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/NCT05963022</url>
    </required_header>
    <id_info>
      <org_study_id>18746</org_study_id>
      <secondary_id>I8F-MC-GPIU</secondary_id>
      <nct_id>NCT05963022</nct_id>
    </id_info>
    <brief_title>A Study of Tirzepatide (LY3298176) in Chinese Participants With Type 2 Diabetes (SURPASS-CN-MONO)</brief_title>
    <official_title>A Randomized, Double-blind, Placebo-controlled Study to Investigate the Efficacy and Safety of Tirzepatide Monotherapy Compared With Placebo in Chinese Participants With Type 2 Diabetes</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 efficacy and safety of Tirzepatide&#xD;
        monotherapy in Chinese participants with Type 2 Diabetes.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">August 21, 2023</start_date>
    <completion_date type="Anticipated">April 14, 2025</completion_date>
    <primary_completion_date type="Anticipated">April 14, 2025</primary_completion_date>
    <phase>Phase 3</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>Treatment</primary_purpose>
      <masking>Double (Participant, Investigator)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Change from Baseline in Hemoglobin A1c (HbA1c)</measure>
      <time_frame>Baseline, Week 40</time_frame>
    </primary_outcome>
    <secondary_outcome>
      <measure>Percentage of Participants with HbA1c Target Values of &lt;7.0% (&lt;53 mmol/mol)</measure>
      <time_frame>Week 40</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change from Baseline in Fasting Serum Glucose</measure>
      <time_frame>Baseline, Week 40</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Percentage of Participants with HbA1c Target Values of ≤6.5% (≤48 mmol/mol)</measure>
      <time_frame>Week 40</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change from Baseline in Body Weight</measure>
      <time_frame>Baseline, Week 40</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Percentage of Participants with HbA1c Target Values of &lt;5.7% (&lt;39 mmol/mol)</measure>
      <time_frame>Week 40</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change from Baseline in Daily Average 7-Point Self-Monitored Blood Glucose Profiles (SMBG)</measure>
      <time_frame>Baseline, Week 40</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Percentage of Participants Who Achieved Weight loss of ≥5%</measure>
      <time_frame>Week 40</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Percentage of Participants Who Achieved Weight loss of ≥10%</measure>
      <time_frame>Week 40</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Percentage of Participants Who Achieved Weight loss of ≥15%</measure>
      <time_frame>Week 40</time_frame>
    </secondary_outcome>
    <number_of_arms>4</number_of_arms>
    <enrollment type="Anticipated">200</enrollment>
    <condition>Type 2 Diabetes</condition>
    <arm_group>
      <arm_group_label>Tirzepatide Dose 1</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants will receive tirzepatide subcutaneously (SC).</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Tirzepatide Dose 2</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants will receive tirzepatide SC.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Tirzepatide Dose 3</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants will receive tirzepatide SC.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Placebo</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <description>Participants will receive placebo.</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Tirzepatide</intervention_name>
      <description>Administered SC</description>
      <arm_group_label>Tirzepatide Dose 1</arm_group_label>
      <arm_group_label>Tirzepatide Dose 2</arm_group_label>
      <arm_group_label>Tirzepatide Dose 3</arm_group_label>
      <other_name>LY3298176</other_name>
    </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;
            -  Have Type 2 Diabetes&#xD;
  &#xD;
            -  Have HbA1c ≥7.0% (≥53 mmol/mol) to ≤9.5% (≤80 mmol/mol) despite diet and exercise&#xD;
               treatment&#xD;
  &#xD;
            -  Are of stable weight 5%) during the 90 days preceding screening and agree not to&#xD;
               initiate a diet and/or exercise program during the study with the intent of reducing&#xD;
               body weight other than the lifestyle and dietary measures for diabetes treatment&#xD;
  &#xD;
            -  Have Body Mass Index (BMI) ≥23.0 kilogram per square meter (kg/m²)&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Have Type 1 Diabetes&#xD;
  &#xD;
            -  Have a history of chronic or acute pancreatitis any time prior to study entry&#xD;
  &#xD;
            -  Are currently receiving treatment for diabetic retinopathy and/or macular edema&#xD;
  &#xD;
            -  Have a history of ketoacidosis or hyperosmolar state/coma&#xD;
  &#xD;
            -  Have a history of New York Heart Association Functional Classification IV congestive&#xD;
               heart failure (CHF)&#xD;
  &#xD;
            -  Have acute or chronic hepatitis including a history of autoimmune hepatitis&#xD;
  &#xD;
            -  Use of insulin 1-year preceding screening and between screening and baseline; use of&#xD;
               any antihyperglycemic medication 90 days preceding screening and between screening and&#xD;
               baseline.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</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>-317-615-4559</phone>
      <email>ClinicalTrials.gov@lilly.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Chinese PLA General Hospital</name>
        <address>
          <city>Beijing</city>
          <state>Beijing</state>
          <zip>100853</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <investigator>
        <last_name>Yiming Mu</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Shunde Hospital of Southern Medical Univesity</name>
        <address>
          <city>Foshan</city>
          <state>Guangdong</state>
          <zip>528399</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <investigator>
        <last_name>Yongqian LIANG</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Huizhou Municipal Central Hospital</name>
        <address>
          <city>Huizhou</city>
          <state>Guangdong</state>
          <zip>516001</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <investigator>
        <last_name>Shu Li</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Zunyi First People's Hospital</name>
        <address>
          <city>Zunyi</city>
          <state>Guizhou</state>
          <zip>563002</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <investigator>
        <last_name>Chengyan Jiang</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Hainan General Hospital</name>
        <address>
          <city>Haikou</city>
          <state>Hainan</state>
          <zip>570311</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <investigator>
        <last_name>Kaining Chen</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>The Fourth Hospital of Harbin Medical University</name>
        <address>
          <city>Harbin</city>
          <state>Heilongjiang</state>
          <zip>150001</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <investigator>
        <last_name>ZhiFeng Cheng</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>The First Affiliated Hospital of Henan University of Science &amp;Technology</name>
        <address>
          <city>Luoyang Shi</city>
          <state>Henan</state>
          <zip>471003</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <investigator>
        <last_name>hongwei Jiang</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>The First Affiliated Hospital of Nanyang Medical College</name>
        <address>
          <city>Nanyang</city>
          <state>Henan</state>
          <zip>473007</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <investigator>
        <last_name>Dexue Liu</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>The Second Affiliated Hospital of Zhengzhou University</name>
        <address>
          <city>Zhengzhou</city>
          <state>Henan</state>
          <zip>450014</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <investigator>
        <last_name>Qingju Li</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Yichang Central People's Hospital</name>
        <address>
          <city>Yichang</city>
          <state>Hubei</state>
          <zip>443003</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <investigator>
        <last_name>Chaoyang Zeng</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>The First People's Hospital of Changde City</name>
        <address>
          <city>Changde</city>
          <state>Hunan</state>
          <zip>415003</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <investigator>
        <last_name>wen ouyang</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Changzhou No.2 People's Hospital</name>
        <address>
          <city>Changzhou</city>
          <state>Jiangsu</state>
          <zip>213000</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <investigator>
        <last_name>Yun Xue</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>The Second Affiliated Hospital of Nanjing Medical University</name>
        <address>
          <city>Nanjing</city>
          <state>Jiangsu</state>
          <zip>210011</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <investigator>
        <last_name>Yibing Lu</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Nanjing First Hospital</name>
        <address>
          <city>Nanjing</city>
          <state>Jiangsu</state>
          <zip>210012</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <investigator>
        <last_name>Jianhua Ma</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Nanjing Medical University - Nanjing Jiangning Hospital</name>
        <address>
          <city>Nanjing</city>
          <state>Jiangsu</state>
          <zip>211100</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <investigator>
        <last_name>Kun Wang</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>The First Affiliated Hospital of Soochow University</name>
        <address>
          <city>Suzhou</city>
          <state>Jiangsu</state>
          <zip>215006</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <investigator>
        <last_name>Bimin Shi</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Affiliated Hospital of Jiangsu University</name>
        <address>
          <city>Zhenjiang</city>
          <state>Jiangsu</state>
          <zip>212000</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <investigator>
        <last_name>Guoyue Yuan</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Jiangxi Pingxiang People's Hospital</name>
        <address>
          <city>Pingxiang</city>
          <state>Jiangxi</state>
          <zip>337055</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <investigator>
        <last_name>Yawei Zhang</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Dalian University - The Affiliated Zhongshan Hospital</name>
        <address>
          <city>Dalian</city>
          <state>Liaoning</state>
          <zip>116001</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <investigator>
        <last_name>Wei Duan</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Dalian Municipal Central Hospital Affiliated of Dalian Medical University</name>
        <address>
          <city>Dalian</city>
          <state>Liaoning</state>
          <zip>116033</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <investigator>
        <last_name>Xinyu Li</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Panjin Liaoyou Baoshihua Hospital</name>
        <address>
          <city>Liaoyou</city>
          <state>Liaoning</state>
          <zip>124009</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <investigator>
        <last_name>Xin Zhang</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>The First Affiliated Hospital of Xi'an Medical University</name>
        <address>
          <city>Xi'an</city>
          <state>Shaanxi</state>
          <zip>710077</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <investigator>
        <last_name>Ya Li</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Jinan Central Hospital</name>
        <address>
          <city>Jinan</city>
          <state>Shandong</state>
          <zip>250013</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <investigator>
        <last_name>Xiaolin Dong</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Pudong New Area People's Hospital Shanghai</name>
        <address>
          <city>Shanghai</city>
          <state>Shanghai</state>
          <zip>201200</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <investigator>
        <last_name>Xiaozhen JIANG</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Jiading District Central Hospital</name>
        <address>
          <city>Shanghai</city>
          <state>Shanghai</state>
          <zip>201800</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <investigator>
        <last_name>Lixia Suo</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>West China Hospital, Sichuan University</name>
        <address>
          <city>Cheng Du</city>
          <state>Sichuan</state>
          <zip>610041</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <investigator>
        <last_name>zhenmei an</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Chengdu Fifth People's Hospital</name>
        <address>
          <city>Chengdu</city>
          <state>Sichuan</state>
          <zip>611130</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <investigator>
        <last_name>Hongyi Cao</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Tianjin Medical University General Hospital</name>
        <address>
          <city>Tianjin</city>
          <state>Tianjin</state>
          <zip>300052</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <investigator>
        <last_name>Ming Liu</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Huzhou Central Hospital</name>
        <address>
          <city>Huzhou</city>
          <state>Zhejiang</state>
          <zip>313000</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <investigator>
        <last_name>Jianping Yao</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Ningbo First Hospital</name>
        <address>
          <city>Ningbo</city>
          <state>Zhejiang</state>
          <zip>315010</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <investigator>
        <last_name>Jialin Li</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 19, 2023</study_first_submitted>
    <study_first_submitted_qc>July 19, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">July 27, 2023</study_first_posted>
    <last_update_submitted>August 22, 2023</last_update_submitted>
    <last_update_submitted_qc>August 22, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 24, 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>Diabetes Mellitus</mesh_term>
      <mesh_term>Diabetes Mellitus, Type 2</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Tirzepatide</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.</ipd_description>
      <ipd_info_type>Study Protocol</ipd_info_type>
      <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
      <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
      <ipd_time_frame>Data are available 6 months after the primary publication and approval of the indication studied in the US and European Union (EU), whichever is later. Data will be indefinitely available for requesting.</ipd_time_frame>
      <ipd_access_criteria>A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.</ipd_access_criteria>
      <ipd_url>http://vivli.org/</ipd_url>
    </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/NCT05963022
  org study id: 18746
  secondary id: I8F-MC-GPIU
  nct id: NCT05963022
  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 efficacy and safety of Tirzepatide
        monotherapy in Chinese participants with Type 2 Diabetes.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Double (Participant, Investigator)
  measure: Change from Baseline in Hemoglobin A1c (HbA1c)
  time frame: Baseline, Week 40
  measure: Percentage of Participants with HbA1c Target Values of <7.0% (<53 mmol/mol)
  time frame: Week 40
  measure: Change from Baseline in Fasting Serum Glucose
  time frame: Baseline, Week 40
  measure: Percentage of Participants with HbA1c Target Values of ≤6.5% (≤48 mmol/mol)
  time frame: Week 40
  measure: Change from Baseline in Body Weight
  time frame: Baseline, Week 40
  measure: Percentage of Participants with HbA1c Target Values of <5.7% (<39 mmol/mol)
  time frame: Week 40
  measure: Change from Baseline in Daily Average 7-Point Self-Monitored Blood Glucose Profiles (SMBG)
  time frame: Baseline, Week 40
  measure: Percentage of Participants Who Achieved Weight loss of ≥5%
  time frame: Week 40
  measure: Percentage of Participants Who Achieved Weight loss of ≥10%
  time frame: Week 40
  measure: Percentage of Participants Who Achieved Weight loss of ≥15%
  time frame: Week 40
  arm group label: Tirzepatide Dose 1
  arm group type: Experimental
  description: Participants will receive tirzepatide subcutaneously (SC).
  arm group label: Tirzepatide Dose 2
  arm group type: Experimental
  description: Participants will receive tirzepatide SC.
  arm group label: Tirzepatide Dose 3
  arm group type: Experimental
  description: Participants will receive tirzepatide SC.
  arm group label: Placebo
  arm group type: Placebo Comparator
  description: Participants will receive placebo.
  intervention type: Drug
  intervention name: Tirzepatide
  description: Administered SC
  arm group label: Tirzepatide Dose 1
  arm group label: Tirzepatide Dose 2
  arm group label: Tirzepatide Dose 3
  other name: LY3298176
  intervention type: Drug
  intervention name: Placebo
  description: Administered SC
  arm group label: Placebo
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  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: -317-615-4559
  email: ClinicalTrials.gov@lilly.com
  facility: 
  status: Recruiting
  investigator: 
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  status: Not yet recruiting
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  status: Recruiting
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  status: Recruiting
  investigator: 
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  status: Not yet recruiting
  investigator: 
  country: China
  responsible party type: Sponsor
  mesh term: Diabetes Mellitus
  mesh term: Diabetes Mellitus, Type 2
  mesh term: Tirzepatide
  sharing ipd: Yes
  ipd description: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
  ipd info type: Study Protocol
  ipd info type: Statistical Analysis Plan (SAP)
  ipd info type: Clinical Study Report (CSR)
  ipd time frame: Data are available 6 months after the primary publication and approval of the indication studied in the US and European Union (EU), whichever is later. Data will be indefinitely available for requesting.
  ipd access criteria: A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
  ipd url: http://vivli.org/