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A Double-blind Study to Assess 2 Doses of an Investigational Product for 16 Weeks in Participants With Non-alcoholic Fatty Liver Disease and Type 2 Diabetes Mellitus
A Double-blind Study to Assess 2 Doses of an Investigational Product for 16 Weeks in Participants With Non-alcoholic Fatty Liver Disease and Type 2 Diabetes Mellitus

NCT03969719

CompletedPhase 2

Sponsor: Pfizer

Conditions: Non-alcoholic Steatohepatitis

Interventions: Placebo, PF-06835919, PF-06835919

Countries: United States, Canada

This is a double-blind, placebo-controlled study in adults with non-alcoholic steatohepatitis and Type 2 Diabetes Mellitis on stable dose of metformin monotherapy. Participants will be treated for 16 weeks with placebo or 1 of 2 doses of investigational product to determine the effect on liver fat, HbA1c, safety, tolerability and pharmacodynamics.

Eligibility overview

Sex: ALL

Age: 18 Years to 70 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
Inclusion Criteria:

* Males, or females of nonchildbearing potential
* 18 to 70 years of age
* Type 2 Diabetes Mellitus
* Liver fat \>/=8% by MRI-PDFF
* On stable dose of metformin monotherapy for at least 2 months (at a dose of at least 500 mg daily)

Exclusion Criteria:

* History of other liver disease
* Unable to have an MRI performed
* Significant weight loss in the previous month and/or participant in current weight loss program
* History of diabetic complications with end-organ damage
Locations (106)
  • Gilbert, Arizona, United States
  • Tempe, Arizona, United States
  • Anaheim, California, United States
  • Anaheim, California, United States
  • Canoga Park, California, United States
  • Chula Vista, California, United States
  • Coronado, California, United States
  • Coronado, California, United States
  • Harbor City, California, United States
  • Harbor City, California, United States
  • Inglewood, California, United States
  • La Mesa, California, United States
  • Lincoln, California, United States
  • Los Angeles, California, United States
  • Northridge, California, United States
  • Pasadena, California, United States
  • Rialto, California, United States
  • Sacramento, California, United States
  • San Diego, California, United States
  • San Diego, California, United States
  • San Diego, California, United States
  • Santa Ana, California, United States
  • Spring Valley, California, United States
  • Tarzana, California, United States
  • Thousand Oaks, California, United States
  • Tustin, California, United States
  • Atlantis, Florida, United States
  • Daytona Beach, Florida, United States
  • Doral, Florida, United States
  • Hallandale, Florida, United States
  • + 76 more on CT.gov