<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/NCT04407234</url>
  </required_header>
  <id_info>
    <org_study_id>17376</org_study_id>
    <secondary_id>I8F-MC-GPHU</secondary_id>
    <nct_id>NCT04407234</nct_id>
  </id_info>
  <brief_title>A Study to Measure Stomach Emptying in Overweight Non-diabetic and Diabetic Participants Using Tirzepatide</brief_title>
  <official_title>The Impact of Tirzepatide on Gastric Emptying (GE) in Overweight/Obese Non-diabetic Subjects and in Overweight/Obese Subjects With Type 2 Diabetes Mellitus</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 purpose of this study is to learn more about how tirzepatide affects stomach emptying in&#xD;
      overweight/very overweight participants. Participants include those without diabetes and&#xD;
      those with type 2 diabetes.&#xD;
&#xD;
      The study will last about 13 weeks for each participant, including screening.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 15, 2020</start_date>
  <completion_date type="Actual">January 7, 2021</completion_date>
  <primary_completion_date type="Actual">January 7, 2021</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): Time of Maximum Concentration (Tmax) of Acetaminophen</measure>
    <time_frame>Pre-dose through 36 hours post-dose on Day-1</time_frame>
    <description>PK: Tmax of Acetaminophen</description>
  </primary_outcome>
  <primary_outcome>
    <measure>PK: Tmax of Acetaminophen</measure>
    <time_frame>Pre-dose through 36 hours post-dose on Day 2</time_frame>
    <description>PK: Tmax of Acetaminophen</description>
  </primary_outcome>
  <primary_outcome>
    <measure>PK: Tmax of Acetaminophen</measure>
    <time_frame>Pre-dose through 36 hours post-dose on Day 37</time_frame>
    <description>PK: Tmax of Acetaminophen</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change from Baseline in Hemoglobin A1c (HbA1c)</measure>
    <time_frame>Pre-dose through 9 weeks</time_frame>
    <description>Change from Baseline in HbA1c</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PK: AUC(0-tlast) of Tirzepatide at Steady State</measure>
    <time_frame>Pre-dose through 9 weeks</time_frame>
    <description>PK: AUC(0-tlast) of Tirzepatide at Steady State</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PK: Cmax of Tirzepatide at Steady State</measure>
    <time_frame>Pre-dose through 9 weeks</time_frame>
    <description>PK: Cmax of Tirzepatide at Steady State</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">36</enrollment>
  <condition>Overweight</condition>
  <condition>Obesity</condition>
  <condition>Diabetes Mellitus, Type 2</condition>
  <arm_group>
    <arm_group_label>Tirzepatide + Acetaminophen</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Tirzepatide administered subcutaneously (SC) and acetaminophen administered orally.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Tirzepatide</intervention_name>
    <description>Tirzepatide administered SC.</description>
    <arm_group_label>Tirzepatide + Acetaminophen</arm_group_label>
    <other_name>LY3298176</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Acetaminophen</intervention_name>
    <description>Acetaminophen administered orally.</description>
    <arm_group_label>Tirzepatide + Acetaminophen</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Have a body mass index (BMI) between 27 to 45 kilograms per meter squared (kg/m²),&#xD;
             inclusive at screening&#xD;
&#xD;
          -  For nondiabetic subjects: as determined by medical history, physical examination, and&#xD;
             safety assessments at screening&#xD;
&#xD;
          -  For participants with a confirmed type 2 diabetes diagnosis: The condition must be&#xD;
             managed either by diet and exercise alone or on a stable dose of metformin for the&#xD;
             past 3 months&#xD;
&#xD;
          -  Willing and agreeable to commit to the duration of the study and undergo study&#xD;
             procedures as instructed by the clinic staff&#xD;
&#xD;
        Key Exclusion Criteria&#xD;
&#xD;
          -  Have undergone gastric bypass or bariatric surgery&#xD;
&#xD;
          -  Have received prescription drugs or over the counter drugs that promote weight loss in&#xD;
             the past 6 months prior to screening&#xD;
&#xD;
          -  For participants with a confirmed type 2 diabetes diagnosis: Have experienced more&#xD;
             than 1 episode of severe low blood sugar that require emergency treatment,&#xD;
             hospitalization or third parties to administer rescue treatment, in the past 6 months&#xD;
&#xD;
          -  Have any lifetime history of a suicide attempt&#xD;
&#xD;
          -  Have other medical conditions or medical history that make participation in the study&#xD;
             unsafe or which may interfere in the interpretation of the results of the study&#xD;
&#xD;
          -  Unwilling to comply with smoking and alcohol restrictions during the study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</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>Clinical Pharmacology of Miami</name>
      <address>
        <city>Hialeah</city>
        <state>Florida</state>
        <zip>33014</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://trials.lillytrialguide.com/en-US/trial/2VTN9N9xaJ4FhSAZuwJdif?conditionId=1wecF0AgauDdWnqHV7GJGP</url>
    <description>Related Info</description>
  </link>
  <verification_date>January 2021</verification_date>
  <study_first_submitted>May 27, 2020</study_first_submitted>
  <study_first_submitted_qc>May 27, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 29, 2020</study_first_posted>
  <last_update_submitted>January 18, 2021</last_update_submitted>
  <last_update_submitted_qc>January 18, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">January 20, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetes Mellitus</mesh_term>
    <mesh_term>Overweight</mesh_term>
    <mesh_term>Diabetes Mellitus, Type 2</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Acetaminophen</mesh_term>
    <mesh_term>Tirzepatide</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <pending_results>
    <submitted>June 7, 2022</submitted>
    <returned>March 17, 2023</returned>
    <submitted>April 11, 2023</submitted>
  </pending_results>
  <!-- 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/NCT04407234
org study id: 17376
secondary id: I8F-MC-GPHU
nct id: NCT04407234
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
The purpose of this study is to learn more about how tirzepatide affects stomach emptying in
      overweight/very overweight participants. Participants include those without diabetes and
      those with type 2 diabetes.

      The study will last about 13 weeks for each participant, including screening.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Pharmacokinetics (PK): Time of Maximum Concentration (Tmax) of Acetaminophen
time frame: Pre-dose through 36 hours post-dose on Day-1
description: PK: Tmax of Acetaminophen
measure: PK: Tmax of Acetaminophen
time frame: Pre-dose through 36 hours post-dose on Day 2
description: PK: Tmax of Acetaminophen
measure: PK: Tmax of Acetaminophen
time frame: Pre-dose through 36 hours post-dose on Day 37
description: PK: Tmax of Acetaminophen
measure: Change from Baseline in Hemoglobin A1c (HbA1c)
time frame: Pre-dose through 9 weeks
description: Change from Baseline in HbA1c
measure: PK: AUC(0-tlast) of Tirzepatide at Steady State
time frame: Pre-dose through 9 weeks
description: PK: AUC(0-tlast) of Tirzepatide at Steady State
measure: PK: Cmax of Tirzepatide at Steady State
time frame: Pre-dose through 9 weeks
description: PK: Cmax of Tirzepatide at Steady State
arm group label: Tirzepatide + Acetaminophen
arm group type: Experimental
description: Tirzepatide administered subcutaneously (SC) and acetaminophen administered orally.
intervention type: Drug
intervention name: Tirzepatide
description: Tirzepatide administered SC.
arm group label: Tirzepatide + Acetaminophen
other name: LY3298176
intervention type: Drug
intervention name: Acetaminophen
description: Acetaminophen administered orally.
arm group label: Tirzepatide + Acetaminophen
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
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 States
url: https://trials.lillytrialguide.com/en-US/trial/2VTN9N9xaJ4FhSAZuwJdif?conditionId=1wecF0AgauDdWnqHV7GJGP
description: Related Info
responsible party type: Sponsor
mesh term: Diabetes Mellitus
mesh term: Overweight
mesh term: Diabetes Mellitus, Type 2
mesh term: Acetaminophen
mesh term: Tirzepatide
sharing ipd: No
submitted: June 7, 2022
returned: March 17, 2023
submitted: April 11, 2023