Trial Search Results

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

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).

Stanford is currently accepting patients for this trial.

Lead Sponsor:

Pfizer

Stanford Investigator(s):

Intervention(s):

  • Drug: Placebo
  • Drug: PF-06865571
  • Drug: PF-05221304

Phase:

Phase 2

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,

Ages Eligible for Study

18 Years - 75 Years

Genders Eligible for Study

All

Now accepting new patients

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
SPECTRUM
6507224478
Recruiting