Phase 2a, Dose-ranging Study With PF-05221304 in Nonalcoholic Fatty Liver Disease (NAFLD)

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NCT03248882

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Study Location
Franco Felizarta MD
Bakersfield, California, 93301, United States
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Contact
1-800-718-1021
ClinicalTrials.gov_In[email protected]
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Contact a representative by phone, email, or visiting the study website. Please see the references below:

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Pfizer Clinical Trials Contact Center

1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Nonalcoholic Fatty Liver Disease, Nonalcoholic Steatohepatitis
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-70 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Body Mass Index >= 25 kg/m2

- Body Weight > 50 kg

- Liver fat (assessed via MRI-PDFF) >= 8%

- Biopsy-proven NASH - diagnosed in previous 24-months

- Presumed NASH - per Sponsor's definition

- NAFLD with minimal inflammation/fibrosis

- Features of Metabolic Syndrome

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- Alcohol-induced steatohepatitis or other forms of chronic liver disease


- Positive for Hepatitis B, Hepatitis C, or Human Deficiency Virus


- Severe Renal Impairment


- Contraindications for MRI

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Nonalcoholic Fatty Liver Disease, Nonalcoholic SteatohepatitisPhase 2a, Dose-ranging Study With PF-05221304 in Nonalcoholic Fatty Liver Disease (NAFLD)
NCT03248882
  1. Bakersfield, California
  2. Chula Vista, California
  3. Chula Vista, California
  4. La Jolla, California
  5. La Jolla, California
  6. La Mesa, California
  7. Lincoln, California
  8. Los Angeles, California
  9. Palo Alto, California
  10. Palo Alto, California
  11. Pasadena, California
  12. Rialto, California
  13. San Diego, California
  14. San Francisco, California
  15. Englewood, Colorado
  16. Jacksonville, Florida
  17. Jacksonville, Florida
  18. Miami Springs, Florida
  19. Miami, Florida
  20. Miami, Florida
  21. Orange City, Florida
  22. Orlando, Florida
  23. Palm Harbor, Florida
  24. South Miami, Florida
  25. Tampa, Florida
  26. Tampa, Florida
  27. Wellington, Florida
  28. Wellington, Florida
  29. Honolulu, Hawaii
  30. Honolulu, Hawaii
  31. Indianapolis, Indiana
  32. Wichita, Kansas
  33. Wichita, Kansas
  34. New Orleans, Louisiana
  35. New Orleans, Louisiana
  36. Baltimore, Maryland
  37. Catonsville, Maryland
  38. Ann Arbor, Michigan
  39. Detroit, Michigan
  40. Rochester, Minnesota
  41. Flowood, Mississippi
  42. Jackson, Mississippi
  43. Rochester, New York
  44. Chapel Hill, North Carolina
  45. Chapel Hill, North Carolina
  46. Chapel Hill, North Carolina
  47. Raleigh, North Carolina
  48. Wilmington, North Carolina
  49. Winston-Salem, North Carolina
  50. Cincinnati, Ohio
  51. Chattanooga, Tennessee
  52. Chattanooga, Tennessee
  53. Austin, Texas
  54. Houston, Texas
  55. Rollingwood, Texas
  56. San Antonio, Texas
  57. San Antonio, Texas
  58. Layton, Utah
  59. Richmond, Virginia
  60. Seattle, Washington
  61. Maroubra, New South Wales
  62. Randwick, New South Wales
  63. Westmead, New South Wales
  64. Westmead, New South Wales
  65. Adelaide, South Australia
  66. Adelaide, South Australia
  67. Adelaide, South Australia
  68. Adelaide, South Australia
  69. Parkville, Victoria
  70. Vancouver, British Columbia
  71. Vancouver, British Columbia
  72. Vancouver, British Columbia
  73. Vancouver, British Columbia
  74. Victoria, British Columbia
  75. Victoria, British Columbia
  76. Halifax, Nova Scotia
  77. Halifax, Nova Scotia
  78. Halifax, Nova Scotia
  79. Brampton, Ontario
  80. London, Ontario
  81. London, Ontario
  82. Mississauga, Ontario
  83. Toronto, Ontario
  84. Toronto, Ontario
  85. Toronto, Ontario
  86. Toronto, Ontario
  87. Toronto, Ontario
  88. Toronto, Ontario
  89. Toronto, Ontario
  90. Chicoutimi, Quebec
  91. Chicoutimi, Quebec
  92. Montreal, Quebec
  93. Montreal, Quebec
  94. Montreal, Quebec
  95. Montreal, Quebec
  96. Montreal, Quebec
  97. Montreal, Quebec
  98. Montreal, Quebec
  99. Montreal, Quebec
  100. Sherbrooke, Quebec
  101. St-Jerome, Quebec
  102. Quebec,
  103. Quebec,
  104. Quebec,
  105. Quebec,
  106. Quebec,
  107. Quebec,
  108. Quebec,
  109. Quebec,
  110. Hadera,
  111. Haifa,
  112. Haifa,
  113. Jerusalem,
  114. Jerusalem,
  115. Nahariya,
  116. Nazareth,
  117. Petah Tikva,
  118. Ramat-Gan,
  119. Tel-Aviv,
  120. Bialystok,
  121. Gdansk,
  122. Gdansk,
  123. Gdynia,
  124. Jaworze,
  125. Katowice,
  126. Katowice,
  127. Krakow,
  128. Krakow,
  129. Lodz,
  130. Poznan,
  131. Rzeszow,
  132. Warszawa,
  133. Wroclaw,
  134. Wroclaw,
  135. Wroclaw,
  136. Changhua city, Changhua County
  137. Kaohsiung,
  138. Tainan,
  139. Taipei,
  140. Taipei,
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Phase 2a, Dose-ranging Study With PF-05221304 in Nonalcoholic Fatty Liver Disease (NAFLD)
Official Title  ICMJE 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
Brief Summary Phase 2a, dose-ranging Study with PF-05221304 in Nonalcoholic Fatty Liver Disease (NAFLD)
Detailed Description 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
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE 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.
Masking: Double (Participant, Investigator)
Masking Description:
Double-Blind
Primary Purpose: Treatment
Condition  ICMJE
  • Nonalcoholic Fatty Liver Disease
  • Nonalcoholic Steatohepatitis
Intervention  ICMJE
  • Drug: Placebo
    Placebo
  • Drug: PF-05221304
    PF-05221304, Experimental Drug
Study Arms  ICMJE
  • Placebo Comparator: Placebo
    Double-Blind, PF-05221304-matching Placebo
    Intervention: Drug: Placebo
  • Active Comparator: PF-05221304 - 2 mg
    PF-05221304 - 2 mg, once-daily
    Intervention: Drug: PF-05221304
  • Active Comparator: PF-05221304 - 10 mg
    PF-05221304 - 10 mg, once-daily
    Intervention: Drug: PF-05221304
  • Active Comparator: PF-05221304 - 25 mg
    PF-05221304 - 25 mg, once-daily
    Intervention: Drug: PF-05221304
  • Active Comparator: PF-05221304 - 50 mg
    PF-05221304 - 50 mg, once-daily
    Intervention: Drug: PF-05221304
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 12, 2019)		305
Original Estimated Enrollment  ICMJE
 (submitted: August 10, 2017)		360
Actual Study Completion Date  ICMJE March 27, 2019
Actual Primary Completion Date February 26, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Body Mass Index >= 25 kg/m2
  • Body Weight > 50 kg
  • Liver fat (assessed via MRI-PDFF) >= 8%
  • Biopsy-proven NASH - diagnosed in previous 24-months
  • Presumed NASH - per Sponsor's definition
  • NAFLD with minimal inflammation/fibrosis
  • Features of Metabolic Syndrome

Exclusion Criteria:

  • Alcohol-induced steatohepatitis or other forms of chronic liver disease
  • Positive for Hepatitis B, Hepatitis C, or Human Deficiency Virus
  • Severe Renal Impairment
  • Contraindications for MRI
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Canada,   Israel,   Poland,   Taiwan,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03248882
Other Study ID Numbers  ICMJE C1171002
2017-001156-55 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD:Yes
Plan 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/d….
URL:https://www.pfizer.com/science/clinical_trials/trial_data_and_results/d…
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date February 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP