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

NCT04321031

Last updated date
Study Location
Cedars-Sinai Advanced Health Sciences Pavilion (Imaging)
Los Angeles, California, 90048, United States
Contact
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 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. Los Angeles, California
  2. Los Angeles, California
  3. Los Angeles, California
  4. Los Angeles, California
  5. New Haven, Connecticut
  6. New Haven, Connecticut
  7. New Haven, Connecticut
  8. New Haven, Connecticut
  9. Oldsmar, Florida
  10. Chicago, Illinois
  11. New Orleans, Louisiana
  12. Ann Arbor, Michigan
  13. Dallas, Texas
  14. DeSoto, Texas
  15. Norfolk, Virginia
  16. Richmond, Virginia
  17. Richmond, Virginia
  18. Richmond, Virginia
  19. Richmond, Virginia
  20. Sofia,
  21. Sofia,
  22. Hong Kong,
  23. Mumbai, Maharashtra
  24. Saket, NEW Delhi
  25. Jaipur, Rajasthan
  26. Gilbert, Arizona
  27. Glendale, Arizona
  28. Sun City, Arizona
  29. Bakersfield, California
  30. Coronado, California
  31. Coronado, California
  32. El Cajon, California
  33. Huntington Park, California
  34. Lancaster, California
  35. Lancaster, California
  36. Lancaster, California
  37. Los Angeles, California
  38. Monterey Park, California
  39. Palmdale, California
  40. Panorama City, California
  41. Panorama City, California
  42. Pasadena, California
  43. Pasadena, California
  44. Pasadena, California
  45. Pasadena, California
  46. Pasadena, California
  47. Rialto, California
  48. Sacramento, California
  49. San Diego, California
  50. San Diego, California
  51. San Diego, California
  52. Tarzana, California
  53. Tustin, California
  54. Upland, California
  55. Brandon, Florida
  56. Brooksville, Florida
  57. Clearwater, Florida
  58. Coral Gables, Florida
  59. Lakewood Ranch, Florida
  60. Maitland, Florida
  61. Maitland, Florida
  62. Miami Lakes, Florida
  63. Miami, Florida
  64. Miami, Florida
  65. Miami, Florida
  66. Miami, Florida
  67. Miami, Florida
  68. Orlando, Florida
  69. Orlando, Florida
  70. Saint Petersburg, Florida
  71. Sarasota, Florida
  72. Sarasota, Florida
  73. Tampa, Florida
  74. Zephyrhills, Florida
  75. Zephyrhills, Florida
  76. Atlanta, Georgia
  77. Atlanta, Georgia
  78. Sandy Springs, Georgia
  79. Snellville, Georgia
  80. Brownsburg, Indiana
  81. Hendricks, Indiana
  82. Clive, Iowa
  83. Clive, Iowa
  84. Clive, Iowa
  85. Des Moines, Iowa
  86. Iowa City, Iowa
  87. Iowa City, Iowa
  88. Topeka, Kansas
  89. Wichita, Kansas
  90. Wichita, Kansas
  91. Lake Charles, Louisiana
  92. Lake Charles, Louisiana
  93. Marrero, Louisiana
  94. Marrero, Louisiana
  95. Shreveport, Louisiana
  96. Catonsville, Maryland
  97. Columbia, Maryland
  98. Detroit, Michigan
  99. Grand Rapids, Michigan
  100. Grand Rapids, Michigan
  101. Wyoming, Michigan
  102. Jefferson City, Missouri
  103. Las Vegas, Nevada
  104. Las Vegas, Nevada
  105. Las Vegas, Nevada
  106. Las Vegas, Nevada
  107. Las Vegas, Nevada
  108. Hillsborough, New Jersey
  109. Hillsborough, New Jersey
  110. Raritan, New Jersey
  111. Manhasset, New York
  112. Raleigh, North Carolina
  113. Winston-Salem, North Carolina
  114. Winston-Salem, North Carolina
  115. Winston-Salem, North Carolina
  116. Oklahoma City, Oklahoma
  117. Oklahoma City, Oklahoma
  118. Oklahoma City, Oklahoma
  119. Pittsburgh, Pennsylvania
  120. Pittsburgh, Pennsylvania
  121. Pittsburgh, Pennsylvania
  122. Pittsburgh, Pennsylvania
  123. Pittsburgh, Pennsylvania
  124. West Reading, Pennsylvania
  125. Providence, Rhode Island
  126. Providence, Rhode Island
  127. Providence, Rhode Island
  128. Chattanooga, Tennessee
  129. Chattanooga, Tennessee
  130. Chattanooga, Tennessee
  131. Nashville, Tennessee
  132. Arlington, Texas
  133. Dallas, Texas
  134. Dallas, Texas
  135. Dallas, Texas
  136. Houston, Texas
  137. Houston, Texas
  138. Houston, Texas
  139. Houston, Texas
  140. McAllen, Texas
  141. Pearland, Texas
  142. San Antonio, Texas
  143. San Antonio, Texas
  144. San Antonio, Texas
  145. San Antonio, Texas
  146. Sugar Land, Texas
  147. Draper, Utah
  148. Fairfax, Virginia
  149. Fairfax, Virginia
  150. Manassas, Virginia
  151. Norfolk, Virginia
  152. Virginia Beach, Virginia
  153. Virginia Beach, Virginia
  154. Seattle, Washington
  155. Seattle, Washington
  156. Seattle, Washington
  157. Seattle, Washington
  158. Seattle, Washington
  159. Seattle, Washington
  160. Plovdiv,
  161. Sofia,
  162. Sofia,
  163. Sofia,
  164. Stara Zagora,
  165. Varna,
  166. Varna,
  167. Calgary, Alberta
  168. Edmonton, Alberta
  169. Edmonton, Alberta
  170. Vancouver, British Columbia
  171. Concord, Ontario
  172. London, Ontario
  173. Toronto, Ontario
  174. Toronto, Ontario
  175. Toronto, Ontario
  176. Toronto, Ontario
  177. Toronto, Ontario
  178. Chicoutimi, Quebec
  179. Chicoutimi, Quebec
  180. Chicoutimi, Quebec
  181. Montreal, Quebec
  182. Montreal, Quebec
  183. Montreal, Quebec
  184. Surat, Gujarat
  185. Surat, Gujarat
  186. Pune, Maharashtra
  187. Nagakute, Aichi
  188. Toon, Ehime
  189. Ogaki, Gifu
  190. Inashiki-gun, Ibaraki
  191. Takamatsu, Kagawa
  192. Yokohama, Kanagawa
  193. Matsumoto, Nagano
  194. Ohmura, Nagasaki
  195. Sakai, Osaka
  196. Suita, Osaka
  197. Izunokuni, Shizuoka
  198. Chiba,
  199. Fukui,
  200. Gifu,
  201. Kagoshima,
  202. Kyoto,
  203. Miyazaki,
  204. Saga,
  205. Yamagata,
  206. Dongjak-gu, Seoul
  207. Busan,
  208. Daegu,
  209. Seoul,
  210. Seoul,
  211. Gdynia,
  212. Katowice,
  213. Katowice,
  214. Katowice,
  215. Katowice,
  216. Katowice,
  217. Krakow,
  218. Krakow,
  219. Myslowice,
  220. Warszawa,
  221. Zamosc,
  222. San Juan,
  223. San Juan,
  224. San Juan,
  225. Bratislava - Mestska Cast Nove Mesto,
  226. Bratislava - Mestska Cast Ruzinov,
  227. Bratislava,
  228. Nitra,
  229. Changhua,
  230. Chia-Yi,
  231. Kaohsiung,
  232. Tainan,
  233. Taipei,
  234. Taipei,
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,   Hong Kong,   India,   Japan,   Korea, Republic of,   Poland,   Puerto Rico,   Slovakia,   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 January 2021

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