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

Completed · Phase 2 · Has a placebo group

Conditions studied: Nonalcoholic Fatty Liver Disease, Nonalcoholic Steatohepatitis With Liver Fibrosis

In brief

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).

Key facts

Study ID

NCT04321031

Run by

Pfizer

People needed

256

Starts

2020-06-15

Expected to finish

2024-02-21

Last updated by the study team

2025-03-21

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Biopsy proven NASH with either F2 or F3 fibrosis, per NASH CRN definition
• BMI >/= 22.5kg/m2

You may not qualify if…

• 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,

Where it is running

• Comprehensive Interventional Care Centers (CICC) — Gilbert, Arizona, United States
• The Institute for Liver Health — Glendale, Arizona, United States
• The Institute for Liver Health — Peoria, Arizona, United States
• Comprehensive Interventional Care Centers (CICC) — Sun City, Arizona, United States
• Institute for Liver Health DBA Arizona Liver Health — Tucson, Arizona, United States
• Hope Clinical Research — Canoga Park, California, United States
• Sharp Coronado Hospital — Coronado, California, United States
• Southern California Research Center — Coronado, California, United States
• Magnolia Surgery Center — El Cajon, California, United States
• Encino Hospital Medical Center — Encino, California, United States
• National Research Institute — Huntington Park, California, United States
• Investigational Drug Service, Altman Clinical and Translational Research Institute (ACTRI) — La Jolla, California, United States
• University of California San Diego, Altman Clinical and Translational Research Institute Clinic — La Jolla, California, United States
• UCSD Altman Clinical and Transitional Research Institute — La Jolla, California, United States
• A V Pediatrics, Allergy & Family Medicine — Lancaster, California, United States
• Jatinder S. Pruthi, M.D. FACG CPI — Lancaster, California, United States
• Om Research LLC — Lancaster, California, United States
• Kaiser Permanente Los Angeles Medical Center — Los Angeles, California, United States
• Cedars-Sinai Advanced Health Sciences Pavilion (Imaging) — Los Angeles, California, United States
• Cedars-Sinai Comprehensive Transplant Center — Los Angeles, California, United States
• Cedars-Sinai Medical Center Investigational Drug Services (Pharmacy) — Los Angeles, California, United States
• S. Mark Taper Foundation Imaging Center (Liver Biopsy) — Los Angeles, California, United States
• Providence Facey Medical Foundation — Mission Hills, California, United States
• Providence Holy Cross Medical Center — Mission Hills, California, United States
• Institute for Liver Health dba Arizona Liver Health — Chandler, Arizona, United States

Full record on ClinicalTrials.gov

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