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/NCT06007651</url>
    </required_header>
    <id_info>
      <org_study_id>18769</org_study_id>
      <secondary_id>J4N-MC-YFAA</secondary_id>
      <nct_id>NCT06007651</nct_id>
    </id_info>
    <brief_title>A Study of LY3885125 in Participants With Dyslipidemia or Non-Alcoholic Fatty Liver Disease (NAFLD)</brief_title>
    <official_title>A Phase 1, Multicenter, Randomized, Placebo-Controlled, Double-Blind Trial of LY3885125 to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of a Single Ascending Dose in Participants With Dyslipidemia and Repeat-Doses in Participants With NAFLD</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Eli Lilly and Company</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Eli Lilly and Company</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The main purpose of this study is to evaluate the safety and tolerability of LY3885125 after&#xD;
        administration of single ascending doses in participants with dyslipidemia (part A) and&#xD;
        multiple doses in participants with non-alcoholic fatty liver disease (part B). Blood tests&#xD;
        will be performed to check how much LY3885125 gets into the bloodstream and how long it takes&#xD;
        the body to eliminate it.&#xD;
  &#xD;
        The study will last up to approximately 49 weeks for part A and 62 weeks for part B, for a&#xD;
        total of approximately 111 weeks.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">August 10, 2023</start_date>
    <completion_date type="Anticipated">November 2025</completion_date>
    <primary_completion_date type="Anticipated">February 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>Sequential Assignment</intervention_model>
      <primary_purpose>Basic Science</primary_purpose>
      <masking>Double (Participant, Investigator)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Part A: Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration</measure>
      <time_frame>Baseline up to 49 weeks (Part A)</time_frame>
      <description>Part A: A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Part B: Number of Participants with One or More SAEs Considered by the Investigator to be Related to Study Drug Administration</measure>
      <time_frame>Baseline up to 62 weeks (Part B)</time_frame>
      <description>Part B: A summary of SAEs and other non-serious AEs, regardless of causality, will be reported in the Reported Adverse Events module</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Part A &amp; B: Pharmacokinetics (PK): Area Under the Plasma Concentration Versus Time Curve (AUC) of LY3885125</measure>
      <time_frame>Baseline up to 49 weeks (Part A) and Baseline up to 62 weeks (Part B)</time_frame>
      <description>Part A &amp; B: PK: AUC of LY3885125</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Part A &amp; B: PK: Maximum Observed Plasma Concentration (Cmax) of LY3885125</measure>
      <time_frame>Baseline up to 49 weeks (Part A) and Baseline up to 62 weeks (Part B)</time_frame>
      <description>Part A &amp; B: PK: Cmax of LY3885125</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Part A &amp; B: PK: Time of Maximum Observed Concentration (Tmax) of LY3885125</measure>
      <time_frame>Baseline up to 49 weeks (Part A) and Baseline up to 62 weeks (Part B)</time_frame>
      <description>Part A &amp; B: PK: Tmax of LY3885125</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Part A &amp; B: Pharmacodynamics (PD): Change From Baseline in Proprotein Convertase Subtilisin/Kexin type 9 (PCSK9)</measure>
      <time_frame>Baseline up to 49 weeks (Part A) and Baseline up to 62 weeks (Part B)</time_frame>
      <description>Part A &amp; B: PD: Change From Baseline in PCSK9</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Part A &amp; B: PD: Change From Baseline in apolipoprotein B (ApoB)</measure>
      <time_frame>Baseline up to 49 weeks (Part A) and Baseline up to 62 weeks (Part B)</time_frame>
      <description>Part A &amp; B: PD: Change From Baseline in ApoB</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Part B only: PD: Change of Liver Fat Content From Baseline by Magnetic Resonance Imaging Proton Density Fat Fraction (MRI-PDFF)</measure>
      <time_frame>Baseline up to 62 weeks (Part B)</time_frame>
      <description>Part B only: PD: Change of Liver Fat Content From Baseline by MRI-PDFF</description>
    </secondary_outcome>
    <number_of_arms>4</number_of_arms>
    <enrollment type="Anticipated">112</enrollment>
    <condition>Dyslipidemias</condition>
    <condition>Non-Alcoholic Fatty Liver Disease</condition>
    <arm_group>
      <arm_group_label>LY3885125 (Part A)</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Single ascending doses of LY3885125 administered subcutaneously (SC)</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Placebo (Part A)</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <description>Placebo administered SC</description>
    </arm_group>
    <arm_group>
      <arm_group_label>LY3885125 (Part B)</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Repeat doses of LY3885125 administered SC</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Placebo (Part B)</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <description>Placebo administered SC</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>LY3885125</intervention_name>
      <description>Administered SC</description>
      <arm_group_label>LY3885125 (Part A)</arm_group_label>
      <arm_group_label>LY3885125 (Part B)</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Placebo</intervention_name>
      <description>Administered SC</description>
      <arm_group_label>Placebo (Part A)</arm_group_label>
      <arm_group_label>Placebo (Part B)</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
          Parts A &amp; B&#xD;
  &#xD;
            -  Males, or females of not of childbearing potential,&#xD;
  &#xD;
            -  On a stable diet for the 3 months prior to randomization and willing to continue the&#xD;
               same stable diet during the study.&#xD;
  &#xD;
          Part A&#xD;
  &#xD;
            -  Dyslipidemia with the following fasted blood levels at screening: 150 mg/dL ≤&#xD;
               triglycerides &lt;500 mg/dL, AND LDL-cholesterol ≥100 mg/dL,&#xD;
  &#xD;
            -  Body mass index (BMI) in range of 18.5 to 45.0 kg/m2. Part B&#xD;
  &#xD;
            -  NAFLD with liver fat content ≥8% as determined by magnetic resonance imaging proton&#xD;
               density fat fraction (MRI-PDFF),&#xD;
  &#xD;
            -  BMI in range of 27 to 45.0 kg/m2&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          Parts A &amp; B&#xD;
  &#xD;
            -  History or presence of medical illness including, but not limited to, any&#xD;
               cardiovascular, thromboembolism or bleeding disorder, hepatic, respiratory,&#xD;
               hematological, endocrine, immune, psychiatric, or neurological disease, convulsions,&#xD;
               or any clinically significant laboratory abnormality that, in the judgment of the&#xD;
               Investigator, indicate a medical problem that would preclude study participation,&#xD;
  &#xD;
            -  Uncontrolled hypertension with a resting blood pressure ≥ 160 mmHg systolic or ≥ 100&#xD;
               mmHg diastolic at visit 1,&#xD;
  &#xD;
            -  Alanine transaminase (ALT) or aspartate aminotransferase (AST) &gt;3.0 × ULN for the&#xD;
               reference range,&#xD;
  &#xD;
            -  Alkaline phosphatase (ALP) &gt;1.5 × ULN for the reference range,&#xD;
  &#xD;
            -  Total bilirubin (TBL) &gt;1.5 × ULN for the reference range,&#xD;
  &#xD;
            -  Taken drugs associated with hepatic steatosis (e.g., amiodarone, valproic acid,&#xD;
               methotrexate, tamoxifen) for more than 2 weeks in the 3 months prior to screening&#xD;
               visit,&#xD;
  &#xD;
            -  Type 1 diabetes mellitus (T1DM) or any other type of diabetes mellitus other than&#xD;
               T2DM,&#xD;
  &#xD;
            -  Poorly controlled T2DM with glycated hemoglobin (HbA1c) of &gt;9.0%,&#xD;
  &#xD;
            -  Treatment with GLP-1 RA and GIP/GLP-1 RA and approved or experimental agents that&#xD;
               target PCSK9 within 9 months prior to screening visit.&#xD;
  &#xD;
          Part B&#xD;
  &#xD;
            -  Evidence of other forms of chronic liver disease,&#xD;
  &#xD;
            -  Initiated treatment with, or changed dose of, medications that may cause significant&#xD;
               weight gain or weight loss, within 3 months prior to the screening visit,&#xD;
  &#xD;
            -  Have a self-reported change in body weight &gt;5 kg (11 pounds) within 3 months prior to&#xD;
               screening visit&#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_official>
      <last_name>Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)</last_name>
      <role>Study Director</role>
      <affiliation>Eli Lilly and Company</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or</last_name>
      <phone>1-317-615-4559</phone>
      <email>ClinicalTrials.gov@Lilly.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Worldwide Clinical Trials, Early Phase Services LLC</name>
        <address>
          <city>San Antonio</city>
          <state>Texas</state>
          <zip>78217</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <phone>210-635-1500</phone>
      </contact>
      <investigator>
        <last_name>Alan Hand, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 18, 2023</study_first_submitted>
    <study_first_submitted_qc>August 18, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 23, 2023</study_first_posted>
    <last_update_submitted>August 18, 2023</last_update_submitted>
    <last_update_submitted_qc>August 18, 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>Dyslipidemias</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </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/NCT06007651
  org study id: 18769
  secondary id: J4N-MC-YFAA
  nct id: NCT06007651
  lead sponsor: 
  has dmc: No
  is fda regulated drug: Yes
  is fda regulated device: No
  The main purpose of this study is to evaluate the safety and tolerability of LY3885125 after
        administration of single ascending doses in participants with dyslipidemia (part A) and
        multiple doses in participants with non-alcoholic fatty liver disease (part B). Blood tests
        will be performed to check how much LY3885125 gets into the bloodstream and how long it takes
        the body to eliminate it.
  
        The study will last up to approximately 49 weeks for part A and 62 weeks for part B, for a
        total of approximately 111 weeks.
  allocation: Randomized
  intervention model: Sequential Assignment
  primary purpose: Basic Science
  masking: Double (Participant, Investigator)
  measure: Part A: Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
  time frame: Baseline up to 49 weeks (Part A)
  description: Part A: A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module
  measure: Part B: Number of Participants with One or More SAEs Considered by the Investigator to be Related to Study Drug Administration
  time frame: Baseline up to 62 weeks (Part B)
  description: Part B: A summary of SAEs and other non-serious AEs, regardless of causality, will be reported in the Reported Adverse Events module
  measure: Part A & B: Pharmacokinetics (PK): Area Under the Plasma Concentration Versus Time Curve (AUC) of LY3885125
  time frame: Baseline up to 49 weeks (Part A) and Baseline up to 62 weeks (Part B)
  description: Part A & B: PK: AUC of LY3885125
  measure: Part A & B: PK: Maximum Observed Plasma Concentration (Cmax) of LY3885125
  time frame: Baseline up to 49 weeks (Part A) and Baseline up to 62 weeks (Part B)
  description: Part A & B: PK: Cmax of LY3885125
  measure: Part A & B: PK: Time of Maximum Observed Concentration (Tmax) of LY3885125
  time frame: Baseline up to 49 weeks (Part A) and Baseline up to 62 weeks (Part B)
  description: Part A & B: PK: Tmax of LY3885125
  measure: Part A & B: Pharmacodynamics (PD): Change From Baseline in Proprotein Convertase Subtilisin/Kexin type 9 (PCSK9)
  time frame: Baseline up to 49 weeks (Part A) and Baseline up to 62 weeks (Part B)
  description: Part A & B: PD: Change From Baseline in PCSK9
  measure: Part A & B: PD: Change From Baseline in apolipoprotein B (ApoB)
  time frame: Baseline up to 49 weeks (Part A) and Baseline up to 62 weeks (Part B)
  description: Part A & B: PD: Change From Baseline in ApoB
  measure: Part B only: PD: Change of Liver Fat Content From Baseline by Magnetic Resonance Imaging Proton Density Fat Fraction (MRI-PDFF)
  time frame: Baseline up to 62 weeks (Part B)
  description: Part B only: PD: Change of Liver Fat Content From Baseline by MRI-PDFF
  arm group label: LY3885125 (Part A)
  arm group type: Experimental
  description: Single ascending doses of LY3885125 administered subcutaneously (SC)
  arm group label: Placebo (Part A)
  arm group type: Placebo Comparator
  description: Placebo administered SC
  arm group label: LY3885125 (Part B)
  arm group type: Experimental
  description: Repeat doses of LY3885125 administered SC
  arm group label: Placebo (Part B)
  arm group type: Placebo Comparator
  description: Placebo administered SC
  intervention type: Drug
  intervention name: LY3885125
  description: Administered SC
  arm group label: LY3885125 (Part A)
  arm group label: LY3885125 (Part B)
  intervention type: Drug
  intervention name: Placebo
  description: Administered SC
  arm group label: Placebo (Part A)
  arm group label: Placebo (Part B)
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 70 Years
  healthy volunteers: No
  last name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
  role: Study Director
  affiliation: Eli Lilly and Company
  last name: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or
  phone: 1-317-615-4559
  email: ClinicalTrials.gov@Lilly.com
  facility: 
  status: Recruiting
  contact: 
  investigator: 
  country: United States
  responsible party type: Sponsor
  mesh term: Liver Diseases
  mesh term: Fatty Liver
  mesh term: Non-alcoholic Fatty Liver Disease
  mesh term: Dyslipidemias
  sharing ipd: No