<clinical_study>
  <!-- This xml conforms to an XML Schema at:
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  <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/NCT03248882</url>
  </required_header>
  <id_info>
    <org_study_id>C1171002</org_study_id>
    <secondary_id>2017-001156-55</secondary_id>
    <nct_id>NCT03248882</nct_id>
  </id_info>
  <brief_title>Phase 2a, Dose-ranging Study With PF-05221304 in Nonalcoholic Fatty Liver Disease (NAFLD)</brief_title>
  <official_title>A PHASE 2A, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, DOSE-RANGING, PARALLEL GROUP STUDY TO EVALUATE SAFETY, TOLERABILITY, AND PHARMACODYNAMICS OF PF-05221304 ADMINISTERED DAILY FOR 16-WEEKS TO ADULT SUBJECTS WITH NONALCOHOLIC FATTY LIVER DISEASE</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>
      Phase 2a, dose-ranging Study with PF-05221304 in Nonalcoholic Fatty Liver Disease (NAFLD)&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A Phase 2a, Randomized, Double-blind, Placebo-controlled, Dose-ranging, Parallel Group Study&#xD;
      To Evaluate Safety, Tolerability, And Pharmacodynamics Of PF-05221304 Administered Daily For&#xD;
      16-weeks To Adult Subjects With Nonalcoholic Fatty Liver Disease&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 22, 2017</start_date>
  <completion_date type="Actual">March 27, 2019</completion_date>
  <primary_completion_date type="Actual">February 26, 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>
    <intervention_model_description>C1171002 is a randomized, double blind, placebo controlled, 5 arm (placebo, plus 4 active doses of PF 05221304), parallel group study.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
    <masking_description>Double-Blind</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Percent Change From Baseline in Liver Fat by Magnetic Resonance Imaging-Proton Density Fat Fraction (MRI- PDFF) at Week 16</measure>
    <time_frame>Baseline (between Day -14 and Day 1), Week 16</time_frame>
    <description>MRI-PDFF utilized a gradient echo sequence with low flip angle (FA) to minimize T1 bias, corrected T2* decay (due to iron overload) via modeling of the fat signal as a superposition of multiple frequency components from 5 different lipid types, and was applied in each of the 9 Couinaud segments. This technique improved fat quantification accuracy for the entire liver permitting quantification of small differences/changes following pharmacological intervention.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percent Change From Baseline in Alanine Aminotransferase at Week 16</measure>
    <time_frame>Baseline (Day 1 pre-dose), Week 16</time_frame>
    <description>Potential improvement in liver function was denoted by reduction in alanine transaminase (ALT)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Treatment-Emergent Adverse Events</measure>
    <time_frame>From first dose of study treatment (Day 1) up to Week 20</time_frame>
    <description>An AE was any untoward medical occurrence in a study subject administered a product or medical device. A serious AE (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; life-threatening; initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect. Any such events with initial onset or increasing in severity after the first dose of study treatment were counted as treatment-emergent.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Laboratory Abnormalities</measure>
    <time_frame>From first dose of study treatment (Day 1) up to Week 20</time_frame>
    <description>Following laboratory parameters were assessed against pre-defined abnormality criteria: hematology (hemoglobin, hematocrit, erythrocytes, reticulocytes, platelets, leukocytes, lymphocytes, neutrophils, basophils, eosinophils, monocytes, activated partial thromboplastin time, prothrombin time [PT], PT/international normalized ratio, reticulocytes); chemistry (indirect bilirubin, direct bilirubin, protein, albumin, blood urea nitrogen, creatinine, creatine kinase, urate, calcium, sodium, potassium, chloride, bicarbonate, urine urobilinogen); urinalysis (pH, urine glucose, urine ketones, urine protein, urine hemoglobin, nitrites, leukocyte esterase, urine erythrocytes, urine leukocytes, urine hyaline casts, urine bilirubin, granular casts).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Vital Signs Data Meeting Predefined Criteria</measure>
    <time_frame>From first dose of study treatment (Day 1) up to Week 18</time_frame>
    <description>Vital signs categorical summarization criteria: 1) sitting systolic blood pressure (SBP) &lt;90 or &gt;180 millimeters of mercury (mmHg); 2) sitting diastolic blood pressure (DBP) &lt;50 mmHg or &gt;110 mmHg; 3) sitting pulse rate &lt;40 or &gt;120 beats per minute (bpm); 4) change from baseline (increase or decrease) in sitting DBP greater than or equal to (&gt;=) 20 mmHg; 5) change from baseline (increase or decrease) in sitting SBP &gt;=30 mmHg.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With 12-Lead Electrocardiogram (ECG) Data Meeting Predefined Criteria</measure>
    <time_frame>From first dose of study treatment (Day 1) up to Week 18</time_frame>
    <description>ECG categorical summarization criteria: 1) QRS interval (time from ECG Q wave to the end of the S wave corresponding to ventricle depolarization) &gt;=140 milliseconds (msec); 2) QRS interval &gt;=50% change from baseline; 3) PR interval (the interval between the start of the P wave and the start of the QRS complex, corresponding to the time between the onset of the atrial depolarization and onset of ventricular depolarization) &gt;=300 msec; 4) PR interval &gt;=25% change when baseline is &gt;200 msec or &gt;=50% change when baseline is &lt;=200 msec; 5) QT interval (time from ECG Q wave to the end of the T wave corresponding to electrical systole): absolute value of &gt;=500 msec; 6) QTcF interval (QT corrected for heart rate using Fridericia's formula) absolute value of 450 to &lt;480 msec; 7) QTcF interval: absolute value of 480 to &lt;500 msec; 8) QTcF interval: absolute value &gt;=500 msec; 9) QTcF interval: a change from baseline of 30 to &lt;60 msec; 10) QTcF interval: a change from baseline &gt;=60 msec.</description>
  </secondary_outcome>
  <number_of_arms>5</number_of_arms>
  <enrollment type="Actual">305</enrollment>
  <condition>Nonalcoholic Fatty Liver Disease</condition>
  <condition>Nonalcoholic Steatohepatitis</condition>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Double-Blind, PF-05221304-matching Placebo</description>
  </arm_group>
  <arm_group>
    <arm_group_label>PF-05221304 - 2 mg</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>PF-05221304 - 2 mg, once-daily</description>
  </arm_group>
  <arm_group>
    <arm_group_label>PF-05221304 - 10 mg</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>PF-05221304 - 10 mg, once-daily</description>
  </arm_group>
  <arm_group>
    <arm_group_label>PF-05221304 - 25 mg</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>PF-05221304 - 25 mg, once-daily</description>
  </arm_group>
  <arm_group>
    <arm_group_label>PF-05221304 - 50 mg</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>PF-05221304 - 50 mg, once-daily</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Placebo</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>PF-05221304</intervention_name>
    <description>PF-05221304, Experimental Drug</description>
    <arm_group_label>PF-05221304 - 10 mg</arm_group_label>
    <arm_group_label>PF-05221304 - 2 mg</arm_group_label>
    <arm_group_label>PF-05221304 - 25 mg</arm_group_label>
    <arm_group_label>PF-05221304 - 50 mg</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Body Mass Index &gt;= 25 kg/m2&#xD;
&#xD;
          -  Body Weight &gt; 50 kg&#xD;
&#xD;
          -  Liver fat (assessed via MRI-PDFF) &gt;= 8%&#xD;
&#xD;
          -  Biopsy-proven NASH - diagnosed in previous 24-months&#xD;
&#xD;
          -  Presumed NASH - per Sponsor's definition&#xD;
&#xD;
          -  NAFLD with minimal inflammation/fibrosis&#xD;
&#xD;
          -  Features of Metabolic Syndrome&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Alcohol-induced steatohepatitis or other forms of chronic liver disease&#xD;
&#xD;
          -  Positive for Hepatitis B, Hepatitis C, or Human Deficiency Virus&#xD;
&#xD;
          -  Severe Renal Impairment&#xD;
&#xD;
          -  Contraindications for MRI&#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>eStudySite</name>
      <address>
        <city>Chula Vista</city>
        <state>California</state>
        <zip>91911</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>San Diego Imaging Chula Vista</name>
      <address>
        <city>Chula Vista</city>
        <state>California</state>
        <zip>91911</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of California, San Diego (Altman Clinical and Translational Research Institute)</name>
      <address>
        <city>La Jolla</city>
        <state>California</state>
        <zip>92037</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of California, San Diego</name>
      <address>
        <city>La Jolla</city>
        <state>California</state>
        <zip>92037</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>eStudySite</name>
      <address>
        <city>La Mesa</city>
        <state>California</state>
        <zip>91942</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Trials Research</name>
      <address>
        <city>Lincoln</city>
        <state>California</state>
        <zip>95648</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Research Institute</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90057</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Stanford University Medical Center, Blake wilbur Building</name>
      <address>
        <city>Palo Alto</city>
        <state>California</state>
        <zip>04304</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Stanford University Medical Center</name>
      <address>
        <city>Palo Alto</city>
        <state>California</state>
        <zip>94304</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Huntington Medical Research Institute</name>
      <address>
        <city>Pasadena</city>
        <state>California</state>
        <zip>91105</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Inland Empire Liver Foundation</name>
      <address>
        <city>Rialto</city>
        <state>California</state>
        <zip>92377</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Precision Research Institute</name>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <zip>92114</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Quest Clinical Research</name>
      <address>
        <city>San Francisco</city>
        <state>California</state>
        <zip>94115</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>South Denver Gastroenterology, P.C.</name>
      <address>
        <city>Englewood</city>
        <state>Colorado</state>
        <zip>80113</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>Borland-Groover Clinic</name>
      <address>
        <city>Jacksonville</city>
        <state>Florida</state>
        <zip>32256</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ocean Blue Medical Research Center, Inc</name>
      <address>
        <city>Miami Springs</city>
        <state>Florida</state>
        <zip>33166</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Schiff Center for Liver Diseases/University of Miami</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33136</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Stand Up MRI of Miami</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33145</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Avail Clinical Research, LLC</name>
      <address>
        <city>Orange City</city>
        <state>Florida</state>
        <zip>32763</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Bioclinica Research</name>
      <address>
        <city>Orlando</city>
        <state>Florida</state>
        <zip>32806</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</name>
      <address>
        <city>South Miami</city>
        <state>Florida</state>
        <zip>33143</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tampa General Medical Group</name>
      <address>
        <city>Tampa</city>
        <state>Florida</state>
        <zip>33606</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of South Florida</name>
      <address>
        <city>Tampa</city>
        <state>Florida</state>
        <zip>33612</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>South Florida Center Of Gastroenterology, PA</name>
      <address>
        <city>Wellington</city>
        <state>Florida</state>
        <zip>33414</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Independent Imaging</name>
      <address>
        <city>Wellington</city>
        <state>Florida</state>
        <zip>33449</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>Invision Imaging</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>Ascension Via Christi Imaging at St. Francis</name>
      <address>
        <city>Wichita</city>
        <state>Kansas</state>
        <zip>67214</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tulane University Health Sciences Center</name>
      <address>
        <city>New Orleans</city>
        <state>Louisiana</state>
        <zip>70112</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ochsner Medical Center</name>
      <address>
        <city>New Orleans</city>
        <state>Louisiana</state>
        <zip>70121</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mercy Medical Center</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Digestive Disease Associates, PA</name>
      <address>
        <city>Catonsville</city>
        <state>Maryland</state>
        <zip>21228</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Michigan</name>
      <address>
        <city>Ann Arbor</city>
        <state>Michigan</state>
        <zip>48109</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Henry Ford Health System</name>
      <address>
        <city>Detroit</city>
        <state>Michigan</state>
        <zip>48202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mayo Clinic- Main Campus</name>
      <address>
        <city>Rochester</city>
        <state>Minnesota</state>
        <zip>55905</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gastrointestinal Associates, PA</name>
      <address>
        <city>Flowood</city>
        <state>Mississippi</state>
        <zip>39232</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Colonnades at Baptist</name>
      <address>
        <city>Jackson</city>
        <state>Mississippi</state>
        <zip>39202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>BioTelemetry Research</name>
      <address>
        <city>Rochester</city>
        <state>New York</state>
        <zip>14623</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Drug Service, University of North Carolina Hospitals</name>
      <address>
        <city>Chapel Hill</city>
        <state>North Carolina</state>
        <zip>27514</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The University of NC at Chapel Hill, Clinical and Translational Research Center (CTRC)</name>
      <address>
        <city>Chapel Hill</city>
        <state>North Carolina</state>
        <zip>27599</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The University of North Carolina at Chapel Hill, Biomedical Research Imaging Center (MRI Facility)</name>
      <address>
        <city>Chapel Hill</city>
        <state>North Carolina</state>
        <zip>27599</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wake Research Associates, LLC</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>PMG Research, Inc.</name>
      <address>
        <city>Winston-Salem</city>
        <state>North Carolina</state>
        <zip>27103</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sterling Research Group, Ltd.</name>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <zip>45219</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Prime Imaging (Chattanooga Outpatient Center)</name>
      <address>
        <city>Chattanooga</city>
        <state>Tennessee</state>
        <zip>37404</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ClinSearch</name>
      <address>
        <city>Chattanooga</city>
        <state>Tennessee</state>
        <zip>37421</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Touchstone</name>
      <address>
        <city>Austin</city>
        <state>Texas</state>
        <zip>78705</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Baylor College of Medicine - Advanced Liver Therapies</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pinnacle Clinical Research</name>
      <address>
        <city>Rollingwood</city>
        <state>Texas</state>
        <zip>78746</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>Pinnacle Clinical Research, PLLC</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78229</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Research Advantage, Inc./Wasatch Peak Family Practice</name>
      <address>
        <city>Layton</city>
        <state>Utah</state>
        <zip>84041</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>
    <facility>
      <name>Harborview Medical Center</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Australian Clinical Research Network</name>
      <address>
        <city>Maroubra</city>
        <state>New South Wales</state>
        <zip>2035</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Spectrum Medical Imaging</name>
      <address>
        <city>Randwick</city>
        <state>New South Wales</state>
        <zip>2013</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Castlereagh Imaging</name>
      <address>
        <city>Westmead</city>
        <state>New South Wales</state>
        <zip>2145</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Storr Liver Centre, Westmead Hospital</name>
      <address>
        <city>Westmead</city>
        <state>New South Wales</state>
        <zip>2145</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dr. Jones &amp; Partners Medical Imaging</name>
      <address>
        <city>Adelaide</city>
        <state>South Australia</state>
        <zip>5000</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Royal Adelaide Hospital, Department of Gastroenterology and Hepatology</name>
      <address>
        <city>Adelaide</city>
        <state>South Australia</state>
        <zip>5000</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Flinders Medical Centre/Department of Gastroenterology &amp; Hepatology</name>
      <address>
        <city>Adelaide</city>
        <state>South Australia</state>
        <zip>5042</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Radiology SA</name>
      <address>
        <city>Adelaide</city>
        <state>South Australia</state>
        <zip>5067</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Royal Melbourne Hospital</name>
      <address>
        <city>Parkville</city>
        <state>Victoria</state>
        <zip>3050</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dr TG Elliott Inc - BC Diabetes</name>
      <address>
        <city>Vancouver</city>
        <state>British Columbia</state>
        <zip>V5Y 3W2</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>False Creek Healthcare Centre</name>
      <address>
        <city>Vancouver</city>
        <state>British Columbia</state>
        <zip>V5Z 1C6</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>False Creek Healthcare</name>
      <address>
        <city>Vancouver</city>
        <state>British Columbia</state>
        <zip>V5Z 1C6</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>LAIR Centre</name>
      <address>
        <city>Vancouver</city>
        <state>British Columbia</state>
        <zip>V5Z 1H2</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Discovery Clinical Services Ltd.</name>
      <address>
        <city>Victoria</city>
        <state>British Columbia</state>
        <zip>V8T 5G4</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>West Coast Medical Imaging</name>
      <address>
        <city>Victoria</city>
        <state>British Columbia</state>
        <zip>V8Z 0B9</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nova Scotia Health Authority, QEII Health Sciences Centre</name>
      <address>
        <city>Halifax</city>
        <state>Nova Scotia</state>
        <zip>B3H 1V7</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nova Scotia Health Authority, QEII Health Sciences Centre</name>
      <address>
        <city>Halifax</city>
        <state>Nova Scotia</state>
        <zip>B3H 2Y9</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nova Scotia Health Authority - QEII Health Sciences Centre</name>
      <address>
        <city>Halifax</city>
        <state>Nova Scotia</state>
        <zip>B3H 3A7</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Aggarwal and Associates Limited</name>
      <address>
        <city>Brampton</city>
        <state>Ontario</state>
        <zip>L6T 0G1</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Joseph's Health Care London</name>
      <address>
        <city>London</city>
        <state>Ontario</state>
        <zip>N6A 4V2</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>London Health Sciences Centre - University Hospital</name>
      <address>
        <city>London</city>
        <state>Ontario</state>
        <zip>N6A 5A5</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Oxford Medical Imaging</name>
      <address>
        <city>Mississauga</city>
        <state>Ontario</state>
        <zip>L5R 3K7</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>LMC Clinical Research Inc. (Bayview)</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M4G 3E8</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Michael's Hospital - MRI Research Centre</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M5B 1W8</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Michael's Hospital</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M5B 1W8</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Health Network (UHN) - Toronto General Hospital - Toronto Centre for Liver Disease (TCLD)</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M5G 2C4</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Toronto - Toronto General Hospital</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M5G 2C4</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Health Network (UHN)</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M5G 2M9</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Toronto Liver Centre - Liver Care Centre Corporation</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M6H 3M1</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Resonance Magnetique du Saguenay-Lac-Saint-Jean</name>
      <address>
        <city>Chicoutimi</city>
        <state>Quebec</state>
        <zip>G7H 4J1</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ecogene-21</name>
      <address>
        <city>Chicoutimi</city>
        <state>Quebec</state>
        <zip>G7H 7K9</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medpharmgene Inc</name>
      <address>
        <city>Montreal</city>
        <state>Quebec</state>
        <zip>H2K 1H2</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinique de Medecine Urbaine du Quartier Latin</name>
      <address>
        <city>Montreal</city>
        <state>Quebec</state>
        <zip>H2L 4E9</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre de recherche du CHUM</name>
      <address>
        <city>Montreal</city>
        <state>Quebec</state>
        <zip>H2X 0A9</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cedar Cancer Center - McGill University Health Centre</name>
      <address>
        <city>Montreal</city>
        <state>Quebec</state>
        <zip>H4A 3J1</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chronic Viral Illness Service - Royal Victoria Hospital - McGill University Health Centre (MUHC)</name>
      <address>
        <city>Montreal</city>
        <state>Quebec</state>
        <zip>H4A 3J1</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>McGill University Health Centre</name>
      <address>
        <city>Montreal</city>
        <state>Quebec</state>
        <zip>H4A 3J1</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Institute of the MUHC</name>
      <address>
        <city>Montreal</city>
        <state>Quebec</state>
        <zip>H4A 3J1</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Radiologie Varad</name>
      <address>
        <city>Montreal</city>
        <state>Quebec</state>
        <zip>H5B 1B2</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Intégré Universitaire de Santé et de Services Sociaux (CIUSSS) de l'Estrie</name>
      <address>
        <city>Sherbrooke</city>
        <state>Quebec</state>
        <zip>J1G 2E8</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Recherche Medicale St-Jerome Inc</name>
      <address>
        <city>St-Jerome</city>
        <state>Quebec</state>
        <zip>J7Z 5T3</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>IRM Quebec</name>
      <address>
        <city>Quebec</city>
        <zip>G1J0H4</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>IRM Quebec</name>
      <address>
        <city>Quebec</city>
        <zip>G1J5B9</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU de Quebec - Universite Laval - site Centre Hospitalier de l'Universite Laval (CHUL)</name>
      <address>
        <city>Quebec</city>
        <zip>G1V 4G2</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre de recherche de l'Institut Universitaire de Cardiologie et de pneumologie de Quebec</name>
      <address>
        <city>Quebec</city>
        <zip>G1V 4G5</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre de recherche Saint-Louis</name>
      <address>
        <city>Quebec</city>
        <zip>G1W 4R4</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>IRM Québec - Clinique St-Louis</name>
      <address>
        <city>Quebec</city>
        <zip>G1W 4R4</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Alpha Recherche Clinique</name>
      <address>
        <city>Quebec</city>
        <zip>G3K 2P8</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinix</name>
      <address>
        <city>Quebec</city>
        <zip>G3K 2P8</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hillel Yaffe Medical Center</name>
      <address>
        <city>Hadera</city>
        <zip>3810101</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rambam Health Care Campus</name>
      <address>
        <city>Haifa</city>
        <zip>3109601</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lady Davis Carmel Medical Center</name>
      <address>
        <city>Haifa</city>
        <zip>3434104</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Shaare Zedek Medical Center</name>
      <address>
        <city>Jerusalem</city>
        <zip>9103102</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hadassah Hebrew University Medical Center - Ein Kerem</name>
      <address>
        <city>Jerusalem</city>
        <zip>9112001</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Galilee Medical Center</name>
      <address>
        <city>Nahariya</city>
        <zip>2210001</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Holy Family Hospital</name>
      <address>
        <city>Nazareth</city>
        <zip>1610001</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rabin Medical Center</name>
      <address>
        <city>Petah Tikva</city>
        <zip>4941492</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Chaim Sheba Medical Center</name>
      <address>
        <city>Ramat-Gan</city>
        <zip>5265601</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tel-Aviv Sourasky Medical Center</name>
      <address>
        <city>Tel-Aviv</city>
        <zip>6423906</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ClinicMed Badurski i wspolnicy Spolka Jawna</name>
      <address>
        <city>Bialystok</city>
        <zip>15-879</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Synexus Polska Sp. z o.o. Oddzial w Gdansku</name>
      <address>
        <city>Gdansk</city>
        <zip>80-382</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centrum Badan Klinicznych PI-House Sp. z o.o.</name>
      <address>
        <city>Gdansk</city>
        <zip>80-546</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Synexus Polska Sp. z o.o. Oddzial w Gdyni</name>
      <address>
        <city>Gdynia</city>
        <zip>81-537</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Osrodek Badan Klinicznych</name>
      <address>
        <city>Jaworze</city>
        <zip>43-384</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Synexus Polska Sp. z o.o. Oddzial w Katowicach</name>
      <address>
        <city>Katowice</city>
        <zip>40-040</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Silmedic Sp. z o.o. Oddzial w Katowicach</name>
      <address>
        <city>Katowice</city>
        <zip>40-282</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centrum Medyczne A-Z Clinic</name>
      <address>
        <city>Krakow</city>
        <zip>31-315</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Krakowskie Centrum Medyczne sp. z o.o.</name>
      <address>
        <city>Krakow</city>
        <zip>31-501</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gabinet Lekarski Malgorzata Saryusz-Wolska</name>
      <address>
        <city>Lodz</city>
        <zip>90-132</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Synexus Polska Sp. z o.o Oddzial w Poznaniu</name>
      <address>
        <city>Poznan</city>
        <zip>60-702</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centrum Medyczne Medyk</name>
      <address>
        <city>Rzeszow</city>
        <zip>35-326</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Synexus Polska Sp. z o. o. Oddzial w Warszawie</name>
      <address>
        <city>Warszawa</city>
        <zip>01-192</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Niepubliczny Zaklad Opieki Zdrowotnej Centrum Badan Klinicznych</name>
      <address>
        <city>Wroclaw</city>
        <zip>50-349</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Synexus Polska Sp. z o.o. Oddzial we Wroclawiu</name>
      <address>
        <city>Wroclaw</city>
        <zip>50-381</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>DOBROSTAN - Gabinety Lekarskie</name>
      <address>
        <city>Wroclaw</city>
        <zip>53-301</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Changhua Christian Hospital</name>
      <address>
        <city>Changhua city</city>
        <state>Changhua County</state>
        <zip>500</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chung-Ho Memorial Hospital, Kaohsiung Medical University</name>
      <address>
        <city>Kaohsiung</city>
        <zip>807</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Cheng-Kung University Hospital</name>
      <address>
        <city>Tainan</city>
        <zip>704</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Taiwan University Hospital</name>
      <address>
        <city>Taipei</city>
        <zip>100</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Taipei Veterans General Hospital</name>
      <address>
        <city>Taipei</city>
        <zip>11217</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Australia</country>
    <country>Canada</country>
    <country>Israel</country>
    <country>Poland</country>
    <country>Taiwan</country>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://pmiform.com/clinical-trial-info-request?StudyID=C1171002</url>
    <description>To obtain contact information for a study center near you, click here.</description>
  </link>
  <verification_date>February 2020</verification_date>
  <study_first_submitted>August 10, 2017</study_first_submitted>
  <study_first_submitted_qc>August 10, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 14, 2017</study_first_posted>
  <results_first_submitted>February 25, 2020</results_first_submitted>
  <results_first_submitted_qc>February 25, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">March 10, 2020</results_first_posted>
  <last_update_submitted>December 7, 2020</last_update_submitted>
  <last_update_submitted_qc>December 7, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">December 9, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>PF-05221304</keyword>
  <keyword>NAFLD</keyword>
  <keyword>NASH</keyword>
  <keyword>features of metabolic syndrome</keyword>
  <keyword>Dose-Ranging Study</keyword>
  <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 3, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/82/NCT03248882/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>March 14, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/82/NCT03248882/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Placebo</title>
          <description>Placebo matched to PF-05221304 tablet was administered orally once daily (QD) for up to 16 weeks.</description>
        </group>
        <group group_id="P2">
          <title>PF-05221304 2 mg</title>
          <description>PF-05221304 tablet was administered orally at 2 mg QD for up to 16 weeks.</description>
        </group>
        <group group_id="P3">
          <title>PF-05221304 10 mg</title>
          <description>PF-05221304 tablet was administered orally at 10 mg QD for up to 16 weeks.</description>
        </group>
        <group group_id="P4">
          <title>PF-05221304 25 mg</title>
          <description>PF-05221304 tablet was administered orally at 25 mg QD for up to 16 weeks.</description>
        </group>
        <group group_id="P5">
          <title>PF-05221304 50 mg</title>
          <description>PF-05221304 tablet was administered orally at 50 mg QD for up to 16 weeks.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="61"/>
                <participants group_id="P2" count="63"/>
                <participants group_id="P3" count="62"/>
                <participants group_id="P4" count="58"/>
                <participants group_id="P5" count="61"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Received Treatment</title>
              <participants_list>
                <participants group_id="P1" count="61"/>
                <participants group_id="P2" count="63"/>
                <participants group_id="P3" count="62"/>
                <participants group_id="P4" count="58"/>
                <participants group_id="P5" count="61"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="54"/>
                <participants group_id="P2" count="58"/>
                <participants group_id="P3" count="55"/>
                <participants group_id="P4" count="48"/>
                <participants group_id="P5" count="48"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
                <participants group_id="P2" count="5"/>
                <participants group_id="P3" count="7"/>
                <participants group_id="P4" count="10"/>
                <participants group_id="P5" count="13"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="3"/>
                <participants group_id="P3" count="2"/>
                <participants group_id="P4" count="6"/>
                <participants group_id="P5" count="9"/>
              </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="0"/>
                <participants group_id="P5" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Protocol Violation</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="2"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="2"/>
                <participants group_id="P3" count="3"/>
                <participants group_id="P4" count="4"/>
                <participants group_id="P5" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>All randomized participants who received at least 1 dose of randomized study treatment.</population>
      <group_list>
        <group group_id="B1">
          <title>Placebo</title>
          <description>Placebo matched to PF-05221304 tablet was administered orally once daily (QD) for up to 16 weeks.</description>
        </group>
        <group group_id="B2">
          <title>PF-05221304 2 mg</title>
          <description>PF-05221304 tablet was administered orally at 2 mg QD for up to 16 weeks.</description>
        </group>
        <group group_id="B3">
          <title>PF-05221304 10 mg</title>
          <description>PF-05221304 tablet was administered orally at 10 mg QD for up to 16 weeks.</description>
        </group>
        <group group_id="B4">
          <title>PF-05221304 25 mg</title>
          <description>PF-05221304 tablet was administered orally at 25 mg QD for up to 16 weeks.</description>
        </group>
        <group group_id="B5">
          <title>PF-05221304 50 mg</title>
          <description>PF-05221304 tablet was administered orally at 50 mg QD for up to 16 weeks.</description>
        </group>
        <group group_id="B6">
          <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="61"/>
            <count group_id="B2" value="63"/>
            <count group_id="B3" value="62"/>
            <count group_id="B4" value="58"/>
            <count group_id="B5" value="61"/>
            <count group_id="B6" value="305"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="53.3" spread="10.8"/>
                    <measurement group_id="B2" value="54.1" spread="11.9"/>
                    <measurement group_id="B3" value="52.7" spread="12.8"/>
                    <measurement group_id="B4" value="54.0" spread="11.6"/>
                    <measurement group_id="B5" value="52.8" spread="13.1"/>
                    <measurement group_id="B6" value="53.38" spread="11.99"/>
                  </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="36"/>
                    <measurement group_id="B2" value="37"/>
                    <measurement group_id="B3" value="33"/>
                    <measurement group_id="B4" value="35"/>
                    <measurement group_id="B5" value="30"/>
                    <measurement group_id="B6" value="171"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="25"/>
                    <measurement group_id="B2" value="26"/>
                    <measurement group_id="B3" value="29"/>
                    <measurement group_id="B4" value="23"/>
                    <measurement group_id="B5" value="31"/>
                    <measurement group_id="B6" value="134"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="53"/>
                    <measurement group_id="B2" value="50"/>
                    <measurement group_id="B3" value="52"/>
                    <measurement group_id="B4" value="46"/>
                    <measurement group_id="B5" value="51"/>
                    <measurement group_id="B6" value="252"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="1"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="7"/>
                    <measurement group_id="B4" value="9"/>
                    <measurement group_id="B5" value="10"/>
                    <measurement group_id="B6" value="38"/>
                  </measurement_list>
                </category>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="1"/>
                  </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="1"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="2"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Percent Change From Baseline in Liver Fat by Magnetic Resonance Imaging-Proton Density Fat Fraction (MRI- PDFF) at Week 16</title>
        <description>MRI-PDFF utilized a gradient echo sequence with low flip angle (FA) to minimize T1 bias, corrected T2* decay (due to iron overload) via modeling of the fat signal as a superposition of multiple frequency components from 5 different lipid types, and was applied in each of the 9 Couinaud segments. This technique improved fat quantification accuracy for the entire liver permitting quantification of small differences/changes following pharmacological intervention.</description>
        <time_frame>Baseline (between Day -14 and Day 1), Week 16</time_frame>
        <population>All randomized participants who received at least 1 dose of randomized study treatment and with non-missing baseline and post-baseline endpoint.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Placebo matched to PF-05221304 tablet was administered orally once daily (QD) for up to 16 weeks.</description>
          </group>
          <group group_id="O2">
            <title>PF-05221304 2 mg</title>
            <description>PF-05221304 tablet was administered orally at 2 mg QD for up to 16 weeks.</description>
          </group>
          <group group_id="O3">
            <title>PF-05221304 10 mg</title>
            <description>PF-05221304 tablet was administered orally at 10 mg QD for up to 16 weeks.</description>
          </group>
          <group group_id="O4">
            <title>PF-05221304 25 mg</title>
            <description>PF-05221304 tablet was administered orally at 25 mg QD for up to 16 weeks.</description>
          </group>
          <group group_id="O5">
            <title>PF-05221304 50 mg</title>
            <description>PF-05221304 tablet was administered orally at 50 mg QD for up to 16 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Change From Baseline in Liver Fat by Magnetic Resonance Imaging-Proton Density Fat Fraction (MRI- PDFF) at Week 16</title>
          <description>MRI-PDFF utilized a gradient echo sequence with low flip angle (FA) to minimize T1 bias, corrected T2* decay (due to iron overload) via modeling of the fat signal as a superposition of multiple frequency components from 5 different lipid types, and was applied in each of the 9 Couinaud segments. This technique improved fat quantification accuracy for the entire liver permitting quantification of small differences/changes following pharmacological intervention.</description>
          <population>All randomized participants who received at least 1 dose of randomized study treatment and with non-missing baseline and post-baseline endpoint.</population>
          <units>Percent change</units>
          <param>Least Squares Mean</param>
          <dispersion>80% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="55"/>
                <count group_id="O2" value="59"/>
                <count group_id="O3" value="57"/>
                <count group_id="O4" value="54"/>
                <count group_id="O5" value="51"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-7.2" lower_limit="-13.9" upper_limit="0.0"/>
                    <measurement group_id="O2" value="-17.1" lower_limit="-22.7" upper_limit="-11.1"/>
                    <measurement group_id="O3" value="-49.9" lower_limit="-53.3" upper_limit="-46.2"/>
                    <measurement group_id="O4" value="-55.9" lower_limit="-59.0" upper_limit="-52.4"/>
                    <measurement group_id="O5" value="-64.8" lower_limit="-67.5" upper_limit="-62.0"/>
                  </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>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>-10.7</param_value>
            <ci_percent>80</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-19.4</ci_lower_limit>
            <ci_upper_limit>-1.1</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>-46.0</param_value>
            <ci_percent>80</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-51.3</ci_lower_limit>
            <ci_upper_limit>-40.1</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>-52.4</param_value>
            <ci_percent>80</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-57.2</ci_lower_limit>
            <ci_upper_limit>-47.1</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O5</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>-62.1</param_value>
            <ci_percent>80</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-66.0</ci_lower_limit>
            <ci_upper_limit>-57.8</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percent Change From Baseline in Alanine Aminotransferase at Week 16</title>
        <description>Potential improvement in liver function was denoted by reduction in alanine transaminase (ALT)</description>
        <time_frame>Baseline (Day 1 pre-dose), Week 16</time_frame>
        <population>All randomized participants who received at least 1 dose of randomized study treatment and diagnosed/presumed with nonalcoholic steatohepatitis.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Placebo matched to PF-05221304 tablet was administered orally once daily (QD) for up to 16 weeks.</description>
          </group>
          <group group_id="O2">
            <title>PF-05221304 2 mg</title>
            <description>PF-05221304 tablet was administered orally at 2 mg QD for up to 16 weeks.</description>
          </group>
          <group group_id="O3">
            <title>PF-05221304 10 mg</title>
            <description>PF-05221304 tablet was administered orally at 10 mg QD for up to 16 weeks.</description>
          </group>
          <group group_id="O4">
            <title>PF-05221304 25 mg</title>
            <description>PF-05221304 tablet was administered orally at 25 mg QD for up to 16 weeks.</description>
          </group>
          <group group_id="O5">
            <title>PF-05221304 50 mg</title>
            <description>PF-05221304 tablet was administered orally at 50 mg QD for up to 16 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Change From Baseline in Alanine Aminotransferase at Week 16</title>
          <description>Potential improvement in liver function was denoted by reduction in alanine transaminase (ALT)</description>
          <population>All randomized participants who received at least 1 dose of randomized study treatment and diagnosed/presumed with nonalcoholic steatohepatitis.</population>
          <units>Percent change</units>
          <param>Least Squares Mean</param>
          <dispersion>80% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="40"/>
                <count group_id="O2" value="42"/>
                <count group_id="O3" value="42"/>
                <count group_id="O4" value="39"/>
                <count group_id="O5" value="40"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-8.5" lower_limit="-15.2" upper_limit="-1.2"/>
                    <measurement group_id="O2" value="-12.5" lower_limit="-18.7" upper_limit="-5.8"/>
                    <measurement group_id="O3" value="-27.7" lower_limit="-32.9" upper_limit="-22.2"/>
                    <measurement group_id="O4" value="-31.3" lower_limit="-36.6" upper_limit="-25.5"/>
                    <measurement group_id="O5" value="-46.8" lower_limit="-50.8" upper_limit="-42.4"/>
                  </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>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>-4.4</param_value>
            <ci_percent>80</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-14.0</ci_lower_limit>
            <ci_upper_limit>6.3</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>-21.0</param_value>
            <ci_percent>80</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-29.0</ci_lower_limit>
            <ci_upper_limit>-12.2</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>-25.0</param_value>
            <ci_percent>80</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-32.8</ci_lower_limit>
            <ci_upper_limit>-16.1</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O5</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>-41.8</param_value>
            <ci_percent>80</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-47.9</ci_lower_limit>
            <ci_upper_limit>-35.0</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Treatment-Emergent Adverse Events</title>
        <description>An AE was any untoward medical occurrence in a study subject administered a product or medical device. A serious AE (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; life-threatening; initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect. Any such events with initial onset or increasing in severity after the first dose of study treatment were counted as treatment-emergent.</description>
        <time_frame>From first dose of study treatment (Day 1) up to Week 20</time_frame>
        <population>All randomized participants who received at least 1 dose of randomized study treatment.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Placebo matched to PF-05221304 tablet was administered orally once daily (QD) for up to 16 weeks.</description>
          </group>
          <group group_id="O2">
            <title>PF-05221304 2 mg</title>
            <description>PF-05221304 tablet was administered orally at 2 mg QD for up to 16 weeks.</description>
          </group>
          <group group_id="O3">
            <title>PF-05221304 10 mg</title>
            <description>PF-05221304 tablet was administered orally at 10 mg QD for up to 16 weeks.</description>
          </group>
          <group group_id="O4">
            <title>PF-05221304 25 mg</title>
            <description>PF-05221304 tablet was administered orally at 25 mg QD for up to 16 weeks.</description>
          </group>
          <group group_id="O5">
            <title>PF-05221304 50 mg</title>
            <description>PF-05221304 tablet was administered orally at 50 mg QD for up to 16 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Treatment-Emergent Adverse Events</title>
          <description>An AE was any untoward medical occurrence in a study subject administered a product or medical device. A serious AE (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; life-threatening; initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect. Any such events with initial onset or increasing in severity after the first dose of study treatment were counted as treatment-emergent.</description>
          <population>All randomized participants who received at least 1 dose of randomized study treatment.</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="61"/>
                <count group_id="O2" value="63"/>
                <count group_id="O3" value="62"/>
                <count group_id="O4" value="58"/>
                <count group_id="O5" value="61"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>All-causality AE</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="41"/>
                    <measurement group_id="O2" value="40"/>
                    <measurement group_id="O3" value="42"/>
                    <measurement group_id="O4" value="45"/>
                    <measurement group_id="O5" value="40"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>All-causality SAE</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="2"/>
                    <measurement group_id="O5" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Treatment-related AE</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16"/>
                    <measurement group_id="O2" value="9"/>
                    <measurement group_id="O3" value="12"/>
                    <measurement group_id="O4" value="16"/>
                    <measurement group_id="O5" value="23"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Treatment-related SAE</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="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Laboratory Abnormalities</title>
        <description>Following laboratory parameters were assessed against pre-defined abnormality criteria: hematology (hemoglobin, hematocrit, erythrocytes, reticulocytes, platelets, leukocytes, lymphocytes, neutrophils, basophils, eosinophils, monocytes, activated partial thromboplastin time, prothrombin time [PT], PT/international normalized ratio, reticulocytes); chemistry (indirect bilirubin, direct bilirubin, protein, albumin, blood urea nitrogen, creatinine, creatine kinase, urate, calcium, sodium, potassium, chloride, bicarbonate, urine urobilinogen); urinalysis (pH, urine glucose, urine ketones, urine protein, urine hemoglobin, nitrites, leukocyte esterase, urine erythrocytes, urine leukocytes, urine hyaline casts, urine bilirubin, granular casts).</description>
        <time_frame>From first dose of study treatment (Day 1) up to Week 20</time_frame>
        <population>All randomized participants who received at least 1 dose of randomized study treatment and had laboratory data.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Placebo matched to PF-05221304 tablet was administered orally once daily (QD) for up to 16 weeks.</description>
          </group>
          <group group_id="O2">
            <title>PF-05221304 2 mg</title>
            <description>PF-05221304 tablet was administered orally at 2 mg QD for up to 16 weeks.</description>
          </group>
          <group group_id="O3">
            <title>PF-05221304 10 mg</title>
            <description>PF-05221304 tablet was administered orally at 10 mg QD for up to 16 weeks.</description>
          </group>
          <group group_id="O4">
            <title>PF-05221304 25 mg</title>
            <description>PF-05221304 tablet was administered orally at 25 mg QD for up to 16 weeks.</description>
          </group>
          <group group_id="O5">
            <title>PF-05221304 50 mg</title>
            <description>PF-05221304 tablet was administered orally at 50 mg QD for up to 16 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Laboratory Abnormalities</title>
          <description>Following laboratory parameters were assessed against pre-defined abnormality criteria: hematology (hemoglobin, hematocrit, erythrocytes, reticulocytes, platelets, leukocytes, lymphocytes, neutrophils, basophils, eosinophils, monocytes, activated partial thromboplastin time, prothrombin time [PT], PT/international normalized ratio, reticulocytes); chemistry (indirect bilirubin, direct bilirubin, protein, albumin, blood urea nitrogen, creatinine, creatine kinase, urate, calcium, sodium, potassium, chloride, bicarbonate, urine urobilinogen); urinalysis (pH, urine glucose, urine ketones, urine protein, urine hemoglobin, nitrites, leukocyte esterase, urine erythrocytes, urine leukocytes, urine hyaline casts, urine bilirubin, granular casts).</description>
          <population>All randomized participants who received at least 1 dose of randomized study treatment and had laboratory data.</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="59"/>
                <count group_id="O2" value="63"/>
                <count group_id="O3" value="62"/>
                <count group_id="O4" value="58"/>
                <count group_id="O5" value="61"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="39"/>
                    <measurement group_id="O2" value="44"/>
                    <measurement group_id="O3" value="36"/>
                    <measurement group_id="O4" value="33"/>
                    <measurement group_id="O5" value="40"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Vital Signs Data Meeting Predefined Criteria</title>
        <description>Vital signs categorical summarization criteria: 1) sitting systolic blood pressure (SBP) &lt;90 or &gt;180 millimeters of mercury (mmHg); 2) sitting diastolic blood pressure (DBP) &lt;50 mmHg or &gt;110 mmHg; 3) sitting pulse rate &lt;40 or &gt;120 beats per minute (bpm); 4) change from baseline (increase or decrease) in sitting DBP greater than or equal to (&gt;=) 20 mmHg; 5) change from baseline (increase or decrease) in sitting SBP &gt;=30 mmHg.</description>
        <time_frame>From first dose of study treatment (Day 1) up to Week 18</time_frame>
        <population>All randomized participants who received at least 1 dose of randomized study treatment and had vital signs data.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Placebo matched to PF-05221304 tablet was administered orally once daily (QD) for up to 16 weeks.</description>
          </group>
          <group group_id="O2">
            <title>PF-05221304 2 mg</title>
            <description>PF-05221304 tablet was administered orally at 2 mg QD for up to 16 weeks.</description>
          </group>
          <group group_id="O3">
            <title>PF-05221304 10 mg</title>
            <description>PF-05221304 tablet was administered orally at 10 mg QD for up to 16 weeks.</description>
          </group>
          <group group_id="O4">
            <title>PF-05221304 25 mg</title>
            <description>PF-05221304 tablet was administered orally at 25 mg QD for up to 16 weeks.</description>
          </group>
          <group group_id="O5">
            <title>PF-05221304 50 mg</title>
            <description>PF-05221304 tablet was administered orally at 50 mg QD for up to 16 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Vital Signs Data Meeting Predefined Criteria</title>
          <description>Vital signs categorical summarization criteria: 1) sitting systolic blood pressure (SBP) &lt;90 or &gt;180 millimeters of mercury (mmHg); 2) sitting diastolic blood pressure (DBP) &lt;50 mmHg or &gt;110 mmHg; 3) sitting pulse rate &lt;40 or &gt;120 beats per minute (bpm); 4) change from baseline (increase or decrease) in sitting DBP greater than or equal to (&gt;=) 20 mmHg; 5) change from baseline (increase or decrease) in sitting SBP &gt;=30 mmHg.</description>
          <population>All randomized participants who received at least 1 dose of randomized study treatment and had vital signs data.</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="60"/>
                <count group_id="O2" value="63"/>
                <count group_id="O3" value="62"/>
                <count group_id="O4" value="58"/>
                <count group_id="O5" value="61"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Sitting SBP &lt;90 mmHg</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="0"/>
                    <measurement group_id="O5" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Sitting SBP &gt;180 mmHg</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 group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Sitting SBP increase &gt;=30 mmHg</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="6"/>
                    <measurement group_id="O3" value="2"/>
                    <measurement group_id="O4" value="2"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Sitting SBP decrease &gt;=30 mmHg</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="5"/>
                    <measurement group_id="O4" value="7"/>
                    <measurement group_id="O5" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Sitting DBP &lt;50 mmHg</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Sitting DBP &gt;110 mmHg</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="0"/>
                    <measurement group_id="O5" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Sitting DBP increase &gt;=20 mmHg</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="4"/>
                    <measurement group_id="O3" value="2"/>
                    <measurement group_id="O4" value="2"/>
                    <measurement group_id="O5" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Sitting DBP decrease &gt;=20 mmHg</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="4"/>
                    <measurement group_id="O3" value="3"/>
                    <measurement group_id="O4" value="4"/>
                    <measurement group_id="O5" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Sitting pulse rate &lt;40 bpm</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="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Sitting pulse rate &gt;120 bpm</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="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With 12-Lead Electrocardiogram (ECG) Data Meeting Predefined Criteria</title>
        <description>ECG categorical summarization criteria: 1) QRS interval (time from ECG Q wave to the end of the S wave corresponding to ventricle depolarization) &gt;=140 milliseconds (msec); 2) QRS interval &gt;=50% change from baseline; 3) PR interval (the interval between the start of the P wave and the start of the QRS complex, corresponding to the time between the onset of the atrial depolarization and onset of ventricular depolarization) &gt;=300 msec; 4) PR interval &gt;=25% change when baseline is &gt;200 msec or &gt;=50% change when baseline is &lt;=200 msec; 5) QT interval (time from ECG Q wave to the end of the T wave corresponding to electrical systole): absolute value of &gt;=500 msec; 6) QTcF interval (QT corrected for heart rate using Fridericia's formula) absolute value of 450 to &lt;480 msec; 7) QTcF interval: absolute value of 480 to &lt;500 msec; 8) QTcF interval: absolute value &gt;=500 msec; 9) QTcF interval: a change from baseline of 30 to &lt;60 msec; 10) QTcF interval: a change from baseline &gt;=60 msec.</description>
        <time_frame>From first dose of study treatment (Day 1) up to Week 18</time_frame>
        <population>All randomized participants who received at least 1 dose of randomized study treatment and had ECG data.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Placebo matched to PF-05221304 tablet was administered orally once daily (QD) for up to 16 weeks.</description>
          </group>
          <group group_id="O2">
            <title>PF-05221304 2 mg</title>
            <description>PF-05221304 tablet was administered orally at 2 mg QD for up to 16 weeks.</description>
          </group>
          <group group_id="O3">
            <title>PF-05221304 10 mg</title>
            <description>PF-05221304 tablet was administered orally at 10 mg QD for up to 16 weeks.</description>
          </group>
          <group group_id="O4">
            <title>PF-05221304 25 mg</title>
            <description>PF-05221304 tablet was administered orally at 25 mg QD for up to 16 weeks.</description>
          </group>
          <group group_id="O5">
            <title>PF-05221304 50 mg</title>
            <description>PF-05221304 tablet was administered orally at 50 mg QD for up to 16 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With 12-Lead Electrocardiogram (ECG) Data Meeting Predefined Criteria</title>
          <description>ECG categorical summarization criteria: 1) QRS interval (time from ECG Q wave to the end of the S wave corresponding to ventricle depolarization) &gt;=140 milliseconds (msec); 2) QRS interval &gt;=50% change from baseline; 3) PR interval (the interval between the start of the P wave and the start of the QRS complex, corresponding to the time between the onset of the atrial depolarization and onset of ventricular depolarization) &gt;=300 msec; 4) PR interval &gt;=25% change when baseline is &gt;200 msec or &gt;=50% change when baseline is &lt;=200 msec; 5) QT interval (time from ECG Q wave to the end of the T wave corresponding to electrical systole): absolute value of &gt;=500 msec; 6) QTcF interval (QT corrected for heart rate using Fridericia's formula) absolute value of 450 to &lt;480 msec; 7) QTcF interval: absolute value of 480 to &lt;500 msec; 8) QTcF interval: absolute value &gt;=500 msec; 9) QTcF interval: a change from baseline of 30 to &lt;60 msec; 10) QTcF interval: a change from baseline &gt;=60 msec.</description>
          <population>All randomized participants who received at least 1 dose of randomized study treatment and had ECG data.</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="60"/>
                <count group_id="O2" value="63"/>
                <count group_id="O3" value="61"/>
                <count group_id="O4" value="58"/>
                <count group_id="O5" value="60"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>PR interval &gt;=300 msec</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="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>%Change in PR interval &gt;=25/50%</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="1"/>
                    <measurement group_id="O5" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>QRS interval &gt;=140 msec</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>%Change in QRS interval &gt;=50%</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="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>QT interval &gt;=500 msec</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 group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>QTcF interval &gt;=450 to &lt;480 msec</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="10"/>
                    <measurement group_id="O3" value="7"/>
                    <measurement group_id="O4" value="9"/>
                    <measurement group_id="O5" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>QTcF interval &gt;=480 to &lt;500 msec</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="1"/>
                    <measurement group_id="O5" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>QTcF interval &gt;=500 msec</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="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>QTcF interval increase &gt;=30 to 60 msec</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="6"/>
                    <measurement group_id="O3" value="8"/>
                    <measurement group_id="O4" value="10"/>
                    <measurement group_id="O5" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>QTcF interval increase &gt;=60 msec</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>From first dose of study treatment up to 20 weeks</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Placebo</title>
          <description>Placebo matched to PF-05221304 tablet was administered orally once daily (QD) for up to 16 weeks.</description>
        </group>
        <group group_id="E2">
          <title>PF-05221304 2 mg</title>
          <description>PF-05221304 tablet was administered orally at 2 mg QD for up to 16 weeks.</description>
        </group>
        <group group_id="E3">
          <title>PF-05221304 10 mg</title>
          <description>PF-05221304 tablet was administered orally at 10 mg QD for up to 16 weeks.</description>
        </group>
        <group group_id="E4">
          <title>PF-05221304 25 mg</title>
          <description>PF-05221304 tablet was administered orally at 25 mg QD for up to 16 weeks.</description>
        </group>
        <group group_id="E5">
          <title>PF-05221304 50 mg</title>
          <description>PF-05221304 tablet was administered orally at 50 mg QD for up to 16 weeks.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA v22.0</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="61"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="63"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="62"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="58"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="61"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="63"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="62"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="58"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="61"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Angina unstable</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="63"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="62"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="58"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="61"/>
              </event>
              <event>
                <sub_title>Myocardial infarction</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="63"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="62"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="58"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="61"/>
              </event>
              <event>
                <sub_title>Myocardial ischaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="63"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="62"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="58"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="61"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="63"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="62"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="58"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="61"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="63"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="62"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="58"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="61"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Rib fracture</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="63"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="62"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="58"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="61"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Renal colic</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="63"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="62"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="58"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="61"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Asthma</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="63"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="62"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="58"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="61"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA v22.0</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="27" subjects_at_risk="61"/>
                <counts group_id="E2" subjects_affected="21" subjects_at_risk="63"/>
                <counts group_id="E3" subjects_affected="25" subjects_at_risk="62"/>
                <counts group_id="E4" subjects_affected="31" subjects_at_risk="58"/>
                <counts group_id="E5" subjects_affected="29" subjects_at_risk="61"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal pain upper</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="61"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="63"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="62"/>
                <counts group_id="E4" subjects_affected="6" subjects_at_risk="58"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="61"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="61"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="63"/>
                <counts group_id="E3" subjects_affected="8" subjects_at_risk="62"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="58"/>
                <counts group_id="E5" subjects_affected="4" subjects_at_risk="61"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="61"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="63"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="62"/>
                <counts group_id="E4" subjects_affected="5" subjects_at_risk="58"/>
                <counts group_id="E5" subjects_affected="4" subjects_at_risk="61"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="61"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="63"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="62"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="58"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="61"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="61"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="63"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="62"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="58"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="61"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="61"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="63"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="62"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="58"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="61"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="61"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="63"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="62"/>
                <counts group_id="E4" subjects_affected="5" subjects_at_risk="58"/>
                <counts group_id="E5" subjects_affected="4" subjects_at_risk="61"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Blood triglycerides increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="63"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="62"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="58"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="61"/>
              </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="2" subjects_at_risk="61"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="63"/>
                <counts group_id="E3" subjects_affected="6" subjects_at_risk="62"/>
                <counts group_id="E4" subjects_affected="4" subjects_at_risk="58"/>
                <counts group_id="E5" subjects_affected="10" subjects_at_risk="61"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Arthralgia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="61"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="63"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="62"/>
                <counts group_id="E4" subjects_affected="4" subjects_at_risk="58"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="61"/>
              </event>
              <event>
                <sub_title>Muscle spasms</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="61"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="63"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="62"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="58"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="61"/>
              </event>
              <event>
                <sub_title>Pain in extremity</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="61"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="63"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="62"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="58"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="61"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="61"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="63"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="62"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="58"/>
                <counts group_id="E5" subjects_affected="3" subjects_at_risk="61"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="61"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="63"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="62"/>
                <counts group_id="E4" subjects_affected="7" subjects_at_risk="58"/>
                <counts group_id="E5" subjects_affected="4" subjects_at_risk="61"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Pruritus</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="61"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="63"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="62"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="58"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="61"/>
              </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/NCT03248882
org study id: C1171002
secondary id: 2017-001156-55
nct id: NCT03248882
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
Phase 2a, dose-ranging Study with PF-05221304 in Nonalcoholic Fatty Liver Disease (NAFLD)
A Phase 2a, Randomized, Double-blind, Placebo-controlled, Dose-ranging, Parallel Group Study
      To Evaluate Safety, Tolerability, And Pharmacodynamics Of PF-05221304 Administered Daily For
      16-weeks To Adult Subjects With Nonalcoholic Fatty Liver Disease
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: C1171002 is a randomized, double blind, placebo controlled, 5 arm (placebo, plus 4 active doses of PF 05221304), parallel group study.
primary purpose: Treatment
masking: Double (Participant, Investigator)
masking description: Double-Blind
measure: Percent Change From Baseline in Liver Fat by Magnetic Resonance Imaging-Proton Density Fat Fraction (MRI- PDFF) at Week 16
time frame: Baseline (between Day -14 and Day 1), Week 16
description: MRI-PDFF utilized a gradient echo sequence with low flip angle (FA) to minimize T1 bias, corrected T2* decay (due to iron overload) via modeling of the fat signal as a superposition of multiple frequency components from 5 different lipid types, and was applied in each of the 9 Couinaud segments. This technique improved fat quantification accuracy for the entire liver permitting quantification of small differences/changes following pharmacological intervention.
measure: Percent Change From Baseline in Alanine Aminotransferase at Week 16
time frame: Baseline (Day 1 pre-dose), Week 16
description: Potential improvement in liver function was denoted by reduction in alanine transaminase (ALT)
measure: Number of Participants With Treatment-Emergent Adverse Events
time frame: From first dose of study treatment (Day 1) up to Week 20
description: An AE was any untoward medical occurrence in a study subject administered a product or medical device. A serious AE (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; life-threatening; initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect. Any such events with initial onset or increasing in severity after the first dose of study treatment were counted as treatment-emergent.
measure: Number of Participants With Laboratory Abnormalities
time frame: From first dose of study treatment (Day 1) up to Week 20
description: Following laboratory parameters were assessed against pre-defined abnormality criteria: hematology (hemoglobin, hematocrit, erythrocytes, reticulocytes, platelets, leukocytes, lymphocytes, neutrophils, basophils, eosinophils, monocytes, activated partial thromboplastin time, prothrombin time [PT], PT/international normalized ratio, reticulocytes); chemistry (indirect bilirubin, direct bilirubin, protein, albumin, blood urea nitrogen, creatinine, creatine kinase, urate, calcium, sodium, potassium, chloride, bicarbonate, urine urobilinogen); urinalysis (pH, urine glucose, urine ketones, urine protein, urine hemoglobin, nitrites, leukocyte esterase, urine erythrocytes, urine leukocytes, urine hyaline casts, urine bilirubin, granular casts).
measure: Number of Participants With Vital Signs Data Meeting Predefined Criteria
time frame: From first dose of study treatment (Day 1) up to Week 18
description: Vital signs categorical summarization criteria: 1) sitting systolic blood pressure (SBP) <90 or >180 millimeters of mercury (mmHg); 2) sitting diastolic blood pressure (DBP) <50 mmHg or >110 mmHg; 3) sitting pulse rate <40 or >120 beats per minute (bpm); 4) change from baseline (increase or decrease) in sitting DBP greater than or equal to (>=) 20 mmHg; 5) change from baseline (increase or decrease) in sitting SBP >=30 mmHg.
measure: Number of Participants With 12-Lead Electrocardiogram (ECG) Data Meeting Predefined Criteria
time frame: From first dose of study treatment (Day 1) up to Week 18
description: ECG categorical summarization criteria: 1) QRS interval (time from ECG Q wave to the end of the S wave corresponding to ventricle depolarization) >=140 milliseconds (msec); 2) QRS interval >=50% change from baseline; 3) PR interval (the interval between the start of the P wave and the start of the QRS complex, corresponding to the time between the onset of the atrial depolarization and onset of ventricular depolarization) >=300 msec; 4) PR interval >=25% change when baseline is >200 msec or >=50% change when baseline is <=200 msec; 5) QT interval (time from ECG Q wave to the end of the T wave corresponding to electrical systole): absolute value of >=500 msec; 6) QTcF interval (QT corrected for heart rate using Fridericia's formula) absolute value of 450 to <480 msec; 7) QTcF interval: absolute value of 480 to <500 msec; 8) QTcF interval: absolute value >=500 msec; 9) QTcF interval: a change from baseline of 30 to <60 msec; 10) QTcF interval: a change from baseline >=60 msec.
arm group label: Placebo
arm group type: Placebo Comparator
description: Double-Blind, PF-05221304-matching Placebo
arm group label: PF-05221304 - 2 mg
arm group type: Active Comparator
description: PF-05221304 - 2 mg, once-daily
arm group label: PF-05221304 - 10 mg
arm group type: Active Comparator
description: PF-05221304 - 10 mg, once-daily
arm group label: PF-05221304 - 25 mg
arm group type: Active Comparator
description: PF-05221304 - 25 mg, once-daily
arm group label: PF-05221304 - 50 mg
arm group type: Active Comparator
description: PF-05221304 - 50 mg, once-daily
intervention type: Drug
intervention name: Placebo
description: Placebo
arm group label: Placebo
intervention type: Drug
intervention name: PF-05221304
description: PF-05221304, Experimental Drug
arm group label: PF-05221304 - 10 mg
arm group label: PF-05221304 - 2 mg
arm group label: PF-05221304 - 25 mg
arm group label: PF-05221304 - 50 mg
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
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country: Australia
country: Canada
country: Israel
country: Poland
country: Taiwan
country: United States
url: https://pmiform.com/clinical-trial-info-request?StudyID=C1171002
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
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