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/NCT05978713</url>
    </required_header>
    <id_info>
      <org_study_id>18614</org_study_id>
      <secondary_id>I8F-MC-GPIN</secondary_id>
      <nct_id>NCT05978713</nct_id>
    </id_info>
    <brief_title>A Study of Tirzepatide (LY3298176) in Healthy Lactating Females</brief_title>
    <official_title>A Study to Evaluate Tirzepatide Concentrations in Breastmilk Following Administration of Single Dose of Tirzepatide by Subcutaneous Injection in Healthy Lactating Females</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>
    </oversight_info>
    <brief_summary>
      <textblock>
        The main purpose of this study is to look if the study drug, tirzepatide, gets into the&#xD;
        breast milk and if yes, how long it takes the body to get rid of it. The study drug will be&#xD;
        given as a single injection under the skin in healthy lactating females. For each&#xD;
        participant, the total duration of the study will be approximately 8 weeks, including&#xD;
        screening.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">July 31, 2023</start_date>
    <completion_date type="Anticipated">July 12, 2024</completion_date>
    <primary_completion_date type="Anticipated">July 12, 2024</primary_completion_date>
    <phase>Phase 1</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>N/A</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <primary_purpose>Basic Science</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Pharmacokinetics (PK): Area Under the Plasma Concentration Versus Time Curve in Breast Milk From Zero to Infinity (AUC [0-∞]) of Tirzepatide</measure>
      <time_frame>Predose up to 30 days postdose</time_frame>
      <description>PK: AUC (0-∞) of Tirzepatide</description>
    </primary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">14</enrollment>
    <condition>Healthy</condition>
    <arm_group>
      <arm_group_label>Tirzepatide</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>A single dose of tirzepatide administered subcutaneously (SC)</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Tirzepatide</intervention_name>
      <description>Administered SC</description>
      <arm_group_label>Tirzepatide</arm_group_label>
      <other_name>LY3298176</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Participants who are overtly healthy females as determined by medical evaluation&#xD;
  &#xD;
            -  Female participants who delivered normal-term infant (at least 37 weeks gestation) and&#xD;
               are at least 6 weeks postpartum at the time of screening&#xD;
  &#xD;
            -  Body mass index (BMI) between 18.5 and 40.0 kilograms per meter squared (kg/m²),&#xD;
               inclusive&#xD;
  &#xD;
            -  Female participants who has well-established lactation and is breastfeeding her&#xD;
               infant. Note: Breastfeeding must be discontinued prior to the administration of&#xD;
               tirzepatide on Day 1 and not resumed for the remaining duration of the study until a&#xD;
               follow-up visit (or for total of 29 days after tirzepatide dosing for participants who&#xD;
               discontinue early).&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Have a history of inadequate lactation (for multiparous females who have previously&#xD;
               breastfed)&#xD;
  &#xD;
            -  Have confirmed type 1 or type 2 diabetes mellitus&#xD;
  &#xD;
            -  Regularly use known drugs of abuse or show positive findings on drug screen&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <gender_based>Yes</gender_based>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</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>This is a single site 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>Las Vegas Clinical Research Unit - PPD</name>
        <address>
          <city>Las Vegas</city>
          <state>Nevada</state>
          <zip>89113</zip>
          <country>United States</country>
        </address>
      </facility>
      <investigator>
        <last_name>Darin Brimhall</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 31, 2023</study_first_submitted>
    <study_first_submitted_qc>July 31, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 7, 2023</study_first_posted>
    <last_update_submitted>July 31, 2023</last_update_submitted>
    <last_update_submitted_qc>July 31, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 7, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Tirzepatide</mesh_term>
    </intervention_browse>
    <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/NCT05978713
  org study id: 18614
  secondary id: I8F-MC-GPIN
  nct id: NCT05978713
  lead sponsor: 
  has dmc: No
  is fda regulated drug: Yes
  is fda regulated device: No
  The main purpose of this study is to look if the study drug, tirzepatide, gets into the
        breast milk and if yes, how long it takes the body to get rid of it. The study drug will be
        given as a single injection under the skin in healthy lactating females. For each
        participant, the total duration of the study will be approximately 8 weeks, including
        screening.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Basic Science
  masking: None (Open Label)
  measure: Pharmacokinetics (PK): Area Under the Plasma Concentration Versus Time Curve in Breast Milk From Zero to Infinity (AUC [0-∞]) of Tirzepatide
  time frame: Predose up to 30 days postdose
  description: PK: AUC (0-∞) of Tirzepatide
  arm group label: Tirzepatide
  arm group type: Experimental
  description: A single dose of tirzepatide administered subcutaneously (SC)
  intervention type: Drug
  intervention name: Tirzepatide
  description: Administered SC
  arm group label: Tirzepatide
  other name: LY3298176
  criteria: 
  gender: Female
  gender based: Yes
  minimum age: 18 Years
  maximum age: N/A
  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: This is a single site clinical trial 1-877-CTLILLY (1-877-285-4559) or
  phone: 1-317-615-4559
  email: ClinicalTrials.gov@Lilly.com
  facility: 
  investigator: 
  country: United States
  responsible party type: Sponsor
  mesh term: Tirzepatide
  sharing ipd: No