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/NCT05989711</url>
    </required_header>
    <id_info>
      <org_study_id>ALT- 801-203</org_study_id>
      <nct_id>NCT05989711</nct_id>
    </id_info>
    <brief_title>Efficacy and Safety of Pemvidutide in Subjects With Nonalcoholic Steatohepatitis (NASH) (IMPACT Trial)</brief_title>
    <acronym>IMPACT</acronym>
    <official_title>A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled Study Evaluating the Efficacy and Safety of Pemvidutide in Non-Cirrhotic Subjects With Nonalcoholic Steatohepatitis (NASH)</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Altimmune, Inc.</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Altimmune, Inc.</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>
        Purpose of this study is to assess the effects of pemvidutide on NASH resolution and NASH&#xD;
        fibrosis.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        A Phase 2, multi-center, double-blind, placebo-controlled study to evaluate the efficacy and&#xD;
        safety of pemvidutide in NASH.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">July 27, 2023</start_date>
    <completion_date type="Anticipated">September 30, 2025</completion_date>
    <primary_completion_date type="Anticipated">February 28, 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>
      <intervention_model_description>Randomized, Double-blind, Placebo-controlled</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Proportion of subjects achieving NASH resolution (NAFLD activity score [NAS], ballooning = 0; lobular inflammation = 0, 1) with at least a 2-point reduction in NAS without worsening of fibrosis</measure>
      <time_frame>24 weeks</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Proportion of subjects achieving at least 1 stage improvement in liver fibrosis without worsening of NASH (defined as no change in the NAS, ie, the sum score for ballooning, inflammation, and steatosis)</measure>
      <time_frame>24 weeks</time_frame>
    </primary_outcome>
    <secondary_outcome>
      <measure>Proportion of subjects achieving the composite of both NASH resolution and at least 1 stage improvement of liver fibrosis at 24 weeks</measure>
      <time_frame>24 weeks</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Relative change (%) in liver fat content by MRI-PDFF</measure>
      <time_frame>24 weeks and 48 weeks</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Absolute change in MRI-based corrected T1 (cT1) imaging</measure>
      <time_frame>24 weeks and 48 weeks</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Absolute change in alanine aminotransferase (ALT)</measure>
      <time_frame>24 weeks and 48 weeks</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Absolute change in Enhanced Liver Fibrosis (ELF) score</measure>
      <time_frame>24 weeks and 48 weeks</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Absolute change in Fibroscan-AST (FAST) score</measure>
      <time_frame>24 weeks and 48 weeks</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Relative (%) change in body weight</measure>
      <time_frame>24 weeks and 48 weeks</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Absolute changes in fasting lipids (total cholesterol, HDL cholesterol, LDL cholesterol, triglycerides)</measure>
      <time_frame>24 weeks and 48 weeks</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in HbA1c (%)</measure>
      <time_frame>24 weeks and 48 weeks</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in glucose (mg/dL)</measure>
      <time_frame>24 weeks and 48 weeks</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in systolic and diastolic blood pressure (mmHg)</measure>
      <time_frame>24 weeks and 48 weeks</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in heart rate (beats per minute)</measure>
      <time_frame>24 weeks and 48 weeks</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The number of subjects with treatment emergent adverse events</measure>
      <time_frame>48 weeks</time_frame>
    </secondary_outcome>
    <number_of_arms>3</number_of_arms>
    <enrollment type="Anticipated">190</enrollment>
    <condition>Non-Alcoholic Steatohepatitis (NASH)</condition>
    <arm_group>
      <arm_group_label>Pemvidutide 1.2 mg (n=38)</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>Pemvidutide 1.8 mg (n=76)</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>Placebo (n=76)</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Pemvidutide</intervention_name>
      <description>Administered by subcutaneous injection</description>
      <arm_group_label>Pemvidutide 1.2 mg (n=38)</arm_group_label>
      <arm_group_label>Pemvidutide 1.8 mg (n=76)</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Placebo</intervention_name>
      <description>Administered by subcutaneous injection</description>
      <arm_group_label>Placebo (n=76)</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Written informed consent&#xD;
  &#xD;
            2. Male or female 18-75 years&#xD;
  &#xD;
            3. Histologic diagnosis of NASH and/or histologic confirmation of NASH based on central&#xD;
               pathology evaluation of a liver biopsy during screening&#xD;
  &#xD;
                 1. A histologic NAFLD Activity Score (NAS) ≥ 4 with a score of at least 1 on each&#xD;
                    subcomponent score based on central pathology evaluation (steatosis [0-3],&#xD;
                    lobular inflammation [0-3], and hepatocyte ballooning [0-2])&#xD;
  &#xD;
                 2. NASH fibrosis stages 2 through 3 according to the NASH CRN fibrosis staging&#xD;
                    system based on central pathology evaluation&#xD;
  &#xD;
            4. Subject agrees to have a liver biopsy performed during the screening period (if no&#xD;
               biopsy within the preceding 6 months is available) and at 24 weeks of treatment&#xD;
  &#xD;
            5. BMI ≥ 27.0 kg/m2&#xD;
  &#xD;
            6. Subjects with Type 2 diabetes mellitus (T2D) should be on a stable treatment regimen&#xD;
               for their T2D for at least 90 days prior to screening&#xD;
  &#xD;
            7. Subject meets at least 3 of the 5 criteria of Metabolic Syndrome (American Heart&#xD;
               Association 2005)&#xD;
  &#xD;
            8. Liver fat content by MRI-PDFF ≥ 8%&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Weight gain or loss &gt; 5% in the 3 months prior to randomization or &gt; 10% in the 6&#xD;
               months prior to screening&#xD;
  &#xD;
            2. History or clinical evidence of Type 1 diabetes mellitus&#xD;
  &#xD;
            3. Hemoglobin A1c (HbA1c) &gt; 9.5% or clinically significant persistent hyperglycemia&#xD;
  &#xD;
            4. Liver conditions:&#xD;
  &#xD;
                 1. History of cirrhosis or complications of cirrhosis, including but not limited to&#xD;
                    variceal bleeding, encephalopathy, or ascites&#xD;
  &#xD;
                 2. Documented causes of chronic liver disease other than NASH&#xD;
  &#xD;
                 3. ALT or AST laboratory values &gt; 5 × ULN&#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_contact>
      <last_name>Altimmune CTM</last_name>
      <phone>2406541450</phone>
      <email>information@altimmune.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Altimmune Clinical Study Site</name>
        <address>
          <city>Fort Myers</city>
          <state>Florida</state>
          <zip>33912</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Altimmune Study Director</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>Altimmune Clinical Study Site</name>
        <address>
          <city>Sarasota</city>
          <state>Florida</state>
          <zip>34240</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Altimmune Study Director</last_name>
      </contact>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 24, 2023</study_first_submitted>
    <study_first_submitted_qc>August 10, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 2023</study_first_posted>
    <last_update_submitted>August 10, 2023</last_update_submitted>
    <last_update_submitted_qc>August 10, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 14, 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>
    <!-- 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/NCT05989711
  org study id: ALT- 801-203
  nct id: NCT05989711
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: Yes
  is fda regulated device: No
  Purpose of this study is to assess the effects of pemvidutide on NASH resolution and NASH
        fibrosis.
  A Phase 2, multi-center, double-blind, placebo-controlled study to evaluate the efficacy and
        safety of pemvidutide in NASH.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: Randomized, Double-blind, Placebo-controlled
  primary purpose: Treatment
  masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  measure: Proportion of subjects achieving NASH resolution (NAFLD activity score [NAS], ballooning = 0; lobular inflammation = 0, 1) with at least a 2-point reduction in NAS without worsening of fibrosis
  time frame: 24 weeks
  measure: Proportion of subjects achieving at least 1 stage improvement in liver fibrosis without worsening of NASH (defined as no change in the NAS, ie, the sum score for ballooning, inflammation, and steatosis)
  time frame: 24 weeks
  measure: Proportion of subjects achieving the composite of both NASH resolution and at least 1 stage improvement of liver fibrosis at 24 weeks
  time frame: 24 weeks
  measure: Relative change (%) in liver fat content by MRI-PDFF
  time frame: 24 weeks and 48 weeks
  measure: Absolute change in MRI-based corrected T1 (cT1) imaging
  time frame: 24 weeks and 48 weeks
  measure: Absolute change in alanine aminotransferase (ALT)
  time frame: 24 weeks and 48 weeks
  measure: Absolute change in Enhanced Liver Fibrosis (ELF) score
  time frame: 24 weeks and 48 weeks
  measure: Absolute change in Fibroscan-AST (FAST) score
  time frame: 24 weeks and 48 weeks
  measure: Relative (%) change in body weight
  time frame: 24 weeks and 48 weeks
  measure: Absolute changes in fasting lipids (total cholesterol, HDL cholesterol, LDL cholesterol, triglycerides)
  time frame: 24 weeks and 48 weeks
  measure: Change in HbA1c (%)
  time frame: 24 weeks and 48 weeks
  measure: Change in glucose (mg/dL)
  time frame: 24 weeks and 48 weeks
  measure: Change in systolic and diastolic blood pressure (mmHg)
  time frame: 24 weeks and 48 weeks
  measure: Change in heart rate (beats per minute)
  time frame: 24 weeks and 48 weeks
  measure: The number of subjects with treatment emergent adverse events
  time frame: 48 weeks
  arm group label: Pemvidutide 1.2 mg (n=38)
  arm group type: Experimental
  arm group label: Pemvidutide 1.8 mg (n=76)
  arm group type: Experimental
  arm group label: Placebo (n=76)
  arm group type: Placebo Comparator
  intervention type: Drug
  intervention name: Pemvidutide
  description: Administered by subcutaneous injection
  arm group label: Pemvidutide 1.2 mg (n=38)
  arm group label: Pemvidutide 1.8 mg (n=76)
  intervention type: Drug
  intervention name: Placebo
  description: Administered by subcutaneous injection
  arm group label: Placebo (n=76)
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 75 Years
  healthy volunteers: No
  last name: Altimmune CTM
  phone: 2406541450
  email: information@altimmune.com
  facility: 
  status: Recruiting
  contact: 
  facility: 
  status: Recruiting
  contact: 
  country: United States
  responsible party type: Sponsor
  mesh term: Fatty Liver
  mesh term: Non-alcoholic Fatty Liver Disease