Metabolic Interventions to Resolve Non-alcoholic Steatohepatitis (NASH) With Fibrosis (MIRNA)

NCT04321031

Last updated date
Study Location
Piedmont Atlanta Hospital/Piedmont Transplant Institute
Atlanta, Georgia, 30309, United States
Contact
1-800-718-1021

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By email

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[email protected]

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Nonalcoholic Fatty Liver Disease, Nonalcoholic Steatohepatitis With Liver Fibrosis
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-75 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Biopsy proven NASH with either F2 or F3 fibrosis, per NASH CRN definition

- BMI >/= 22.5kg/m2

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


- Evidence of other causes of liver disease such as Alcoholic steatohepatitis,
(de)compensated cirrhosis, active viral hepatitis


- Any condition possibly affecting drug absorption -Unstable concomitant medical
conditions, based on medical history or screening laboratory results including-


- unstable liver function tests, recent cardiovascular event(s) significant
malignancies,

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Nonalcoholic Fatty Liver Disease, Nonalcoholic Steatohepatitis With Liver FibrosisMetabolic Interventions to Resolve Non-alcoholic Steatohepatitis (NASH) With Fibrosis (MIRNA)
NCT04321031
  1. Atlanta, Georgia
  2. Atlanta, Georgia
  3. Brownsburg, Indiana
  4. Hendricks, Indiana
  5. Catonsville, Maryland
  6. Manassas, Virginia
  7. Plovdiv,
  8. Calgary, Alberta
  9. Toronto, Ontario
  10. Toronto, Ontario
  11. Toronto, Ontario
  12. Montreal, Quebec
  13. Montreal, Quebec
  14. Montreal, Quebec
  15. Krakow,
  16. Krakow,
  17. Mayaguez,
  18. Mayaguez,
  19. Ponce,
  20. Ponce,
  21. San Juan,
  22. Taipei,
  23. El Cajon, California
  24. Huntington Park, California
  25. Lancaster, California
  26. Lancaster, California
  27. Lancaster, California
  28. Monterey Park, California
  29. Palmdale, California
  30. Panorama City, California
  31. Panorama City, California
  32. Pasadena, California
  33. Pasadena, California
  34. Pasadena, California
  35. Pasadena, California
  36. Pasadena, California
  37. Rialto, California
  38. Sacramento, California
  39. San Diego, California
  40. San Diego, California
  41. San Diego, California
  42. Tarzana, California
  43. Tustin, California
  44. Upland, California
  45. Brandon, Florida
  46. Brooksville, Florida
  47. Clearwater, Florida
  48. Clearwater, Florida
  49. Coral Gables, Florida
  50. Lakewood Ranch, Florida
  51. Maitland, Florida
  52. Maitland, Florida
  53. Miami Lakes, Florida
  54. Miami, Florida
  55. Miami, Florida
  56. Miami, Florida
  57. Miami, Florida
  58. Miami, Florida
  59. Oldsmar, Florida
  60. Orlando, Florida
  61. Orlando, Florida
  62. Saint Petersburg, Florida
  63. Sarasota, Florida
  64. Sarasota, Florida
  65. Tampa, Florida
  66. Zephyrhills, Florida
  67. Zephyrhills, Florida
  68. Zephyrhills, Florida
  69. Snellville, Georgia
  70. Iowa City, Iowa
  71. Iowa City, Iowa
  72. Topeka, Kansas
  73. Wichita, Kansas
  74. Wichita, Kansas
  75. Lake Charles, Louisiana
  76. Lake Charles, Louisiana
  77. Marrero, Louisiana
  78. Marrero, Louisiana
  79. Shreveport, Louisiana
  80. Columbia, Maryland
  81. Detroit, Michigan
  82. Grand Rapids, Michigan
  83. Grand Rapids, Michigan
  84. Wyoming, Michigan
  85. Las Vegas, Nevada
  86. Las Vegas, Nevada
  87. Las Vegas, Nevada
  88. Las Vegas, Nevada
  89. Las Vegas, Nevada
  90. Hillsborough, New Jersey
  91. Hillsborough, New Jersey
  92. Raritan, New Jersey
  93. Manhasset, New York
  94. Raleigh, North Carolina
  95. Winston-Salem, North Carolina
  96. Winston-Salem, North Carolina
  97. Winston-Salem, North Carolina
  98. Oklahoma City, Oklahoma
  99. Oklahoma City, Oklahoma
  100. Oklahoma City, Oklahoma
  101. Providence, Rhode Island
  102. Providence, Rhode Island
  103. Providence, Rhode Island
  104. Chattanooga, Tennessee
  105. Chattanooga, Tennessee
  106. Nashville, Tennessee
  107. Arlington, Texas
  108. Dallas, Texas
  109. DeSoto, Texas
  110. Houston, Texas
  111. Houston, Texas
  112. Houston, Texas
  113. Houston, Texas
  114. Houston, Texas
  115. McAllen, Texas
  116. Pearland, Texas
  117. San Antonio, Texas
  118. San Antonio, Texas
  119. San Antonio, Texas
  120. San Antonio, Texas
  121. Sugar Land, Texas
  122. Draper, Utah
  123. Fairfax, Virginia
  124. Fairfax, Virginia
  125. Norfolk, Virginia
  126. Norfolk, Virginia
  127. Virginia Beach, Virginia
  128. Virginia Beach, Virginia
  129. Seattle, Washington
  130. Seattle, Washington
  131. Seattle, Washington
  132. Sofia,
  133. Stara Zagora,
  134. Varna,
  135. Varna,
  136. Vancouver, British Columbia
  137. Concord, Ontario
  138. London, Ontario
  139. Toronto, Ontario
  140. Toronto, Ontario
  141. Chicoutimi, Quebec
  142. Chicoutimi, Quebec
  143. Chicoutimi, Quebec
  144. Nagakute, Aichi
  145. Toon, Ehime
  146. Ogaki, Gifu
  147. Inashiki-gun, Ibaraki
  148. Takamatsu, Kagawa
  149. Yokohama, Kanagawa
  150. Matsumoto, Nagano
  151. Ohmura, Nagasaki
  152. Sakai, Osaka
  153. Suita, Osaka
  154. Izunokuni, Shizuoka
  155. Chiba,
  156. Fukui,
  157. Gifu,
  158. Kagoshima,
  159. Kyoto,
  160. Miyazaki,
  161. Saga,
  162. Yamagata,
  163. Dongjak-gu, Seoul
  164. Busan,
  165. Daegu,
  166. Seoul,
  167. Seoul,
  168. Katowice,
  169. Katowice,
  170. Myslowice,
  171. Warszawa,
  172. Zamosc,
  173. Zamosc,
  174. San Juan,
  175. San Juan,
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Metabolic Interventions to Resolve Non-alcoholic Steatohepatitis (NASH) With Fibrosis (MIRNA)
Official Title  ICMJE A PHASE 2, RANDOMIZED, DOUBLE-BLIND, DOUBLE-DUMMY, PLACEBO-CONTROLLED, DOSE-RANGING, DOSE-FINDING, PARALLEL GROUP STUDY TO ASSESS EFFICACY AND SAFETY OF PF-06865571 (DGAT2I) ALONE AND WHEN COADMINISTERED WITH PF-05221304 (ACCI) IN ADULT PARTICIPANTS WITH BIOPSY-CONFIRMED NONALCOHOLIC STEATOHEPATITIS AND FIBROSIS STAGE 2 OR 3
Brief Summary The study aims to evaluate two, orally administered, investigational agents - PF-06865571 (DGAT2 inhibitor) and the coadministration of PF-06865571 with PF-05221304 (ACC inhibitor). This study is specifically designed to evaluate the effect of a range of doses of DGAT2i alone, and DGAT2i + ACCi, on resolution of NASH or improvement in liver fibrosis, as assessed histologically (via liver biopsy).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
dose ranging, dose finding
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:
Double blind, double dummy, placebo controlled
Primary Purpose: Basic Science
Condition  ICMJE
  • Nonalcoholic Fatty Liver Disease
  • Nonalcoholic Steatohepatitis With Liver Fibrosis
Intervention  ICMJE
  • Drug: Placebo
    Tablet
  • Drug: PF-06865571
    Tablet
  • Drug: PF-05221304
    Tablet
Study Arms  ICMJE
  • Placebo Comparator: Placebo
    participants will receive medication for 48 weeks
    Intervention: Drug: Placebo
  • Experimental: PF-06865571 25 milligrams (mg) twice daily (BID)
    participants will receive medication for 48 weeks
    Intervention: Drug: PF-06865571
  • Experimental: PF-06865571 75 mg BID
    participants will receive medication for 48 weeks
    Intervention: Drug: PF-06865571
  • Experimental: PF-06865571 150 mg BID
    participants will receive medication for 48 weeks
    Intervention: Drug: PF-06865571
  • Experimental: PF-06865571 300 mg BID
    participants will receive medication for 48 weeks
    Intervention: Drug: PF-06865571
  • Experimental: PF-06865571 150 mg once daily (QD) + placebo QD
    participants will receive medication for 48 weeks
    Interventions:
    • Drug: Placebo
    • Drug: PF-06865571
  • Experimental: PF-06865571 300 mg QD + placebo QD
    participants will receive medication for 48 weeks
    Interventions:
    • Drug: Placebo
    • Drug: PF-06865571
  • Experimental: PF-06865571 (150 mg BID) + PF-05221304 (5 mg BID)
    participants will receive medication for 48 weeks
    Interventions:
    • Drug: PF-06865571
    • Drug: PF-05221304
  • Experimental: PF-06865771 (300 mg BID) + PF-05221304 (10 mg BID)
    participants will receive medication for 48 weeks
    Interventions:
    • Drug: PF-06865571
    • 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 Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 23, 2020)
450
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 1, 2022
Estimated Primary Completion Date November 1, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Biopsy proven NASH with either F2 or F3 fibrosis, per NASH CRN definition
  • BMI >/= 22.5kg/m2

Exclusion Criteria:

  • Evidence of other causes of liver disease such as Alcoholic steatohepatitis, (de)compensated cirrhosis, active viral hepatitis
  • Any condition possibly affecting drug absorption -Unstable concomitant medical conditions, based on medical history or screening laboratory results including-
  • unstable liver function tests, recent cardiovascular event(s) significant malignancies,
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Pfizer CT.gov Call Center1-800-718-1021[email protected]
Listed Location Countries  ICMJE Bulgaria,   Canada,   Japan,   Korea, Republic of,   Poland,   Puerto Rico,   Taiwan,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04321031
Other Study ID Numbers  ICMJE C2541013
2019-004775-39 ( 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 October 2020

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