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

NCT04321031

CompletedPhase 2

Sponsor: Pfizer

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

Interventions: Placebo, PF-06865571, PF-05221304

Countries: United States, Bulgaria, Canada, China, Hong Kong, India, Japan, Poland

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 overview

Sex: ALL

Age: 18 Years to 75 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
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,
Locations (291)
  • Chandler, Arizona, United States
  • Gilbert, Arizona, United States
  • Glendale, Arizona, United States
  • Peoria, Arizona, United States
  • Sun City, Arizona, United States
  • Tucson, Arizona, United States
  • Canoga Park, California, United States
  • Coronado, California, United States
  • Coronado, California, United States
  • El Cajon, California, United States
  • Encino, California, United States
  • Huntington Park, California, United States
  • La Jolla, California, United States
  • La Jolla, California, United States
  • La Jolla, California, United States
  • Lancaster, California, United States
  • Lancaster, California, United States
  • Lancaster, California, United States
  • Los Angeles, California, United States
  • Los Angeles, California, United States
  • Los Angeles, California, United States
  • Los Angeles, California, United States
  • Los Angeles, California, United States
  • Mission Hills, California, United States
  • Mission Hills, California, United States
  • Montebello, California, United States
  • Murrieta, California, United States
  • Newport Beach, California, United States
  • Palmdale, California, United States
  • Palo Alto, California, United States
  • + 261 more on CT.gov