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Metabolic Interventions to Resolve Non-alcoholic Steatohepatitis (NASH) With Fibrosis (MIRNA)
Recruiting
I'm InterestedTrial ID: NCT04321031
Purpose
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).
Official Title
A PHASE 2, RANDOMIZED, DOUBLE-BLIND, DOUBLE-DUMMY, PLACEBO-CONTROLLED, DOSE-RANGING, DOSE-FINDING, PARALLEL GROUP STUDY TO ASSESS EFFICACY AND SAFETY OF PF-06865571 (DGAT2I) ALONE AND WHEN COADMINISTERED WITH PF-05221304 (ACCI) IN ADULT PARTICIPANTS WITH BIOPSY-CONFIRMED NONALCOHOLIC STEATOHEPATITIS AND FIBROSIS STAGE 2 OR 3
Stanford Investigator(s)
Mindie H. Nguyen, MD, MAS, AGAF, FAASLD
Professor of Medicine (Gastroenterology and Hepatology) and, by courtesy, of Epidemiology and Population Health
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,
Intervention(s):
drug: Placebo
drug: PF-06865571
drug: PF-05221304
Recruiting
I'm InterestedContact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
SPECTRUM
6507224478