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

NCT04321031

Last updated date
Study Location
Altman Clinical and Translational Research Institute (ACTRI)
La Jolla, California, 92037, 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. La Jolla, California
  2. La Jolla, California
  3. La Jolla, California
  4. Bristol, Connecticut
  5. Beijing, Beijing
  6. Beijing,
  7. Nitra,
  8. Gilbert, Arizona
  9. Glendale, Arizona
  10. Sun City, Arizona
  11. Bakersfield, California
  12. Coronado, California
  13. Coronado, California
  14. El Cajon, California
  15. Huntington Park, California
  16. Lancaster, California
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  19. Los Angeles, California
  20. Los Angeles, California
  21. Los Angeles, California
  22. Los Angeles, California
  23. Los Angeles, California
  24. Monterey Park, California
  25. Palmdale, California
  26. Palo Alto, California
  27. Palo Alto, California
  28. Panorama City, California
  29. Panorama City, California
  30. Pasadena, California
  31. Pasadena, California
  32. Pasadena, California
  33. Pasadena, California
  34. Pasadena, California
  35. Redwood City, California
  36. Rialto, California
  37. Sacramento, California
  38. San Diego, California
  39. San Diego, California
  40. San Diego, California
  41. San Jose, California
  42. Tarzana, California
  43. Tustin, California
  44. Upland, California
  45. Bristol, Connecticut
  46. New Haven, Connecticut
  47. New Haven, Connecticut
  48. New Haven, Connecticut
  49. New Haven, Connecticut
  50. Brandon, Florida
  51. Brooksville, Florida
  52. Clearwater, Florida
  53. Clearwater, Florida
  54. Coral Gables, Florida
  55. Lakewood Ranch, Florida
  56. Maitland, Florida
  57. Maitland, Florida
  58. Miami Lakes, Florida
  59. Miami, Florida
  60. Miami, Florida
  61. Miami, Florida
  62. Miami, Florida
  63. Miami, Florida
  64. Oldsmar, Florida
  65. Orlando, Florida
  66. Orlando, Florida
  67. Saint Petersburg, Florida
  68. Sarasota, Florida
  69. Sarasota, Florida
  70. Tampa, Florida
  71. Zephyrhills, Florida
  72. Zephyrhills, Florida
  73. Atlanta, Georgia
  74. Atlanta, Georgia
  75. Sandy Springs, Georgia
  76. Snellville, Georgia
  77. Chicago, Illinois
  78. Brownsburg, Indiana
  79. Hendricks, Indiana
  80. Clive, Iowa
  81. Clive, Iowa
  82. Clive, Iowa
  83. Des Moines, Iowa
  84. Iowa City, Iowa
  85. Iowa City, Iowa
  86. Topeka, Kansas
  87. Wichita, Kansas
  88. Wichita, Kansas
  89. Lake Charles, Louisiana
  90. Lake Charles, Louisiana
  91. Marrero, Louisiana
  92. Marrero, Louisiana
  93. New Orleans, Louisiana
  94. Shreveport, Louisiana
  95. Shreveport, Louisiana
  96. Shreveport, Louisiana
  97. Catonsville, Maryland
  98. Columbia, Maryland
  99. Boston, Massachusetts
  100. Ann Arbor, Michigan
  101. Detroit, Michigan
  102. Grand Rapids, Michigan
  103. Grand Rapids, Michigan
  104. Wyoming, Michigan
  105. Jefferson City, Missouri
  106. Las Vegas, Nevada
  107. Las Vegas, Nevada
  108. Las Vegas, Nevada
  109. Las Vegas, Nevada
  110. Las Vegas, Nevada
  111. Hillsborough, New Jersey
  112. Hillsborough, New Jersey
  113. Raritan, New Jersey
  114. Manhasset, New York
  115. New York, New York
  116. New York, New York
  117. New York, New York
  118. New York, New York
  119. Raleigh, North Carolina
  120. Winston-Salem, North Carolina
  121. Winston-Salem, North Carolina
  122. Winston-Salem, North Carolina
  123. Oklahoma City, Oklahoma
  124. Oklahoma City, Oklahoma
  125. Oklahoma City, Oklahoma
  126. Philadelphia, Pennsylvania
  127. Pittsburgh, Pennsylvania
  128. Pittsburgh, Pennsylvania
  129. Pittsburgh, Pennsylvania
  130. Pittsburgh, Pennsylvania
  131. Pittsburgh, Pennsylvania
  132. West Reading, Pennsylvania
  133. Providence, Rhode Island
  134. Providence, Rhode Island
  135. Providence, Rhode Island
  136. Chattanooga, Tennessee
  137. Chattanooga, Tennessee
  138. Chattanooga, Tennessee
  139. Nashville, Tennessee
  140. Nashville, Tennessee
  141. Nashville, Tennessee
  142. Nashville, Tennessee
  143. Nashville, Tennessee
  144. Arlington, Texas
  145. Dallas, Texas
  146. Dallas, Texas
  147. Dallas, Texas
  148. Dallas, Texas
  149. DeSoto, Texas
  150. Houston, Texas
  151. Houston, Texas
  152. Houston, Texas
  153. Houston, Texas
  154. McAllen, Texas
  155. Pearland, Texas
  156. San Antonio, Texas
  157. San Antonio, Texas
  158. San Antonio, Texas
  159. San Antonio, Texas
  160. Sugar Land, Texas
  161. Draper, Utah
  162. Fairfax, Virginia
  163. Fairfax, Virginia
  164. Manassas, Virginia
  165. Norfolk, Virginia
  166. Norfolk, Virginia
  167. Richmond, Virginia
  168. Richmond, Virginia
  169. Richmond, Virginia
  170. Richmond, Virginia
  171. Virginia Beach, Virginia
  172. Virginia Beach, Virginia
  173. Seattle, Washington
  174. Seattle, Washington
  175. Seattle, Washington
  176. Seattle, Washington
  177. Seattle, Washington
  178. Seattle, Washington
  179. Plovdiv,
  180. Sofia,
  181. Sofia,
  182. Sofia,
  183. Sofia,
  184. Sofia,
  185. Sofia,
  186. Stara Zagora,
  187. Varna,
  188. Varna,
  189. Calgary, Alberta
  190. Edmonton, Alberta
  191. Edmonton, Alberta
  192. Vancouver, British Columbia
  193. Concord, Ontario
  194. London, Ontario
  195. Toronto, Ontario
  196. Toronto, Ontario
  197. Toronto, Ontario
  198. Toronto, Ontario
  199. Chicoutimi, Quebec
  200. Chicoutimi, Quebec
  201. Chicoutimi, Quebec
  202. Montreal, Quebec
  203. Montreal, Quebec
  204. Montreal, Quebec
  205. Montréal, Quebec
  206. Montréal, Quebec
  207. Guangzhou, Guangdong
  208. Hong Kong,
  209. Shatin,
  210. Tai Po,
  211. Surat, Gujarat
  212. Surat, Gujarat
  213. Mumbai, Maharashtra
  214. Pune, Maharashtra
  215. Saket, NEW Delhi
  216. Jaipur, Rajasthan
  217. Gurugram,
  218. New Delhi,
  219. Nagakute, Aichi
  220. Toon, Ehime
  221. Ogaki, Gifu
  222. Inashiki-gun, Ibaraki
  223. Takamatsu, Kagawa
  224. Yokohama, Kanagawa
  225. Matsumoto, Nagano
  226. Ohmura, Nagasaki
  227. Sakai, Osaka
  228. Suita, Osaka
  229. Izunokuni, Shizuoka
  230. Chiba,
  231. Fukui,
  232. Gifu,
  233. Kagoshima,
  234. Kyoto,
  235. Miyazaki,
  236. Saga,
  237. Yamagata,
  238. Dongjak-gu, Seoul
  239. Busan,
  240. Daegu,
  241. Seoul,
  242. Seoul,
  243. Katowice,
  244. Katowice,
  245. Katowice,
  246. Katowice,
  247. Katowice,
  248. Lodz,
  249. Myslowice,
  250. Warszawa,
  251. Zamosc,
  252. Zamosc,
  253. San Juan,
  254. San Juan,
  255. San Juan,
  256. Banska Bystrica,
  257. Bratislava - Mestska Cast Nove Mesto,
  258. Bratislava - Mestska Cast Ruzinov,
  259. Bratislava,
  260. Nitra,
  261. Changhua,
  262. Chia-Yi,
  263. Kaohsiung,
  264. Tainan,
  265. Taipei,
  266. Taipei,
  267. Taoyuan,
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,   China,   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 April 2021

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