<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/NCT02972645</url>
  </required_header>
  <id_info>
    <org_study_id>16350</org_study_id>
    <secondary_id>I8P-MC-OXAA</secondary_id>
    <nct_id>NCT02972645</nct_id>
  </id_info>
  <brief_title>A Study of LY3305677 in Healthy Participants</brief_title>
  <official_title>A First-in-Human, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LY3305677 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>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate the safety of LY3305677 and any side effects that&#xD;
      might be associated with it.&#xD;
&#xD;
      This study will also look at how much LY3305677 gets into the blood stream, how long it takes&#xD;
      the body to remove it.&#xD;
&#xD;
      This study involves a single dose of LY3305677 administered by subcutaneous injection (SC).&#xD;
&#xD;
      Participation in this study is expected to last up to 16 weeks.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 5, 2016</start_date>
  <completion_date type="Actual">July 14, 2017</completion_date>
  <primary_completion_date type="Actual">July 14, 2017</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>Single Group 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 to Study Completion (approximately 16 weeks)</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Pharmacokinetics (PK): Area Under the Concentration Curve (AUC) of LY3305677</measure>
    <time_frame>Day 1 Pre-dose through Day 85</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pharmacokinetics (PK): Maximum Drug Concentration (Cmax) of LY3305677</measure>
    <time_frame>Day 1 Pre-dose through Day 85</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">66</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>LY3305677</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Single escalating doses of LY3305677 administered subcutaneously (SC)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo administered SC</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>LY3305677</intervention_name>
    <description>Administered SC</description>
    <arm_group_label>LY3305677</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Administered SC</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Overtly healthy as determined by medical history and physical examination&#xD;
&#xD;
          -  Male participants: will agree to use a reliable method of birth control and will not&#xD;
             donate sperm during the study and for at least 3 months following the last dose of the&#xD;
             investigational product&#xD;
&#xD;
          -  Female participants: women not of child-bearing potential due to surgical&#xD;
             sterilization confirmed by medical history or menopause&#xD;
&#xD;
          -  First generation Japanese participants or non-Japanese participants&#xD;
&#xD;
          -  Have a body weight of more than 50 kilograms (kg)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Have participated within the last 3 months in a clinical trial involving an&#xD;
             investigational product&#xD;
&#xD;
          -  Have known allergies to glucagon-like peptide-1 (GLP-1) analogs, or any components of&#xD;
             the formulation, or history of significant atopy&#xD;
&#xD;
          -  Have an abnormality in the 12-lead electrocardiogram (ECG) at screening and/or Day -1&#xD;
&#xD;
          -  Have undergone any form of bariatric surgery&#xD;
&#xD;
          -  Have obvious clinical signs or symptoms of liver disease, acute or chronic hepatitis&#xD;
&#xD;
          -  Have a history of acute or chronic pancreatitis or elevation in serum lipase and/or&#xD;
             amylase&#xD;
&#xD;
          -  Show evidence of human immunodeficiency virus (HIV) or Hepatitis B or C&#xD;
&#xD;
          -  Have used or intend to use medications that promote weight loss&#xD;
&#xD;
          -  Have donated blood of more than 500 milliliter (mL) within the last month&#xD;
&#xD;
          -  Currently smoke more than 10 cigarettes per day&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 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>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>Leeds</city>
        <zip>LS2-9LH</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>July 2017</verification_date>
  <study_first_submitted>November 21, 2016</study_first_submitted>
  <study_first_submitted_qc>November 21, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 23, 2016</study_first_posted>
  <last_update_submitted>July 21, 2017</last_update_submitted>
  <last_update_submitted_qc>July 21, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">July 24, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <!-- 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/NCT02972645
org study id: 16350
secondary id: I8P-MC-OXAA
nct id: NCT02972645
lead sponsor: 
has dmc: No
The purpose of this study is to evaluate the safety of LY3305677 and any side effects that
      might be associated with it.

      This study will also look at how much LY3305677 gets into the blood stream, how long it takes
      the body to remove it.

      This study involves a single dose of LY3305677 administered by subcutaneous injection (SC).

      Participation in this study is expected to last up to 16 weeks.
allocation: Randomized
intervention model: Single Group 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 to Study Completion (approximately 16 weeks)
measure: Pharmacokinetics (PK): Area Under the Concentration Curve (AUC) of LY3305677
time frame: Day 1 Pre-dose through Day 85
measure: Pharmacokinetics (PK): Maximum Drug Concentration (Cmax) of LY3305677
time frame: Day 1 Pre-dose through Day 85
arm group label: LY3305677
arm group type: Experimental
description: Single escalating doses of LY3305677 administered subcutaneously (SC)
arm group label: Placebo
arm group type: Placebo Comparator
description: Placebo administered SC
intervention type: Drug
intervention name: LY3305677
description: Administered SC
arm group label: LY3305677
intervention type: Drug
intervention name: Placebo
description: Administered SC
arm group label: Placebo
criteria: 
gender: All
minimum age: 20 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 Kingdom
responsible party type: Sponsor