<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/NCT03025009</url>
  </required_header>
  <id_info>
    <org_study_id>16242</org_study_id>
    <secondary_id>I8M-MC-BIXA</secondary_id>
    <secondary_id>2016-003274-40</secondary_id>
    <nct_id>NCT03025009</nct_id>
  </id_info>
  <brief_title>A Study of LY3192767 in Healthy Participants</brief_title>
  <official_title>A Single-Site, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Glucodynamic Effects of LY3192767 in Healthy Subjects</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 is to investigate the side effects related to LY3192767 when&#xD;
      given as an injection under the skin to healthy participants. Blood tests will be done to&#xD;
      check how much LY3192767 is absorbed into the bloodstream, how long it takes for the body to&#xD;
      get rid of it, and how it affects blood sugar levels. The study has two parts: Part A and&#xD;
      Part B. Each participant will enroll in one part. For each participant, Part A will last up&#xD;
      to about 32 days after last dose and Part B will last up to about 49 days after last dose.&#xD;
      Screening must be completed prior to study start.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 6, 2017</start_date>
  <completion_date type="Actual">April 11, 2018</completion_date>
  <primary_completion_date type="Actual">April 11, 2018</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>Parallel 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 Study Completion (up to about Day 49)</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): Time to Maximum Concentration (Tmax) of LY3192767</measure>
    <time_frame>Predose through 336 Hours</time_frame>
    <description>PK: Tmax of LY3192767</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PK: Maximum Serum Concentration (Cmax) of LY3192767</measure>
    <time_frame>Predose through 336 Hours</time_frame>
    <description>PK: Cmax of LY3192767</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PK: Area Under the Concentration-Time Curve from Time Zero to Infinity (AUC[0-inf] of LY3192767</measure>
    <time_frame>Predose through 336 Hours</time_frame>
    <description>PK: AUC(0-inf) of LY3192767</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pharmacodynamics (PD): Total Amount of Glucose Infused (Gtot) of LY3192767</measure>
    <time_frame>Predose through 36 Hours During Clamp Procedure</time_frame>
    <description>PD: Total Amount of Glucose Infused (Gtot) of LY3192767</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PD: Maximum Glucose Infusion Rate (Rmax) of LY3192767</measure>
    <time_frame>Predose through 36 Hours During Clamp Procedure</time_frame>
    <description>PD: Rmax of LY3192767</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PD: Time of Maximum Glucose Infusion Rate (TRmax) of LY3192767</measure>
    <time_frame>Predose through 36 Hours During Clamp Procedure</time_frame>
    <description>PD: TRmax of LY3192767</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PD: Change from Baseline in Free Fatty Acids</measure>
    <time_frame>Predose through 48 Hours Postdose</time_frame>
    <description>PD: Change from Baseline in Free Fatty Acids</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PD: Change from Baseline in Glycerol</measure>
    <time_frame>Predose through 48 Hours Postdose</time_frame>
    <description>PD: Change from Baseline in Glycerol</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PD: Change from Baseline in Triglycerides</measure>
    <time_frame>Predose through 48 Hours Postdose</time_frame>
    <description>PD: Change from Baseline in Triglycerides</description>
  </secondary_outcome>
  <number_of_arms>5</number_of_arms>
  <enrollment type="Actual">57</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>LY3192767 (Part A)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Escalating doses of LY3192767 administered subcutaneously (SC).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo (Part A)</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo matching LY3192767 administered subcutaneously (SC).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>LY3192767 (Part B)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>LY3192767 administered as a SC injection in one of three study periods.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Basal Insulin Peglispro (Part B)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Basal insulin peglispro administered as a SC injection in one of three study periods.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Insulin Glargine (Part B)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Insulin glargine administered as a SC injection in one of three study periods.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>LY3192767</intervention_name>
    <description>Administered SC.</description>
    <arm_group_label>LY3192767 (Part A)</arm_group_label>
    <arm_group_label>LY3192767 (Part B)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Basal Insulin Peglispro</intervention_name>
    <description>Administered SC.</description>
    <arm_group_label>Basal Insulin Peglispro (Part B)</arm_group_label>
    <other_name>LY2605541</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Insulin Glargine</intervention_name>
    <description>Administered SC.</description>
    <arm_group_label>Insulin Glargine (Part B)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Administered SC.</description>
    <arm_group_label>Placebo (Part A)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Are overtly healthy males or females, as determined by medical history and physical&#xD;
             examination&#xD;
&#xD;
          -  Have a body mass index (BMI) of &gt;18.5 and &lt;30.0 kilogram per square meter (kg/m²),&#xD;
             inclusive&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Are currently enrolled in a clinical trial involving an investigational product or any&#xD;
             other type of medical research judged not to be scientifically or medically compatible&#xD;
             with this study&#xD;
&#xD;
          -  Have participated, within the last 30 days, in a clinical trial involving an&#xD;
             investigational product. If the previous investigational product has a long half-life,&#xD;
             3 months or 5 half-lives (whichever is longer) should have passed&#xD;
&#xD;
          -  Have participated as a participant in a first-in-human study within 90 days of the&#xD;
             initial dose of study drug&#xD;
&#xD;
          -  Have known allergies to insulin, heparin, or related drugs, or history of relevant&#xD;
             allergic reactions of any origin&#xD;
&#xD;
          -  Have a history or presence of cardiovascular, respiratory, hepatic, renal,&#xD;
             gastrointestinal, endocrine, hematological, chronic inflammatory disease, or&#xD;
             neurological disorders capable of significantly altering the absorption, metabolism,&#xD;
             or elimination of drugs; of constituting a risk when taking the study medication; or&#xD;
             of interfering with the interpretation of data&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>64 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>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST) or speak with your personal physician.</name>
      <address>
        <city>Neuss</city>
        <state>Nordrhein-Westfalen</state>
        <zip>41460</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>April 2019</verification_date>
  <study_first_submitted>January 17, 2017</study_first_submitted>
  <study_first_submitted_qc>January 17, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 19, 2017</study_first_posted>
  <last_update_submitted>April 3, 2019</last_update_submitted>
  <last_update_submitted_qc>April 3, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">April 5, 2019</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>Insulin</mesh_term>
    <mesh_term>Insulin, Globin Zinc</mesh_term>
    <mesh_term>Insulin Glargine</mesh_term>
  </intervention_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/NCT03025009
org study id: 16242
secondary id: I8M-MC-BIXA
secondary id: 2016-003274-40
nct id: NCT03025009
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 is to investigate the side effects related to LY3192767 when
      given as an injection under the skin to healthy participants. Blood tests will be done to
      check how much LY3192767 is absorbed into the bloodstream, how long it takes for the body to
      get rid of it, and how it affects blood sugar levels. The study has two parts: Part A and
      Part B. Each participant will enroll in one part. For each participant, Part A will last up
      to about 32 days after last dose and Part B will last up to about 49 days after last dose.
      Screening must be completed prior to study start.
allocation: Randomized
intervention model: Parallel 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 Study Completion (up to about Day 49)
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): Time to Maximum Concentration (Tmax) of LY3192767
time frame: Predose through 336 Hours
description: PK: Tmax of LY3192767
measure: PK: Maximum Serum Concentration (Cmax) of LY3192767
time frame: Predose through 336 Hours
description: PK: Cmax of LY3192767
measure: PK: Area Under the Concentration-Time Curve from Time Zero to Infinity (AUC[0-inf] of LY3192767
time frame: Predose through 336 Hours
description: PK: AUC(0-inf) of LY3192767
measure: Pharmacodynamics (PD): Total Amount of Glucose Infused (Gtot) of LY3192767
time frame: Predose through 36 Hours During Clamp Procedure
description: PD: Total Amount of Glucose Infused (Gtot) of LY3192767
measure: PD: Maximum Glucose Infusion Rate (Rmax) of LY3192767
time frame: Predose through 36 Hours During Clamp Procedure
description: PD: Rmax of LY3192767
measure: PD: Time of Maximum Glucose Infusion Rate (TRmax) of LY3192767
time frame: Predose through 36 Hours During Clamp Procedure
description: PD: TRmax of LY3192767
measure: PD: Change from Baseline in Free Fatty Acids
time frame: Predose through 48 Hours Postdose
description: PD: Change from Baseline in Free Fatty Acids
measure: PD: Change from Baseline in Glycerol
time frame: Predose through 48 Hours Postdose
description: PD: Change from Baseline in Glycerol
measure: PD: Change from Baseline in Triglycerides
time frame: Predose through 48 Hours Postdose
description: PD: Change from Baseline in Triglycerides
arm group label: LY3192767 (Part A)
arm group type: Experimental
description: Escalating doses of LY3192767 administered subcutaneously (SC).
arm group label: Placebo (Part A)
arm group type: Placebo Comparator
description: Placebo matching LY3192767 administered subcutaneously (SC).
arm group label: LY3192767 (Part B)
arm group type: Experimental
description: LY3192767 administered as a SC injection in one of three study periods.
arm group label: Basal Insulin Peglispro (Part B)
arm group type: Active Comparator
description: Basal insulin peglispro administered as a SC injection in one of three study periods.
arm group label: Insulin Glargine (Part B)
arm group type: Active Comparator
description: Insulin glargine administered as a SC injection in one of three study periods.
intervention type: Drug
intervention name: LY3192767
description: Administered SC.
arm group label: LY3192767 (Part A)
arm group label: LY3192767 (Part B)
intervention type: Drug
intervention name: Basal Insulin Peglispro
description: Administered SC.
arm group label: Basal Insulin Peglispro (Part B)
other name: LY2605541
intervention type: Drug
intervention name: Insulin Glargine
description: Administered SC.
arm group label: Insulin Glargine (Part B)
intervention type: Drug
intervention name: Placebo
description: Administered SC.
arm group label: Placebo (Part A)
criteria: 
gender: All
minimum age: 20 Years
maximum age: 64 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: Germany
responsible party type: Sponsor
mesh term: Insulin
mesh term: Insulin, Globin Zinc
mesh term: Insulin Glargine
sharing ipd: No