<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/NCT03776175</url>
  </required_header>
  <id_info>
    <org_study_id>C3711001</org_study_id>
    <nct_id>NCT03776175</nct_id>
  </id_info>
  <brief_title>A Study To Assess Pharmacodynamics, Safety And Tolerability Of PF-05221304 And PF-06865571 Co-Administered For 6 Weeks In Adults With Non-Alcoholic Fatty Liver Disease.</brief_title>
  <official_title>A PHASE 2A, RANDOMIZED, DOUBLE BLIND (SPONSOR-OPEN), PLACEBO CONTROLLED, PARALLEL GROUP STUDY TO ASSESS THE PHARMACODYNAMICS, SAFETY AND TOLERABILITY OF PF-05221304 AND PF-06865571 CO-ADMINISTERED FOR 6 WEEKS IN ADULTS WITH NON-ALCOHOLIC FATTY LIVER DISEASE (NAFLD)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Pfizer</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Pfizer</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 to assess the effect of PF 05221304 alone, PF 06865571 alone, the co&#xD;
      administration of PF 05221304 and PF 06865571, or placebo on whole liver fat in subjects with&#xD;
      NAFLD. In addition, this study will evaluate the safety and tolerability of co administration&#xD;
      of PF 05221304 and PF 06865571 along with the effects on selected pharmacodynamics&#xD;
      (PD)/exploratory parameters, compared to administration of PF 05221304 alone, PF 06865571&#xD;
      alone, and placebo in adults with NAFLD.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 4, 2019</start_date>
  <completion_date type="Actual">October 11, 2019</completion_date>
  <primary_completion_date type="Actual">September 9, 2019</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>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percent Change From Baseline in Whole Liver Proton Density Fat Fraction (PDFF) at Day 42</measure>
    <time_frame>Baseline, Day 42</time_frame>
    <description>Magnetic resonance imaging proton density fat fraction (MRI-PDFF) technique is an established method that enables quantification of fat content in the liver. It measures the fraction of mobile protons in the liver attributable to fat content and provides whole liver coverage so that fat content can be assessed across 8 Couinaud liver segments. Whole liver PDFF = PDFFs for (Segment I + Segment II + Segment III + Segment IVa + Segment IVb + Segment V + Segment VI + Segment VII + Segment VIII) divided by total number of segments assessed.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)</measure>
    <time_frame>Baseline up to 35 days from last dose of study drug or early termination: (maximum up to Day 77)</time_frame>
    <description>An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly; medically important events. A treatment emergent AE was defined as an event that emerged during the treatment period that was absent before treatment, or worsened during the treatment period relative to the pretreatment state. AEs included all serious and non-serious adverse events.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Laboratory Abnormalities</measure>
    <time_frame>Baseline up to 35 days last from dose of study drug or early termination (maximum up to Day 77)</time_frame>
    <description>Clinical chemistry: Bilirubin (milligram per deciliter [mg/dL]), direct bilirubin (mg/dL)&gt;3.0*upper limit of normal (ULN), alanine aminotransferase international units per liter (U/L), aspartate aminotransferase (U/L), alkaline phosphatase (U/L), gamma glutamyl transferase (U/L)&gt;5.0*ULN, urea nitrogen (mg/dL)&gt;2.0*ULN, low density lipoprotein direct endpoint measure (mg/dL)&gt;1.5*ULN, triglycerides (mg/dL)&gt;2.0*ULN, creatinine based estimated glomerular filtration rate by modification of diet in renal disease equation and cystatin based eGFR by chronic kidney disease epidemiology collaboration equation (C &lt;60 milliliter per minute per 1.73 square of meter), very low density lipoprotein (millimoles per liter), Cholesterol &gt;2.0*ULN.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maximum Change (Increase or Decrease) From Baseline to Post-last Dose of Study Drug in Vital Signs: Blood Pressure</measure>
    <time_frame>Baseline, Post-last dose of study drug (up to Day 42)</time_frame>
    <description>Vital signs included systolic blood pressure, diastolic blood pressure and pulse rate.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maximum Change (Increase or Decrease) From Baseline to Post-last Dose of Study Drug in Vital Signs: Pulse Rate</measure>
    <time_frame>Baseline, Post- last dose of study drug (up to Day 42)</time_frame>
    <description>Vital signs included systolic blood pressure, diastolic blood pressure and pulse rate.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Meeting Pre-Specified Electrocardiogram (ECG) Criteria</measure>
    <time_frame>Baseline up to 35 days last dose of study drug or early termination (maximum up to Day 77)</time_frame>
    <description>ECG criteria included: 1) PR interval (milliseconds [msec]): baseline greater than (&gt;) 200 msec and maximum increase from baseline greater than or equal to (&gt;=) 25 percent (%) or baseline less than or equal to (&lt;=) 200 msec and maximum increase from baseline &gt;=50%; 2) QRS interval (msec): maximum increase from baseline &gt;=50%; 3) QT interval corrected using Fridericia's formula (QTcF): a) change from baseline &gt;30 msec and &lt;=60 msec, b) change from baseline &gt;60 msec.</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">99</enrollment>
  <condition>Non-Alcoholic Fatty Liver Disease (NAFLD)</condition>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo (PF 05221304) BID Placebo (PF 06865571) BID</description>
  </arm_group>
  <arm_group>
    <arm_group_label>PF-05221304 Monotherapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>15 mg PF-05221304 BID Placebo (PF-06865571) BID</description>
  </arm_group>
  <arm_group>
    <arm_group_label>PF-06865571 Monotherapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Placebo (PF-05221304) BID 300 mg PF-06865571 BID</description>
  </arm_group>
  <arm_group>
    <arm_group_label>PF-05221304 and PF-06865571 Combination</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>15 mg PF-05221304 BID 300 mg PF-06865571 BID</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>PF-05221304 Monotherapy</intervention_name>
    <description>Participants enrolled in this Arm will receive 15 mg dose of PF-05221304 (3 tablets of 5 mg each) and 3 tablets of Placebo for PF-06865571, each to be taken twice daily for 41 days and once on Day 42.</description>
    <arm_group_label>PF-05221304 Monotherapy</arm_group_label>
    <arm_group_label>PF-05221304 and PF-06865571 Combination</arm_group_label>
    <other_name>Arm B</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>PF-06865571 Monotherapy</intervention_name>
    <description>Participants enrolled in this Arm will receive 300 mg dose of PF-06865571 (3 tablets of 100 mg each) and 3 tablets of Placebo for PF-05221304, all to be taken twice daily for 41 days and once on Day 42.</description>
    <arm_group_label>PF-05221304 and PF-06865571 Combination</arm_group_label>
    <arm_group_label>PF-06865571 Monotherapy</arm_group_label>
    <other_name>Arm C</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Participants enrolled in this Arm will receive 3 tablets for Placebo of PF-05221304 and 3 tablets of Placebo of PF-06865571, to be taken twice daily for 41 days and once on Day 42.</description>
    <arm_group_label>PF-05221304 Monotherapy</arm_group_label>
    <arm_group_label>PF-06865571 Monotherapy</arm_group_label>
    <arm_group_label>Placebo</arm_group_label>
    <other_name>Arm A</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>PF-05221304 and PF-06865571 Combination</intervention_name>
    <description>Participants enrolled in this Arm will receive 15 mg dose of PF-05221304 (3 tablets of 5 mg each) and 3 tablets of PF-06865571 (3 tablets of 100 mg each), each to be taken twice daily for 41 days and once on Day 42.</description>
    <arm_group_label>PF-05221304 and PF-06865571 Combination</arm_group_label>
    <other_name>Arm D</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male subjects or female subjects of non childbearing potential&#xD;
&#xD;
          -  Total body weight of &gt;50 kg (110 lbs) and a BMI greater than or equal to 25 kg/m2&#xD;
&#xD;
          -  Medical diagnosis of Type 2 Diabetes Mellitus (T2DM) being treated with no more than 1&#xD;
             acceptable oral antidiabetic drug OR Subjects without a diagnosis of T2DM that meet 2&#xD;
             or more of the following 5 criteria commonly associated with metabolic syndrome&#xD;
&#xD;
               -  Fasting Plasma Glucose (FPG) greater than or equal to 100 mg/dL;&#xD;
&#xD;
               -  Documentation of at least stage 1 hypertension or medical history of&#xD;
                  hypertension;&#xD;
&#xD;
               -  Fasting serum HDL C &lt;40 mg/dL for males and &lt;50 mg/dL for females, or on&#xD;
                  pharmacological agents with explicit purpose to increase HDL-C;&#xD;
&#xD;
               -  Fasting serum triglyceride (TG) greater than or equal to 150 mg/dL or on&#xD;
                  pharmacological agents with explicit purpose to decrease TG;&#xD;
&#xD;
               -  Waist circumference greater than or equal to 40 inches (102 cm) for males and 35&#xD;
                  inches (89 cm) for females.&#xD;
&#xD;
          -  Liver fat greater than or equal to 8% measured by MRI PDFF&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subjects with acute or chronic medical or psychiatric condition.&#xD;
&#xD;
          -  Subjects with any of the following clinical laboratory abnormalities:&#xD;
&#xD;
               -  Fasting TG &gt;400 mg/dL;&#xD;
&#xD;
               -  AST, ALT, or GGT &gt;2.0x ULN;&#xD;
&#xD;
               -  Hemoglobin A1c (HbA1c) &gt;7.0%;&#xD;
&#xD;
               -  Fasting plasma glucose &gt;270 mg/dL;&#xD;
&#xD;
               -  Total bilirubin &gt;1.5x ULN;&#xD;
&#xD;
               -  Albumin &lt; lower limit of normal (LLN);&#xD;
&#xD;
               -  Platelet count &lt;0.95x LLN;&#xD;
&#xD;
               -  International normalized ratio (INR) greater than or equal to 1.3.&#xD;
&#xD;
          -  A positive urine test for illicit drugs.&#xD;
&#xD;
          -  History of regular alcohol consumption.&#xD;
&#xD;
          -  Seated systolic BP&gt;=160 mmHg and/or diastolic BP&gt;=100 mmHg.&#xD;
&#xD;
          -  Supine 12 lead ECG demonstrating a corrected QT (QTcF) interval &gt;450 msec or a QRS&#xD;
             interval &gt;120 msec.&#xD;
&#xD;
          -  Subjects with an estimated GFR &lt;60 mL/min/1.73m2.&#xD;
&#xD;
          -  Evidence or diagnosis of other forms of chronic liver diseases.&#xD;
&#xD;
          -  Subjects with any of the following medical conditions:&#xD;
&#xD;
               -  Any condition possibly affecting drug absorption (eg prior bariatric surgery,&#xD;
                  gastrectomy, ileal resection);&#xD;
&#xD;
               -  Diagnosis of type 1 diabetes mellitus;&#xD;
&#xD;
               -  History of congestive heart failure, unstable angina, myocardial infarction,&#xD;
                  stroke, or transient ischemic attack;&#xD;
&#xD;
               -  Any malignancy not considered cured (except basal cell carcinoma and squamous&#xD;
                  cell carcinoma of the skin);&#xD;
&#xD;
               -  Active placement of medical devices in/on thoracic or abdominal cavities such as&#xD;
                  pacemakers, defibrillators;&#xD;
&#xD;
          -  Subjects with any anatomical or pathological abnormality that would either preclude or&#xD;
             tend to confound the analysis of study data.&#xD;
&#xD;
          -  Blood donation of approximately 1 pint or more within 60 days prior to dosing.&#xD;
&#xD;
          -  Subjects taking prohibited concomitant medication(s) or those unwilling/unable to&#xD;
             switch to permitted concomitant medication(s)&#xD;
&#xD;
          -  Weight loss of greater than or equal to 5% within 1 month prior to Screening.&#xD;
&#xD;
          -  Unwilling or unable to comply with the Lifestyle Requirements criteria of the&#xD;
             protocol.&#xD;
&#xD;
          -  Pregnant female subjects; breastfeeding female subjects; female subjects of&#xD;
             childbearing potential; fertile male subjects who are unwilling or unable to use&#xD;
             highly effective method(s) of contraception.&#xD;
&#xD;
          -  Investigator site staff members or Pfizer employees, including their family members,&#xD;
             directly involved in the conduct of the study.&#xD;
&#xD;
          -  Subjects with known prior treatment with or participation in a clinical trial&#xD;
             involving any of the IPs&#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>Pfizer CT.gov Call Center</last_name>
    <role>Study Director</role>
    <affiliation>Pfizer</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Franco Felizarta, Md</name>
      <address>
        <city>Bakersfield</city>
        <state>California</state>
        <zip>93301</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Westside Medical Associates of Los Angeles</name>
      <address>
        <city>Beverly Hills</city>
        <state>California</state>
        <zip>90211</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ProSciento, Inc.</name>
      <address>
        <city>Chula Vista</city>
        <state>California</state>
        <zip>91911</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Research Institute - Wilshire</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90057</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Catalina Research Institute, LLC</name>
      <address>
        <city>Montclair</city>
        <state>California</state>
        <zip>91763</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Floridian Clinical Research, LLC</name>
      <address>
        <city>Hialeah</city>
        <state>Florida</state>
        <zip>33016</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Centers of America, LLC</name>
      <address>
        <city>Hollywood</city>
        <state>Florida</state>
        <zip>33024</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Jacksonville Center for Clinical Research</name>
      <address>
        <city>Jacksonville</city>
        <state>Florida</state>
        <zip>32216</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pharmax Research Clinic</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33126</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Omega Research Maitland</name>
      <address>
        <city>Orlando</city>
        <state>Florida</state>
        <zip>32810</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Accel Research Sites</name>
      <address>
        <city>Orlando</city>
        <state>Florida</state>
        <zip>32819</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Advanced Gastroenterology Associates, LLC</name>
      <address>
        <city>Palm Harbor</city>
        <state>Florida</state>
        <zip>34684</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>QPS-MRA, LLC-Main Office</name>
      <address>
        <city>South Miami</city>
        <state>Florida</state>
        <zip>33143</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>East-West Medical Research Institute</name>
      <address>
        <city>Honolulu</city>
        <state>Hawaii</state>
        <zip>96814</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Midwest Institute for Clinical Research</name>
      <address>
        <city>Indianapolis</city>
        <state>Indiana</state>
        <zip>46260</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Heartland Research Associates, LLC</name>
      <address>
        <city>Wichita</city>
        <state>Kansas</state>
        <zip>67207</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>L-MARC Research Center</name>
      <address>
        <city>Louisville</city>
        <state>Kentucky</state>
        <zip>40213</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clarity Clinical Research</name>
      <address>
        <city>East Syracuse</city>
        <state>New York</state>
        <zip>13057</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>High Point Clinical Trials Center</name>
      <address>
        <city>High Point</city>
        <state>North Carolina</state>
        <zip>27265</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>M3 Wake Research, Inc</name>
      <address>
        <city>Raleigh</city>
        <state>North Carolina</state>
        <zip>27612</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wake Gastroenterology</name>
      <address>
        <city>Raleigh</city>
        <state>North Carolina</state>
        <zip>27612</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>PMG Research of Wilmington, LLC</name>
      <address>
        <city>Wilmington</city>
        <state>North Carolina</state>
        <zip>28401</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sterling Research Group - Mt. Auburn</name>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <zip>45219</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>New Horizons Clinical Research</name>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <zip>45242</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>WR-Clinsearch, LLC</name>
      <address>
        <city>Chattanooga</city>
        <state>Tennessee</state>
        <zip>37421</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>New Orleans Center for Clinical Research</name>
      <address>
        <city>Knoxville</city>
        <state>Tennessee</state>
        <zip>37920</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Tennessee Medical Center - Radiology</name>
      <address>
        <city>Knoxville</city>
        <state>Tennessee</state>
        <zip>37920</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Trials of Texas, Inc.</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78229</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Clinical Research-Richmond, Inc.</name>
      <address>
        <city>Richmond</city>
        <state>Virginia</state>
        <zip>23294</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://pmiform.com/clinical-trial-info-request?StudyID=C3711001</url>
    <description>To obtain contact information for a study center near you, click here.</description>
  </link>
  <verification_date>September 2020</verification_date>
  <study_first_submitted>December 12, 2018</study_first_submitted>
  <study_first_submitted_qc>December 12, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 14, 2018</study_first_posted>
  <results_first_submitted>September 2, 2020</results_first_submitted>
  <results_first_submitted_qc>September 2, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">September 23, 2020</results_first_posted>
  <last_update_submitted>September 2, 2020</last_update_submitted>
  <last_update_submitted_qc>September 2, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">September 23, 2020</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>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.</ipd_description>
    <ipd_url>https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests</ipd_url>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>October 2, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/75/NCT03776175/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>August 16, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/75/NCT03776175/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Placebo</title>
          <description>Participants were randomized to receive placebo (3 tablets) matched to PF-05221304 and placebo (3 tablets) matched to PF-06865571 orally, twice daily for 41 days and once on Day 42. Participants were followed up to maximum of 35 days after last dose of study drug.</description>
        </group>
        <group group_id="P2">
          <title>PF-05221304 15mg + Placebo</title>
          <description>Participants were randomized to receive PF-05221304 15 milligram (mg) tablets (3 tablets, each of 5 mg) and placebo (3 tablets) matched to PF-06865571, orally, twice daily for 41 days and once on Day 42. Participants were followed up to maximum of 35 days after last dose of study drug.</description>
        </group>
        <group group_id="P3">
          <title>PF-06865571 300 mg + Placebo</title>
          <description>Participants were randomized to receive PF-06865571 300 mg (3 tablets, each of 100 mg) and placebo (3 tablets) matched to PF-05221304 orally, twice daily for 41 days and once on Day 42. Participants were followed up to maximum of 35 days after last dose of study drug.</description>
        </group>
        <group group_id="P4">
          <title>PF-05221304 15 mg + PF-06865571 300 mg</title>
          <description>Participants were randomized to receive PF-05221304 15 mg (3 tablets, each of 5 mg) and PF-06865571 300 mg (3 tablets, each of 100 mg) orally, twice daily for 41 days and once on Day 42. Participants were followed up to maximum of 35 days after last dose of study drug.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Treatment Period (42 Days)</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="14"/>
                <participants group_id="P2" count="29"/>
                <participants group_id="P3" count="28"/>
                <participants group_id="P4" count="28"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Treated</title>
              <participants_list>
                <participants group_id="P1" count="14"/>
                <participants group_id="P2" count="29"/>
                <participants group_id="P3" count="28"/>
                <participants group_id="P4" count="28"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="13"/>
                <participants group_id="P2" count="22"/>
                <participants group_id="P3" count="24"/>
                <participants group_id="P4" count="26"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="7"/>
                <participants group_id="P3" count="4"/>
                <participants group_id="P4" count="2"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Participants screened at other site</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="2"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="2"/>
                <participants group_id="P3" count="3"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Unable to attend study visits</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="2"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>Follow-Up Period (35 Days)</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="13"/>
                <participants group_id="P2" count="22"/>
                <participants group_id="P3" count="24"/>
                <participants group_id="P4" count="26"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="13"/>
                <participants group_id="P2" count="22"/>
                <participants group_id="P3" count="24"/>
                <participants group_id="P4" count="24"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="2"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Safety analysis population included all participants who received at least 1 dose of investigational product post-randomization.</population>
      <group_list>
        <group group_id="B1">
          <title>Placebo</title>
          <description>Participants were randomized to receive placebo (3 tablets) matched to PF-05221304 and placebo (3 tablets) matched to PF-06865571 orally, twice daily for 41 days and once on Day 42. Participants were followed up to maximum of 35 days after last dose of study drug.</description>
        </group>
        <group group_id="B2">
          <title>PF-05221304 15mg + Placebo</title>
          <description>Participants were randomized to receive PF-05221304 15 mg tablets (3 tablets, each of 5 mg) and placebo (3 tablets) matched to PF-06865571, orally, twice daily for 41 days and once on Day 42. Participants were followed up to maximum of 35 days after last dose of study drug.</description>
        </group>
        <group group_id="B3">
          <title>PF-06865571 300 mg + Placebo</title>
          <description>Participants were randomized to receive PF-06865571 300 mg (3 tablets, each of 100 mg) and placebo (3 tablets) matched to PF-05221304 orally, twice daily for 41 days and once on Day 42. Participants were followed up to maximum of 35 days after last dose of study drug.</description>
        </group>
        <group group_id="B4">
          <title>PF-05221304 15 mg + PF-06865571 300 mg</title>
          <description>Participants were randomized to receive PF-05221304 15 mg (3 tablets, each of 5 mg) and PF-06865571 300 mg (3 tablets, each of 100 mg) orally, twice daily for 41 days and once on Day 42. Participants were followed up to maximum of 35 days after last dose of study drug.</description>
        </group>
        <group group_id="B5">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="14"/>
            <count group_id="B2" value="29"/>
            <count group_id="B3" value="28"/>
            <count group_id="B4" value="28"/>
            <count group_id="B5" value="99"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                    <measurement group_id="B2" value="22"/>
                    <measurement group_id="B3" value="26"/>
                    <measurement group_id="B4" value="25"/>
                    <measurement group_id="B5" value="83"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="3"/>
                    <measurement group_id="B5" value="16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="14"/>
                    <measurement group_id="B3" value="15"/>
                    <measurement group_id="B4" value="10"/>
                    <measurement group_id="B5" value="46"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="15"/>
                    <measurement group_id="B3" value="13"/>
                    <measurement group_id="B4" value="18"/>
                    <measurement group_id="B5" value="53"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                    <measurement group_id="B2" value="17"/>
                    <measurement group_id="B3" value="13"/>
                    <measurement group_id="B4" value="21"/>
                    <measurement group_id="B5" value="61"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="12"/>
                    <measurement group_id="B3" value="14"/>
                    <measurement group_id="B4" value="7"/>
                    <measurement group_id="B5" value="37"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="2"/>
                    <measurement group_id="B5" value="6"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="13"/>
                    <measurement group_id="B2" value="25"/>
                    <measurement group_id="B3" value="26"/>
                    <measurement group_id="B4" value="25"/>
                    <measurement group_id="B5" value="89"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="1"/>
                    <measurement group_id="B5" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Percent Change From Baseline in Whole Liver Proton Density Fat Fraction (PDFF) at Day 42</title>
        <description>Magnetic resonance imaging proton density fat fraction (MRI-PDFF) technique is an established method that enables quantification of fat content in the liver. It measures the fraction of mobile protons in the liver attributable to fat content and provides whole liver coverage so that fat content can be assessed across 8 Couinaud liver segments. Whole liver PDFF = PDFFs for (Segment I + Segment II + Segment III + Segment IVa + Segment IVb + Segment V + Segment VI + Segment VII + Segment VIII) divided by total number of segments assessed.</description>
        <time_frame>Baseline, Day 42</time_frame>
        <population>Full analysis set population included all randomized participants who received at least 1 dose of investigational product and participants were assigned to the randomized treatment regardless of what treatment was received. Here 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants were randomized to receive placebo (3 tablets) matched to PF-05221304 and placebo (3 tablets) matched to PF-06865571 orally, twice daily for 41 days and once on Day 42. Participants were followed up to maximum of 35 days after last dose of study drug.</description>
          </group>
          <group group_id="O2">
            <title>PF-05221304 15mg + Placebo</title>
            <description>Participants were randomized to receive PF-05221304 15 mg tablets (3 tablets, each of 5 mg) and placebo (3 tablets) matched to PF-06865571, orally, twice daily for 41 days and once on Day 42. Participants were followed up to maximum of 35 days after last dose of study drug.</description>
          </group>
          <group group_id="O3">
            <title>PF-06865571 300 mg + Placebo</title>
            <description>Participants were randomized to receive PF-06865571 300 mg (3 tablets, each of 100 mg) and placebo (3 tablets) matched to PF-05221304 orally, twice daily for 41 days and once on Day 42. Participants were followed up to maximum of 35 days after last dose of study drug.</description>
          </group>
          <group group_id="O4">
            <title>PF-05221304 15 mg + PF-06865571 300 mg</title>
            <description>Participants were randomized to receive PF-05221304 15 mg (3 tablets, each of 5 mg) and PF-06865571 300 mg (3 tablets, each of 100 mg) orally, twice daily for 41 days and once on Day 42. Participants were followed up to maximum of 35 days after last dose of study drug.</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Change From Baseline in Whole Liver Proton Density Fat Fraction (PDFF) at Day 42</title>
          <description>Magnetic resonance imaging proton density fat fraction (MRI-PDFF) technique is an established method that enables quantification of fat content in the liver. It measures the fraction of mobile protons in the liver attributable to fat content and provides whole liver coverage so that fat content can be assessed across 8 Couinaud liver segments. Whole liver PDFF = PDFFs for (Segment I + Segment II + Segment III + Segment IVa + Segment IVb + Segment V + Segment VI + Segment VII + Segment VIII) divided by total number of segments assessed.</description>
          <population>Full analysis set population included all randomized participants who received at least 1 dose of investigational product and participants were assigned to the randomized treatment regardless of what treatment was received. Here 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure.</population>
          <units>percent change</units>
          <param>Least Squares Mean</param>
          <dispersion>90% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
                <count group_id="O2" value="22"/>
                <count group_id="O3" value="24"/>
                <count group_id="O4" value="26"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.14" lower_limit="-8.56" upper_limit="27.89"/>
                    <measurement group_id="O2" value="-40.01" lower_limit="-47.00" upper_limit="-32.09"/>
                    <measurement group_id="O3" value="-30.14" lower_limit="-37.97" upper_limit="-21.33"/>
                    <measurement group_id="O4" value="-40.13" lower_limit="-46.58" upper_limit="-32.90"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Natural log-transformed of individual relative change from baseline to Day 42 was analyzed using the ANCOVA model with treatment as a fixed effect, natural log-transformed baseline whole liver fat by MRI-PDFF as covariate. Values were back-transformed from the log scale. 90% CI was calculated on difference in least square (LS) mean between groups</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0000</p_value>
            <method>ANCOVA</method>
            <param_type>Difference in LS mean</param_type>
            <param_value>-44.52</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-54.97</ci_lower_limit>
            <ci_upper_limit>-31.65</ci_upper_limit>
            <estimate_desc>LS mean difference was not a simple subtraction between LS means of groups but through statistical model.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Natural log-transformed of individual relative change from baseline to Day 42 was analyzed using the ANCOVA model with treatment as a fixed effect, natural log-transformed baseline whole liver fat by MRI-PDFF as covariate. Values were back-transformed from the log scale. 90% CI was calculated on difference LS mean between groups.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0007</p_value>
            <method>ANCOVA</method>
            <param_type>Difference in LS Mean</param_type>
            <param_value>-35.40</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-47.40</ci_lower_limit>
            <ci_upper_limit>-20.68</ci_upper_limit>
            <estimate_desc>LS mean difference was not a simple subtraction between LS means of groups but through statistical model.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Natural log-transformed of individual relative change from baseline to Day 42 was analyzed using the ANCOVA model with treatment as a fixed effect, natural log-transformed baseline whole liver fat by MRI-PDFF as covariate. Values were back-transformed from the log scale. 90% CI was calculated on difference in LS mean between groups.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0000</p_value>
            <method>ANCOVA</method>
            <param_type>Difference in LS Mean</param_type>
            <param_value>-44.64</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-54.80</ci_lower_limit>
            <ci_upper_limit>-32.19</ci_upper_limit>
            <estimate_desc>LS mean difference was not a simple subtraction between LS means of groups but through statistical model.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Natural log-transformed of individual relative change from baseline to Day 42 was analyzed using the ANCOVA model with treatment as a fixed effect, natural log-transformed baseline whole liver fat by MRI-PDFF as covariate. Values were back-transformed from the log scale. 90% CI was calculated on difference in LS mean between groups.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.9836</p_value>
            <method>ANCOVA</method>
            <param_type>Difference in LS Mean</param_type>
            <param_value>-0.21</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-15.66</ci_lower_limit>
            <ci_upper_limit>18.08</ci_upper_limit>
            <estimate_desc>LS mean difference was not a simple subtraction between LS means of groups but through statistical model.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Natural log-transformed of individual relative change from baseline to Day 42 was analyzed using the ANCOVA model with treatment as a fixed effect, natural log-transformed baseline whole liver fat by MRI-PDFF as covariate. Values were back-transformed from the log scale. 90% CI was calculated on difference in LS mean between groups.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.1233</p_value>
            <method>ANCOVA</method>
            <param_type>Difference in LS Mean</param_type>
            <param_value>-14.30</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-27.32</ci_lower_limit>
            <ci_upper_limit>1.06</ci_upper_limit>
            <estimate_desc>LS mean difference was not a simple subtraction between LS means of groups but through statistical model.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Natural log-transformed of individual relative change from baseline to Day 42 was analyzed using the ANCOVA model with treatment as a fixed effect, natural log-transformed baseline whole liver fat by MRI-PDFF as covariate. Values were back-transformed from the log scale. 50% CI was calculated on difference in LS mean between groups.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <param_type>Difference in LS Mean</param_type>
            <param_value>-0.21</param_value>
            <ci_percent>50</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-6.82</ci_lower_limit>
            <ci_upper_limit>6.87</ci_upper_limit>
            <estimate_desc>LS mean difference was not a simple subtraction between LS means of groups but through statistical model.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Natural log-transformed of individual relative change from baseline to Day 42 was analyzed using the ANCOVA model with treatment as a fixed effect, natural log-transformed baseline whole liver fat by MRI-PDFF as covariate. Values were back-transformed from the log scale. 50% CI was calculated on difference in LS mean between groups.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <param_type>Difference in LS Mean</param_type>
            <param_value>-14.30</param_value>
            <ci_percent>50</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-19.86</ci_lower_limit>
            <ci_upper_limit>-8.35</ci_upper_limit>
            <estimate_desc>LS mean difference was not a simple subtraction between LS means of groups but through statistical model.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)</title>
        <description>An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly; medically important events. A treatment emergent AE was defined as an event that emerged during the treatment period that was absent before treatment, or worsened during the treatment period relative to the pretreatment state. AEs included all serious and non-serious adverse events.</description>
        <time_frame>Baseline up to 35 days from last dose of study drug or early termination: (maximum up to Day 77)</time_frame>
        <population>Safety analysis population included all participants who received at least 1 dose of investigational product post-randomization.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants were randomized to receive placebo (3 tablets) matched to PF-05221304 and placebo (3 tablets) matched to PF-06865571 orally, twice daily for 41 days and once on Day 42. Participants were followed up to maximum of 35 days after last dose of study drug.</description>
          </group>
          <group group_id="O2">
            <title>PF-05221304 15mg + Placebo</title>
            <description>Participants were randomized to receive PF-05221304 15 mg tablets (3 tablets, each of 5 mg) and placebo (3 tablets) matched to PF-06865571, orally, twice daily for 41 days and once on Day 42. Participants were followed up to maximum of 35 days after last dose of study drug.</description>
          </group>
          <group group_id="O3">
            <title>PF-06865571 300 mg + Placebo</title>
            <description>Participants were randomized to receive PF-06865571 300 mg (3 tablets, each of 100 mg) and placebo (3 tablets) matched to PF-05221304 orally, twice daily for 41 days and once on Day 42. Participants were followed up to maximum of 35 days after last dose of study drug.</description>
          </group>
          <group group_id="O4">
            <title>PF-05221304 15 mg + PF-06865571 300 mg</title>
            <description>Participants were randomized to receive PF-05221304 15 mg (3 tablets, each of 5 mg) and PF-06865571 300 mg (3 tablets, each of 100 mg) orally, twice daily for 41 days and once on Day 42. Participants were followed up to maximum of 35 days after last dose of study drug.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)</title>
          <description>An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly; medically important events. A treatment emergent AE was defined as an event that emerged during the treatment period that was absent before treatment, or worsened during the treatment period relative to the pretreatment state. AEs included all serious and non-serious adverse events.</description>
          <population>Safety analysis population included all participants who received at least 1 dose of investigational product post-randomization.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="14"/>
                <count group_id="O2" value="29"/>
                <count group_id="O3" value="28"/>
                <count group_id="O4" value="28"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Participants With AEs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="10"/>
                    <measurement group_id="O3" value="10"/>
                    <measurement group_id="O4" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Participants With SAEs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Laboratory Abnormalities</title>
        <description>Clinical chemistry: Bilirubin (milligram per deciliter [mg/dL]), direct bilirubin (mg/dL)&gt;3.0*upper limit of normal (ULN), alanine aminotransferase international units per liter (U/L), aspartate aminotransferase (U/L), alkaline phosphatase (U/L), gamma glutamyl transferase (U/L)&gt;5.0*ULN, urea nitrogen (mg/dL)&gt;2.0*ULN, low density lipoprotein direct endpoint measure (mg/dL)&gt;1.5*ULN, triglycerides (mg/dL)&gt;2.0*ULN, creatinine based estimated glomerular filtration rate by modification of diet in renal disease equation and cystatin based eGFR by chronic kidney disease epidemiology collaboration equation (C &lt;60 milliliter per minute per 1.73 square of meter), very low density lipoprotein (millimoles per liter), Cholesterol &gt;2.0*ULN.</description>
        <time_frame>Baseline up to 35 days last from dose of study drug or early termination (maximum up to Day 77)</time_frame>
        <population>Safety analysis population included all participants who received at least 1 dose of investigational product. Here 'Overall Number of Participants Analyzed' signifies participants evaluable for laboratory abnormalities.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants were randomized to receive placebo (3 tablets) matched to PF-05221304 and placebo (3 tablets) matched to PF-06865571 orally, twice daily for 41 days and once on Day 42. Participants were followed up to maximum of 35 days after last dose of study drug.</description>
          </group>
          <group group_id="O2">
            <title>PF-05221304 15mg + Placebo</title>
            <description>Participants were randomized to receive PF-05221304 15 mg tablets (3 tablets, each of 5 mg) and placebo (3 tablets) matched to PF-06865571, orally, twice daily for 41 days and once on Day 42. Participants were followed up to maximum of 35 days after last dose of study drug.</description>
          </group>
          <group group_id="O3">
            <title>PF-06865571 300 mg + Placebo</title>
            <description>Participants were randomized to receive PF-06865571 300 mg (3 tablets, each of 100 mg) and placebo (3 tablets) matched to PF-05221304 orally, twice daily for 41 days and once on Day 42. Participants were followed up to maximum of 35 days after last dose of study drug.</description>
          </group>
          <group group_id="O4">
            <title>PF-05221304 15 mg + PF-06865571 300 mg</title>
            <description>Participants were randomized to receive PF-05221304 15 mg (3 tablets, each of 5 mg) and PF-06865571 300 mg (3 tablets, each of 100 mg) orally, twice daily for 41 days and once on Day 42. Participants were followed up to maximum of 35 days after last dose of study drug.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Laboratory Abnormalities</title>
          <description>Clinical chemistry: Bilirubin (milligram per deciliter [mg/dL]), direct bilirubin (mg/dL)&gt;3.0*upper limit of normal (ULN), alanine aminotransferase international units per liter (U/L), aspartate aminotransferase (U/L), alkaline phosphatase (U/L), gamma glutamyl transferase (U/L)&gt;5.0*ULN, urea nitrogen (mg/dL)&gt;2.0*ULN, low density lipoprotein direct endpoint measure (mg/dL)&gt;1.5*ULN, triglycerides (mg/dL)&gt;2.0*ULN, creatinine based estimated glomerular filtration rate by modification of diet in renal disease equation and cystatin based eGFR by chronic kidney disease epidemiology collaboration equation (C &lt;60 milliliter per minute per 1.73 square of meter), very low density lipoprotein (millimoles per liter), Cholesterol &gt;2.0*ULN.</description>
          <population>Safety analysis population included all participants who received at least 1 dose of investigational product. Here 'Overall Number of Participants Analyzed' signifies participants evaluable for laboratory abnormalities.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="14"/>
                <count group_id="O2" value="29"/>
                <count group_id="O3" value="27"/>
                <count group_id="O4" value="26"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="17"/>
                    <measurement group_id="O3" value="11"/>
                    <measurement group_id="O4" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Maximum Change (Increase or Decrease) From Baseline to Post-last Dose of Study Drug in Vital Signs: Blood Pressure</title>
        <description>Vital signs included systolic blood pressure, diastolic blood pressure and pulse rate.</description>
        <time_frame>Baseline, Post-last dose of study drug (up to Day 42)</time_frame>
        <population>Safety analysis population included all participants who received at least 1 dose of investigational product post-randomization. Here 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants were randomized to receive placebo (3 tablets) matched to PF-05221304 and placebo (3 tablets) matched to PF-06865571 orally, twice daily for 41 days and once on Day 42. Participants were followed up to maximum of 35 days after last dose of study drug.</description>
          </group>
          <group group_id="O2">
            <title>PF-05221304 15mg + Placebo</title>
            <description>Participants were randomized to receive PF-05221304 15 mg tablets (3 tablets, each of 5 mg) and placebo (3 tablets) matched to PF-06865571, orally, twice daily for 41 days and once on Day 42. Participants were followed up to maximum of 35 days after last dose of study drug.</description>
          </group>
          <group group_id="O3">
            <title>PF-06865571 300 mg + Placebo</title>
            <description>Participants were randomized to receive PF-06865571 300 mg (3 tablets, each of 100 mg) and placebo (3 tablets) matched to PF-05221304 orally, twice daily for 41 days and once on Day 42. Participants were followed up to maximum of 35 days after last dose of study drug.</description>
          </group>
          <group group_id="O4">
            <title>PF-05221304 15 mg + PF-06865571 300 mg</title>
            <description>Participants were randomized to receive PF-05221304 15 mg (3 tablets, each of 5 mg) and PF-06865571 300 mg (3 tablets, each of 100 mg) orally, twice daily for 41 days and once on Day 42. Participants were followed up to maximum of 35 days after last dose of study drug.</description>
          </group>
        </group_list>
        <measure>
          <title>Maximum Change (Increase or Decrease) From Baseline to Post-last Dose of Study Drug in Vital Signs: Blood Pressure</title>
          <description>Vital signs included systolic blood pressure, diastolic blood pressure and pulse rate.</description>
          <population>Safety analysis population included all participants who received at least 1 dose of investigational product post-randomization. Here 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure.</population>
          <units>millimeter of mercury</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="14"/>
                <count group_id="O2" value="29"/>
                <count group_id="O3" value="28"/>
                <count group_id="O4" value="26"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Maximum increase: Systolic blood pressure</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.8" spread="6.59"/>
                    <measurement group_id="O2" value="7.0" spread="7.77"/>
                    <measurement group_id="O3" value="9.6" spread="11.38"/>
                    <measurement group_id="O4" value="7.5" spread="12.58"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Maximum increase: Diastolic blood pressure</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.1" spread="6.86"/>
                    <measurement group_id="O2" value="3.9" spread="7.15"/>
                    <measurement group_id="O3" value="5.0" spread="7.20"/>
                    <measurement group_id="O4" value="4.3" spread="8.11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Maximum decrease: Systolic blood pressure</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-9.7" spread="11.12"/>
                    <measurement group_id="O2" value="-8.9" spread="7.69"/>
                    <measurement group_id="O3" value="-9.2" spread="10.69"/>
                    <measurement group_id="O4" value="-12.0" spread="12.54"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Maximum decrease: Diastolic blood pressure</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-6.2" spread="7.56"/>
                    <measurement group_id="O2" value="-7.7" spread="7.58"/>
                    <measurement group_id="O3" value="-7.3" spread="6.69"/>
                    <measurement group_id="O4" value="-7.2" spread="8.09"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Maximum Change (Increase or Decrease) From Baseline to Post-last Dose of Study Drug in Vital Signs: Pulse Rate</title>
        <description>Vital signs included systolic blood pressure, diastolic blood pressure and pulse rate.</description>
        <time_frame>Baseline, Post- last dose of study drug (up to Day 42)</time_frame>
        <population>Safety analysis population included all participants who received at least 1 dose of investigational product post-randomization. Here 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants were randomized to receive placebo (3 tablets) matched to PF-05221304 and placebo (3 tablets) matched to PF-06865571 orally, twice daily for 41 days and once on Day 42. Participants were followed up to maximum of 35 days after last dose of study drug.</description>
          </group>
          <group group_id="O2">
            <title>PF-05221304 15mg + Placebo</title>
            <description>Participants were randomized to receive PF-05221304 15 mg tablets (3 tablets, each of 5 mg) and placebo (3 tablets) matched to PF-06865571, orally, twice daily for 41 days and once on Day 42. Participants were followed up to maximum of 35 days after last dose of study drug.</description>
          </group>
          <group group_id="O3">
            <title>PF-06865571 300 mg + Placebo</title>
            <description>Participants were randomized to receive PF-06865571 300 mg (3 tablets, each of 100 mg) and placebo (3 tablets) matched to PF-05221304 orally, twice daily for 41 days and once on Day 42. Participants were followed up to maximum of 35 days after last dose of study drug.</description>
          </group>
          <group group_id="O4">
            <title>PF-05221304 15 mg + PF-06865571 300 mg</title>
            <description>Participants were randomized to receive PF-05221304 15 mg (3 tablets, each of 5 mg) and PF-06865571 300 mg (3 tablets, each of 100 mg) orally, twice daily for 41 days and once on Day 42. Participants were followed up to maximum of 35 days after last dose of study drug.</description>
          </group>
        </group_list>
        <measure>
          <title>Maximum Change (Increase or Decrease) From Baseline to Post-last Dose of Study Drug in Vital Signs: Pulse Rate</title>
          <description>Vital signs included systolic blood pressure, diastolic blood pressure and pulse rate.</description>
          <population>Safety analysis population included all participants who received at least 1 dose of investigational product post-randomization. Here 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure.</population>
          <units>beats per minute</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="14"/>
                <count group_id="O2" value="29"/>
                <count group_id="O3" value="28"/>
                <count group_id="O4" value="26"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Maximum increase: Pulse rate</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.5" spread="8.56"/>
                    <measurement group_id="O2" value="8.1" spread="9.35"/>
                    <measurement group_id="O3" value="6.8" spread="9.13"/>
                    <measurement group_id="O4" value="6.9" spread="8.69"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Maximum decrease: Pulse rate</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-3.4" spread="7.62"/>
                    <measurement group_id="O2" value="-2.9" spread="7.25"/>
                    <measurement group_id="O3" value="-7.5" spread="7.47"/>
                    <measurement group_id="O4" value="-5.8" spread="7.91"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Meeting Pre-Specified Electrocardiogram (ECG) Criteria</title>
        <description>ECG criteria included: 1) PR interval (milliseconds [msec]): baseline greater than (&gt;) 200 msec and maximum increase from baseline greater than or equal to (&gt;=) 25 percent (%) or baseline less than or equal to (&lt;=) 200 msec and maximum increase from baseline &gt;=50%; 2) QRS interval (msec): maximum increase from baseline &gt;=50%; 3) QT interval corrected using Fridericia's formula (QTcF): a) change from baseline &gt;30 msec and &lt;=60 msec, b) change from baseline &gt;60 msec.</description>
        <time_frame>Baseline up to 35 days last dose of study drug or early termination (maximum up to Day 77)</time_frame>
        <population>Safety analysis population included all participants who received at least 1 dose of investigational product post-randomization. Here 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure and &quot;Number Analyzed&quot; signifies number of participants evaluable for specified rows.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants were randomized to receive placebo (3 tablets) matched to PF-05221304 and placebo (3 tablets) matched to PF-06865571 orally, twice daily for 41 days and once on Day 42. Participants were followed up to maximum of 35 days after last dose of study drug.</description>
          </group>
          <group group_id="O2">
            <title>PF-05221304 15mg + Placebo</title>
            <description>Participants were randomized to receive PF-05221304 15 mg tablets (3 tablets, each of 5 mg) and placebo (3 tablets) matched to PF-06865571, orally, twice daily for 41 days and once on Day 42. Participants were followed up to maximum of 35 days after last dose of study drug.</description>
          </group>
          <group group_id="O3">
            <title>PF-06865571 300 mg + Placebo</title>
            <description>Participants were randomized to receive PF-06865571 300 mg (3 tablets, each of 100 mg) and placebo (3 tablets) matched to PF-05221304 orally, twice daily for 41 days and once on Day 42. Participants were followed up to maximum of 35 days after last dose of study drug.</description>
          </group>
          <group group_id="O4">
            <title>PF-05221304 15 mg + PF-06865571 300 mg</title>
            <description>Participants were randomized to receive PF-05221304 15 mg (3 tablets, each of 5 mg) and PF-06865571 300 mg (3 tablets, each of 100 mg) orally, twice daily for 41 days and once on Day 42. Participants were followed up to maximum of 35 days after last dose of study drug.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Meeting Pre-Specified Electrocardiogram (ECG) Criteria</title>
          <description>ECG criteria included: 1) PR interval (milliseconds [msec]): baseline greater than (&gt;) 200 msec and maximum increase from baseline greater than or equal to (&gt;=) 25 percent (%) or baseline less than or equal to (&lt;=) 200 msec and maximum increase from baseline &gt;=50%; 2) QRS interval (msec): maximum increase from baseline &gt;=50%; 3) QT interval corrected using Fridericia's formula (QTcF): a) change from baseline &gt;30 msec and &lt;=60 msec, b) change from baseline &gt;60 msec.</description>
          <population>Safety analysis population included all participants who received at least 1 dose of investigational product post-randomization. Here 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure and &quot;Number Analyzed&quot; signifies number of participants evaluable for specified rows.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="14"/>
                <count group_id="O2" value="29"/>
                <count group_id="O3" value="28"/>
                <count group_id="O4" value="26"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>PR interval: %Change &gt;=25/50%</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="14"/>
                    <count group_id="O2" value="28"/>
                    <count group_id="O3" value="28"/>
                    <count group_id="O4" value="26"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>QRS interval: %Change &gt;=50%</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="14"/>
                    <count group_id="O2" value="29"/>
                    <count group_id="O3" value="28"/>
                    <count group_id="O4" value="26"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>QTcF: Change &gt;30 msec and &lt;=60 msec</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="14"/>
                    <count group_id="O2" value="29"/>
                    <count group_id="O3" value="28"/>
                    <count group_id="O4" value="26"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>QTcF: Change &gt;60 msec</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="14"/>
                    <count group_id="O2" value="29"/>
                    <count group_id="O3" value="28"/>
                    <count group_id="O4" value="26"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Baseline up to 35 days from last dose of study drug or early termination (maximum up to Day 77 days)</time_frame>
      <desc>Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population included all participants who received at least 1 dose of investigational product post-randomization.</desc>
      <group_list>
        <group group_id="E1">
          <title>Placebo</title>
          <description>Participants were randomized to receive placebo (3 tablets) matched to PF-05221304 and placebo (3 tablets) matched to PF-06865571 orally, twice daily for 41 days and once on Day 42. Participants were followed up to maximum of 35 days after last dose of study drug.</description>
        </group>
        <group group_id="E2">
          <title>PF-05221304 15mg + Placebo</title>
          <description>Participants were randomized to receive PF-05221304 15 mg tablets (3 tablets, each of 5 mg) and placebo (3 tablets) matched to PF-06865571, orally, twice daily for 41 days and once on Day 42. Participants were followed up to maximum of 35 days after last dose of study drug.</description>
        </group>
        <group group_id="E3">
          <title>PF-06865571 300 mg + Placebo</title>
          <description>Participants were randomized to receive PF-06865571 300 mg (3 tablets, each of 100 mg) and placebo (3 tablets) matched to PF-05221304 orally, twice daily for 41 days and once on Day 42. Participants were followed up to maximum of 35 days after last dose of study drug.</description>
        </group>
        <group group_id="E4">
          <title>PF-05221304 |15mg Q12H + |PF-06865571 |300mg Q12H</title>
          <description>Participants were randomized to receive PF-05221304 15 mg tablets and PF-06865571 300 mg tablets, orally, twice daily for 42 days. Participants were followed up to maximum of 35 days after last dose of study drug.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA v22.1</default_vocab>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="28"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Abscess jaw</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="28"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA v22.1</default_vocab>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="29"/>
                <counts group_id="E3" subjects_affected="6" subjects_at_risk="28"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="28"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="28"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="29"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="28"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="29"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="28"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="28"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="28"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Folliculitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="29"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="28"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Blood thyroid stimulating hormone increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="28"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Hypertriglyceridaemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Type 2 diabetes mellitus</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="29"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="28"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="29"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="28"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="28"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Rash</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="28"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="28"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Pfizer ClinicalTrials.gov Call Center</name_or_title>
      <organization>Pfizer Inc.</organization>
      <phone>1-800-718-1021</phone>
      <email>ClinicalTrials.gov_Inquiries@pfizer.com</email>
    </point_of_contact>
  </clinical_results>
</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/NCT03776175
org study id: C3711001
nct id: NCT03776175
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
This study is to assess the effect of PF 05221304 alone, PF 06865571 alone, the co
      administration of PF 05221304 and PF 06865571, or placebo on whole liver fat in subjects with
      NAFLD. In addition, this study will evaluate the safety and tolerability of co administration
      of PF 05221304 and PF 06865571 along with the effects on selected pharmacodynamics
      (PD)/exploratory parameters, compared to administration of PF 05221304 alone, PF 06865571
      alone, and placebo in adults with NAFLD.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Investigator)
measure: Percent Change From Baseline in Whole Liver Proton Density Fat Fraction (PDFF) at Day 42
time frame: Baseline, Day 42
description: Magnetic resonance imaging proton density fat fraction (MRI-PDFF) technique is an established method that enables quantification of fat content in the liver. It measures the fraction of mobile protons in the liver attributable to fat content and provides whole liver coverage so that fat content can be assessed across 8 Couinaud liver segments. Whole liver PDFF = PDFFs for (Segment I + Segment II + Segment III + Segment IVa + Segment IVb + Segment V + Segment VI + Segment VII + Segment VIII) divided by total number of segments assessed.
measure: Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
time frame: Baseline up to 35 days from last dose of study drug or early termination: (maximum up to Day 77)
description: An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly; medically important events. A treatment emergent AE was defined as an event that emerged during the treatment period that was absent before treatment, or worsened during the treatment period relative to the pretreatment state. AEs included all serious and non-serious adverse events.
measure: Number of Participants With Laboratory Abnormalities
time frame: Baseline up to 35 days last from dose of study drug or early termination (maximum up to Day 77)
description: Clinical chemistry: Bilirubin (milligram per deciliter [mg/dL]), direct bilirubin (mg/dL)>3.0*upper limit of normal (ULN), alanine aminotransferase international units per liter (U/L), aspartate aminotransferase (U/L), alkaline phosphatase (U/L), gamma glutamyl transferase (U/L)>5.0*ULN, urea nitrogen (mg/dL)>2.0*ULN, low density lipoprotein direct endpoint measure (mg/dL)>1.5*ULN, triglycerides (mg/dL)>2.0*ULN, creatinine based estimated glomerular filtration rate by modification of diet in renal disease equation and cystatin based eGFR by chronic kidney disease epidemiology collaboration equation (C <60 milliliter per minute per 1.73 square of meter), very low density lipoprotein (millimoles per liter), Cholesterol >2.0*ULN.
measure: Maximum Change (Increase or Decrease) From Baseline to Post-last Dose of Study Drug in Vital Signs: Blood Pressure
time frame: Baseline, Post-last dose of study drug (up to Day 42)
description: Vital signs included systolic blood pressure, diastolic blood pressure and pulse rate.
measure: Maximum Change (Increase or Decrease) From Baseline to Post-last Dose of Study Drug in Vital Signs: Pulse Rate
time frame: Baseline, Post- last dose of study drug (up to Day 42)
description: Vital signs included systolic blood pressure, diastolic blood pressure and pulse rate.
measure: Number of Participants Meeting Pre-Specified Electrocardiogram (ECG) Criteria
time frame: Baseline up to 35 days last dose of study drug or early termination (maximum up to Day 77)
description: ECG criteria included: 1) PR interval (milliseconds [msec]): baseline greater than (>) 200 msec and maximum increase from baseline greater than or equal to (>=) 25 percent (%) or baseline less than or equal to (<=) 200 msec and maximum increase from baseline >=50%; 2) QRS interval (msec): maximum increase from baseline >=50%; 3) QT interval corrected using Fridericia's formula (QTcF): a) change from baseline >30 msec and <=60 msec, b) change from baseline >60 msec.
arm group label: Placebo
arm group type: Placebo Comparator
description: Placebo (PF 05221304) BID Placebo (PF 06865571) BID
arm group label: PF-05221304 Monotherapy
arm group type: Experimental
description: 15 mg PF-05221304 BID Placebo (PF-06865571) BID
arm group label: PF-06865571 Monotherapy
arm group type: Experimental
description: Placebo (PF-05221304) BID 300 mg PF-06865571 BID
arm group label: PF-05221304 and PF-06865571 Combination
arm group type: Experimental
description: 15 mg PF-05221304 BID 300 mg PF-06865571 BID
intervention type: Drug
intervention name: PF-05221304 Monotherapy
description: Participants enrolled in this Arm will receive 15 mg dose of PF-05221304 (3 tablets of 5 mg each) and 3 tablets of Placebo for PF-06865571, each to be taken twice daily for 41 days and once on Day 42.
arm group label: PF-05221304 Monotherapy
arm group label: PF-05221304 and PF-06865571 Combination
other name: Arm B
intervention type: Drug
intervention name: PF-06865571 Monotherapy
description: Participants enrolled in this Arm will receive 300 mg dose of PF-06865571 (3 tablets of 100 mg each) and 3 tablets of Placebo for PF-05221304, all to be taken twice daily for 41 days and once on Day 42.
arm group label: PF-05221304 and PF-06865571 Combination
arm group label: PF-06865571 Monotherapy
other name: Arm C
intervention type: Drug
intervention name: Placebo
description: Participants enrolled in this Arm will receive 3 tablets for Placebo of PF-05221304 and 3 tablets of Placebo of PF-06865571, to be taken twice daily for 41 days and once on Day 42.
arm group label: PF-05221304 Monotherapy
arm group label: PF-06865571 Monotherapy
arm group label: Placebo
other name: Arm A
intervention type: Drug
intervention name: PF-05221304 and PF-06865571 Combination
description: Participants enrolled in this Arm will receive 15 mg dose of PF-05221304 (3 tablets of 5 mg each) and 3 tablets of PF-06865571 (3 tablets of 100 mg each), each to be taken twice daily for 41 days and once on Day 42.
arm group label: PF-05221304 and PF-06865571 Combination
other name: Arm D
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: Pfizer CT.gov Call Center
role: Study Director
affiliation: Pfizer
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: United States
url: https://pmiform.com/clinical-trial-info-request?StudyID=C3711001
description: To obtain contact information for a study center near you, click here.
responsible party type: Sponsor
mesh term: Liver Diseases
mesh term: Fatty Liver
mesh term: Non-alcoholic Fatty Liver Disease
sharing ipd: Yes
ipd description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
ipd url: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 