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/NCT05970640</url>
    </required_header>
    <id_info>
      <org_study_id>1466-0002</org_study_id>
      <nct_id>NCT05970640</nct_id>
    </id_info>
    <brief_title>A Study to Test How Well Different Doses of BI 3006337 Are Tolerated by People With Overweight or Obesity and With Fatty Liver Disease</brief_title>
    <official_title>Phase Ib Trial to Assess Safety and Tolerability of Multiple Subcutaneous Doses of BI 3006337 in Patients With Overweight or Obesity and Hepatic Steatosis</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Boehringer Ingelheim</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Boehringer Ingelheim</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 open to adults with overweight or obesity who also have fatty liver disease.&#xD;
        The purpose of this study is to find the highest dose of BI 3006337 that people with&#xD;
        overweight or obesity and with fatty liver disease can tolerate.&#xD;
  &#xD;
        Participants are divided into 4 groups of equal size randomly, which means by chance.&#xD;
        Different doses of BI 3006337 are given to participants in each group. Participants in each&#xD;
        group receive an injection of either BI 3006337 or placebo once a week. Placebo injections&#xD;
        look like BI 3006337 injections but do not contain any medicine.&#xD;
  &#xD;
        Participants are in the study for about 4 months. During this time, they visit the study site&#xD;
        18 times. Three of the visits include overnight stays at the study site. The doctors check&#xD;
        the health of the participants and note any health problems that could have been caused by BI&#xD;
        3006337.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">August 2, 2023</start_date>
    <completion_date type="Anticipated">January 23, 2025</completion_date>
    <primary_completion_date type="Anticipated">January 23, 2025</primary_completion_date>
    <phase>Phase 1</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>Single (Participant)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Occurrence of drug-related adverse events (AEs)</measure>
      <time_frame>Up to 99 days</time_frame>
    </primary_outcome>
    <secondary_outcome>
      <measure>Area under the concentration-time curve of the analyte in serum over the dosing interval tau at steady state (AUCτ,ss) after the last dose in Week 12</measure>
      <time_frame>Up to 99 days</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Maximum measured concentration of the analyte in serum at steady state (Cmax,ss) after the last dose in Week 12</measure>
      <time_frame>Up to 99 days</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Time from dosing to the maximum measured concentration of the analyte in serum at steady state (tmax,ss) after the last dose in Week 12</measure>
      <time_frame>Up to 99 days</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Relative percentage change in liver steatosis from baseline after 12 weeks of treatment</measure>
      <time_frame>At baseline and at week 12</time_frame>
      <description>Liver steatosis is measured by Magnetic resonance imaging proton density fat fraction (MRI-PDFF)</description>
    </secondary_outcome>
    <number_of_arms>4</number_of_arms>
    <enrollment type="Anticipated">56</enrollment>
    <condition>Non-alcoholic Fatty Liver Disease</condition>
    <condition>Obesity</condition>
    <arm_group>
      <arm_group_label>BI 3006337 dose group 1 or placebo</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>BI 3006337 dose group 2 or placebo</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>BI 3006337 dose group 3 or placebo</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>BI 3006337 dose group 4</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>BI 3006337</intervention_name>
      <description>BI 3006337</description>
      <arm_group_label>BI 3006337 dose group 1 or placebo</arm_group_label>
      <arm_group_label>BI 3006337 dose group 2 or placebo</arm_group_label>
      <arm_group_label>BI 3006337 dose group 3 or placebo</arm_group_label>
      <arm_group_label>BI 3006337 dose group 4</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Placebo matching BI 3006337</intervention_name>
      <description>Placebo matching BI 3006337</description>
      <arm_group_label>BI 3006337 dose group 1 or placebo</arm_group_label>
      <arm_group_label>BI 3006337 dose group 2 or placebo</arm_group_label>
      <arm_group_label>BI 3006337 dose group 3 or placebo</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
          - Male or female trial participants ≥18 years and ≤75 years of age at time of consent.&#xD;
  &#xD;
          Women of child-bearing potential (WOCBP) must be willing and able to use 2 forms of&#xD;
          effective contraception where at least 1 form is a highly effective method of birth control&#xD;
          per ICH M3 (R2) that results in a low failure rate of less than 1% per year when used&#xD;
          consistently and correctly. Male trial participants must be willing and able to use condom&#xD;
          if their partner is a WOCBP&#xD;
  &#xD;
            -  Body mass index (BMI) ≥25 - &lt;40 kg/m^2&#xD;
  &#xD;
            -  Liver fat fraction ≥8% as measured by Magnetic resonance imaging proton density fat&#xD;
               fraction (MRI-PDFF)&#xD;
  &#xD;
            -  Signed and dated written informed consent in accordance with International Council for&#xD;
               Harmonisation-Good Clinical Practice (ICH-GCP) and local legislation prior to&#xD;
               admission to the trial&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          - Current or past significant alcohol consumption (daily alcohol consumption in women&#xD;
          should not exceed more than one standard drink per day and two drinks per day for men,&#xD;
          whereby one standard drink is equivalent to 12 oz beer [5% alcohol]; 5 ounces of wine [12%&#xD;
          alcohol], 1.5 ounces of 80 proof [40% alcohol]) or inability to reliably quantify alcohol&#xD;
          consumption based on Investigator judgement within the last 5 years.&#xD;
  &#xD;
          The Alcohol Use Disorders Identification Test (AUDIT) shall be used a standardized&#xD;
          screening tool for alcohol use disorder&#xD;
  &#xD;
            -  Intake of medications historically associated with liver injury, hepatic steatosis, or&#xD;
               steatohepatitis (e.g. oral or intravenous corticosteroids, methotrexate, valproic&#xD;
               acid, tamoxifen, tetracycline, amiodarone) for more than 14 consecutive days within 12&#xD;
               weeks prior to the screening visit&#xD;
  &#xD;
            -  Presence of any form of acute or chronic liver disease other than simple steatosis&#xD;
               (e.g. viral hepatitis, autoimmune liver disease, primary biliary sclerosis, primary&#xD;
               sclerosing cholangitis, Wilson's disease, hemochromatosis, alpha-1 antitrypsin&#xD;
               deficiency). Chronic viral hepatitis parameters that would be considered exclusionary&#xD;
               for the participation to this trial are (hepatitis B and C testing will be done at the&#xD;
               screening visit):&#xD;
  &#xD;
                 -  Hepatitis B virus (HBV): trial participants with positive Hepatitis B virus&#xD;
                    surface antigen (HbsAg)&#xD;
  &#xD;
                 -  Hepatitis C virus (HCV): trial participants with positive HCV RNA. Trial&#xD;
                    participants treated for hepatitis C must have a negative RNA test at screening&#xD;
                    and also be HCV RNA negative for at least 3 years prior to screening in order to&#xD;
                    be eligible for the trial&#xD;
  &#xD;
            -  Liver stiffness &gt;10 Kilopascal (kPa) as measured using Fibroscan. In patients with a&#xD;
               non-valid Fibroscan measurement, a Fib-4 score &gt;1.3 should be considered exclusionary.&#xD;
  &#xD;
            -  Suspicion, confirmed diagnosis, or history of hepatocellular carcinoma&#xD;
  &#xD;
            -  Treatment with vitamin E (at a minimum dose of 800 IU/day) or pioglitazone not stable&#xD;
               (in the opinion of the Investigator) within 90 days before screening&#xD;
  &#xD;
            -  History of type 1 diabetes&#xD;
  &#xD;
            -  Use of Glucagon-like peptide 1 (GLP1)-receptor agonists within last 90 days before&#xD;
               screening Further exclusion criteria apply.&#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>Boehringer Ingelheim</last_name>
      <phone>1-800-243-0127</phone>
      <email>clintriage.rdg@boehringer-ingelheim.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Catalina Research Institute, LLC</name>
        <address>
          <city>Montclair</city>
          <state>California</state>
          <zip>91763</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Boehringer Ingelheim</last_name>
        <phone>833-602-2368</phone>
        <email>unitedstates@bitrialsupport.com</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Accel Research Sites</name>
        <address>
          <city>DeLand</city>
          <state>Florida</state>
          <zip>32720</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Boehringer Ingelheim</last_name>
        <phone>833-602-2368</phone>
        <email>unitedstates@bitrialsupport.com</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>American Research Corporation at the Texas Liver Institute</name>
        <address>
          <city>San Antonio</city>
          <state>Texas</state>
          <zip>78215</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Boehringer Ingelheim</last_name>
        <phone>833-602-2368</phone>
        <email>unitedstates@bitrialsupport.com</email>
      </contact>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <link>
      <url>https://www.mystudywindow.com</url>
      <description>Related Info</description>
    </link>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 21, 2023</study_first_submitted>
    <study_first_submitted_qc>July 25, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 1, 2023</study_first_posted>
    <last_update_submitted>August 22, 2023</last_update_submitted>
    <last_update_submitted_qc>August 22, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 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>Liver Diseases</mesh_term>
      <mesh_term>Fatty Liver</mesh_term>
      <mesh_term>Non-alcoholic Fatty Liver Disease</mesh_term>
      <mesh_term>Obesity</mesh_term>
      <mesh_term>Overweight</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
      <ipd_description>Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization).&#xD;
  For more details refer to:&#xD;
  https://www.mystudywindow.com/msw/datatransparency</ipd_description>
    </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/NCT05970640
  org study id: 1466-0002
  nct id: NCT05970640
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: Yes
  is fda regulated device: No
  This study is open to adults with overweight or obesity who also have fatty liver disease.
        The purpose of this study is to find the highest dose of BI 3006337 that people with
        overweight or obesity and with fatty liver disease can tolerate.
  
        Participants are divided into 4 groups of equal size randomly, which means by chance.
        Different doses of BI 3006337 are given to participants in each group. Participants in each
        group receive an injection of either BI 3006337 or placebo once a week. Placebo injections
        look like BI 3006337 injections but do not contain any medicine.
  
        Participants are in the study for about 4 months. During this time, they visit the study site
        18 times. Three of the visits include overnight stays at the study site. The doctors check
        the health of the participants and note any health problems that could have been caused by BI
        3006337.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Single (Participant)
  measure: Occurrence of drug-related adverse events (AEs)
  time frame: Up to 99 days
  measure: Area under the concentration-time curve of the analyte in serum over the dosing interval tau at steady state (AUCτ,ss) after the last dose in Week 12
  time frame: Up to 99 days
  measure: Maximum measured concentration of the analyte in serum at steady state (Cmax,ss) after the last dose in Week 12
  time frame: Up to 99 days
  measure: Time from dosing to the maximum measured concentration of the analyte in serum at steady state (tmax,ss) after the last dose in Week 12
  time frame: Up to 99 days
  measure: Relative percentage change in liver steatosis from baseline after 12 weeks of treatment
  time frame: At baseline and at week 12
  description: Liver steatosis is measured by Magnetic resonance imaging proton density fat fraction (MRI-PDFF)
  arm group label: BI 3006337 dose group 1 or placebo
  arm group type: Experimental
  arm group label: BI 3006337 dose group 2 or placebo
  arm group type: Experimental
  arm group label: BI 3006337 dose group 3 or placebo
  arm group type: Experimental
  arm group label: BI 3006337 dose group 4
  arm group type: Experimental
  intervention type: Drug
  intervention name: BI 3006337
  description: BI 3006337
  arm group label: BI 3006337 dose group 1 or placebo
  arm group label: BI 3006337 dose group 2 or placebo
  arm group label: BI 3006337 dose group 3 or placebo
  arm group label: BI 3006337 dose group 4
  intervention type: Drug
  intervention name: Placebo matching BI 3006337
  description: Placebo matching BI 3006337
  arm group label: BI 3006337 dose group 1 or placebo
  arm group label: BI 3006337 dose group 2 or placebo
  arm group label: BI 3006337 dose group 3 or placebo
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 75 Years
  healthy volunteers: No
  last name: Boehringer Ingelheim
  phone: 1-800-243-0127
  email: clintriage.rdg@boehringer-ingelheim.com
  facility: 
  status: Recruiting
  contact: 
  facility: 
  status: Recruiting
  contact: 
  facility: 
  status: Recruiting
  contact: 
  country: United States
  url: https://www.mystudywindow.com
  description: Related Info
  responsible party type: Sponsor
  mesh term: Liver Diseases
  mesh term: Fatty Liver
  mesh term: Non-alcoholic Fatty Liver Disease
  mesh term: Obesity
  mesh term: Overweight
  sharing ipd: No
  ipd description: Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization).
  For more details refer to:
  https://www.mystudywindow.com/msw/datatransparency