<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/NCT03764774</url>
  </required_header>
  <id_info>
    <org_study_id>17110</org_study_id>
    <secondary_id>J1D-MC-GZAA</secondary_id>
    <nct_id>NCT03764774</nct_id>
  </id_info>
  <brief_title>A Study of LY3463251 in Healthy Participants</brief_title>
  <official_title>A Randomized, Placebo-Controlled, Subject- and Investigator-Blind, Single and Multiple Dose, Safety, Tolerability, and Pharmacokinetics Study of LY3463251 in Healthy and Overweight 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>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate the safety and tolerability (side effects) of single&#xD;
      (Part A) and multiple (Part B) doses of the study drug when it is administered subcutaneously&#xD;
      (under the skin) into the abdomen.&#xD;
&#xD;
      This is a two-part study. Participants will enroll in only one part. For each participant,&#xD;
      Part A will last about 10 weeks and Part B will last about 23 weeks, including screening.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Trial was terminated due to an insufficient benefit/tolerability ratio&#xD;
  </why_stopped>
  <start_date type="Actual">December 6, 2018</start_date>
  <completion_date type="Actual">December 7, 2020</completion_date>
  <primary_completion_date type="Actual">December 7, 2020</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 follow up in Part A (up to Day 42); Baseline through follow up in Part B (up to Day 123)</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 Drug Concentration (Cmax) of LY3463251</measure>
    <time_frame>Baseline to Day 29 (Part A); Baseline to Day 107 (Part B)</time_frame>
    <description>PK: Cmax of LY3463251</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PK: Area Under the Concentration Versus Time Curve (AUC) of LY3463251</measure>
    <time_frame>Baseline to Day 29 (Part A); Baseline to Day 107(Part B)</time_frame>
    <description>PK: AUC of LY3463251</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pharmacodynamics (PD): AUC of glucose</measure>
    <time_frame>Baseline to Day 85 (Part B)</time_frame>
    <description>PD: AUC of glucose</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from Baseline in Body Weight</measure>
    <time_frame>Baseline, Day 85 (Part B)</time_frame>
    <description>Change from Baseline in Body Weight</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">118</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>LY3463251 Single dose</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Single dose of LY3463251 administered subcutaneously (SC)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo Single dose</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Single dose of placebo administered SC</description>
  </arm_group>
  <arm_group>
    <arm_group_label>LY3463251 Multiple Dose</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Multiple doses of LY3463251 administered SC</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo Multiple Dose</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Multiple doses of placebo administered SC</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>LY3463251</intervention_name>
    <description>Administered SC</description>
    <arm_group_label>LY3463251 Multiple Dose</arm_group_label>
    <arm_group_label>LY3463251 Single dose</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Administered SC</description>
    <arm_group_label>Placebo Multiple Dose</arm_group_label>
    <arm_group_label>Placebo Single dose</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy males and females&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Diagnosed with Type 1 or Type 2 diabetes&#xD;
&#xD;
          -  Women who are of childbearing potential or who are breastfeeding&#xD;
&#xD;
          -  Donated blood of more than 500 millilitres (mL) within the previous 3 months of study&#xD;
             screening&#xD;
&#xD;
          -  Have used any tobacco product within 3 months of Day -1, or are unwilling to refrain&#xD;
             from the use of tobacco during the study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 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>Covance Clinical Research Inc</name>
      <address>
        <city>Daytona Beach</city>
        <state>Florida</state>
        <zip>32117</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2020</verification_date>
  <study_first_submitted>December 4, 2018</study_first_submitted>
  <study_first_submitted_qc>December 4, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 5, 2018</study_first_posted>
  <last_update_submitted>December 18, 2020</last_update_submitted>
  <last_update_submitted_qc>December 18, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">December 21, 2020</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>


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/NCT03764774
org study id: 17110
secondary id: J1D-MC-GZAA
nct id: NCT03764774
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
The purpose of this study is to evaluate the safety and tolerability (side effects) of single
      (Part A) and multiple (Part B) doses of the study drug when it is administered subcutaneously
      (under the skin) into the abdomen.

      This is a two-part study. Participants will enroll in only one part. For each participant,
      Part A will last about 10 weeks and Part B will last about 23 weeks, including screening.
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 follow up in Part A (up to Day 42); Baseline through follow up in Part B (up to Day 123)
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 Drug Concentration (Cmax) of LY3463251
time frame: Baseline to Day 29 (Part A); Baseline to Day 107 (Part B)
description: PK: Cmax of LY3463251
measure: PK: Area Under the Concentration Versus Time Curve (AUC) of LY3463251
time frame: Baseline to Day 29 (Part A); Baseline to Day 107(Part B)
description: PK: AUC of LY3463251
measure: Pharmacodynamics (PD): AUC of glucose
time frame: Baseline to Day 85 (Part B)
description: PD: AUC of glucose
measure: Change from Baseline in Body Weight
time frame: Baseline, Day 85 (Part B)
description: Change from Baseline in Body Weight
arm group label: LY3463251 Single dose
arm group type: Experimental
description: Single dose of LY3463251 administered subcutaneously (SC)
arm group label: Placebo Single dose
arm group type: Placebo Comparator
description: Single dose of placebo administered SC
arm group label: LY3463251 Multiple Dose
arm group type: Experimental
description: Multiple doses of LY3463251 administered SC
arm group label: Placebo Multiple Dose
arm group type: Placebo Comparator
description: Multiple doses of placebo administered SC
intervention type: Drug
intervention name: LY3463251
description: Administered SC
arm group label: LY3463251 Multiple Dose
arm group label: LY3463251 Single dose
intervention type: Drug
intervention name: Placebo
description: Administered SC
arm group label: Placebo Multiple Dose
arm group label: Placebo Single dose
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 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: United States
responsible party type: Sponsor
sharing ipd: No