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Metabolic Interventions to Resolve NASH with Fibrosis (MIRNA)

Condition: Nonalcoholic steatohepatitis, fibrosis

Eligibility

Key Inclusion Criteria:

  • Between 18-75 years old (or the minimum country-specific age of consent if >18)
  • BMI ≥25 kg/m2 (in Africa, Europe, North/South America) or ≥22.5 kg/m2 (in Asia)
  • Ultrasound-guided liver biopsy meeting the NASH Clinical Research Network definition

Key Exclusion Criteria:

  • Current significant alcohol consumption
  • Evidence of other causes of liver disease
  • History of pancreatitis

Study Name

A Phase II, Randomized, Double-Blind, Double-Dummy, PHASE 2, Placebo-Controlled, Dose-Ranging, Dose-Finding, Parallel Group Study to Assess Efficacy and Safety of PF-06865571 (DGAT2I) Alone and When Co-Administered With PF-05221304 (ACCI) in Adult Participants With Biopsy-Confirmed Nonalcoholic Steatohepatitis and Fibrosis Stage 2 or 3 (IRB no. 00000691)

Summary

This study focuses on individuals who may have an abnormally high amount of fat and swelling (inflammation) of the liver along with some fibrosis (scarring) that is not related to excessive alcohol consumption. The purpose of the study is to determine whether the investigational drugs PF-06865571 and PF-05221304 (PF-06865571 alone or when given together with PF-05221304) improve nonalcoholic steatohepatitis (NASH) with liver fibrosis compared to placebo (inactive substance).

Both PF-06865571 and PF-05221304 block specific proteins/enzymes and reduce the amount of fat made by the liver. This may subsequently (or indirectly) decrease inflammation and scarring of the liver and hence treat NASH with liver fibrosis. Researchers aim to identify the dose that works best by measuring the body’s response to the drug on specific tests.

Principal Investigator
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