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

NCT04321031

Last updated date
Study Location
A V Pediatrics, Allergy & Family Medicine
Lancaster, California, 93534, 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. Lancaster, California
  2. Lancaster, California
  3. Lancaster, California
  4. Palmdale, California
  5. Panorama City, California
  6. Panorama City, California
  7. Pasadena, California
  8. San Diego, California
  9. Tarzana, California
  10. Tampa, Florida
  11. Wichita, Kansas
  12. Wichita, Kansas
  13. Marrero, Louisiana
  14. Marrero, Louisiana
  15. Shreveport, Louisiana
  16. Columbia, Maryland
  17. Detroit, Michigan
  18. Las Vegas, Nevada
  19. Las Vegas, Nevada
  20. Las Vegas, Nevada
  21. Las Vegas, Nevada
  22. Houston, Texas
  23. McAllen, Texas
  24. San Antonio, Texas
  25. San Antonio, Texas
  26. Yokohama, Kanagawa
  27. Chiba,
  28. Yamagata,
  29. San Juan,
  30. El Cajon, California
  31. Huntington Park, California
  32. Monterey Park, 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. Tustin, California
  42. Coral Gables, Florida
  43. Lakewood Ranch, Florida
  44. Miami Lakes, Florida
  45. Miami, Florida
  46. Miami, Florida
  47. Miami, Florida
  48. Orlando, Florida
  49. Orlando, Florida
  50. Saint Petersburg, Florida
  51. Sarasota, Florida
  52. Sarasota, Florida
  53. Topeka, Kansas
  54. Lake Charles, Louisiana
  55. Lake Charles, Louisiana
  56. Las Vegas, Nevada
  57. Raleigh, North Carolina
  58. Winston-Salem, North Carolina
  59. Winston-Salem, North Carolina
  60. Winston-Salem, North Carolina
  61. Providence, Rhode Island
  62. Providence, Rhode Island
  63. Providence, Rhode Island
  64. Chattanooga, Tennessee
  65. Chattanooga, Tennessee
  66. Nashville, Tennessee
  67. Arlington, Texas
  68. Dallas, Texas
  69. DeSoto, Texas
  70. Houston, Texas
  71. Houston, Texas
  72. Houston, Texas
  73. Houston, Texas
  74. Pearland, Texas
  75. San Antonio, Texas
  76. Sugar Land, Texas
  77. Draper, Utah
  78. Brampton, Ontario
  79. Chicoutimi, Quebec
  80. Chicoutimi, Quebec
  81. Chicoutimi, Quebec
  82. Izunokuni, Shizuoka
  83. Fukui,
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 Canada,   Japan,   Puerto Rico,   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 August 2020

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