<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/NCT04426474</url>
  </required_header>
  <id_info>
    <org_study_id>17681</org_study_id>
    <secondary_id>J2A-MC-GZGC</secondary_id>
    <secondary_id>2020-000125-86</secondary_id>
    <nct_id>NCT04426474</nct_id>
  </id_info>
  <brief_title>A Study of LY3502970 in Participants With Type 2 Diabetes</brief_title>
  <official_title>A Multiple-Dose Study in Participants With Type 2 Diabetes Mellitus to Investigate the Safety, Tolerability, Pharmacokinetics,and Pharmacodynamics of LY3502970</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 learn more about the safety of LY3502970 and any side&#xD;
      effects that might be associated with it. Blood tests will be done to measure how much&#xD;
      LY3502970 is in the bloodstream, how long it takes the body to eliminate it, and how it&#xD;
      affects blood sugar. Participation could last up to 18 weeks and may include up to 14 visits&#xD;
      (including three overnight stays) in the study center.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 8, 2020</start_date>
  <completion_date type="Actual">July 12, 2021</completion_date>
  <primary_completion_date type="Actual">July 12, 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</measure>
    <time_frame>Baseline through Follow-up (up to Day 105)</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 Concentration (Cmax) of LY3502970</measure>
    <time_frame>Day 1 through Day 84: Predose up to 96 hours postdose</time_frame>
    <description>PK: Cmax of LY3502970</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PK: Area Under the Concentration Versus Time Curve of LY3502970</measure>
    <time_frame>Day 1 through Day 84: Predose up to 96 hours postdose</time_frame>
    <description>PK: AUC of LY3502970</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pharmacodynamics (PD): Change from Baseline to Week 12 in Fasting Plasma Glucose (FPG)</measure>
    <time_frame>Baseline, Week 12</time_frame>
    <description>Pharmacodynamics (PD): Change from Baseline to Week 12 in FPG</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PD: Change from Baseline to Week 12 in Fasting Insulin</measure>
    <time_frame>Baseline, Week 12</time_frame>
    <description>PD: Change from Baseline to Week 12 in Fasting Insulin</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">68</enrollment>
  <condition>Diabetes Mellitus, Type 2</condition>
  <arm_group>
    <arm_group_label>LY3502970</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>LY3502970 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>LY3502970</intervention_name>
    <description>Administered orally.</description>
    <arm_group_label>LY3502970</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;
          -  Have type 2 diabetes mellitus (T2DM) for at least 6 months&#xD;
&#xD;
          -  Have a glycated hemoglobin (HbA1c) value at screening of greater than or equal to&#xD;
             (≥)7.0 percent (%) and less than or equal to (≤)10.5% and are treated with diet and&#xD;
             exercise alone or a stable dose of metformin for at least 3 months prior to screening&#xD;
&#xD;
          -  Have a body weight of ≥45 kilograms (kg) and have a body mass index of 18.5 to 45&#xD;
             kilograms per square meter (kg/m²), inclusive&#xD;
&#xD;
          -  Have had a stable body weight for the 3 months prior to screening (less than [&lt;]5%&#xD;
             body weight change)&#xD;
&#xD;
          -  Males and females (not considered woman of childbearing potential)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Have type 1 diabetes mellitus, latent autoimmune diabetes in adults or have had an&#xD;
             episode of ketoacidosis or hyperosmolar state requiring hospitalization in the 6&#xD;
             months prior to screening&#xD;
&#xD;
          -  Have had any of the following within the past 6 months prior to screening: myocardial&#xD;
             infarction, unstable angina, coronary artery bypass graft, percutaneous coronary&#xD;
             intervention (diagnostic angiograms are permitted), transient ischemic attack,&#xD;
             cerebrovascular accident or decompensated congestive heart failure, or currently have&#xD;
             New York Health Association Class III or IV heart failure&#xD;
&#xD;
          -  Show evidence of hepatitis B, and/or positive hepatitis B surface antigen&#xD;
&#xD;
          -  Show evidence of human immunodeficiency virus (HIV) infection and/or positive human&#xD;
             HIV antibodies&#xD;
&#xD;
          -  Any glucose-lowering medications other than metformin within 3 months prior to&#xD;
             screening&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 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>
    <facility>
      <name>Hassman Research Institute</name>
      <address>
        <city>Marlton</city>
        <state>New Jersey</state>
        <zip>08053</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Midwest Clinical Research Unit</name>
      <address>
        <city>Dayton</city>
        <state>Ohio</state>
        <zip>45417</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Endeavor Clinical Trials</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78229</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Profil Institut für Stoffwechselforschung</name>
      <address>
        <city>Neuss</city>
        <state>Nordrhein-Westfalen</state>
        <zip>41460</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Profil Mainz</name>
      <address>
        <city>Mainz</city>
        <zip>55116</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://trials.lillytrialguide.com/en-US/trial/7zwMq2LwDbIpQoxy04CHQ7</url>
    <description>A Study of LY3502970 in Participants With Type 2 Diabetes</description>
  </link>
  <verification_date>July 2021</verification_date>
  <study_first_submitted>June 8, 2020</study_first_submitted>
  <study_first_submitted_qc>June 8, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 11, 2020</study_first_posted>
  <last_update_submitted>July 26, 2021</last_update_submitted>
  <last_update_submitted_qc>July 26, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">July 27, 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>Diabetes Mellitus, Type 2</mesh_term>
  </condition_browse>
  <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/NCT04426474
org study id: 17681
secondary id: J2A-MC-GZGC
secondary id: 2020-000125-86
nct id: NCT04426474
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
The main purpose of this study is to learn more about the safety of LY3502970 and any side
      effects that might be associated with it. Blood tests will be done to measure how much
      LY3502970 is in the bloodstream, how long it takes the body to eliminate it, and how it
      affects blood sugar. Participation could last up to 18 weeks and may include up to 14 visits
      (including three overnight stays) in the study 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
time frame: Baseline through Follow-up (up to Day 105)
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 Concentration (Cmax) of LY3502970
time frame: Day 1 through Day 84: Predose up to 96 hours postdose
description: PK: Cmax of LY3502970
measure: PK: Area Under the Concentration Versus Time Curve of LY3502970
time frame: Day 1 through Day 84: Predose up to 96 hours postdose
description: PK: AUC of LY3502970
measure: Pharmacodynamics (PD): Change from Baseline to Week 12 in Fasting Plasma Glucose (FPG)
time frame: Baseline, Week 12
description: Pharmacodynamics (PD): Change from Baseline to Week 12 in FPG
measure: PD: Change from Baseline to Week 12 in Fasting Insulin
time frame: Baseline, Week 12
description: PD: Change from Baseline to Week 12 in Fasting Insulin
arm group label: LY3502970
arm group type: Experimental
description: LY3502970 administered orally.
arm group label: Placebo
arm group type: Placebo Comparator
description: Placebo administered orally.
intervention type: Drug
intervention name: LY3502970
description: Administered orally.
arm group label: LY3502970
intervention type: Drug
intervention name: Placebo
description: Administered orally.
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 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: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Germany
country: United States
url: https://trials.lillytrialguide.com/en-US/trial/7zwMq2LwDbIpQoxy04CHQ7
description: A Study of LY3502970 in Participants With Type 2 Diabetes
responsible party type: Sponsor
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 2
sharing ipd: No