<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/NCT04451408</url>
  </required_header>
  <id_info>
    <org_study_id>17755</org_study_id>
    <secondary_id>J1G-MC-LAKB</secondary_id>
    <nct_id>NCT04451408</nct_id>
  </id_info>
  <brief_title>A Study of LY3372993 in Participants With Alzheimer's Disease (AD) and Healthy Participants</brief_title>
  <official_title>A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LY3372993 in Participants With Alzheimer's Disease and Healthy Participants</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 evaluate the safety and tolerability of LY3372993 in&#xD;
      participants with AD, non-Japanese, and Japanese healthy participants who are of&#xD;
      first-generation Japanese origin. The study will also investigate how much LY3372993 gets&#xD;
      into the bloodstream and will test the effects of LY3372993. The study will be conducted in&#xD;
      two parts. The part A includes participants with AD and part B includes healthy participants.&#xD;
      Participation could last up to about 61 weeks and may include up to 31 visits to the study&#xD;
      center.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">July 7, 2020</start_date>
  <completion_date type="Anticipated">June 30, 2024</completion_date>
  <primary_completion_date type="Anticipated">June 30, 2024</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>Triple (Participant, Care Provider, 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 Week 61 (part A) and Week 13 (Part B)</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 Concentration (Cmax) of LY3372993</measure>
    <time_frame>Day 1 Predose through Week 61 (part A) and Week 13 (Part B)</time_frame>
    <description>PK: Cmax of LY3372993</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PK: Area Under the Concentration Versus Time Curve (AUC) of LY3372993</measure>
    <time_frame>Day 1 Predose through Week 61 (part A) and Week 13 (Part B)</time_frame>
    <description>PK: AUC of LY3372993</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pharmacodynamics (PD): Change from Baseline in Cerebral Amyloid Plaque Level (Part A only)</measure>
    <time_frame>Baseline and Week 61 (part A)</time_frame>
    <description>PD: Cerebral amyloid plaque level measured using florbetapir positron emission tomography</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Anticipated">224</enrollment>
  <condition>Alzheimer Disease</condition>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>LY3372993 (Part A)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>LY3372993 administered as multiple doses either intravenously (IV) or subcutaneously (SC).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>LY3372993 (Part B)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>LY3372993 administered as single dose IV or 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 administered as multiple doses IV or SC.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo (Part B)</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo administered as single dose IV or SC.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>LY3372993</intervention_name>
    <description>Administered IV or SC.</description>
    <arm_group_label>LY3372993 (Part A)</arm_group_label>
    <arm_group_label>LY3372993 (Part B)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Administered IV or SC.</description>
    <arm_group_label>Placebo (Part A)</arm_group_label>
    <arm_group_label>Placebo (Part B)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        (Part A)&#xD;
&#xD;
          -  Gradual and progressive changes in memory function reported by participants or their&#xD;
             partners for greater than or equal to (≥) 6 months at screening, and a clinical&#xD;
             diagnosis of mild cognitive impairment due to AD, or AD dementia, as determined by the&#xD;
             investigator or based upon medical history&#xD;
&#xD;
          -  Mini-Mental State Examination score ≥16&#xD;
&#xD;
          -  Have clinical laboratory test results within normal reference range or results with&#xD;
             acceptable deviations that are judged to be not clinically significant by the&#xD;
             investigator&#xD;
&#xD;
          -  Have a study partner who will provide written informed consent to participate, is in&#xD;
             frequent contact with the participant (defined as at least 10 hours per week), and&#xD;
             will accompany the participant to study visits or be available through telephone at&#xD;
             designated times&#xD;
&#xD;
        (Part B)&#xD;
&#xD;
          -  overtly healthy males or females&#xD;
&#xD;
          -  have a body mass index of 18.0 to 32.0 kg/m2, inclusive&#xD;
&#xD;
          -  To qualify as a participant of the first-generation Japanese origin, the participant,&#xD;
             the participant's biological parents, and all of the participant's biological&#xD;
             grandparents must be of exclusive Japanese descent and born in Japan.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        (Part A)&#xD;
&#xD;
          -  Have history or presence of uncontrolled asthma, significant autoimmune disease,&#xD;
             hereditary angioedema, or known history of common variable immune deficiency&#xD;
&#xD;
          -  Contraindication to positron emission tomography (PET)&#xD;
&#xD;
          -  Have a history or presence of serious or unstable illnesses including cardiovascular,&#xD;
             hepatic, renal, gastrointestinal, respiratory, endocrine, psychiatric, immunologic, or&#xD;
             hematologic disease and other conditions that, in the investigator's opinion, could&#xD;
             interfere with the analyses in this study, or increase risk for study intervention&#xD;
             administration, or result in a participant's life expectancy of less than (&lt;)24 months&#xD;
&#xD;
          -  Have received treatment with biologic agents (such as monoclonal antibodies, including&#xD;
             marketed drugs) within 3 months or 5 half-lives (whichever is longer) prior to dosing&#xD;
&#xD;
          -  Have had significant medical history of dizziness, syncope, or vasovagal attacks&#xD;
             within the past 3 years&#xD;
&#xD;
          -  Contraindication to magnetic resonance imaging (MRI), including claustrophobia that&#xD;
             cannot be managed with low-dose sedatives or the presence of contraindicated metal&#xD;
             (ferromagnetic) implants/cardiac pacemaker&#xD;
&#xD;
        (Part B)&#xD;
&#xD;
          -  have a family history of early onset AD (AD diagnosed prior to 65 years of age)&#xD;
&#xD;
          -  have used or intend to use over-the-counter or prescription medication including&#xD;
             herbal medications within 14 days prior to dosing.&#xD;
&#xD;
          -  have a history or presence of significant psychiatric disorders&#xD;
&#xD;
          -  have an abnormal blood pressure and/or pulse rate as determined by the investigator,&#xD;
             or a pre-existing history of hypertension&#xD;
&#xD;
          -  any clinically significant ECG or brain MRI abnormalities&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>85 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>Altasciences Clinical Los Angeles, Inc</name>
      <address>
        <city>Cypress</city>
        <state>California</state>
        <zip>90630</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Collaborative Neuroscience Research, LLC</name>
      <address>
        <city>Long Beach</city>
        <state>California</state>
        <zip>90806</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Accel Research Sites- Clinical Research Unit</name>
      <address>
        <city>DeLand</city>
        <state>Florida</state>
        <zip>32720</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Velocity Clinical Research, Hallandale Beach</name>
      <address>
        <city>Hallandale Beach</city>
        <state>Florida</state>
        <zip>33009</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>IMIC, Inc.</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33176</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ppd Development</name>
      <address>
        <city>Orlando</city>
        <state>Florida</state>
        <zip>32806-1041</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Progressive Medical Research</name>
      <address>
        <city>Port Orange</city>
        <state>Florida</state>
        <zip>32127</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>BioClinica Inc</name>
      <address>
        <city>The Villages</city>
        <state>Florida</state>
        <zip>32162</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Charter Research</name>
      <address>
        <city>The Villages</city>
        <state>Florida</state>
        <zip>32162</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Covance Dallas</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75247</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Oita University Hospital</name>
      <address>
        <city>Yufu</city>
        <state>Oita</state>
        <zip>879-5503</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The University of Tokyo Hospital</name>
      <address>
        <city>Bunkyo-ku</city>
        <state>Tokyo</state>
        <zip>113-8655</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Research Hospital Tokyo</name>
      <address>
        <city>Shinjuku-ku</city>
        <state>Tokyo</state>
        <zip>162-0053</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Japan</country>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://trials.lillytrialguide.com/en-US/trial/3qQDrJd2dTslGhNmqMga6Q</url>
    <description>A Study of LY3372993 in Participants With Alzheimer's Disease (AD)</description>
  </link>
  <verification_date>July 2023</verification_date>
  <study_first_submitted>June 26, 2020</study_first_submitted>
  <study_first_submitted_qc>June 26, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 30, 2020</study_first_posted>
  <last_update_submitted>July 11, 2023</last_update_submitted>
  <last_update_submitted_qc>July 11, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">July 12, 2023</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>Alzheimer Disease</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/NCT04451408
org study id: 17755
secondary id: J1G-MC-LAKB
nct id: NCT04451408
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
The main purpose of this study is to evaluate the safety and tolerability of LY3372993 in
      participants with AD, non-Japanese, and Japanese healthy participants who are of
      first-generation Japanese origin. The study will also investigate how much LY3372993 gets
      into the bloodstream and will test the effects of LY3372993. The study will be conducted in
      two parts. The part A includes participants with AD and part B includes healthy participants.
      Participation could last up to about 61 weeks and may include up to 31 visits to the study
      center.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Basic Science
masking: Triple (Participant, Care Provider, 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 Week 61 (part A) and Week 13 (Part B)
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 Concentration (Cmax) of LY3372993
time frame: Day 1 Predose through Week 61 (part A) and Week 13 (Part B)
description: PK: Cmax of LY3372993
measure: PK: Area Under the Concentration Versus Time Curve (AUC) of LY3372993
time frame: Day 1 Predose through Week 61 (part A) and Week 13 (Part B)
description: PK: AUC of LY3372993
measure: Pharmacodynamics (PD): Change from Baseline in Cerebral Amyloid Plaque Level (Part A only)
time frame: Baseline and Week 61 (part A)
description: PD: Cerebral amyloid plaque level measured using florbetapir positron emission tomography
arm group label: LY3372993 (Part A)
arm group type: Experimental
description: LY3372993 administered as multiple doses either intravenously (IV) or subcutaneously (SC).
arm group label: LY3372993 (Part B)
arm group type: Experimental
description: LY3372993 administered as single dose IV or SC.
arm group label: Placebo (Part A)
arm group type: Placebo Comparator
description: Placebo administered as multiple doses IV or SC.
arm group label: Placebo (Part B)
arm group type: Placebo Comparator
description: Placebo administered as single dose IV or SC.
intervention type: Drug
intervention name: LY3372993
description: Administered IV or SC.
arm group label: LY3372993 (Part A)
arm group label: LY3372993 (Part B)
intervention type: Drug
intervention name: Placebo
description: Administered IV or SC.
arm group label: Placebo (Part A)
arm group label: Placebo (Part B)
criteria: 
gender: All
minimum age: 18 Years
maximum age: 85 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: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Japan
country: United States
url: https://trials.lillytrialguide.com/en-US/trial/3qQDrJd2dTslGhNmqMga6Q
description: A Study of LY3372993 in Participants With Alzheimer's Disease (AD)
responsible party type: Sponsor
mesh term: Alzheimer Disease
sharing ipd: No