Summary:
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 alone and when Coadministered with PF-05221304 in Adults with NASH with liver fibrosis.
The purpose of the this Study is to learn if the study drug alone or when given together will imporve NASH with liver Fibrosis compared to placebo. It is thought that this will subsequently decrease inflammation (swelling) and scarring (fibrosis) of the liver and hence treat NASH with liver fibrosis.
Qualified Participants Must:
• Men or Woman, age 18-75 with Fatty Liver or NASH
OR
•
Diagnosed with 2 of the following conditions:-
Obesity
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High Blood Pressure or on Blood Pressure Medication
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Waist circumference of greater than 40 inches for men or greater than 35 inches for women
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Diabetic Type 2
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Have High Cholesterol or taking Medication for High Cholesterol/Triglycerides
Must be available to participate 15.5 – 17 months with approximately 22 visits.
Qualified Participants May Receive:
Participants will receive at no cost to them:Insurance is not needed
- Fibroscan/Ultrasound of the liver
- Study related exams
- Study related testing
- Compensation for time and travel
- MRI If applicable-
- Liver testing if applicable-