xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT06003465</url>
    </required_header>
    <id_info>
      <org_study_id>18530</org_study_id>
      <secondary_id>J1I-MC-GZBX</secondary_id>
      <nct_id>NCT06003465</nct_id>
    </id_info>
    <brief_title>A Research Study Looking at Similarity Between LY3437943 Versions for Different Injection Devices</brief_title>
    <official_title>A Relative Bioavailability Study to Compare the Pharmacokinetics of LY3437943 Administered Subcutaneously by a Test Device (Test Formulation) Versus Reference Device (Reference Formulation) 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>Yes</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The main purpose of this study is to look at the amount of the study drug, LY3437943, that&#xD;
        gets into the blood stream and how long it takes the body to get rid of it when given using&#xD;
        two different devices. The study will also evaluate the safety and tolerability of LY3437943&#xD;
        and information about any side effects experienced will be collected. For each participant,&#xD;
        the total duration of the study will be approximately 16 weeks, including screening.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 29, 2023</start_date>
    <completion_date type="Anticipated">December 20, 2023</completion_date>
    <primary_completion_date type="Anticipated">December 20, 2023</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>Crossover Assignment</intervention_model>
      <primary_purpose>Basic Science</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3437943</measure>
      <time_frame>Predose up to 43 days postdose</time_frame>
      <description>PK: Cmax of LY3437943</description>
    </primary_outcome>
    <primary_outcome>
      <measure>PK: Area Under the Plasma Concentration Versus Time Curve from Zero to T, Last Time Point (AUC[0-tlast]) of LY3437943</measure>
      <time_frame>Predose up to 43 days postdose</time_frame>
      <description>PK: AUC[0-tlast] of LY3437943</description>
    </primary_outcome>
    <primary_outcome>
      <measure>PK: Area Under the Plasma Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of LY3437943</measure>
      <time_frame>Predose up to 43 days postdose</time_frame>
      <description>PK: AUC(0-∞) of LY3437943</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">55</enrollment>
    <condition>Healthy</condition>
    <arm_group>
      <arm_group_label>LY3437943 - Test</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>A single dose of LY3437943 administered by subcutaneous (SC) injection via a test device (test formulation)</description>
    </arm_group>
    <arm_group>
      <arm_group_label>LY3437943 - Reference</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>A single dose of LY3437943 administered by SC injection via a reference device (reference formulation)</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>LY3437943</intervention_name>
      <description>Administered SC</description>
      <arm_group_label>LY3437943 - Reference</arm_group_label>
      <arm_group_label>LY3437943 - Test</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Test</intervention_name>
      <description>Used to administer LY3437943 SC</description>
      <arm_group_label>LY3437943 - Test</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Reference</intervention_name>
      <description>Used to administer LY3437943 SC</description>
      <arm_group_label>LY3437943 - Reference</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Healthy males or non-pregnant females as determined by medical history, physical&#xD;
               examination, and other screening procedures&#xD;
  &#xD;
            -  Body mass index (BMI) between 18.5 and 32.0 kilograms per meter squared (kg/m²),&#xD;
               inclusive&#xD;
  &#xD;
            -  Have clinical laboratory test results, blood pressure and pulse rate that are&#xD;
               acceptable for the study&#xD;
  &#xD;
            -  Are agreeable to receiving study treatment by injections under the skin&#xD;
  &#xD;
            -  Males who agree to use highly effective/effective methods of contraception and women&#xD;
               not of childbearing potential (postmenopausal or oophorectomized)&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Have or used to have health problems that, in the opinion of the doctor, could make it&#xD;
               unsafe to participate, or could interfere with understanding the results of the study&#xD;
  &#xD;
            -  Smoke more than the equivalent of 10 cigarettes per day&#xD;
  &#xD;
            -  Is a known user of drugs of abuse&#xD;
  &#xD;
            -  Have known allergies to LY3437943 or related compounds&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>70 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>
    <overall_contact>
      <last_name>There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or</last_name>
      <phone>1-317-615-4559</phone>
      <email>ClinicalTrials.gov@Lilly.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Qps-Mra, Llc</name>
        <address>
          <city>Miami</city>
          <state>Florida</state>
          <zip>33143</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <phone>305-722-0970</phone>
      </contact>
      <investigator>
        <last_name>Martha Hernandez-Illas</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>ICON Early Phase Services</name>
        <address>
          <city>San Antonio</city>
          <state>Texas</state>
          <zip>78209</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <phone>210-283-4500</phone>
      </contact>
      <investigator>
        <last_name>Chinonye Ogbonnaya-Odor</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>ICON</name>
        <address>
          <city>Salt Lake City</city>
          <state>Utah</state>
          <zip>84124</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <phone>801-904-4545</phone>
      </contact>
      <investigator>
        <last_name>Shawn Searle</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>August 15, 2023</verification_date>
    <study_first_submitted>August 16, 2023</study_first_submitted>
    <study_first_submitted_qc>August 16, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 22, 2023</study_first_posted>
    <last_update_submitted>August 16, 2023</last_update_submitted>
    <last_update_submitted_qc>August 16, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 22, 2023</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>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT06003465
  org study id: 18530
  secondary id: J1I-MC-GZBX
  nct id: NCT06003465
  lead sponsor: 
  has dmc: No
  is fda regulated drug: Yes
  is fda regulated device: Yes
  The main purpose of this study is to look at the amount of the study drug, LY3437943, that
        gets into the blood stream and how long it takes the body to get rid of it when given using
        two different devices. The study will also evaluate the safety and tolerability of LY3437943
        and information about any side effects experienced will be collected. For each participant,
        the total duration of the study will be approximately 16 weeks, including screening.
  allocation: Randomized
  intervention model: Crossover Assignment
  primary purpose: Basic Science
  masking: None (Open Label)
  measure: Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3437943
  time frame: Predose up to 43 days postdose
  description: PK: Cmax of LY3437943
  measure: PK: Area Under the Plasma Concentration Versus Time Curve from Zero to T, Last Time Point (AUC[0-tlast]) of LY3437943
  time frame: Predose up to 43 days postdose
  description: PK: AUC[0-tlast] of LY3437943
  measure: PK: Area Under the Plasma Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of LY3437943
  time frame: Predose up to 43 days postdose
  description: PK: AUC(0-∞) of LY3437943
  arm group label: LY3437943 - Test
  arm group type: Experimental
  description: A single dose of LY3437943 administered by subcutaneous (SC) injection via a test device (test formulation)
  arm group label: LY3437943 - Reference
  arm group type: Active Comparator
  description: A single dose of LY3437943 administered by SC injection via a reference device (reference formulation)
  intervention type: Drug
  intervention name: LY3437943
  description: Administered SC
  arm group label: LY3437943 - Reference
  arm group label: LY3437943 - Test
  intervention type: Device
  intervention name: Test
  description: Used to administer LY3437943 SC
  arm group label: LY3437943 - Test
  intervention type: Device
  intervention name: Reference
  description: Used to administer LY3437943 SC
  arm group label: LY3437943 - Reference
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 70 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
  last name: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or
  phone: 1-317-615-4559
  email: ClinicalTrials.gov@Lilly.com
  facility: 
  contact: 
  investigator: 
  facility: 
  contact: 
  investigator: 
  facility: 
  contact: 
  investigator: 
  country: United States
  responsible party type: Sponsor
  sharing ipd: No