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

ID#: NCT04321031

Age: 18 - 75 years

Gender: All

Healthy Subjects: No

Study Phase: Phase 2

Recruitment Status: Recruiting

Start Date: June 15, 2020

End Date: December 01, 2022

Contact Information:
Pfizer CT.gov Call Center
1-800-718-1021
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).
Eligibility:

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,