Metabolic Interventions to Resolve Non-alcoholic Steatohepatitis (NASH) With Fibrosis (MIRNA) (MIRNA)
Nonalcoholic Fatty Liver Disease, Nonalcoholic Steatohepatitis With Liver Fibrosis
About this trial
This is an interventional basic science trial for Nonalcoholic Fatty Liver Disease
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,
Sites / Locations
- Institute for Liver Health dba Arizona Liver Health
- Comprehensive Interventional Care Centers (CICC)
- The Institute for Liver Health
- The Institute for Liver Health
- Comprehensive Interventional Care Centers (CICC)
- Institute for Liver Health DBA Arizona Liver Health
- Hope Clinical Research
- Sharp Coronado Hospital
- Southern California Research Center
- Magnolia Surgery Center
- Encino Hospital Medical Center
- National Research Institute
- Altman Clinical and Translational Research Institute (ACTRI)
- Investigational Drug Service, Altman Clinical and Translational Research Institute (ACTRI)
- University of California San Diego, Altman Clinical and Translational Research Institute Clinic
- UCSD Altman Clinical and Transitional Research Institute
- A V Pediatrics, Allergy & Family Medicine
- Jatinder S. Pruthi, M.D. FACG CPI
- Om Research LLC
- Kaiser Permanente Los Angeles Medical Center
- Cedars-Sinai Advanced Health Sciences Pavilion (Imaging)
- Cedars-Sinai Comprehensive Transplant Center
- Cedars-Sinai Medical Center Investigational Drug Services (Pharmacy)
- S. Mark Taper Foundation Imaging Center (Liver Biopsy)
- Providence Facey Medical Foundation
- Providence Holy Cross Medical Center
- ART Vascular
- ART Vascular
- United Medical Doctors
- Back Bay Imaging (Liver Biopsy)
- Advanced Imaging Center
- Blake Wilbur Outpatient Clinic (MRI)
- Stanford Hospital and Clinics
- Huntington-Hill Imaging Center, Cordova
- California Liver Research Institute
- HMRI
- Huntington Medical Research Institute
- Huntington-Hill Imaging Center, Fair Oaks
- Stanford Medicine Outpatient Center (Liver clinic/MRI)
- Inland Empire Clinical Trials, LLC
- Clinical Trials Research
- Precision Research Institute
- WR-MCCR
- Sharp and Children's MRI Center, LLC
- Stanford Cancer Center South Bay (MRI)
- Liberty Pacific Advanced Imaging
- Orange County Research Center
- Upland Clinical Research
- Bristol Hospital
- Bristol Radiology Center
- Connecticut Clinical Research Institute, LLC
- Yale New Haven Hospital
- Yale New Haven Hospital, Saint Raphael Campus (MRE location)
- Yale Center for Clinical Investigators, Church Street South Research Unit (CSRU)
- Yale Digestive Diseases (Fibroscan location)
- Tower Radiology (MRI-PDFF)
- Tower Radiology - Parsons
- Gastro Florida
- Gastro Florida
- Integrity Clinical Research, LLC
- Mayo Clinic Florida
- FDHS Pathology Lab
- Florida Research Institute
- Center for Advanced Gastroenterology
- Sandlake Imaging
- San Marcus Research Clinic, Inc.
- Optimus U Corporation
- Unique Imaging (Biscayne Imaging Center)
- Acevedo Clinical Research Associates
- Ivetmar Medical Group LLC
- Vascular and Interventional Specialists of Florida (Liver Biopsy)
- Care Research Center Inc
- TGH Imaging Powered by Tower Radiology Center (MRI)
- Clinical Neuroscience Solutions, Inc
- Omega Research Maitland, LLC
- Innovation Medical Research Center, Inc
- GCP, Global Clinical Professionals
- Gateway (Ultrasound)
- Partners Imaging Center
- Radiology Associates
- Center for Clinical Studies
- AdventHealth Zephyrhills
- Florida Medical Clinic, LLC
- Digestive Healthcare of Georgia
- Piedmont Atlanta Hospital/Piedmont Transplant Institute
- Piedmont Atlanta Hospital
- Columbus Regional Research Institute
- WR-Mount Vernon Clinical Research, LLC
- Tekton Research, Inc.
- Rush University Medical Center
- Investigators Research Group, LLC
- Hendricks Regional Health
- Heartland Medical Research, Inc. (Administrative Only)
- Iowa Digestive Disease Center
- Iowa Radiology
- MercyOne Des Moines Medical Center (Mercy Medical Center)
- University of Iowa Hospitals and Clinics
- University of Iowa Magnetic Resonance Research Facility
- Kansas Medical Clinic PA
- Alliance for Multispecialty Research, LLC
- Cypress Interventional
- Centex Studies, Inc.
- Lake Charles Memorial Hospital
- Metropolitan Gastroenterology Associates
- Tandem Clinical Research GI, LLC
- Ochsner Clinic Foundation
- Louisiana Research Center, LLC
- Gastro Health Research
- Gastro Center of Maryland
- Beth Israel Deaconess Medical Center
- Michigan Clinical Research Unit (MCRU)
- University of Michigan
- Henry Ford Health System
- Aa Mrc Llc
- Mercy Health
- M1 Imaging Center
- Gastroenterology Associates of Western Michigan, PLC d.b.a. West Michigan Clinical Research Center
- Mayo Clinic
- Jefferson City Medical Group, P.C.
- Desert Radiology
- Machuca Family Medicine
- The Machuca Foundation, Inc.
- Sierra Clinical Research
- Las Vegas Medical Research
- Pueblo Medical Imaging
- Digestive Healthcare Associates
- University Radiology
- Amici Clinical Research
- Northwell Health Center for Liver Diseases
- Icahn School of Medicine at Mount Sinai Beth Israel
- Mount Sinai Downtown Union Square
- Hess Building- CMS
- Icahn School of Medicine at Mount Sinai/The Mount Sinai Hospital
- The Mount Sinai Hospital: Department of Pharmacy
- M3-Wake Research, Inc.
- Gastroenterology Associates of the Piedmont, PA
- Novant Health Medical Center
- PMG Research of Winston-Salem, LLC
- Paramount Medical Research & Consulting, LLC
- Comprehensive Diagnostic Imaging
- Digestive Disease Specialists, Inc. Endoscopy Lab
- Digestive Disease Specialists, Inc.
- Oklahoma Spine Hospital
- Thomas Jefferson University
- UPMC - Center for Liver Diseases at the Thomas E. Starzl Institute
- UPMC - Center for Liver Diseases in the Digestive Disorders Clinic
- UPMC - Translational Research Center
- UPMC Presbyterian Shadyside; Presbyterian Campus Pharmacy
- UPMC
- University Gastroenterology
- Roger Williams Hospital
- Medical University of South Carolina
- MUSC- Ashley River Tower
- Chattanooga Imaging Center
- WR-Clinsearch, LLC
- Quality Medical Research, PLLC
- Vanderbilt University Medical Center - GI Research Office
- Vanderbilt Hepatology and Liver Transplant
- Vanderbilt University Medical Center - Digestive Disease Center
- Vanderbilt University Medical Center - Heart Station
- Vanderbilt University Medical Center - Interventional Radiology
- Texas Center for Interventional Surgery (Liver Biopsy Facility)
- Texas Clinical Research Institute
- Methodist Dallas Medical Center (Liver Biopsy)
- Methodist Dallas Medical Center (MRI-PDFF)
- The Liver Institute at Methodist Dallas Medical Center
- Touchstone Imaging
- Center For Diagnostic Imaging
- GI Alliance
- Therapeutic Concepts, PA
- Centex Studies, Inc.
- Biopharma Informatic, LLC
- Premier Vein and Vascular
- Centex Studies, Inc
- HCA Houston Healthcare Pearland
- American Research Corporation at the Texas Liver Institute
- Clinical Trials of Texas, Inc.
- Diabetes and Glandular Disease Clinic, P.A.
- Reddy Cardiac Wellness
- Impact Research Institute
- Gastro Health Research
- Manassas Clinical Research Center
- Digestive and Liver Disease Specialists
- Sentara Leigh Hospital
- McGuire VA Medical Center
- VCU Medical Center Investigational Drug Service
- Virginia Commonwealth University
- Virginia Gastroenterology Clinical Research
- Harborview Medical Center Investigational Drug Services
- Harborview Medical Center
- Seattle Radiology
- Liver Institute Northwest
- Swedish Medical Center
- University of Washington Medical Center
- MHAT Dr. Tota Venkova AD
- MHAT Medline Clinic AD
- Acibadem City Clinic MHAT Tokuda EAD
- DCC Alexandrovska EOOD
- UMHAT Alexandrovska EAD
- UMHAT Sv. Ivan Rilski EAD
- UMHAT Sofiamed OOD
- MC New Rehabilitation Center EOOD
- DCC Mladost-M Varna OOD
- MC VIP Clinic OOD
- University of Calgary - Heritage Medical Research Clinic (HMRC)
- University of Alberta Hospital
- University of Alberta
- Gordon and Leslie Diamond Health Care Centre
- (G.I.R.I.) GI Research Institute
- Nova Scotia Health Authority QEII (Queen Elizabeth II) Health Sciences Centre
- Manna Research (London)
- Toronto Liver Centre
- Resonance Magnetique du Saguenay-Lac-Saint-Jean
- Centre integre universitaire de sante et de services sociaux du Saguenay-Lac-Saint-Jean
- Ecogene-21
- McGill University Health Centre (MUHC)
- Philips Radiation Oncology
- Research Institute of the MUHC
- Centre de recherche du Centre hospitalier de l'Université de Montréal (CRCHUM)
- Diex Recherche Quebec Inc.
- Beijing Friendship Hospital, Capital Medical University
- The First Affiliated Hospital, Sun Yat-sen University
- The Third Hospital of Hebei Medical University
- Hunan Provincial People's Hospital
- The First Bethune Hospital of Jilin University
- General Hospital of Ningxia Medical University
- Qingdao Central Hospital
- The Affiliated Hospital of Hangzhou Normal University
- The First Affiliated Hospital of Wenzhou Medical University
- Peking University People's Hospital
- Beijing YouAn Hosptial,Capital Medical University
- Beijing Tsinghua Changgung Hospital
- Tianjin Third Central Hospital
- Tianjin Second People's Hospital
- Queen Mary Hospital
- Prince of Wales Hospital
- Alice Ho Miu Ling Nethersole Hospital
- Surat Institute of Digestive Sciences
- Gujarat Hospital - Gastro and Vascular Centre
- Global Hospital - Super Speciality & Transplant Centre
- Max Smart Super Speciality Hospital
- S.M.S. Medical College & Hospital
- Institute of Post Graduate Medical Education and Research & SSKM Hospital
- Medanta - The Medicity
- Institute of Liver and Biliary Sciences (ILBS)
- All India Institute of Medical Sciences (AIIMS)
- Aichi Medical University Hospital
- Ehime University Hospital
- Ogaki Municipal Hospital
- Tokyo Medical University Ibaraki Medical Center
- Kagawa Prefectural Central Hospital
- Yokohama City University Hospital
- Shinshu University Hospital
- National Hospital Organization Nagasaki Medical Center
- Osaka Rosai Hospital
- Saiseikai Suita Hospital
- Juntendo University Shizuoka Hospital
- Chiba University Hospital
- Fukui-Ken Saiseikai Hospital
- Gifu Municipal Hospital
- Kagoshima University Hospital
- University Hospital, Kyoto Prefectural University of Medicine
- Miyazaki Medical Center Hospital
- Saga University Hospital
- Yamagata University Hospital
- SMG-SNU Boramae Medical Center
- Pusan National University Hospital
- Kyungpook National University Hospital
- Yeungnam University Hospital
- Severance Hospital Yonsei University Health System
- Szpital Zakonu Bonifratrow
- NZOZ Vita Longa Sp. z o.o.
- Uniwersyteckie Centrum Kliniczne im. prof. K. Gibinskiego Slaskiego Uniwersytetu Medycznego
- Orthos Szpital Wielospecjalistyczny Sp. z o.o. (Liver Biopsy)
- SPZOZ Szpital Uniwersytecki w Krakowie
- Szpital Zakonu Bonifratrów św. Jana Grandego w Krakowie sp. z o.o. (Liver Biopsy)
- Krakowskie Centrum Medyczne
- Wojewodzki Specjalistyczny Szpital im. Dr. Wl. Bieganskiego w Lodzi
- ID Clinic
- WIP Warsaw IBD Point Profesor Kierkus
- Futuremeds Sp. z o.o.
- ETG Zamo??
- ETG Zamosc
- Samodzielny Publiczny Szpital Wojewodzki im. Papieza Jana Pawla II
- Clinical Research Puerto Rico
- Latin Clinical Trial Center
- GCM Medical Group PSC
- FDI Clinical Research
- Fakultna nemocnica s poliklinikou F. D. Roosevelta Banska Bystrica
- SUMMIT CLINICAL RESEARCH, s.r.o.
- Lama Medical Care s.r.o.
- Medispektrum, s.r.o
- Univerzitna nemocnica L. Pasteura Kosice
- KM Management spol. s.r.o., Gastroenterologicke a hepatologicke centrum Nitra
- Fakultna nemocnica Nitra
- JAL, s.r.o.
- Changhua Christian Hospital
- Ditmanson Medical Foundation Chia-Yi Christian Hospital
- Kaohsiung Medical University Chung-Ho Memorial Hospital
- National Cheng Kung University (NCKU) Hospital
- National Taiwan University Hospital
- Taipei Veterans General Hospital
- Chang Gung Medical Foundation Linkou Chang Gung Memorial Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm 7
Placebo Comparator
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Placebo
PF-06865571 25 milligrams (mg) twice daily (BID)
PF-06865571 75 mg BID
PF-06865571 150 mg BID
PF-06865571 300 mg BID
PF-06865571 (150 mg BID) + PF-05221304 (5 mg BID)
PF-06865771 (300 mg BID) + PF-05221304 (10 mg BID)
participants will receive medication for 48 weeks
participants will receive medication for 48 weeks
participants will receive medication for 48 weeks
participants will receive medication for 48 weeks
participants will receive medication for 48 weeks
participants will receive medication for 48 weeks
participants will receive medication for 48 weeks