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/NCT06037252</url>
    </required_header>
    <id_info>
      <org_study_id>18739</org_study_id>
      <secondary_id>I8F-MC-GPIT</secondary_id>
      <secondary_id>2023-504561-24-00</secondary_id>
      <nct_id>NCT06037252</nct_id>
    </id_info>
    <brief_title>A Study of Investigational Tirzepatide (LY3298176) Doses in Participants With Type 2 Diabetes and Obesity</brief_title>
    <official_title>A Phase 2, Randomized, Double-blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Investigational Tirzepatide Doses in Participants With Type 2 Diabetes and Obesity</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 learn more about the safety and efficacy of&#xD;
        investigational tirzepatide doses in participants with Type 2 diabetes and obesity that are&#xD;
        already taking metformin. The study will last for about 89 weeks.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The study will include a screening period of up to 5 weeks. The primary endpoint will be at&#xD;
        Week 44 with a tirzepatide extension until week 80. A safety follow up will be performed&#xD;
        approximately 4 weeks after end of treatment.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 21, 2023</start_date>
    <completion_date type="Anticipated">September 30, 2025</completion_date>
    <primary_completion_date type="Anticipated">December 24, 2024</primary_completion_date>
    <phase>Phase 2</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>Percent Change From Baseline in Body Weight</measure>
      <time_frame>Baseline (Week 0), Week 44</time_frame>
    </primary_outcome>
    <secondary_outcome>
      <measure>Change from Baseline in HbA1c</measure>
      <time_frame>Baseline (Week 0), Week 44</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change from Baseline in HbA1c</measure>
      <time_frame>Baseline (Week 24), Week 80</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Percent Change from Baseline in Body Weight</measure>
      <time_frame>Baseline (Week 24), Week 80</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Absolute Change from Baseline in Body Weight</measure>
      <time_frame>Baseline (Week 0), Week 44</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Absolute Change from Baseline in Body Weight</measure>
      <time_frame>Baseline (Week 24), Week 80</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change from Baseline in Body Mass Index (BMI)</measure>
      <time_frame>Baseline (Week 0), Week 44</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change from Baseline in BMI</measure>
      <time_frame>Baseline (Week 24), Week 80</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change from Baseline in Waist Circumference</measure>
      <time_frame>Baseline (Week 0), Week 44</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change from Baseline in Waist Circumference</measure>
      <time_frame>Baseline (Week 24), Week 80</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Percentage of Participants Achieving ≥15% Body Weight Reduction</measure>
      <time_frame>Baseline (Week 0), Week 44</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Percentage of Participants Achieving ≥15% Body Weight Reduction</measure>
      <time_frame>Baseline (Week 0), Week 80</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Pharmacokinetics (PK): Steady State Area Under the Concentration Time Curve (AUC)</measure>
      <time_frame>Baseline through Week 44</time_frame>
      <description>Steady State Area Under the Concentration Time Curve (AUC) presented as a single average measure of AUC across the time frame.</description>
    </secondary_outcome>
    <number_of_arms>4</number_of_arms>
    <enrollment type="Anticipated">350</enrollment>
    <condition>Type 2 Diabetes</condition>
    <condition>Obesity</condition>
    <arm_group>
      <arm_group_label>Tirzepatide High 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 High 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</arm_group_label>
      <arm_group_type>Active Comparator</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</arm_group_label>
      <arm_group_label>Tirzepatide High Dose 1</arm_group_label>
      <arm_group_label>Tirzepatide High Dose 2</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 a Body Mass Index (BMI) ≥35 kilogram/square meter (kg/m²) at screening.&#xD;
  &#xD;
            -  Have had stable body weight (±5%) during the 90 days preceding screening.&#xD;
  &#xD;
            -  Have been diagnosed with Type 2 Diabetes (T2D).&#xD;
  &#xD;
            -  Have been on a stable treatment of metformin only at least 90 days preceding screening&#xD;
               and between screening and randomization with the minimum effective dose of ≥1500&#xD;
               milligram (mg)/day.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Have Type 1 Diabetes (T1D), history of ketoacidosis or hyperosmolar state/coma, or any&#xD;
               other types of diabetes except T2D.&#xD;
  &#xD;
            -  Have had 1 or more episode of severe hypoglycemia and/or 1 or more episode of&#xD;
               hypoglycemia unawareness within 6 months prior to screening.&#xD;
  &#xD;
            -  Are currently receiving or planning to receive treatment for diabetic retinopathy&#xD;
               and/or macular edema.&#xD;
  &#xD;
            -  Have a prior or planned surgical treatment for obesity.&#xD;
  &#xD;
            -  Use products intended for weight loss including prescription drugs, over the counter&#xD;
               (OTC) drugs, and herbal preparations, within 3 months prior to screening.&#xD;
  &#xD;
            -  Have renal impairment measured as estimated glomerular filtration rate (eGFR) &lt;45&#xD;
               milliliter/min (mL/min)/1.73 m².&#xD;
  &#xD;
            -  Have any of the following cardiovascular (CV) conditions within 2 months prior to&#xD;
               screening.&#xD;
  &#xD;
                 -  acute myocardial infarction.&#xD;
  &#xD;
                 -  cerebrovascular accident (stroke).&#xD;
  &#xD;
                 -  unstable angina .&#xD;
  &#xD;
                 -  hospitalization due to congestive heart failure, or&#xD;
  &#xD;
                 -  coronary artery revascularization.&#xD;
  &#xD;
            -  Have a family or personal history of medullary thyroid carcinoma or multiple endocrine&#xD;
               neoplasia (MEN) syndrome Type 2.&#xD;
  &#xD;
            -  Have a history of chronic or acute pancreatitis.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>75 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>
    <location>
      <facility>
        <name>CEDIC</name>
        <address>
          <city>Caba</city>
          <state>Buenos Aires</state>
          <zip>C1060ABN</zip>
          <country>Argentina</country>
        </address>
      </facility>
      <investigator>
        <last_name>Elizabeth Gelersztein</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>CEDIC</name>
        <address>
          <city>Caba</city>
          <state>Buenos Aires</state>
          <zip>C1060ABN</zip>
          <country>Argentina</country>
        </address>
      </facility>
      <contact>
        <phone>541148236838</phone>
      </contact>
      <investigator>
        <last_name>Elizabeth Gelersztein</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Consultorio de Investigación Clínica EMO SRL</name>
        <address>
          <city>Ciudad Autonoma de Buenos Aires</city>
          <state>Buenos Aires</state>
          <zip>1405</zip>
          <country>Argentina</country>
        </address>
      </facility>
      <investigator>
        <last_name>Pablo Rene Costanzo</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Centro de Investigaciones Metabólicas (CINME)</name>
        <address>
          <city>Ciudad Autónoma de Buenos Aires</city>
          <state>Buenos Aires</state>
          <zip>1056</zip>
          <country>Argentina</country>
        </address>
      </facility>
      <investigator>
        <last_name>Federico C. Perez Manghi</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Centro de Investigaciones Metabólicas (CINME)</name>
        <address>
          <city>Ciudad Autónoma de Buenos Aire</city>
          <state>Buenos Aires</state>
          <zip>1056</zip>
          <country>Argentina</country>
        </address>
      </facility>
      <contact>
        <phone>00541139842826</phone>
      </contact>
      <investigator>
        <last_name>Federico C. Perez Manghi</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Centro Médico Viamonte</name>
        <address>
          <city>Buenos Aires</city>
          <state>Ciudad Aut</state>
          <zip>C1120AAC</zip>
          <country>Argentina</country>
        </address>
      </facility>
      <contact>
        <phone>541149635650</phone>
      </contact>
      <investigator>
        <last_name>Diego Aizenberg</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Centro Médico Viamonte</name>
        <address>
          <city>Buenos Aires</city>
          <state>Ciudad Autónoma De Buenos Aires</state>
          <zip>C1120AAC</zip>
          <country>Argentina</country>
        </address>
      </facility>
      <investigator>
        <last_name>Diego Aizenberg</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada</name>
        <address>
          <city>Ciudad Autonoma de Buenos Aires</city>
          <state>Ciudad Autónoma De Buenos Aires</state>
          <zip>C1425AGC</zip>
          <country>Argentina</country>
        </address>
      </facility>
      <investigator>
        <last_name>Maria Jimena Coronel</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Consultorio de Investigación Clínica EMO SRL</name>
        <address>
          <city>Ciudad Autonoma de Buenos Aire</city>
          <state>Ciudad Autónoma De Buenos Aire</state>
          <zip>1405</zip>
          <country>Argentina</country>
        </address>
      </facility>
      <contact>
        <phone>5491157417654</phone>
      </contact>
      <investigator>
        <last_name>Pablo Rene Costanzo</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada</name>
        <address>
          <city>Ciudad Autonoma de Buenos Aire</city>
          <state>Ciudad Autónoma De Buenos Aire</state>
          <zip>C1425AGC</zip>
          <country>Argentina</country>
        </address>
      </facility>
      <contact>
        <phone>541148019001</phone>
      </contact>
      <investigator>
        <last_name>Maria Jimena Coronel</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Praktik Velim s.r.o</name>
        <address>
          <city>Velim</city>
          <state>Kolín</state>
          <zip>281 01</zip>
          <country>Czechia</country>
        </address>
      </facility>
      <investigator>
        <last_name>Josef Slaby</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>MUDr. Tomas Edelsberger</name>
        <address>
          <city>Krnov</city>
          <state>Moravskoslezský Kraj</state>
          <zip>79401</zip>
          <country>Czechia</country>
        </address>
      </facility>
      <investigator>
        <last_name>Tomas Edelsberger</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>MUDr. Tomas Edelsberger</name>
        <address>
          <city>Krnov</city>
          <state>Moravskosl</state>
          <zip>79401</zip>
          <country>Czechia</country>
        </address>
      </facility>
      <contact>
        <phone>420606703809</phone>
      </contact>
      <investigator>
        <last_name>Tomas Edelsberger</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Milan Kvapil s.r.o., Diabetologicka ambulance</name>
        <address>
          <city>Praha</city>
          <state>Praha 4</state>
          <zip>14900</zip>
          <country>Czechia</country>
        </address>
      </facility>
      <investigator>
        <last_name>Dagmar Bartaskova</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Milan Kvapil s.r.o., Diabetologicka ambulance</name>
        <address>
          <city>Praha</city>
          <state>Praha 4</state>
          <zip>14900</zip>
          <country>Czechia</country>
        </address>
      </facility>
      <contact>
        <phone>420272917011</phone>
      </contact>
      <investigator>
        <last_name>Dagmar Bartaskova</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>ResTrial s.r.o.</name>
        <address>
          <city>Praha</city>
          <state>Praha 8</state>
          <zip>18100</zip>
          <country>Czechia</country>
        </address>
      </facility>
      <investigator>
        <last_name>Emilia Malicherova</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>ResTrial s.r.o.</name>
        <address>
          <city>Praha</city>
          <state>Praha 8</state>
          <zip>18100</zip>
          <country>Czechia</country>
        </address>
      </facility>
      <contact>
        <phone>420257211886</phone>
      </contact>
      <investigator>
        <last_name>Emilia Malicherova</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>FLEDIP s.r.o.</name>
        <address>
          <city>Prague</city>
          <state>Praha, Hlavní Mešto</state>
          <zip>160 00</zip>
          <country>Czechia</country>
        </address>
      </facility>
      <investigator>
        <last_name>Milan Flekac</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>FLEDIP s.r.o.</name>
        <address>
          <city>Prague</city>
          <state>Praha, Hlavní Mešto</state>
          <zip>160 00</zip>
          <country>Czechia</country>
        </address>
      </facility>
      <contact>
        <phone>420736204140</phone>
      </contact>
      <investigator>
        <last_name>Milan Flekac</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Diacentrum Brandys n.L. s.r.o.</name>
        <address>
          <city>Brandys nad Labem</city>
          <state>Praha-východ</state>
          <zip>25001</zip>
          <country>Czechia</country>
        </address>
      </facility>
      <investigator>
        <last_name>Sarka Kopecka</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Diacentrum Brandys n.L. s.r.o.</name>
        <address>
          <city>Brandys nad Labem</city>
          <state>Praha-vých</state>
          <zip>25001</zip>
          <country>Czechia</country>
        </address>
      </facility>
      <investigator>
        <last_name>Sarka Kopecka</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>MUDr. Vladimira Fleischmannova, s.r.o.</name>
        <address>
          <city>Kolín</city>
          <state>Středočeský Kraj</state>
          <zip>280 02</zip>
          <country>Czechia</country>
        </address>
      </facility>
      <contact>
        <phone>420321752571</phone>
      </contact>
      <investigator>
        <last_name>Vladimira Fleischmannova</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>MUDr. Vladimira Fleischmannova, s.r.o.</name>
        <address>
          <city>Kolín</city>
          <state>Středočeský Kraj</state>
          <zip>280 02</zip>
          <country>Czechia</country>
        </address>
      </facility>
      <investigator>
        <last_name>Vladimira Fleischmannova</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Diahaza s.r.o.</name>
        <address>
          <city>Holesov</city>
          <state>Zlínský Kraj</state>
          <zip>769 01</zip>
          <country>Czechia</country>
        </address>
      </facility>
      <investigator>
        <last_name>Jitka Hasalova Zapletalova</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Diahaza s.r.o.</name>
        <address>
          <city>Holesov</city>
          <state>Zlínský Kraj</state>
          <zip>769 01</zip>
          <country>Czechia</country>
        </address>
      </facility>
      <contact>
        <phone>420573399559</phone>
      </contact>
      <investigator>
        <last_name>Jitka Hasalova Zapletalova</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Diabetologie a Podiatrie</name>
        <address>
          <city>Mladá Boleslav</city>
          <zip>293 01</zip>
          <country>Czechia</country>
        </address>
      </facility>
      <investigator>
        <last_name>Martina Koskova</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Praglandia s.r.o</name>
        <address>
          <city>Praha 5</city>
          <zip>150 00</zip>
          <country>Czechia</country>
        </address>
      </facility>
      <contact>
        <phone>420731586736</phone>
      </contact>
      <investigator>
        <last_name>Vera Klokocnikova</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Praglandia s.r.o</name>
        <address>
          <city>Praha 5</city>
          <zip>150 00</zip>
          <country>Czechia</country>
        </address>
      </facility>
      <investigator>
        <last_name>Vera Klokocnikova</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Centro de Investigacion Cardiovascular y Metabólica</name>
        <address>
          <city>Tijuana</city>
          <state>Baja California</state>
          <zip>22500</zip>
          <country>Mexico</country>
        </address>
      </facility>
      <investigator>
        <last_name>Pedro Fajardo Campos</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Cryptex Investigación Clínica S.A. de C.V.</name>
        <address>
          <city>Cuauhtémoc</city>
          <state>Distrito Federal</state>
          <zip>06100</zip>
          <country>Mexico</country>
        </address>
      </facility>
      <investigator>
        <last_name>MIGUEL ANGEL GOMEZ-SAMANO</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Centro Especializado En Diabetes, Obesidad Y Prevencion De Enfermedades Cardiovasculares</name>
        <address>
          <city>Mexico City</city>
          <state>Distrito Federal</state>
          <zip>11650</zip>
          <country>Mexico</country>
        </address>
      </facility>
      <investigator>
        <last_name>Melchor Alpizar</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Centro Especializado En Diabetes, Obesidad Y Prevencion De Enfermedades Cardiovasculares</name>
        <address>
          <city>Mexico City</city>
          <state>Distrito Federal</state>
          <zip>11650</zip>
          <country>Mexico</country>
        </address>
      </facility>
      <contact>
        <phone>525585340943</phone>
      </contact>
      <investigator>
        <last_name>Melchor Alpizar</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Virgen Cardiovascular Research SC</name>
        <address>
          <city>Guadalajara</city>
          <state>Jalisco</state>
          <zip>44670</zip>
          <country>Mexico</country>
        </address>
      </facility>
      <contact>
        <phone>3338131040</phone>
      </contact>
      <investigator>
        <last_name>Luis Ramon Virgen Carrillo</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Virgen Cardiovascular Research SC</name>
        <address>
          <city>Guadalajara</city>
          <state>Jalisco</state>
          <zip>44670</zip>
          <country>Mexico</country>
        </address>
      </facility>
      <investigator>
        <last_name>Luis Ramon Virgen Carrillo</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Endocrinology</name>
        <address>
          <city>Monterrey</city>
          <state>Nuevo León</state>
          <zip>66460</zip>
          <country>Mexico</country>
        </address>
      </facility>
      <investigator>
        <last_name>Jose Gerardo Gonzalez-Gonzalez</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Subinvestigation</name>
        <address>
          <city>Ciudad Madero</city>
          <state>Tamaulipas</state>
          <zip>89440</zip>
          <country>Mexico</country>
        </address>
      </facility>
      <investigator>
        <last_name>Rafael Margarito Violante Ortiz</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>IN-DIA</name>
        <address>
          <city>Lučenec</city>
          <state>Banskobystrický Kraj</state>
          <zip>984 01</zip>
          <country>Slovakia</country>
        </address>
      </facility>
      <contact>
        <phone>00421905503919</phone>
      </contact>
      <investigator>
        <last_name>LIVIA TOMASOVA</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>IN-DIA</name>
        <address>
          <city>Lučenec</city>
          <state>Banskobystrický Kraj</state>
          <zip>984 01</zip>
          <country>Slovakia</country>
        </address>
      </facility>
      <investigator>
        <last_name>LIVIA TOMASOVA</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Fakultná nemocnica Nitra</name>
        <address>
          <city>Nitra</city>
          <state>Nitriansky Kraj</state>
          <zip>950 01</zip>
          <country>Slovakia</country>
        </address>
      </facility>
      <contact>
        <phone>421907705249</phone>
      </contact>
      <investigator>
        <last_name>Peter Minarik</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>FUNKYSTUFF s.r.o.</name>
        <address>
          <city>Nove Zamky</city>
          <state>Nitriansky Kraj</state>
          <zip>940 02</zip>
          <country>Slovakia</country>
        </address>
      </facility>
      <contact>
        <phone>421356420746</phone>
      </contact>
      <investigator>
        <last_name>Miriam Teplanova</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>FUNKYSTUFF s.r.o.</name>
        <address>
          <city>Nove Zamky</city>
          <state>Nitriansky Kraj</state>
          <zip>940 02</zip>
          <country>Slovakia</country>
        </address>
      </facility>
      <investigator>
        <last_name>Miriam Teplanova</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Diabetol</name>
        <address>
          <city>Prešov</city>
          <state>Prešovský Kraj</state>
          <zip>080 01</zip>
          <country>Slovakia</country>
        </address>
      </facility>
      <investigator>
        <last_name>Marek Macko</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Diabetol</name>
        <address>
          <city>Prešov</city>
          <state>Prešovský Kraj</state>
          <zip>080 01</zip>
          <country>Slovakia</country>
        </address>
      </facility>
      <contact>
        <phone>0903625849</phone>
      </contact>
      <investigator>
        <last_name>Marek Macko</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>ENDIAMED s.r.o</name>
        <address>
          <city>Dolny Kubin</city>
          <state>Žilinský Kraj</state>
          <zip>026 01</zip>
          <country>Slovakia</country>
        </address>
      </facility>
      <contact>
        <phone>421433709580</phone>
      </contact>
      <investigator>
        <last_name>Jan Truban</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>ENDIAMED s.r.o</name>
        <address>
          <city>Dolny Kubin</city>
          <state>Žilinský Kraj</state>
          <zip>026 01</zip>
          <country>Slovakia</country>
        </address>
      </facility>
      <investigator>
        <last_name>Jan Truban</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>NEDÚ - Národný endokrinologický a diabetologický ústav n.o.</name>
        <address>
          <city>Lubochna</city>
          <state>Žilinský Kraj</state>
          <zip>034 91</zip>
          <country>Slovakia</country>
        </address>
      </facility>
      <investigator>
        <last_name>Emil Martinka</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>NEDÚ - Národný endokrinologický a diabetologický ústav n.o.</name>
        <address>
          <city>Lubochna</city>
          <state>Žilinský Kraj</state>
          <zip>034 91</zip>
          <country>Slovakia</country>
        </address>
      </facility>
      <contact>
        <phone>0911444616</phone>
      </contact>
      <investigator>
        <last_name>Emil Martinka</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>IRIDIA</name>
        <address>
          <city>Vrutky</city>
          <state>Žilinský Kraj</state>
          <zip>038 61</zip>
          <country>Slovakia</country>
        </address>
      </facility>
      <contact>
        <phone>421907454191</phone>
      </contact>
      <investigator>
        <last_name>Radovan Plasil</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>IRIDIA</name>
        <address>
          <city>Vrutky</city>
          <state>Žilinský Kraj</state>
          <zip>038 61</zip>
          <country>Slovakia</country>
        </address>
      </facility>
      <investigator>
        <last_name>Radovan Plasil</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>Argentina</country>
      <country>Czechia</country>
      <country>Mexico</country>
      <country>Slovakia</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 8, 2023</study_first_submitted>
    <study_first_submitted_qc>September 8, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 14, 2023</study_first_posted>
    <last_update_submitted>September 8, 2023</last_update_submitted>
    <last_update_submitted_qc>September 8, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Diabetes Mellitus</keyword>
    <keyword>Glucose Metabolism Disorders</keyword>
    <keyword>Metabolic Disease</keyword>
    <keyword>Endocrine System Diseases</keyword>
    <keyword>Overnutrition</keyword>
    <keyword>Nutrition Disorders</keyword>
    <keyword>Body Weight</keyword>
    <keyword>Tirzepatide</keyword>
    <keyword>Incretins</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Diabetes Mellitus</mesh_term>
      <mesh_term>Obesity</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>ata 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/NCT06037252
  org study id: 18739
  secondary id: I8F-MC-GPIT
  secondary id: 2023-504561-24-00
  nct id: NCT06037252
  lead sponsor: 
  has dmc: No
  is fda regulated drug: Yes
  is fda regulated device: No
  The main purpose of this study is to learn more about the safety and efficacy of
        investigational tirzepatide doses in participants with Type 2 diabetes and obesity that are
        already taking metformin. The study will last for about 89 weeks.
  The study will include a screening period of up to 5 weeks. The primary endpoint will be at
        Week 44 with a tirzepatide extension until week 80. A safety follow up will be performed
        approximately 4 weeks after end of treatment.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Double (Participant, Investigator)
  measure: Percent Change From Baseline in Body Weight
  time frame: Baseline (Week 0), Week 44
  measure: Change from Baseline in HbA1c
  time frame: Baseline (Week 0), Week 44
  measure: Change from Baseline in HbA1c
  time frame: Baseline (Week 24), Week 80
  measure: Percent Change from Baseline in Body Weight
  time frame: Baseline (Week 24), Week 80
  measure: Absolute Change from Baseline in Body Weight
  time frame: Baseline (Week 0), Week 44
  measure: Absolute Change from Baseline in Body Weight
  time frame: Baseline (Week 24), Week 80
  measure: Change from Baseline in Body Mass Index (BMI)
  time frame: Baseline (Week 0), Week 44
  measure: Change from Baseline in BMI
  time frame: Baseline (Week 24), Week 80
  measure: Change from Baseline in Waist Circumference
  time frame: Baseline (Week 0), Week 44
  measure: Change from Baseline in Waist Circumference
  time frame: Baseline (Week 24), Week 80
  measure: Percentage of Participants Achieving ≥15% Body Weight Reduction
  time frame: Baseline (Week 0), Week 44
  measure: Percentage of Participants Achieving ≥15% Body Weight Reduction
  time frame: Baseline (Week 0), Week 80
  measure: Pharmacokinetics (PK): Steady State Area Under the Concentration Time Curve (AUC)
  time frame: Baseline through Week 44
  description: Steady State Area Under the Concentration Time Curve (AUC) presented as a single average measure of AUC across the time frame.
  arm group label: Tirzepatide High Dose 1
  arm group type: Experimental
  description: Participants will receive tirzepatide subcutaneously (SC).
  arm group label: Tirzepatide High Dose 2
  arm group type: Experimental
  description: Participants will receive tirzepatide SC.
  arm group label: Tirzepatide
  arm group type: Active Comparator
  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
  arm group label: Tirzepatide High Dose 1
  arm group label: Tirzepatide High Dose 2
  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: 75 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
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  country: Argentina
  country: Czechia
  country: Mexico
  country: Slovakia
  responsible party type: Sponsor
  mesh term: Diabetes Mellitus
  mesh term: Obesity
  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: ata 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/