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/NCT05971940</url>
    </required_header>
    <id_info>
      <org_study_id>18564</org_study_id>
      <secondary_id>J2A-MC-GZGT</secondary_id>
      <secondary_id>U1111-1290-5157</secondary_id>
      <nct_id>NCT05971940</nct_id>
    </id_info>
    <brief_title>A Study of Orforglipron (LY3502970) in Adult Participants With Type 2 Diabetes and Inadequate Glycemic Control With Diet and Exercise Alone</brief_title>
    <acronym>ACHIEVE-1</acronym>
    <official_title>A Phase 3, Randomized, Double-Blind Study to Investigate the Efficacy and Safety of Once Daily Oral LY3502970 Compared With Placebo in Adult Participants With Type 2 Diabetes and Inadequate Glycemic Control With Diet and Exercise Alone</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 determine safety and efficacy of orforglipron compared&#xD;
        with placebo in adult participants with type 2 diabetes and inadequate glycemic control with&#xD;
        diet and exercise alone. The study will last approximately 54 weeks.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 15, 2023</start_date>
    <completion_date type="Anticipated">January 15, 2025</completion_date>
    <primary_completion_date type="Anticipated">January 15, 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>Week 40</time_frame>
    </primary_outcome>
    <secondary_outcome>
      <measure>Percentage of Participants with an HbA1c target value of &lt;7.0% (53 mmol/mol)</measure>
      <time_frame>Week 40</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Percentage of Participants with an HbA1c target value of ≤6.5% (48 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 Change from Baseline in Body Weight</measure>
      <time_frame>Baseline, 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>Change from Baseline in Daily Average 7-point Self-Monitored Blood Glucose (SMBG)</measure>
      <time_frame>Baseline, Week 40</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change from Baseline in Systolic Blood Pressure (SBP)</measure>
      <time_frame>Baseline, Week 40</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change from Baseline in Triglycerides</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>Change from Baseline in Short Form 36 Version 2 (SF-36v2) Acute Form Domain Scores</measure>
      <time_frame>Baseline, Week 40</time_frame>
    </secondary_outcome>
    <number_of_arms>4</number_of_arms>
    <enrollment type="Anticipated">520</enrollment>
    <condition>Type 2 Diabetes</condition>
    <arm_group>
      <arm_group_label>Orforglipron Dose 1</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants will receive orforglipron orally.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Orforglipron Dose 2</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants will receive orforglipron orally.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Orforglipron Dose 3</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants will receive orforglipron orally.</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>Orforglipron</intervention_name>
      <description>Administered orally.</description>
      <arm_group_label>Orforglipron Dose 1</arm_group_label>
      <arm_group_label>Orforglipron Dose 2</arm_group_label>
      <arm_group_label>Orforglipron Dose 3</arm_group_label>
      <other_name>LY3502970</other_name>
    </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;
            -  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, as determined by the central laboratory at screening.&#xD;
  &#xD;
            -  Are naïve to insulin therapy except for gestational diabetes or ≤14 days use for acute&#xD;
               treatment and have not used any oral or injectable antihyperglycemic medications&#xD;
               during the 90 days preceding screening or between screening and randomization.&#xD;
  &#xD;
            -  Are of stable weight (±5%) for at least 90 days prior to screening and agree to not&#xD;
               initiate an intensive diet or exercise program during the study with the intent of&#xD;
               reducing body weight other than the lifestyle and/or dietary measures for diabetes&#xD;
               treatment.&#xD;
  &#xD;
            -  Have a body mass index (BMI) ≥23.0 kilogram/square meter (kg/m²) at screening.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Have Type 1 Diabetes&#xD;
  &#xD;
            -  Have a history of ketoacidosis or hyperosmolar state or coma within the last 6 months&#xD;
               prior to screening, or between screening and randomization.&#xD;
  &#xD;
            -  Currently receiving or planning to receive treatment for diabetic retinopathy and/or&#xD;
               macular edema&#xD;
  &#xD;
            -  Have New York Heart Association functional classification IV congestive heart failure.&#xD;
  &#xD;
            -  Have acute or chronic hepatitis&#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>1-317-615-4559</phone>
      <email>ClinicalTrials.gov@lilly.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Syed Research Consultants Llc</name>
        <address>
          <city>Sheffield</city>
          <state>Alabama</state>
          <zip>35660</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <phone>256-383-4473</phone>
      </contact>
      <investigator>
        <last_name>AARON W KARR</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Epic Medical Research - Surprise</name>
        <address>
          <city>Surprise</city>
          <state>Arizona</state>
          <zip>85378</zip>
          <country>United States</country>
        </address>
      </facility>
      <investigator>
        <last_name>Rachel Greatwood</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Quality of Life Medical &amp; Research Center</name>
        <address>
          <city>Tucson</city>
          <state>Arizona</state>
          <zip>85712</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <phone>520-731-2333</phone>
      </contact>
      <investigator>
        <last_name>Walter S. Patton</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Neighborhood Healthcare Institute of Health</name>
        <address>
          <city>Escondido</city>
          <state>California</state>
          <zip>92025</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <phone>760-737-6984</phone>
      </contact>
      <investigator>
        <last_name>James H Schultz</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Velocity Clinical Research, Huntington Park</name>
        <address>
          <city>Huntington Park</city>
          <state>California</state>
          <zip>90255</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <phone>323-588-1990</phone>
      </contact>
      <investigator>
        <last_name>Stanley H. Hsia</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Ark Clinical Research</name>
        <address>
          <city>Long Beach</city>
          <state>California</state>
          <zip>90815</zip>
          <country>United States</country>
        </address>
      </facility>
      <investigator>
        <last_name>Martha G Navarro</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Velocity Clinical Research, Westlake</name>
        <address>
          <city>Los Angeles</city>
          <state>California</state>
          <zip>90057</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <phone>2134831800</phone>
      </contact>
      <investigator>
        <last_name>Juan Pablo Frias</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Infinity Clinical Research - Norco</name>
        <address>
          <city>Norco</city>
          <state>California</state>
          <zip>92860</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <phone>714-252-6689</phone>
      </contact>
      <investigator>
        <last_name>Peter Mattar</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Norcal Endocrinology &amp; Internal Medicine</name>
        <address>
          <city>San Ramon</city>
          <state>California</state>
          <zip>94583</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <phone>707-628-6428</phone>
      </contact>
      <investigator>
        <last_name>Yshay Shlesinger</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>University Clinical Investigators, Inc.</name>
        <address>
          <city>Tustin</city>
          <state>California</state>
          <zip>92780</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <phone>714-734-7944</phone>
      </contact>
      <investigator>
        <last_name>John Kim</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Connecticut Clinical Research - Cromwell</name>
        <address>
          <city>Cromwell</city>
          <state>Connecticut</state>
          <zip>06416</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <phone>8606320144</phone>
      </contact>
      <investigator>
        <last_name>Charles Brendan Montano</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Invictus Clinical Research Group</name>
        <address>
          <city>Coconut Creek</city>
          <state>Florida</state>
          <zip>33073</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <phone>954-842-6434</phone>
      </contact>
      <investigator>
        <last_name>Juan F Zapata</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Hillcrest Medical Research</name>
        <address>
          <city>DeLand</city>
          <state>Florida</state>
          <zip>32720</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <phone>386-999-7616</phone>
      </contact>
      <investigator>
        <last_name>John M Hill</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>K2 Medical Research</name>
        <address>
          <city>Maitland</city>
          <state>Florida</state>
          <zip>32751</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <phone>407-810-2790</phone>
      </contact>
      <investigator>
        <last_name>Neel Patel</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Global Health Research Center, Inc.</name>
        <address>
          <city>Miami Lakes</city>
          <state>Florida</state>
          <zip>33016</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <phone>305-824-0026</phone>
      </contact>
      <investigator>
        <last_name>Maray Rocher</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>West Orange Endocrinology</name>
        <address>
          <city>Ocoee</city>
          <state>Florida</state>
          <zip>34761</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <phone>4074804830</phone>
      </contact>
      <investigator>
        <last_name>Jose Manuel Mandry</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Clinical Research Atlanta</name>
        <address>
          <city>Stockbridge</city>
          <state>Georgia</state>
          <zip>30281</zip>
          <country>United States</country>
        </address>
      </facility>
      <investigator>
        <last_name>Deon Miller</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Rophe Adult and Pediatric Medicine/SKYCRNG</name>
        <address>
          <city>Union City</city>
          <state>Georgia</state>
          <zip>30291</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <phone>470-317-3604</phone>
      </contact>
      <investigator>
        <last_name>Dwight Blake</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Family First Medical Center</name>
        <address>
          <city>Idaho Falls</city>
          <state>Idaho</state>
          <zip>83404</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <phone>2085527700</phone>
      </contact>
      <investigator>
        <last_name>Flint Rudd Packer</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Tekton Research, Inc</name>
        <address>
          <city>Wichita</city>
          <state>Kansas</state>
          <zip>67218</zip>
          <country>United States</country>
        </address>
      </facility>
      <investigator>
        <last_name>Brandon Alleman</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Alliance for Multispecialty Research, LLC</name>
        <address>
          <city>New Orleans</city>
          <state>Louisiana</state>
          <zip>70119</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <phone>504-821-8158</phone>
      </contact>
      <investigator>
        <last_name>Robert J Noveck</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Revival Research Institute</name>
        <address>
          <city>Dearborn</city>
          <state>Michigan</state>
          <zip>48126</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <phone>586-276-7453</phone>
      </contact>
      <investigator>
        <last_name>Abdulhassan Saad</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Billings Clinic</name>
        <address>
          <city>Billings</city>
          <state>Montana</state>
          <zip>59101</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <phone>406-435-8470</phone>
      </contact>
      <investigator>
        <last_name>Haleigh James</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Synexus Clinical Research US</name>
        <address>
          <city>Henderson</city>
          <state>Nevada</state>
          <zip>89052</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <phone>702-444-4770</phone>
      </contact>
      <investigator>
        <last_name>Cornell Calinescu</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Ellipsis Research Group</name>
        <address>
          <city>Brooklyn</city>
          <state>New York</state>
          <zip>11215</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <phone>718-499-6099</phone>
      </contact>
      <investigator>
        <last_name>Jorge Serje</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Central New York Clinical Research</name>
        <address>
          <city>Manlius</city>
          <state>New York</state>
          <zip>13104</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <phone>3156823263</phone>
      </contact>
      <investigator>
        <last_name>Jon Chri Stringer</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Monroe Biomedical Research</name>
        <address>
          <city>Monroe</city>
          <state>North Carolina</state>
          <zip>28112</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <phone>704-283-7359</phone>
      </contact>
      <investigator>
        <last_name>Awawu Igbinadolor</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Lucas Research - New Bern</name>
        <address>
          <city>New Bern</city>
          <state>North Carolina</state>
          <zip>28562</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <phone>2522225700</phone>
      </contact>
      <investigator>
        <last_name>Claire Ann Presswood</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Aventiv Research</name>
        <address>
          <city>Dublin</city>
          <state>Ohio</state>
          <zip>43016</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <phone>614-336-7880</phone>
      </contact>
      <investigator>
        <last_name>Roy C St. John</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Alliance for Multispecialty Research, LLC</name>
        <address>
          <city>Norman</city>
          <state>Oklahoma</state>
          <zip>73069</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <phone>405-701-8999</phone>
      </contact>
      <investigator>
        <last_name>Lisa Connery</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>The Corvallis Clinic, P.C.</name>
        <address>
          <city>Corvallis</city>
          <state>Oregon</state>
          <zip>97330</zip>
          <country>United States</country>
        </address>
      </facility>
      <investigator>
        <last_name>Shannon Hopson</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Preferred Primary Care Physicians, Preferred Clinical Research-St. Clair</name>
        <address>
          <city>Pittsburgh</city>
          <state>Pennsylvania</state>
          <zip>15243</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <phone>412-942-0023</phone>
      </contact>
      <investigator>
        <last_name>Raman S Purighalla</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Preferred Primary Care Physicians</name>
        <address>
          <city>Uniontown</city>
          <state>Pennsylvania</state>
          <zip>15401</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <phone>724-912-0033</phone>
      </contact>
      <investigator>
        <last_name>Paul A. Hartley</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>The Research Center of The Upstate</name>
        <address>
          <city>Greenville</city>
          <state>South Carolina</state>
          <zip>29607</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <phone>864-626-3117</phone>
      </contact>
      <investigator>
        <last_name>Harlicia Farley</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>MD First Research</name>
        <address>
          <city>Lancaster</city>
          <state>South Carolina</state>
          <zip>29720</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <phone>704-491-1102</phone>
      </contact>
      <investigator>
        <last_name>AMRENDRA KUMAR</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>The Jackson Clinic</name>
        <address>
          <city>Jackson</city>
          <state>Tennessee</state>
          <zip>38305</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <phone>731-660-8396</phone>
      </contact>
      <investigator>
        <last_name>Kellie Wallace-Wilding</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>DiscoveResearch</name>
        <address>
          <city>Beaumont</city>
          <state>Texas</state>
          <zip>77701</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <phone>4098131190</phone>
      </contact>
      <investigator>
        <last_name>Robert Cameron Hood</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Velocity Clinical Research, Dallas</name>
        <address>
          <city>Dallas</city>
          <state>Texas</state>
          <zip>75230</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <phone>972-566-7799</phone>
      </contact>
      <investigator>
        <last_name>Julio Rosenstock</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Endocrine Ips, Pllc</name>
        <address>
          <city>Houston</city>
          <state>Texas</state>
          <zip>77079</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <phone>713-973-3415</phone>
      </contact>
      <investigator>
        <last_name>Amer S Al-Karadsheh</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Amir A Hassan, MD, PA</name>
        <address>
          <city>Houston</city>
          <state>Texas</state>
          <zip>77089</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <phone>2819443610</phone>
      </contact>
      <investigator>
        <last_name>Amir Ali Hassan, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Burke Internal Medicine and Research</name>
        <address>
          <city>Burke</city>
          <state>Virginia</state>
          <zip>22015</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <phone>703-455-9711</phone>
      </contact>
      <investigator>
        <last_name>Nashwa Gabra</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Wannan Medical College Yijishan Hospital</name>
        <address>
          <city>Wuhu</city>
          <state>Anhui</state>
          <zip>241001</zip>
          <country>China</country>
        </address>
      </facility>
      <contact>
        <phone>18355335266</phone>
      </contact>
      <investigator>
        <last_name>Jialin Gao</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Luhe Hospital</name>
        <address>
          <city>Beijing</city>
          <state>Beijing</state>
          <zip>100000</zip>
          <country>China</country>
        </address>
      </facility>
      <contact>
        <phone>0106954390169</phone>
      </contact>
      <investigator>
        <last_name>Dong Zhao</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Beijing Hospital</name>
        <address>
          <city>Beijing</city>
          <state>Beijing</state>
          <zip>100730</zip>
          <country>China</country>
        </address>
      </facility>
      <contact>
        <phone>13901317569</phone>
      </contact>
      <investigator>
        <last_name>Lixin Guo</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Beijing Pinggu District Hospital</name>
        <address>
          <city>Beijing</city>
          <state>Beijing</state>
          <zip>101200</zip>
          <country>China</country>
        </address>
      </facility>
      <contact>
        <phone>13911080328</phone>
      </contact>
      <investigator>
        <last_name>yufeng li</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>
      <investigator>
        <last_name>Lan Liu</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>
      <investigator>
        <last_name>Shu Li</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Nanyang First People's Hospital</name>
        <address>
          <city>Nanyang</city>
          <state>Henan</state>
          <zip>473014</zip>
          <country>China</country>
        </address>
      </facility>
      <investigator>
        <last_name>Yihua Wang</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>
      <contact>
        <phone>15838123695</phone>
      </contact>
      <investigator>
        <last_name>Qingju Li</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Nanjing First Hospital</name>
        <address>
          <city>Nanjing</city>
          <state>Jiangsu</state>
          <zip>210006</zip>
          <country>China</country>
        </address>
      </facility>
      <investigator>
        <last_name>Jianhua Ma</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>
      <contact>
        <phone>18951762690</phone>
      </contact>
      <investigator>
        <last_name>Yibing Lu</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>
      <contact>
        <phone>13505289352</phone>
      </contact>
      <investigator>
        <last_name>Guoyue Yuan</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>The Affiliated Hospital of Beihua University</name>
        <address>
          <city>Jilin</city>
          <state>Jilin</state>
          <zip>132000</zip>
          <country>China</country>
        </address>
      </facility>
      <investigator>
        <last_name>Yushan Guo</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>
      <contact>
        <phone>041184412001</phone>
      </contact>
      <investigator>
        <last_name>Xinyu Li</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>The Fourth Hospital of Harbin Medical University</name>
        <address>
          <city>Harbin</city>
          <state>Nangang District</state>
          <zip>150001</zip>
          <country>China</country>
        </address>
      </facility>
      <contact>
        <phone>18903602198</phone>
      </contact>
      <investigator>
        <last_name>ZhiFeng Cheng</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>
      <contact>
        <phone>15318816218</phone>
      </contact>
      <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>
      <investigator>
        <last_name>Xiaozhen JIANG</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>West China Hospital of Sichuan University</name>
        <address>
          <city>Chengdu</city>
          <state>Sichuan</state>
          <zip>610041</zip>
          <country>China</country>
        </address>
      </facility>
      <contact>
        <phone>18980601658</phone>
      </contact>
      <investigator>
        <last_name>zhenmei an</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>B. J. Medical College &amp; Civil Hospital</name>
        <address>
          <city>Ahmedabad</city>
          <state>Gujarat</state>
          <zip>380016</zip>
          <country>India</country>
        </address>
      </facility>
      <contact>
        <phone>919924643799</phone>
      </contact>
      <investigator>
        <last_name>Kartikeya Parmar</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>GMERS Medical College and General Hospital</name>
        <address>
          <city>Baroda</city>
          <state>Gujarat</state>
          <zip>390021</zip>
          <country>India</country>
        </address>
      </facility>
      <contact>
        <phone>912652772799</phone>
      </contact>
      <investigator>
        <last_name>Meenakshi Shah</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>M S Ramaiah Medical College and Hospitals</name>
        <address>
          <city>Bangalore</city>
          <state>Karnataka</state>
          <zip>560054</zip>
          <country>India</country>
        </address>
      </facility>
      <contact>
        <phone>918197132111</phone>
      </contact>
      <investigator>
        <last_name>Dr Chitra Selvan</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Medstar Speciality Hospital</name>
        <address>
          <city>Bangalore</city>
          <state>Karnataka</state>
          <zip>560092</zip>
          <country>India</country>
        </address>
      </facility>
      <contact>
        <phone>09884457106</phone>
      </contact>
      <investigator>
        <last_name>ambrish c</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>BSES MG Hospital</name>
        <address>
          <city>Mumbai</city>
          <state>Maharashtra</state>
          <zip>400058</zip>
          <country>India</country>
        </address>
      </facility>
      <investigator>
        <last_name>Manoj Chawla</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>All India Institute of Medical Sciences (AIIMS) - Nagpur</name>
        <address>
          <city>Nagpur</city>
          <state>Maharashtra</state>
          <zip>441108</zip>
          <country>India</country>
        </address>
      </facility>
      <contact>
        <phone>9930805548</phone>
      </contact>
      <investigator>
        <last_name>Udit Narang</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Grant Medical Foundation - Ruby Hall Clinic</name>
        <address>
          <city>Pune</city>
          <state>Maharashtra</state>
          <zip>411001</zip>
          <country>India</country>
        </address>
      </facility>
      <contact>
        <phone>9822091220</phone>
      </contact>
      <investigator>
        <last_name>Sanjay Chunilal Agarwal</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Madras Diabetes Research Foundation</name>
        <address>
          <city>Chennai</city>
          <state>Tamil Nadu</state>
          <zip>600086</zip>
          <country>India</country>
        </address>
      </facility>
      <contact>
        <phone>9840134505</phone>
      </contact>
      <investigator>
        <last_name>VISWANATHAN MOHAN</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Kumudini Devi Diabetes Research Center</name>
        <address>
          <city>Hyderabad</city>
          <state>Telangana</state>
          <zip>500072</zip>
          <country>India</country>
        </address>
      </facility>
      <contact>
        <phone>917842041355</phone>
      </contact>
      <investigator>
        <last_name>Vishnupriya Rao Paturi</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Institute of Post Graduate Medical Education and Research and Seth Sukhlal Karnani Memorial Hospital</name>
        <address>
          <city>Kolkata</city>
          <state>West Bengal</state>
          <zip>700020</zip>
          <country>India</country>
        </address>
      </facility>
      <investigator>
        <last_name>Sujoy Ghosh</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Tokuyama Clinic</name>
        <address>
          <city>Chiba City</city>
          <state>Chiba</state>
          <zip>261-0004</zip>
          <country>Japan</country>
        </address>
      </facility>
      <contact>
        <phone>81432396539</phone>
      </contact>
      <investigator>
        <last_name>Takahiko Tokuyama</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Steel Memorial Yawata Hospital</name>
        <address>
          <city>Kitakyushu</city>
          <state>Fukuoka</state>
          <zip>805-8508</zip>
          <country>Japan</country>
        </address>
      </facility>
      <investigator>
        <last_name>Udai Nakamura</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>MinamiAkatsukaClinic</name>
        <address>
          <city>Mito</city>
          <state>Ibaraki</state>
          <zip>311-4153</zip>
          <country>Japan</country>
        </address>
      </facility>
      <contact>
        <phone>81292576060</phone>
      </contact>
      <investigator>
        <last_name>Hideo Takahashi</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Iwamoto Clinic</name>
        <address>
          <city>Marugame</city>
          <state>Kagawa</state>
          <zip>765-0071</zip>
          <country>Japan</country>
        </address>
      </facility>
      <investigator>
        <last_name>Masahiro Iwamoto</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Hayashi Diabetes Internal Medicine Clinic</name>
        <address>
          <city>Chigasaki</city>
          <state>Kanagawa</state>
          <zip>253-0044</zip>
          <country>Japan</country>
        </address>
      </facility>
      <investigator>
        <last_name>Tsutomu Hayashi</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Medical Corporation Yuga Tsuruma Kaneshiro Diabetes Clinic</name>
        <address>
          <city>Yamato-shi</city>
          <state>Kanagawa</state>
          <zip>242-0004</zip>
          <country>Japan</country>
        </address>
      </facility>
      <contact>
        <phone>81462717410</phone>
      </contact>
      <investigator>
        <last_name>Taro Asakura</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Medical Corporation Heishinkai OCROM Clinic</name>
        <address>
          <city>Suita-shi</city>
          <state>Osaka</state>
          <zip>565-0853</zip>
          <country>Japan</country>
        </address>
      </facility>
      <contact>
        <phone>0663308810</phone>
      </contact>
      <investigator>
        <last_name>Satoshi Inoue</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>The Institute of Medical Science, Asahi Life Foundation</name>
        <address>
          <city>Chuo-ku</city>
          <state>Tokyo</state>
          <zip>103-0002</zip>
          <country>Japan</country>
        </address>
      </facility>
      <investigator>
        <last_name>Yukiko Onishi</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Tokyo-Eki Center-building Clinic</name>
        <address>
          <city>Chuo-ku</city>
          <state>Tokyo</state>
          <zip>103-0027</zip>
          <country>Japan</country>
        </address>
      </facility>
      <investigator>
        <last_name>Arihiro Kiyosue</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Fukuwa Clinic</name>
        <address>
          <city>Chuo-ku</city>
          <state>Tokyo</state>
          <zip>104-0031</zip>
          <country>Japan</country>
        </address>
      </facility>
      <contact>
        <phone>81362623751</phone>
      </contact>
      <investigator>
        <last_name>Yasushi Fukushima</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Heishinkai Medical Group ToCROM Clinic</name>
        <address>
          <city>Shinjuku-ku</city>
          <state>Tokyo</state>
          <zip>160-0008</zip>
          <country>Japan</country>
        </address>
      </facility>
      <investigator>
        <last_name>Osamu Matsuoka</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Morinaga Ueno Clinic</name>
        <address>
          <city>Kumamoto</city>
          <zip>860-0863</zip>
          <country>Japan</country>
        </address>
      </facility>
      <contact>
        <phone>810963460111</phone>
      </contact>
      <investigator>
        <last_name>Hiroshi Morinaga</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Abe Clinic</name>
        <address>
          <city>Oita</city>
          <zip>870-0039</zip>
          <country>Japan</country>
        </address>
      </facility>
      <investigator>
        <last_name>Katsushige Abe</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>AMC Nishiumeda Clinic</name>
        <address>
          <city>Osaka</city>
          <zip>530-0001</zip>
          <country>Japan</country>
        </address>
      </facility>
      <contact>
        <phone>0647975660</phone>
      </contact>
      <investigator>
        <last_name>Yoshimitsu Yamasaki</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Unidad de Investigaci�n Cl�nica Cardiometabolica de Occidente</name>
        <address>
          <city>Guadalajara</city>
          <state>Jalisco</state>
          <zip>44150</zip>
          <country>Mexico</country>
        </address>
      </facility>
      <investigator>
        <last_name>Maricela Vidrio</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Centro de Investigacion Medica Integral</name>
        <address>
          <city>Guadalajara</city>
          <state>Jalisco</state>
          <zip>44160</zip>
          <country>Mexico</country>
        </address>
      </facility>
      <contact>
        <phone>523311070722</phone>
      </contact>
      <investigator>
        <last_name>Carlos Alejandro Stobschinski de Alba</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Nucleo Medico la Paz</name>
        <address>
          <city>Guadalajara</city>
          <state>Jalisco</state>
          <zip>44860</zip>
          <country>Mexico</country>
        </address>
      </facility>
      <contact>
        <phone>5213336392861</phone>
      </contact>
      <investigator>
        <last_name>Agustin Lopez</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Centro de Investigacion Medica de Occidente, S.C.</name>
        <address>
          <city>Zapopan</city>
          <state>Jalisco</state>
          <zip>44260</zip>
          <country>Mexico</country>
        </address>
      </facility>
      <contact>
        <phone>523312044280</phone>
      </contact>
      <investigator>
        <last_name>Emilia Susana Pelayo Orozco</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Investigacion En Salud Y Metabolismo S.C / Nutricion Clinica / Unidad de Base de Datos</name>
        <address>
          <city>Chihuahua</city>
          <zip>31110</zip>
          <country>Mexico</country>
        </address>
      </facility>
      <contact>
        <phone>526144398618</phone>
      </contact>
      <investigator>
        <last_name>Luis Alejandro Nevarez</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>PanAmerican Clinical Research - Querétaro - Avenida Antea</name>
        <address>
          <city>Querétaro</city>
          <zip>76100</zip>
          <country>Mexico</country>
        </address>
      </facility>
      <contact>
        <phone>524422502985</phone>
      </contact>
      <investigator>
        <last_name>Juan Villagordoa Mesa</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Instituto Veracruzano en Investigación Clínica S.C.</name>
        <address>
          <city>Veracruz</city>
          <zip>91851</zip>
          <country>Mexico</country>
        </address>
      </facility>
      <contact>
        <phone>2299323157</phone>
      </contact>
      <investigator>
        <last_name>Rosa Isela Luna Ceballos</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>FAICIC S. de R.L. de C.V.</name>
        <address>
          <city>Veracruz</city>
          <zip>91900</zip>
          <country>Mexico</country>
        </address>
      </facility>
      <contact>
        <phone>522299327808</phone>
      </contact>
      <investigator>
        <last_name>Alejandro Quintin Barrat Hernandez</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Puerto Rico Health Institute</name>
        <address>
          <city>Dorado</city>
          <zip>00646</zip>
          <country>Puerto Rico</country>
        </address>
      </facility>
      <contact>
        <phone>7877961049</phone>
      </contact>
      <investigator>
        <last_name>Elham Shana Ghorbani</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Advance Medical Research Center</name>
        <address>
          <city>San Juan</city>
          <zip>00926</zip>
          <country>Puerto Rico</country>
        </address>
      </facility>
      <contact>
        <phone>5208410241</phone>
      </contact>
      <investigator>
        <last_name>Orvil F. Martinez Rivera</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>China</country>
      <country>India</country>
      <country>Japan</country>
      <country>Mexico</country>
      <country>Puerto Rico</country>
      <country>United States</country>
    </location_countries>
    <verification_date>July 15, 2023</verification_date>
    <study_first_submitted>July 25, 2023</study_first_submitted>
    <study_first_submitted_qc>July 25, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 2, 2023</study_first_posted>
    <last_update_submitted>July 25, 2023</last_update_submitted>
    <last_update_submitted_qc>July 25, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 2, 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>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>Anonymized individual participant 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/NCT05971940
  org study id: 18564
  secondary id: J2A-MC-GZGT
  secondary id: U1111-1290-5157
  nct id: NCT05971940
  lead sponsor: 
  has dmc: No
  is fda regulated drug: Yes
  is fda regulated device: No
  The main purpose of this study is to determine safety and efficacy of orforglipron compared
        with placebo in adult participants with type 2 diabetes and inadequate glycemic control with
        diet and exercise alone. The study will last approximately 54 weeks.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Double (Participant, Investigator)
  measure: Change from Baseline in Hemoglobin A1c (HbA1c)
  time frame: Week 40
  measure: Percentage of Participants with an HbA1c target value of <7.0% (53 mmol/mol)
  time frame: Week 40
  measure: Percentage of Participants with an HbA1c target value of ≤6.5% (48 mmol/mol)
  time frame: Week 40
  measure: Change from Baseline in Fasting Serum Glucose
  time frame: Baseline, Week 40
  measure: Percentage Change from Baseline in Body Weight
  time frame: Baseline, Week 40
  measure: Change from Baseline in Body Weight
  time frame: Baseline, Week 40
  measure: Change from Baseline in Daily Average 7-point Self-Monitored Blood Glucose (SMBG)
  time frame: Baseline, Week 40
  measure: Change from Baseline in Systolic Blood Pressure (SBP)
  time frame: Baseline, Week 40
  measure: Change from Baseline in Triglycerides
  time frame: Baseline, Week 40
  measure: Percentage of Participants Who Achieved Weight Loss of ≥5%
  time frame: Week 40
  measure: Change from Baseline in Short Form 36 Version 2 (SF-36v2) Acute Form Domain Scores
  time frame: Baseline, Week 40
  arm group label: Orforglipron Dose 1
  arm group type: Experimental
  description: Participants will receive orforglipron orally.
  arm group label: Orforglipron Dose 2
  arm group type: Experimental
  description: Participants will receive orforglipron orally.
  arm group label: Orforglipron Dose 3
  arm group type: Experimental
  description: Participants will receive orforglipron orally.
  arm group label: Placebo
  arm group type: Placebo Comparator
  description: Participants will receive placebo.
  intervention type: Drug
  intervention name: Orforglipron
  description: Administered orally.
  arm group label: Orforglipron Dose 1
  arm group label: Orforglipron Dose 2
  arm group label: Orforglipron Dose 3
  other name: LY3502970
  intervention type: Drug
  intervention name: Placebo
  description: Administered orally
  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: 1-317-615-4559
  email: ClinicalTrials.gov@lilly.com
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  country: China
  country: India
  country: Japan
  country: Mexico
  country: Puerto Rico
  country: United States
  responsible party type: Sponsor
  mesh term: Diabetes Mellitus
  mesh term: Diabetes Mellitus, Type 2
  sharing ipd: Yes
  ipd description: Anonymized individual participant 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/