xml: <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/NCT06023095</url>
    </required_header>
    <id_info>
      <org_study_id>18610</org_study_id>
      <secondary_id>J2A-GH-GZGX</secondary_id>
      <nct_id>NCT06023095</nct_id>
    </id_info>
    <brief_title>A Study of LY3502970 in Chinese Participants With Obesity or Are Overweight With Weight-related Comorbidities</brief_title>
    <official_title>A Multiple Dose Titration Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LY3502970 in Chinese Participants Who Have Obesity or Are Overweight With Weight-related Comorbidities</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 learn about the safety and tolerability of LY3502970&#xD;
        when given to Chinese participants with obesity or overweight with weight-related&#xD;
        comorbidities. Blood tests will be performed to investigate how the body processes the study&#xD;
        drug and how the study drug affects the body. Each enrolled participant will receive&#xD;
        LY3502970, or placebo given orally. For each participant, the study will last about&#xD;
        approximately 22- and 30-weeks for both cohort 1 and 2, respectively including screening&#xD;
        period.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 28, 2023</start_date>
    <completion_date type="Anticipated">November 29, 2024</completion_date>
    <primary_completion_date type="Anticipated">November 29, 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>Double (Participant, Investigator)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Number of Participants with One or More Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration</measure>
      <time_frame>Baseline through Week 18 (Cohort 1) &amp; Week 26 (Cohort 2)</time_frame>
      <description>A summary of TEAEs, 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>Predose on Day 1 up to 116 (Cohort 1) &amp; 172 (Cohort 2) Days postdose</time_frame>
      <description>PK: Cmax of LY3502970</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>PK: Area Under the Concentration Versus Time Curve From Time 0 to 24 hour Time Point (AUC0-24) of LY3502970</measure>
      <time_frame>Predose on Day 1 up to 116 (Cohort 1) &amp; 172 (Cohort 2) Days postdose</time_frame>
      <description>PK: AUC0-24 of LY3502970</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Pharmacodynamics (PD): Change From Baseline in Body Weight</measure>
      <time_frame>Baseline through 113 Days (Cohort 1) and 169 Days (Cohort 2)</time_frame>
      <description>PD: Change From Baseline in Body Weight</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>PD: Change From Baseline in Body Mass Index</measure>
      <time_frame>Baseline through 113 Days (Cohort 1) and 169 Days (Cohort 2)</time_frame>
      <description>PD: Change From Baseline in Body Mass Index</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>PD: Change From Baseline in Waist Circumference</measure>
      <time_frame>Baseline through 113 Days (Cohort 1) and 169 Days (Cohort 2)</time_frame>
      <description>PD: Change From Baseline in Waist Circumference</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>PD: Change From Baseline in Fasting Plasma Glucose</measure>
      <time_frame>Baseline through 113 Days (Cohort 1) and 169 Days (Cohort 2)</time_frame>
      <description>PD: Change From Baseline in Fasting Plasma Glucose</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">24</enrollment>
    <condition>Overweight</condition>
    <condition>Obesity</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;
            -  Are native Chinese males or females&#xD;
  &#xD;
            -  Have had a stable body weight for the 3 months prior to randomization (less than 5%&#xD;
               body weight change) and body mass index of ≥ 30.0 kilograms per square meter (kg/m²)&#xD;
               or between 27.0 up to 30.0 kg/m² with at least 1 of the following weight-related&#xD;
               comorbidities including Hypertension, Dyslipidemia, Cardiovascular disease,&#xD;
               Obstructive sleep apnea&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Have any prior diagnosis of type 1 diabetes mellitus (T1DM) or type 2 diabetes&#xD;
               mellitus (T2DM), or rare forms of diabetes mellitus&#xD;
  &#xD;
            -  Have used or intend to use any prescription or over-the-counter medications or&#xD;
               traditional Chinese treatments within 3 months prior to screening, exception of&#xD;
               medications for the treatment of concurrent medical conditions with a stable dose&#xD;
  &#xD;
            -  Have known allergies to GLP-1RAs, LY3502970, related compounds, any components of the&#xD;
               formulation, or have a history of significant atopy&#xD;
  &#xD;
            -  Are overweight or have obesity induced by other endocrinological disorders, diagnosed&#xD;
               monogenetic, or syndromic forms of obesity&#xD;
  &#xD;
            -  Have or plan to have a surgical, endoscopic or device-based treatment for obesity&#xD;
  &#xD;
            -  Have a history or presence of psychiatric disorder, a moderately severe or severe&#xD;
               depression status, or a significantly risk for suicide&#xD;
  &#xD;
            -  Have a history of acute or chronic pancreatitis&#xD;
  &#xD;
            -  Have a known self or family history of multiple endocrine neoplasia type 2A or type&#xD;
               2B, thyroid C-cell hyperplasia, or medullary thyroid carcinoma&#xD;
  &#xD;
            -  Have other acute, chronic, or uncontrolled medical conditions, vital organ failure or&#xD;
               abnormal laboratory value in the judgment of the investigator would make the&#xD;
               participant inappropriate for entry into this study&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>65 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>
    <overall_contact>
      <last_name>There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or</last_name>
      <phone>1-317-615-4559</phone>
      <email>ClinicalTrials.gov@Lilly.com</email>
    </overall_contact>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 29, 2023</study_first_submitted>
    <study_first_submitted_qc>August 29, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 5, 2023</study_first_posted>
    <last_update_submitted>August 29, 2023</last_update_submitted>
    <last_update_submitted_qc>August 29, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 5, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Safety and Tolerability</keyword>
    <keyword>Chinese</keyword>
    <keyword>LY3502970</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Obesity</mesh_term>
      <mesh_term>Overweight</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06023095
  org study id: 18610
  secondary id: J2A-GH-GZGX
  nct id: NCT06023095
  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 learn about the safety and tolerability of LY3502970
        when given to Chinese participants with obesity or overweight with weight-related
        comorbidities. Blood tests will be performed to investigate how the body processes the study
        drug and how the study drug affects the body. Each enrolled participant will receive
        LY3502970, or placebo given orally. For each participant, the study will last about
        approximately 22- and 30-weeks for both cohort 1 and 2, respectively including screening
        period.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Basic Science
  masking: Double (Participant, Investigator)
  measure: Number of Participants with One or More Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
  time frame: Baseline through Week 18 (Cohort 1) & Week 26 (Cohort 2)
  description: A summary of TEAEs, 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: Predose on Day 1 up to 116 (Cohort 1) & 172 (Cohort 2) Days postdose
  description: PK: Cmax of LY3502970
  measure: PK: Area Under the Concentration Versus Time Curve From Time 0 to 24 hour Time Point (AUC0-24) of LY3502970
  time frame: Predose on Day 1 up to 116 (Cohort 1) & 172 (Cohort 2) Days postdose
  description: PK: AUC0-24 of LY3502970
  measure: Pharmacodynamics (PD): Change From Baseline in Body Weight
  time frame: Baseline through 113 Days (Cohort 1) and 169 Days (Cohort 2)
  description: PD: Change From Baseline in Body Weight
  measure: PD: Change From Baseline in Body Mass Index
  time frame: Baseline through 113 Days (Cohort 1) and 169 Days (Cohort 2)
  description: PD: Change From Baseline in Body Mass Index
  measure: PD: Change From Baseline in Waist Circumference
  time frame: Baseline through 113 Days (Cohort 1) and 169 Days (Cohort 2)
  description: PD: Change From Baseline in Waist Circumference
  measure: PD: Change From Baseline in Fasting Plasma Glucose
  time frame: Baseline through 113 Days (Cohort 1) and 169 Days (Cohort 2)
  description: PD: Change From Baseline in Fasting Plasma Glucose
  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: 65 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
  last name: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or
  phone: 1-317-615-4559
  email: ClinicalTrials.gov@Lilly.com
  responsible party type: Sponsor
  mesh term: Obesity
  mesh term: Overweight
  sharing ipd: No