<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/NCT04498390</url>
  </required_header>
  <id_info>
    <org_study_id>17451</org_study_id>
    <secondary_id>J1X-MC-GZHB</secondary_id>
    <nct_id>NCT04498390</nct_id>
  </id_info>
  <brief_title>A Safety Study of LY3493269 in Healthy Participants</brief_title>
  <official_title>A Multiple-Ascending Dose Study to Investigate the Safety, Tolerability, and Pharmacokinetics of LY3493269 in Healthy Participants</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>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The main purpose of this study in healthy participants is to learn more about the safety of&#xD;
      LY3493269 and any side effects that might be associated with it. Blood tests will be&#xD;
      performed to check how much LY3493269 gets into the bloodstream and how long it takes the&#xD;
      body to eliminate it. For each participant, the study will last about 10 weeks and may&#xD;
      include 12 visits, including five nights in a row in the clinical research center.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 3, 2020</start_date>
  <completion_date type="Actual">December 28, 2020</completion_date>
  <primary_completion_date type="Actual">December 28, 2020</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 through Day 43</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): Maximum Observed Drug Concentration (Cmax) of LY3493269</measure>
    <time_frame>Days 1 and 3: Predose through 24 hours post-dose</time_frame>
    <description>PK: Cmax of LY3493269</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PK: Area Under the Concentration Versus Time Curve (AUC) of LY3493269</measure>
    <time_frame>Days 1 and 3: Predose through 24 hours post-dose</time_frame>
    <description>PK: AUC of LY3493269</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>LY3493269</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>LY3493269 administered orally.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo administered orally.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>LY3493269</intervention_name>
    <description>Administered orally.</description>
    <arm_group_label>LY3493269</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Administered orally.</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Are male or female not of childbearing potential&#xD;
&#xD;
          -  Body mass index within the range of 19.0 to 40.0 kilograms per square meter (kg/m²)&#xD;
             (inclusive)&#xD;
&#xD;
          -  Participants who are healthy as determined through medical evaluation including&#xD;
             screening medical history, physical examination, vital signs, clinical laboratory&#xD;
             tests, and electrocardiogram (ECG)&#xD;
&#xD;
          -  Have clinical laboratory test results within normal reference range for the population&#xD;
             or clinical research unit (CRU), or results with acceptable deviations that are judged&#xD;
             to be not clinically significant by the investigator&#xD;
&#xD;
          -  Have glycated hemoglobin level of less than (&lt;)6.5 percent (%)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Have a supine heart rate (HR) less than 50 beats per minute (bpm) or greater than 100&#xD;
             bpm. If a repeat measurement shows values within the range, the participant can be&#xD;
             included in the trial&#xD;
&#xD;
          -  Have a mean supine systolic blood pressure (BP) higher than 160 millimeters of Mercury&#xD;
             (mmHg) and a mean supine diastolic BP higher than 95 mmHg from 2 assessments at&#xD;
             screening (excluding white-coat hypertension); therefore, if a repeated measurement&#xD;
             shows values within the range, the participant can be included in the trial&#xD;
&#xD;
          -  Have undergone any form of bariatric surgery&#xD;
&#xD;
          -  Have a history of gastrointestinal (GI) bleeding or duodenal ulcers&#xD;
&#xD;
          -  Have a personal or family history of medullary thyroid carcinoma or have multiple&#xD;
             endocrine neoplasia syndrome type 2&#xD;
&#xD;
          -  Have a history of acute or chronic pancreatitis, or elevation in serum lipase and/or&#xD;
             amylase levels greater than 1.5 times the upper limit of normal (ULN)&#xD;
&#xD;
          -  Have obvious clinical signs or symptoms of liver disease, acute or chronic hepatitis&#xD;
&#xD;
          -  Have been treated with prescription drugs that promote weight loss within 3 months&#xD;
             prior to screening&#xD;
&#xD;
          -  Have participated within the past 30 days of screening in a clinical study involving&#xD;
             an investigational product (IP); at least 5 half-lives or 30 days, whichever is&#xD;
             longer, should have passed&#xD;
&#xD;
          -  Have an abnormality in the 12-lead ECG at screening that, in the opinion of the&#xD;
             investigator, increases the risks associated with participating in the study or may&#xD;
             confound ECG (QT) data analysis, such as a QT interval corrected using Fridericia's&#xD;
             formula (QTcF) greater than (&gt;)450 milliseconds (msec) for males and &gt;470 msec for&#xD;
             females, short PR interval (&lt;120 msec), or PR interval &gt;220 msec, second and third&#xD;
             atrioventricular block, intraventricular conduction delay with QRS &gt;120 msec, right&#xD;
             bundle branch block, left bundle branch block or Wolff-Parkinson-White syndrome&#xD;
&#xD;
          -  Have serum aspartate aminotransferase (AST) or alanine aminotransferase (ALT) &gt;1.5&#xD;
             times (X) ULN or total bilirubin level (TBL) &gt;1.5X ULN&#xD;
&#xD;
          -  Have known allergies to LY3493269, related compounds, or any components of the&#xD;
             formulation (including C10), or a history of significant atopy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 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>Lilly Centre for Clinical Pharmacology</name>
      <address>
        <city>Singapore</city>
        <zip>138623</zip>
        <country>Singapore</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Singapore</country>
  </location_countries>
  <verification_date>January 2021</verification_date>
  <study_first_submitted>July 31, 2020</study_first_submitted>
  <study_first_submitted_qc>July 31, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 4, 2020</study_first_posted>
  <last_update_submitted>January 20, 2021</last_update_submitted>
  <last_update_submitted_qc>January 20, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">January 22, 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/NCT04498390
org study id: 17451
secondary id: J1X-MC-GZHB
nct id: NCT04498390
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
is us export: Yes
The main purpose of this study in healthy participants is to learn more about the safety of
      LY3493269 and any side effects that might be associated with it. Blood tests will be
      performed to check how much LY3493269 gets into the bloodstream and how long it takes the
      body to eliminate it. For each participant, the study will last about 10 weeks and may
      include 12 visits, including five nights in a row in the clinical research center.
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 through Day 43
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): Maximum Observed Drug Concentration (Cmax) of LY3493269
time frame: Days 1 and 3: Predose through 24 hours post-dose
description: PK: Cmax of LY3493269
measure: PK: Area Under the Concentration Versus Time Curve (AUC) of LY3493269
time frame: Days 1 and 3: Predose through 24 hours post-dose
description: PK: AUC of LY3493269
arm group label: LY3493269
arm group type: Experimental
description: LY3493269 administered orally.
arm group label: Placebo
arm group type: Placebo Comparator
description: Placebo administered orally.
intervention type: Drug
intervention name: LY3493269
description: Administered orally.
arm group label: LY3493269
intervention type: Drug
intervention name: Placebo
description: Administered orally.
arm group label: Placebo
criteria: 
gender: All
minimum age: 21 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: Singapore
responsible party type: Sponsor
sharing ipd: No