healthy Subjects</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Eli Lilly and Company</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Eli Lilly and Company</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The main purpose of this study in healthy participants is to learn more about the safety of&#xD;
      LY3473329 and any side effects that might be associated with it. Blood tests will be&#xD;
      performed to check how much LY3473329 gets into the bloodstream and how long the body takes&#xD;
      to eliminate it. This is a two-part study. Participants may only enroll in one part.&#xD;
&#xD;
      For each participant:&#xD;
&#xD;
        -  Part A will last up to about 19 weeks and may include 9 visits.&#xD;
&#xD;
        -  Part B will last up to about 28 weeks and may include 11 visits.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 18, 2020</start_date>
  <completion_date type="Actual">November 9, 2021</completion_date>
  <primary_completion_date type="Actual">November 9, 2021</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>Baseline up to Day 137</time_frame>
    <description>A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY3473329</measure>
    <time_frame>Baseline up to Day 137</time_frame>
    <description>PK: AUC of LY3473329</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PK: Maximum Observed Drug Concentration (Cmax) of LY3473329</measure>
    <time_frame>Baseline up to Day 137</time_frame>
    <description>PK: Cmax of LY3473329</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">86</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>LY3473329 (Part A)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>LY3473329 administered orally.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo (Part A)</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo administered orally.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>LY3473329 (Part B)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>LY3473329 administered orally.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo (Part B)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Placebo administered orally.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>LY3473329</intervention_name>
    <description>Administered orally.</description>
    <arm_group_label>LY3473329 (Part A)</arm_group_label>
    <arm_group_label>LY3473329 (Part B)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Administered orally.</description>
    <arm_group_label>Placebo (Part A)</arm_group_label>
    <arm_group_label>Placebo (Part B)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Males and females must adhere to contraception restrictions&#xD;
&#xD;
          -  Have clinical laboratory test results within normal reference range or with acceptable&#xD;
             deviations&#xD;
&#xD;
          -  Body mass index (BMI) less than or equal to (≤)30 kilograms per square meter (kg/m²)&#xD;
&#xD;
          -  For Part B:&#xD;
&#xD;
               -  Lipoprotein (a) (Lp[a]) greater than or equal to (≥)75 nanomoles per Liter&#xD;
                  (nmol/L) or 30 milligrams per deciliter (mg/dL) at screening&#xD;
&#xD;
               -  Plasminogen is within the normal range at screening&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Are currently enrolled in, or discontinued within the past 30 days from, a clinical&#xD;
             trial involving an investigational drug that has not received regulatory approval for&#xD;
             any indication, except for any trial involving antisense Lp(a), for which 6 months&#xD;
             must have passed from the participant's last study drug dose&#xD;
&#xD;
          -  Have previously completed or withdrawn from this study or any other study&#xD;
             investigating LY3473329&#xD;
&#xD;
          -  Are pregnant or breast feeding&#xD;
&#xD;
          -  Glomerular filtration rate (GFR) is lower than estimated GFR 60 milliliters per minute&#xD;
             per 1.73 square meters (mL/min/1.73 m2) using the Modification of Diet in Renal&#xD;
             Disease Study equation&#xD;
&#xD;
          -  Have a history or presence of medical illness including, but not limited to, any&#xD;
             cardiovascular, thromboembolism or bleeding disorder, hepatic, respiratory,&#xD;
             hematological, endocrine, immune, psychiatric or neurological disease, convulsions, or&#xD;
             any clinically significant laboratory abnormality that, in the judgment of the&#xD;
             investigator, indicate a medical problem that would preclude study participation&#xD;
&#xD;
          -  Have an abnormality in the 12-lead electrocardiogram (ECG) that, in the opinion of the&#xD;
             investigator, increases the risks associated with participating in the study. In&#xD;
             addition, participants with the following findings will be excluded: Confirmed&#xD;
             Fridericia's corrected QT interval greater than (&gt;)450 milliseconds (msec) for men and&#xD;
             &gt;470 msec for women. One additional ECG may be performed if required&#xD;
&#xD;
          -  Have an elevated high-sensitivity C-reactive protein (&gt;3 milligrams per Liter [mg/L])&#xD;
             or have a prothrombin time/international normalized ratio (PT/INR) or activated&#xD;
             partial thromboplastin time (aPTT) &gt;1.25 times (x) upper limit of normal (ULN)&#xD;
&#xD;
          -  Are an investigator or site personnel directly affiliated or immediate families.&#xD;
             Immediate family is defined as a spouse, parent, child or sibling, whether biological&#xD;
             or legally adopted&#xD;
&#xD;
          -  Are Lilly employees or contractors or an immediate family member of such&#xD;
&#xD;
          -  Show evidence of human immunodeficiency virus (HIV) and/or positive human HIV&#xD;
             antibodies, hepatitis C and/or positive hepatitis C antibody, or hepatitis B and/or&#xD;
             positive hepatitis B surface antigen&#xD;
&#xD;
          -  Have donated more than 500 milliliters (mL) of blood within the past month&#xD;
&#xD;
          -  Are unwilling to stop alcohol consumption while resident in the clinical research unit&#xD;
             (CRU)&#xD;
&#xD;
          -  Have an average weekly alcohol intake that exceeds 21 units per week (1 unit = 12&#xD;
             ounces [oz] or 360 mL of beer; 5 oz or 150 mL of wine; 1.5 oz or 45 mL of distilled&#xD;
             spirits)&#xD;
&#xD;
          -  Have an abnormal blood pressure (supine) defined as diastolic blood pressure &gt;95 or&#xD;
             less than (&lt;)45 millimeters of Mercury (mmHg) and/or systolic blood pressure &gt;160 or&#xD;
             &lt;90 mmHg. Re-testing may occur once during screening within 2 hours of the initial&#xD;
             abnormal blood pressure measurement at the discretion of the investigator at screening&#xD;
&#xD;
          -  Have positive findings for known drugs of abuse on urinary drug screening&#xD;
&#xD;
          -  Positive severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) virus&#xD;
             nasopharyngeal polymerase chain reaction (PCR) test at Day -1&#xD;
&#xD;
          -  Contact with SARS-CoV-2- positive or corona virus disease 2019 (COVID-19) patient&#xD;
             within the last 14 days prior to admission to the clinical unit&#xD;
&#xD;
          -  In the opinion of the investigator or the sponsor, are unsuitable for inclusion in the&#xD;
             study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>54 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>PRA Health Sciences</name>
      <address>
        <city>Groningen</city>
        <zip>9728</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Netherlands</country>
  </location_countries>
  <verification_date>December 2021</verification_date>
  <study_first_submitted>July 14, 2020</study_first_submitted>
  <study_first_submitted_qc>July 14, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 15, 2020</study_first_posted>
  <last_update_submitted>December 13, 2021</last_update_submitted>
  <last_update_submitted_qc>December 13, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">December 14, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04472676
org study id: 17611
secondary id: J2O-MC-EKBA
secondary id: 2020-002522-91
nct id: NCT04472676
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The main purpose of this study in healthy participants is to learn more about the safety of
      LY3473329 and any side effects that might be associated with it. Blood tests will be
      performed to check how much LY3473329 gets into the bloodstream and how long the body takes
      to eliminate it. This is a two-part study. Participants may only enroll in one part.

      For each participant:

        -  Part A will last up to about 19 weeks and may include 9 visits.

        -  Part B will last up to about 28 weeks and may include 11 visits.
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: Baseline up to Day 137
description: A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module
measure: Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY3473329
time frame: Baseline up to Day 137
description: PK: AUC of LY3473329
measure: PK: Maximum Observed Drug Concentration (Cmax) of LY3473329
time frame: Baseline up to Day 137
description: PK: Cmax of LY3473329
arm group label: LY3473329 (Part A)
arm group type: Experimental
description: LY3473329 administered orally.
arm group label: Placebo (Part A)
arm group type: Placebo Comparator
description: Placebo administered orally.
arm group label: LY3473329 (Part B)
arm group type: Experimental
description: LY3473329 administered orally.
arm group label: Placebo (Part B)
arm group type: Experimental
description: Placebo administered orally.
intervention type: Drug
intervention name: LY3473329
description: Administered orally.
arm group label: LY3473329 (Part A)
arm group label: LY3473329 (Part B)
intervention type: Drug
intervention name: Placebo
description: Administered orally.
arm group label: Placebo (Part A)
arm group label: Placebo (Part B)
criteria: 
gender: All
minimum age: 18 Years
maximum age: 54 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: Netherlands
responsible party type: Sponsor
sharing ipd: No