<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/NCT04505436</url>
  </required_header>
  <id_info>
    <org_study_id>HM-TRIA-201</org_study_id>
    <nct_id>NCT04505436</nct_id>
  </id_info>
  <brief_title>Study to Evaluate Efficacy, Safety and Tolerability of HM15211 in Subjects</brief_title>
  <official_title>A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate Efficacy, Safety and Tolerability of HM15211 Treatment for 12 Months in Subjects With Biopsy Confirmed NASH</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hanmi Pharmaceutical Company Limited</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hanmi Pharmaceutical Company Limited</source>
  <oversight_info>
    <has_dmc>Yes</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>
      This study is a phase 2 study to Evaluate Efficacy, Safety and Tolerability of HM15211&#xD;
      Treatment for 12 Months in Subjects with Biopsy Confirmed NASH&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">July 31, 2020</start_date>
  <completion_date type="Anticipated">November 10, 2025</completion_date>
  <primary_completion_date type="Anticipated">May 11, 2025</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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>pharmacodynamic (PD) effect of HM15211</measure>
    <time_frame>12 months</time_frame>
    <description>Proportion of subjects who achieve resolution of steatohepatitis on overall histopathological reading and no worsening of liver fibrosis</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">217</enrollment>
  <condition>NASH - Nonalcoholic Steatohepatitis</condition>
  <arm_group>
    <arm_group_label>HM15211</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>HM15211</intervention_name>
    <description>A sterile solution of HM15211 contained in pre-filled syringes</description>
    <arm_group_label>HM15211</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo of HM15211</intervention_name>
    <description>A sterile, matching solution in pre-filled syringes</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adults ≥ 18 to ≤ 70 years.&#xD;
&#xD;
          -  BMI ≥ 18 kg/m2, with stable body weight (defined as change &lt; 5%) by history for 3&#xD;
             months prior to screening or since baseline liver biopsy, whichever is earlier.&#xD;
&#xD;
          -  Subjects have a diagnosis of noncirrhotic NASH with liver fibrosis (Fibrosis stage&#xD;
             F1-F3) confirmed by liver biopsy within 6 months of Day -7.&#xD;
&#xD;
          -  MRI-PDFF performed at screening with ≥ 8% steatosis.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subjects with a history of active or chronic liver disease, including alcoholic liver&#xD;
             disease, viral hepatitis, primary biliary cirrhosis, primary sclerosing cholangitis,&#xD;
             autoimmune hepatitis, Wilson's disease, hemochromatosis, alpha-1 antitrypsin&#xD;
             deficiency, human immunodeficiency virus (HIV).&#xD;
&#xD;
          -  Any history of clinically significant chronic liver disease including esophageal&#xD;
             varices, ascites, hepatic encephalopathy, splenomegaly, or any hospitalization for&#xD;
             treatment of chronic liver disease; or Model for End Stage Liver Disease &gt;12.&#xD;
&#xD;
          -  Recent (within 3 months of baseline biopsy) use of therapies associated with&#xD;
             development of NAFLD (e.g., systemic corticosteroids, methotrexate, tamoxifen,&#xD;
             aromatase inhibitors, amiodarone, or long-term use of tetracyclines).&#xD;
&#xD;
          -  Type 1 diabetes subjects, or T2DM subjects on insulin and/or GLP-1 receptor agonist&#xD;
             therapy, or other therapies not allowed for this study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Jiyeon Kang</last_name>
    <phone>+82 2 410 0377</phone>
    <email>jiyeon.kang@hanmi.co.kr</email>
  </overall_contact>
  <location>
    <facility>
      <name>North Alabama GI Research Center</name>
      <address>
        <city>Madison</city>
        <state>Alabama</state>
        <zip>35758-2632</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Michael Brown</last_name>
    </contact>
    <investigator>
      <last_name>Michael Brown</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>UC San Diego School of Medicine - Altman Clinical and Translational Research Institute</name>
      <address>
        <city>La Jolla</city>
        <state>California</state>
        <zip>92037</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Rohit Loomba</last_name>
    </contact>
    <investigator>
      <last_name>Rohit Loomba</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Tandem Clinical Research, LLC</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>70072-3155</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Gary Reiss</last_name>
    </contact>
    <investigator>
      <last_name>Gary Reiss</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>UC Davis Health System - Midtown Ambulatory Care Center</name>
      <address>
        <city>Sacramento</city>
        <state>California</state>
        <zip>95816</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Souvik Sarkar</last_name>
    </contact>
    <investigator>
      <last_name>Souvik Sarkar</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Precision Research Institute, LLC. (PRI)</name>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <zip>92114-3629</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ivan Cubas</last_name>
    </contact>
    <investigator>
      <last_name>Ivan Cubas</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>University of Florida College of Medicine</name>
      <address>
        <city>Gainesville</city>
        <state>Florida</state>
        <zip>32610</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Virginia Clark</last_name>
    </contact>
    <investigator>
      <last_name>Virginia Clark</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>San Marcus Research Clinic</name>
      <address>
        <city>Miami Lakes</city>
        <state>Florida</state>
        <zip>330145602</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Maria Cuesta torres</last_name>
    </contact>
    <investigator>
      <last_name>Maria Cuesta torres</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Floridian Clinical Research, LLC</name>
      <address>
        <city>Miami Lakes</city>
        <state>Florida</state>
        <zip>33016</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>William Sanchez</last_name>
    </contact>
    <investigator>
      <last_name>William Sanchez</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Schiff Center for Liver Diseases - University of Miami Leonard M. Miller School of Medicine(UMMSM)</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33136</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Eugene Schiff</last_name>
    </contact>
    <investigator>
      <last_name>Eugene Schiff</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Ocala GI Research</name>
      <address>
        <city>Ocala</city>
        <state>Florida</state>
        <zip>34471</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Robert Barish</last_name>
    </contact>
    <investigator>
      <last_name>Robert Barish</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Bioclinica Research - Orlando/Synexus Clinical Research US, Inc.</name>
      <address>
        <city>Orlando</city>
        <state>Florida</state>
        <zip>32806</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Judith White</last_name>
    </contact>
    <investigator>
      <last_name>Judith White</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Synexus Clinical Research US, Inc. - The Villages</name>
      <address>
        <city>The Villages</city>
        <state>Florida</state>
        <zip>32162</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Terminated</status>
  </location>
  <location>
    <facility>
      <name>Synexus Clinical Research US, Inc</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60602</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Terminated</status>
  </location>
  <location>
    <facility>
      <name>Kansas Medical Clinic PA (KMC) - Gastrointestinal Medical Plaza</name>
      <address>
        <city>Topeka</city>
        <state>Kansas</state>
        <zip>66606-1707</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Shekhar Challa</last_name>
    </contact>
    <investigator>
      <last_name>Shekhar Challa</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Tandem Clinical Research, LLC</name>
      <address>
        <city>Marrero</city>
        <state>Louisiana</state>
        <zip>70072</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Lincoln Hernandez</last_name>
    </contact>
    <investigator>
      <last_name>Lincoln Hernandez</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>University of Maryland Medical Center</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21201</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Kirti Shetty</last_name>
    </contact>
    <investigator>
      <last_name>Kirti Shetty</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Mercy Medical Center - The Institute for Digestive Health and Liver Disease</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21202-2102</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Anurag Maheshwari</last_name>
    </contact>
    <investigator>
      <last_name>Anurag Maheshwari</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Henry Ford Hospital</name>
      <address>
        <city>Detroit</city>
        <state>Michigan</state>
        <zip>48202-2608</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Humberto Gonzalez</last_name>
    </contact>
    <investigator>
      <last_name>Humberto Gonzalez</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Gastroenterology Associates of Western Michigan</name>
      <address>
        <city>Wyoming</city>
        <state>Michigan</state>
        <zip>49519</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Allan Coates</last_name>
    </contact>
    <investigator>
      <last_name>Allan Coates</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Mayo Clinic Rochester</name>
      <address>
        <city>Rochester</city>
        <state>Minnesota</state>
        <zip>55905</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Manal F Abdelmalek</last_name>
    </contact>
    <investigator>
      <last_name>Manal F Abdelmalek</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Synexus Clinical Research US, Inc - Henderson</name>
      <address>
        <city>Henderson</city>
        <state>Nevada</state>
        <zip>98052</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Cornell Calinescu</last_name>
    </contact>
    <investigator>
      <last_name>Cornell Calinescu</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>UNC Health Care System</name>
      <address>
        <city>Chapel Hill</city>
        <state>North Carolina</state>
        <zip>27514</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Alfred Barritt</last_name>
    </contact>
    <investigator>
      <last_name>Alfred Barritt</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Duke University Medical Center</name>
      <address>
        <city>Durham</city>
        <state>North Carolina</state>
        <zip>27710-4000</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ayako Suzuki</last_name>
    </contact>
    <investigator>
      <last_name>Ayako Suzuki</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Carolinas Center for Liver Disease, Carolinas HealthCare System/Atrium Health</name>
      <address>
        <city>Huntersville</city>
        <state>North Carolina</state>
        <zip>28078</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Robert Reindollar</last_name>
    </contact>
    <investigator>
      <last_name>Robert Reindollar</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Lucas Research</name>
      <address>
        <city>Morehead City</city>
        <state>North Carolina</state>
        <zip>28557</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Kathryn Lucas</last_name>
    </contact>
    <investigator>
      <last_name>Kathryn Lucas</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Ohio Gastroenterology &amp; Liver Institute (GI) (Greater Cincinnati Gastroenterology Associates Inc) - Montgomery Office</name>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <zip>45249-2291</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ravi Ravinuthala</last_name>
    </contact>
    <investigator>
      <last_name>Ravi Ravinuthala</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>University of Pittsburgh Medical Center (UPMC) - The Center for Liver Diseases</name>
      <address>
        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <zip>15213</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Mordechai Rabinovitz</last_name>
    </contact>
    <investigator>
      <last_name>Mordechai Rabinovitz</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Wake Research Associates, LLC (WRA)</name>
      <address>
        <city>Chattanooga</city>
        <state>Tennessee</state>
        <zip>37421-1688</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Mark Mckenzie</last_name>
    </contact>
    <investigator>
      <last_name>Mark Mckenzie</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Texas Digestive Disease Consultants, P.A. (TDDC)</name>
      <address>
        <city>Arlington</city>
        <state>Texas</state>
        <zip>76012</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Reem Ghalib</last_name>
    </contact>
    <investigator>
      <last_name>Reem Ghalib</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>The Liver Institute at Methodist Dallas</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75203</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Parvez Mantry</last_name>
    </contact>
    <investigator>
      <last_name>Parvez Mantry</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Dallas Diabetes and Endocrine Center</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75230</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Julio Rosenstock</last_name>
    </contact>
    <investigator>
      <last_name>Julio Rosenstock</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Liver Center of Texas, PLLC</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75234</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Abdullah Mubarak</last_name>
    </contact>
    <investigator>
      <last_name>Abdullah Mubarak</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Synexus Clinical Research US, Inc</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75234</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Terminated</status>
  </location>
  <location>
    <facility>
      <name>St. Luke's Episcopal Hospital - Advanced Liver Therapies Research</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>John Vierling</last_name>
    </contact>
    <investigator>
      <last_name>John Vierling</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Pioneer Research Solutions Inc</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77099-4307</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Francisco Velazquez</last_name>
    </contact>
    <investigator>
      <last_name>Francisco Velazquez</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Digestive Health Associates of Texas, P.A. (DHAT)</name>
      <address>
        <city>Rockwall</city>
        <state>Texas</state>
        <zip>75032-7045</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Harry Sarles</last_name>
    </contact>
    <investigator>
      <last_name>Harry Sarles</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Texas Liver Institute (TLI) - Texas Metabolic Center</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78215-1610</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Eric Lawitz</last_name>
    </contact>
    <investigator>
      <last_name>Eric Lawitz</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>University of Utah Health Care - UUHC - Kidney &amp; Liver Clinic</name>
      <address>
        <city>Salt Lake City</city>
        <state>Utah</state>
        <zip>84132</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Juan Gallegos-Orozco</last_name>
    </contact>
    <investigator>
      <last_name>Juan Gallegos-Orozco</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Bon Secours Liver Institute of Virginia - Newport News</name>
      <address>
        <city>Newport News</city>
        <state>Virginia</state>
        <zip>23602</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Mitchell Shiffman</last_name>
    </contact>
    <investigator>
      <last_name>Mitchell Shiffman</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Virginia Commonwealth University (VCU) Medical Center</name>
      <address>
        <city>Richmond</city>
        <state>Virginia</state>
        <zip>23298</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Velimir Luketic</last_name>
    </contact>
    <investigator>
      <last_name>Velimir Luketic</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>University of Washington (UW) - Harborview Medical Center (HMC) - Hepatitis and Liver Clinic</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98104</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Terminated</status>
  </location>
  <location>
    <facility>
      <name>Liver Institute Northwest</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98105</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Kris Kowdley</last_name>
    </contact>
    <investigator>
      <last_name>Kris Kowdley</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Seoul National University College of Medicine - Liver Research Institute</name>
      <address>
        <city>Seoul</city>
        <zip>03080</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Yoon Jun Kim, Ph.D</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Severance Hospital</name>
      <address>
        <city>Seoul</city>
        <zip>03722</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>JunYong Park</last_name>
    </contact>
    <investigator>
      <last_name>JunYong Park</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>SMG-SNU Boramae Medical Center</name>
      <address>
        <city>Seoul</city>
        <zip>07061</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Won Kim</last_name>
    </contact>
    <investigator>
      <last_name>Won Kim</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Korea University Guro Hospital</name>
      <address>
        <city>Seoul</city>
        <zip>08308</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ji Hoon Kim</last_name>
    </contact>
    <investigator>
      <last_name>Ji Hoon Kim</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Natinal health insurance service Ilsan hospital</name>
      <address>
        <city>Seoul</city>
        <zip>10444</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Chun Kyon Lee</last_name>
    </contact>
    <investigator>
      <last_name>Chun Kyon Lee</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>August 7, 2020</study_first_submitted>
  <study_first_submitted_qc>August 7, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 10, 2020</study_first_posted>
  <last_update_submitted>May 22, 2023</last_update_submitted>
  <last_update_submitted_qc>May 22, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 23, 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>Fatty Liver</mesh_term>
    <mesh_term>Non-alcoholic Fatty Liver Disease</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


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/NCT04505436
org study id: HM-TRIA-201
nct id: NCT04505436
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
This study is a phase 2 study to Evaluate Efficacy, Safety and Tolerability of HM15211
      Treatment for 12 Months in Subjects with Biopsy Confirmed NASH
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: pharmacodynamic (PD) effect of HM15211
time frame: 12 months
description: Proportion of subjects who achieve resolution of steatohepatitis on overall histopathological reading and no worsening of liver fibrosis
arm group label: HM15211
arm group type: Experimental
arm group label: Placebo
arm group type: Placebo Comparator
intervention type: Drug
intervention name: HM15211
description: A sterile solution of HM15211 contained in pre-filled syringes
arm group label: HM15211
intervention type: Drug
intervention name: Placebo of HM15211
description: A sterile, matching solution in pre-filled syringes
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: Jiyeon Kang
phone: +82 2 410 0377
email: jiyeon.kang@hanmi.co.kr
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Terminated
facility: 
status: Terminated
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Terminated
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Terminated
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
country: Korea, Republic of
country: United States
responsible party type: Sponsor
mesh term: Fatty Liver
mesh term: Non-alcoholic Fatty Liver Disease
sharing ipd: No