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/NCT06010004</url>
    </required_header>
    <id_info>
      <org_study_id>18745</org_study_id>
      <secondary_id>J2A-JE-GZPE</secondary_id>
      <nct_id>NCT06010004</nct_id>
    </id_info>
    <brief_title>A Long-term Safety Study of Orforglipron (LY3502970) in Participants With Type 2 Diabetes</brief_title>
    <acronym>ACHIEVE-J</acronym>
    <official_title>A Phase 3, Long-term Safety Study of LY3502970 in Adult Participants With Type 2 Diabetes and Inadequate Glycemic Control With Diet and Exercise Alone or in Combination With Oral Antihyperglycemic Medications (ACHIEVE-J)</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Eli Lilly and Company</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Eli Lilly and Company</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
      <is_us_export>Yes</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        The purpose of this study is to determine the long-term safety of the study intervention&#xD;
        orforglipron as a monotherapy or in combination with oral antihyperglycemic medication.&#xD;
  &#xD;
        This study includes 3 periods as follows:&#xD;
  &#xD;
          -  screening and lead-in period: up to 4 weeks&#xD;
  &#xD;
          -  treatment period: 52 weeks, including 20 weeks of dose escalation, and&#xD;
  &#xD;
          -  safety follow-up period: 2 weeks.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 11, 2023</start_date>
    <completion_date type="Anticipated">June 4, 2025</completion_date>
    <primary_completion_date type="Anticipated">June 4, 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>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Number of Participants with Treatment Emergent Adverse Events (TEAEs)</measure>
      <time_frame>Baseline through Week 52</time_frame>
    </primary_outcome>
    <secondary_outcome>
      <measure>Change from Baseline in Hemoglobin A1c (HbA1c)</measure>
      <time_frame>Baseline, Week 52</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Percentage of Participants who Achieve HbA1c &lt;7.0% (&lt;53 mmol/mol)</measure>
      <time_frame>Week 52</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Percentage of Participants who Achieve HbA1c ≤6.5% (&lt;48 mmol/mol)</measure>
      <time_frame>Week 52</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Percentage of Participants who Achieve HbA1c &lt;5.7% (&lt;39 mmol/mol)</measure>
      <time_frame>Week 52</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change from Baseline in Fasting Serum Glucose</measure>
      <time_frame>Baseline, Week 52</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change from Baseline in Body Weight</measure>
      <time_frame>Baseline, Week 52</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Percentage of Participants who Achieve Weight Loss of ≥5%</measure>
      <time_frame>Week 52</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Percentage of Participants who Achieve Weight Loss of ≥10%</measure>
      <time_frame>Week 52</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Percentage of Participants who Achieve Weight Loss of ≥15%</measure>
      <time_frame>Week 52</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change from Baseline in Waist Circumference</measure>
      <time_frame>Baseline, Week 52</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change from Baseline in Body Mass Index (BMI)</measure>
      <time_frame>Baseline, Week 52</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 52</time_frame>
    </secondary_outcome>
    <number_of_arms>3</number_of_arms>
    <enrollment type="Anticipated">399</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 administered 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 administered 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 administered orally.</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>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Have Type 2 Diabetes (T2D)&#xD;
  &#xD;
            -  Have HbA1c ≥7.0% (≥53 mmol/mol) to ≤10.5% (≤91 mmol/mol) as determined by the central&#xD;
               laboratory at screening.&#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 BMI ≥23.0 kilogram/square meter (kg/m²) at screening.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Have Type 1 Diabetes (T1D).&#xD;
  &#xD;
            -  Have a history of severe hypoglycemia or hypoglycemia unawareness within the last 6&#xD;
               months prior to screening, or between screening and randomization.&#xD;
  &#xD;
            -  Have New York Heart Association functional classification IV congestive heart failure.&#xD;
  &#xD;
            -  Have had any of the following cardiovascular (CV) conditions within 60 days prior to&#xD;
               screening, or between screening and randomization.&#xD;
  &#xD;
                 -  acute myocardial infarction&#xD;
  &#xD;
                 -  cerebrovascular accident (stroke), or&#xD;
  &#xD;
                 -  hospitalization for congestive heart failure&#xD;
  &#xD;
            -  Have acute or chronic hepatitis and pancreatitis&#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 Phone: 1-317-615-4559</last_name>
      <phone>1-317-615-4559</phone>
      <email>ClinicalTrials.gov@lilly.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Nakayama Clinic</name>
        <address>
          <city>Nagoya</city>
          <state>Aichi</state>
          <zip>456-0058</zip>
          <country>Japan</country>
        </address>
      </facility>
      <investigator>
        <last_name>Mikihiro Nakayama</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Shinkashiwa Clinic</name>
        <address>
          <city>Kashiwa</city>
          <state>Chiba</state>
          <zip>277-0084</zip>
          <country>Japan</country>
        </address>
      </facility>
      <investigator>
        <last_name>Noriko Sakamoto</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Kashiwa City Hospital</name>
        <address>
          <city>Kashiwa</city>
          <state>Chiba</state>
          <zip>277-0825</zip>
          <country>Japan</country>
        </address>
      </facility>
      <investigator>
        <last_name>Takeshi Inazawa</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Mikannohana Clinic, Diabetes, Endocrinology and Metabolism</name>
        <address>
          <city>Matsuyama</city>
          <state>Ehime</state>
          <zip>116099</zip>
          <country>Japan</country>
        </address>
      </facility>
      <investigator>
        <last_name>Tetsuji Niiya</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>Hasegawa Medical Clinic</name>
        <address>
          <city>Chitose</city>
          <state>Hokkaido</state>
          <zip>066-0032</zip>
          <country>Japan</country>
        </address>
      </facility>
      <investigator>
        <last_name>Atsushi Hasegawa</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Odori Diabetes</name>
        <address>
          <city>Sapporo</city>
          <state>Hokkaido</state>
          <zip>060-0001</zip>
          <country>Japan</country>
        </address>
      </facility>
      <investigator>
        <last_name>hikaru kamoshima</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Matsuda Clinic</name>
        <address>
          <city>Kobe</city>
          <state>Hyogo</state>
          <zip>651-2135</zip>
          <country>Japan</country>
        </address>
      </facility>
      <investigator>
        <last_name>Tomokazu Matsuda</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Nakamoto Internal Medicine Clinic</name>
        <address>
          <city>Mito</city>
          <state>Ibaraki</state>
          <zip>310-0826</zip>
          <country>Japan</country>
        </address>
      </facility>
      <investigator>
        <last_name>shinya nakamoto</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>
      <investigator>
        <last_name>Hideo Takahashi</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Nakakinen clinic</name>
        <address>
          <city>Naka</city>
          <state>Ibaraki</state>
          <zip>311-0113</zip>
          <country>Japan</country>
        </address>
      </facility>
      <investigator>
        <last_name>Takeshi Osonoi</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Nishiyamadou Keiwa Hospital</name>
        <address>
          <city>Naka</city>
          <state>Ibaraki</state>
          <zip>311-0133</zip>
          <country>Japan</country>
        </address>
      </facility>
      <investigator>
        <last_name>Sumiko Hasumi</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Taya Clinic Koueikai Medical Corporation</name>
        <address>
          <city>Tsuchiura</city>
          <state>Ibaraki</state>
          <zip>300-0047</zip>
          <country>Japan</country>
        </address>
      </facility>
      <investigator>
        <last_name>Koichi Taya</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Takai Internal Medicine Clinic</name>
        <address>
          <city>Kamakura-shi</city>
          <state>Kanagawa</state>
          <zip>247-0056</zip>
          <country>Japan</country>
        </address>
      </facility>
      <investigator>
        <last_name>Masahiko Takai</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Shonan Takai Clinic</name>
        <address>
          <city>Kamakura</city>
          <state>Kanagawa</state>
          <zip>247-0055</zip>
          <country>Japan</country>
        </address>
      </facility>
      <investigator>
        <last_name>Kuninobu Takai</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>
      <investigator>
        <last_name>Taro Asakura</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Yokohama Minoru Clinic</name>
        <address>
          <city>Yokohama</city>
          <state>Kanagawa</state>
          <zip>232-0064</zip>
          <country>Japan</country>
        </address>
      </facility>
      <investigator>
        <last_name>Chino Nakamura</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Yokkaichi Diabetes Clinic</name>
        <address>
          <city>Yokkaichi</city>
          <state>Mie</state>
          <zip>510-0829</zip>
          <country>Japan</country>
        </address>
      </facility>
      <investigator>
        <last_name>Ryuichi Mizubayashi</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Gibo Hepatology Clinic</name>
        <address>
          <city>Matsumoto</city>
          <state>Nagano</state>
          <zip>399-0036</zip>
          <country>Japan</country>
        </address>
      </facility>
      <investigator>
        <last_name>Yukio Gibo</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Shiraiwa Medical Clinic</name>
        <address>
          <city>Kashiwara</city>
          <state>Osaka</state>
          <zip>582-0005</zip>
          <country>Japan</country>
        </address>
      </facility>
      <investigator>
        <last_name>Toshihiko Shiraiwa</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Kitada Clinic</name>
        <address>
          <city>Osaka-city</city>
          <state>Osaka</state>
          <zip>538-0044</zip>
          <country>Japan</country>
        </address>
      </facility>
      <investigator>
        <last_name>Hirokazu Kitada</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>
      <investigator>
        <last_name>Satoshi Inoue</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>OHAMA Diabetes Clinic</name>
        <address>
          <city>Kawaguchi</city>
          <state>Saitama</state>
          <zip>332-0015</zip>
          <country>Japan</country>
        </address>
      </facility>
      <investigator>
        <last_name>Toshihiko Ohama</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Sugiura Internal Medicine Clinic</name>
        <address>
          <city>Soka</city>
          <state>Saitama</state>
          <zip>340-0034</zip>
          <country>Japan</country>
        </address>
      </facility>
      <investigator>
        <last_name>Tatsushi Sugiura</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Seiwa Clinic</name>
        <address>
          <city>Adachi-ku</city>
          <state>Tokyo</state>
          <zip>120-0011</zip>
          <country>Japan</country>
        </address>
      </facility>
      <investigator>
        <last_name>Hideki Tanaka</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>
      <investigator>
        <last_name>Yasushi Fukushima</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Hachioji Diabetes Clinic</name>
        <address>
          <city>Hachioji-shi</city>
          <state>Tokyo</state>
          <zip>192-0083</zip>
          <country>Japan</country>
        </address>
      </facility>
      <investigator>
        <last_name>Naoyuki Yamamoto</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Kanno Naika</name>
        <address>
          <city>Mitaka</city>
          <state>Tokyo</state>
          <zip>181-0013</zip>
          <country>Japan</country>
        </address>
      </facility>
      <investigator>
        <last_name>Kazuo Kanno</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Medical Corporation Heishinkai 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>Medical Corporation Tao Internal Medicine Clinic</name>
        <address>
          <city>Ube</city>
          <state>Yamaguchi</state>
          <zip>755-0047</zip>
          <country>Japan</country>
        </address>
      </facility>
      <investigator>
        <last_name>Tsuyoshi Tao</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Fujii Clinic</name>
        <address>
          <city>Ube</city>
          <state>Yamaguchi</state>
          <zip>755-0049</zip>
          <country>Japan</country>
        </address>
      </facility>
      <investigator>
        <last_name>Shinya Fujii</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Tokuyama Clinic</name>
        <address>
          <city>Chiba</city>
          <zip>261-0004</zip>
          <country>Japan</country>
        </address>
      </facility>
      <investigator>
        <last_name>Takahiko Tokuyama</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Tashiro Endocrinology Clinic</name>
        <address>
          <city>Fukuoka</city>
          <zip>814-0153</zip>
          <country>Japan</country>
        </address>
      </facility>
      <investigator>
        <last_name>Naotaka Tashiro</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>
      <investigator>
        <last_name>Hiroshi Morinaga</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Jinnouchi Hospital</name>
        <address>
          <city>Kumamoto</city>
          <zip>862-0976</zip>
          <country>Japan</country>
        </address>
      </facility>
      <investigator>
        <last_name>Hideaki Jinnouchi</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Heiwadai Hospital</name>
        <address>
          <city>Miyazaki</city>
          <zip>880-0034</zip>
          <country>Japan</country>
        </address>
      </facility>
      <investigator>
        <last_name>Shuji Nakamura</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>
      <investigator>
        <last_name>Yoshimitsu Yamasaki</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Kansai Electric Power Hospital</name>
        <address>
          <city>Osaka</city>
          <zip>553-0003</zip>
          <country>Japan</country>
        </address>
      </facility>
      <investigator>
        <last_name>Yoshiyuki Initials Hamamoto</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>Japan</country>
    </location_countries>
    <verification_date>September 1, 2023</verification_date>
    <study_first_submitted>August 21, 2023</study_first_submitted>
    <study_first_submitted_qc>August 21, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 24, 2023</study_first_posted>
    <last_update_submitted>September 7, 2023</last_update_submitted>
    <last_update_submitted_qc>September 7, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 11, 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 patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.</ipd_description>
      <ipd_info_type>Study Protocol</ipd_info_type>
      <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
      <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
      <ipd_time_frame>Data are available 6 months after the primary publication and approval of the indication studied in the US and European Union (EU), whichever is later. Data will be indefinitely available for requesting.</ipd_time_frame>
      <ipd_access_criteria>A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.</ipd_access_criteria>
      <ipd_url>http://vivli.org/</ipd_url>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT06010004
  org study id: 18745
  secondary id: J2A-JE-GZPE
  nct id: NCT06010004
  lead sponsor: 
  has dmc: No
  is fda regulated drug: Yes
  is fda regulated device: No
  is us export: Yes
  The purpose of this study is to determine the long-term safety of the study intervention
        orforglipron as a monotherapy or in combination with oral antihyperglycemic medication.
  
        This study includes 3 periods as follows:
  
          -  screening and lead-in period: up to 4 weeks
  
          -  treatment period: 52 weeks, including 20 weeks of dose escalation, and
  
          -  safety follow-up period: 2 weeks.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Number of Participants with Treatment Emergent Adverse Events (TEAEs)
  time frame: Baseline through Week 52
  measure: Change from Baseline in Hemoglobin A1c (HbA1c)
  time frame: Baseline, Week 52
  measure: Percentage of Participants who Achieve HbA1c <7.0% (<53 mmol/mol)
  time frame: Week 52
  measure: Percentage of Participants who Achieve HbA1c ≤6.5% (<48 mmol/mol)
  time frame: Week 52
  measure: Percentage of Participants who Achieve HbA1c <5.7% (<39 mmol/mol)
  time frame: Week 52
  measure: Change from Baseline in Fasting Serum Glucose
  time frame: Baseline, Week 52
  measure: Change from Baseline in Body Weight
  time frame: Baseline, Week 52
  measure: Percentage of Participants who Achieve Weight Loss of ≥5%
  time frame: Week 52
  measure: Percentage of Participants who Achieve Weight Loss of ≥10%
  time frame: Week 52
  measure: Percentage of Participants who Achieve Weight Loss of ≥15%
  time frame: Week 52
  measure: Change from Baseline in Waist Circumference
  time frame: Baseline, Week 52
  measure: Change from Baseline in Body Mass Index (BMI)
  time frame: Baseline, Week 52
  measure: Change from Baseline in Daily Average 7-Point Self-Monitored Blood Glucose (SMBG)
  time frame: Baseline, Week 52
  arm group label: Orforglipron Dose 1
  arm group type: Experimental
  description: Participants will receive orforglipron administered orally.
  arm group label: Orforglipron Dose 2
  arm group type: Experimental
  description: Participants will receive orforglipron administered orally.
  arm group label: Orforglipron Dose 3
  arm group type: Experimental
  description: Participants will receive orforglipron administered orally.
  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
  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
  phone: 1-317-615-4559
  email: ClinicalTrials.gov@lilly.com
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  country: Japan
  responsible party type: Sponsor
  mesh term: Diabetes Mellitus
  mesh term: Diabetes Mellitus, Type 2
  sharing ipd: Yes
  ipd description: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
  ipd info type: Study Protocol
  ipd info type: Statistical Analysis Plan (SAP)
  ipd info type: Clinical Study Report (CSR)
  ipd time frame: Data are available 6 months after the primary publication and approval of the indication studied in the US and European Union (EU), whichever is later. Data will be indefinitely available for requesting.
  ipd access criteria: A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
  ipd url: http://vivli.org/