Metabolic Interventions to Resolve Non-alcoholic Steatohepatitis (NASH) With Fibrosis (MIRNA)
About the study
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).
Who can take part
You may be eligible to participate in the study if you meet the following criteria:
INCLUSION CRITERIA
Inclusion Criteria:
- Biopsy proven NASH with either F2 or F3 fibrosis, per NASH CRN definition
- BMI >/= 22.5kg/m2
EXCLUSION CRITERIA
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,
Study Locations
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How to Apply
Contact the study center to learn if this study is a good match for you.
Study’s details
Contition
Nonalcoholic Fatty Liver Disease,Nonalcoholic Steatohepatitis With Liver Fibrosis
Age (in years)
18 - 75
Phase
Phase 2
Participants needed
258
Est. Completion Date
Feb 22, 2024
Treatment type
Interventional
Sponsor
Pfizer
ClinicalTrials.gov identifier
NCT04321031
Study number
C2541013
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