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

April 2, 2024 updated by: Pfizer

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

258

Phase

Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Bulgaria
- - Gabrovo, Bulgaria, 5300
    - Mhat Dr. Tota Venkova Ad
  - Plovdiv, Bulgaria, 4002
    - MHAT Medline Clinic AD
  - Sofia, Bulgaria, 1407
    - Acibadem City Clinic MHAT Tokuda EAD
  - Sofia, Bulgaria, 1431
    - DCC Alexandrovska EOOD
  - Sofia, Bulgaria, 1431
    - UMHAT Alexandrovska EAD
  - Sofia, Bulgaria, 1431
    - Umhat Sv. Ivan Rilski Ead
  - Sofia, Bulgaria, 1797
    - UMHAT Sofiamed OOD
  - Stara Zagora, Bulgaria, 6001
    - MC New Rehabilitation Center EOOD
  - Varna, Bulgaria, 9020
    - DCC Mladost-M Varna OOD
  - Varna, Bulgaria, 9020
    - MC VIP Clinic OOD
Canada
- - Quebec, Canada, G1V 4T3
    - Diex Recherche Quebec Inc.
- Alberta
  - Calgary, Alberta, Canada, T2N 4Z6
    - University of Calgary - Heritage Medical Research Clinic (HMRC)
  - Edmonton, Alberta, Canada, T6G 2B7
    - University of Alberta Hospital
  - Edmonton, Alberta, Canada, T6G 2X8
    - University of Alberta
- British Columbia
  - Vancouver, British Columbia, Canada, V5Z 1M9
    - Gordon and Leslie Diamond Health Care Centre
  - Vancouver, British Columbia, Canada, V6Z 2K5
    - (G.I.R.I.) GI Research Institute
- Nova Scotia
  - Halifax, Nova Scotia, Canada, B3H 1V7
    - Nova Scotia Health Authority QEII (Queen Elizabeth II) Health Sciences Centre
- Ontario
  - London, Ontario, Canada, N6A 2C2
    - Manna Research (London)
  - Toronto, Ontario, Canada, M6H 3M1
    - Toronto Liver Centre
- Quebec
  - Chicoutimi, Quebec, Canada, G7H 7K9
    - Ecogene-21
  - Chicoutimi, Quebec, Canada, G7H 4J1
    - Resonance Magnetique du Saguenay-Lac-Saint-Jean
  - Chicoutimi, Quebec, Canada, G7H 5H6
    - Centre integre universitaire de sante et de services sociaux du Saguenay-Lac-Saint-Jean
  - Montreal, Quebec, Canada, H4A 3J1
    - McGill University Health Centre (MUHC)
  - Montreal, Quebec, Canada, H4A 3J1
    - Philips Radiation Oncology
  - Montreal, Quebec, Canada, H4A 3J1
    - Research Institute of the MUHC
  - Montréal, Quebec, Canada, H2X 0A9
    - Centre de Recherche du Centre Hospitalier de l'Universite de Montreal (CRCHUM)
China
- - Beijing, China, 100044
    - Peking University People's Hospital
  - Beijing, China, 102218
    - Beijing Tsinghua Changgung Hospital
  - Beijing, China, 100069
    - Beijing YouAn Hosptial,Capital Medical University
  - Tianjin, China, 300170
    - Tianjin Third Central Hospital
  - Tianjin, China, 300192
    - Tianjin Second People's Hospital
- Beijing
  - Beijing, Beijing, China, 100050
    - Beijing Friendship Hospital, Capital Medical University
- Guangdong
  - Guangzhou, Guangdong, China, 510080
    - The First Affiliated Hospital, Sun Yat-sen University
- Hebei
  - Shijiazhuang, Hebei, China, 050051
    - The Third Hospital of Hebei Medical University
- Hunan
  - Changsha, Hunan, China, 410005
    - Hunan Provincial People's Hospital
- Jilin
  - Changchun, Jilin, China, 130021
    - The First Bethune Hospital of Jilin University
- Ningxia
  - Yinchuan, Ningxia, China, 750004
    - General Hospital of Ningxia Medical University
- Shandong
  - Qingdao, Shandong, China, 266042
    - Qingdao Central Hospital
- Zhejiang
  - Hangzhou, Zhejiang, China, 310000
    - The Affiliated Hospital of Hangzhou Normal University
  - Wenzhou, Zhejiang, China, 325000
    - The First Affiliated Hospital of Wenzhou Medical University
Hong Kong
- - Hong Kong, Hong Kong
    - Queen Mary Hospital
  - Shatin, Hong Kong
    - Prince of Wales Hospital
  - Tai Po, Hong Kong
    - Alice Ho Miu Ling Nethersole Hospital
India
- - Gurugram, India, 122001
    - Medanta - The Medicity
  - New Delhi, India, 110 070
    - Institute of Liver and Biliary Sciences (ILBS)
  - New Delhi, India, 110029
    - All India Institute of Medical Sciences (AIIMS)
- Gujarat
  - Surat, Gujarat, India, 395009
    - Gujarat Hospital - Gastro and Vascular Centre
  - Surat, Gujarat, India, 395002
    - Surat Institute of Digestive Sciences
- Maharashtra
  - Mumbai, Maharashtra, India, 400012
    - Global Hospital - Super Speciality & Transplant Centre
- NEW Delhi
  - Saket, NEW Delhi, India, 110017
    - Max Smart Super Speciality Hospital
- Rajasthan
  - Jaipur, Rajasthan, India, 302004
    - S.M.S. Medical College & Hospital
- WEST Bengal
  - Kolkata, WEST Bengal, India, 700020
    - Institute of Post Graduate Medical Education and Research & SSKM Hospital
Japan
- - Chiba, Japan, 260-8677
    - Chiba University Hospital
  - Fukui, Japan, 918-8503
    - Fukui-ken Saiseikai Hospital
  - Gifu, Japan, 500-8513
    - Gifu Municipal Hospital
  - Kagoshima, Japan, 890-8520
    - Kagoshima University Hospital
  - Kyoto, Japan, 602-8566
    - University Hospital, Kyoto Prefectural University of Medicine
  - Miyazaki, Japan, 880-0003
    - Miyazaki Medical Center Hospital
  - Saga, Japan, 849-8501
    - Saga University Hospital
  - Yamagata, Japan, 990-9585
    - Yamagata University Hospital
- Aichi
  - Nagakute, Aichi, Japan, 480-1195
    - Aichi Medical University Hospital
- Ehime
  - Toon, Ehime, Japan, 791-0295
    - Ehime University Hospital
- Gifu
  - Ogaki, Gifu, Japan, 503-8502
    - Ogaki Municipal Hospital
- Ibaraki
  - Inashiki-gun, Ibaraki, Japan, 300-0395
    - Tokyo Medical University Ibaraki Medical Center
- Kagawa
  - Takamatsu, Kagawa, Japan, 760-8557
    - Kagawa Prefectural Central Hospital
- Kanagawa
  - Yokohama, Kanagawa, Japan, 236-0004
    - Yokohama City University Hospital
- Nagano
  - Matsumoto, Nagano, Japan, 3908621
    - Shinshu University Hospital
- Nagasaki
  - Ohmura, Nagasaki, Japan, 856-8562
    - National Hospital Organization Nagasaki Medical Center
- Osaka
  - Sakai, Osaka, Japan, 591-8025
    - Osaka Rosai Hospital
  - Suita, Osaka, Japan, 564-0013
    - Saiseikai Suita Hospital
- Shizuoka
  - Izunokuni, Shizuoka, Japan, 410-2295
    - Juntendo University Shizuoka Hospital
Korea, Republic of
- - Busan, Korea, Republic of, 49241
    - Pusan National University Hospital
  - Daegu, Korea, Republic of, 42415
    - Yeungnam University Hospital
  - Daegu, Korea, Republic of, 41944
    - Kyungpook National University Hospital
  - Seoul, Korea, Republic of, 03722
    - Severance Hospital Yonsei University Health System
- Seoul
  - Dongjak-gu, Seoul, Korea, Republic of, 07061
    - SMG-SNU Boramae Medical Center
Poland
- - Katowice, Poland, 40-211
    - Szpital Zakonu Bonifratrow
  - Katowice, Poland, 40-748
    - NZOZ Vita Longa Sp. z o.o.
  - Katowice, Poland, 40-752
    - Uniwersyteckie Centrum Kliniczne im. prof. K. Gibinskiego Slaskiego Uniwersytetu Medycznego
  - Komorowice, Poland, 52-229
    - Orthos Szpital Wielospecjalistyczny Sp. z o.o. (Liver Biopsy)
  - Krakow, Poland, 30-688
    - SPZOZ Szpital Uniwersytecki w Krakowie
  - Krakow, Poland, 31-061
    - Szpital Zakonu Bonifratrów św. Jana Grandego w Krakowie sp. z o.o. (Liver Biopsy)
  - Krakow, Poland, 31-501
    - Krakowskie Centrum Medyczne
  - Lodz, Poland, 91-347
    - Wojewodzki Specjalistyczny Szpital im. Dr. Wl. Bieganskiego w Lodzi
  - Myslowice, Poland, 41-400
    - ID Clinic
  - Warszawa, Poland, 00-728
    - WIP Warsaw IBD Point Profesor Kierkus
  - Wroclaw, Poland, 50-088
    - FutureMeds Sp. z o.o.
  - Zamosc, Poland, 22-400
    - ETG Zamosc
  - Zamosc, Poland, 22-400
    - Samodzielny Publiczny Szpital Wojewodzki im. Papieza Jana Pawla II
  - Zamosc, Poland, 22-400
    - ETG Zamo??
Puerto Rico
- - San Juan, Puerto Rico, 00909
    - Clinical Research Puerto Rico
  - San Juan, Puerto Rico, 00917
    - GCM Medical Group PSC
  - San Juan, Puerto Rico, 00909
    - Latin Clinical Trial Center
  - San Juan, Puerto Rico, 00927
    - FDI Clinical Research
Slovakia
- - Banska Bystrica, Slovakia, 974 01
    - Fakultna nemocnica s poliklinikou F. D. Roosevelta Banska Bystrica
  - Bratislava, Slovakia, 851 01
    - Medispektrum, s.r.o
  - Bratislava - Mestska Cast Nove Mesto, Slovakia, 831 01
    - Summit Clinical Research, s.r.o.
  - Bratislava - Mestska Cast Ruzinov, Slovakia, 831 04
    - Lama Medical Care s.r.o.
  - Kosice - Mestska Cast Zapad, Slovakia, 040 11
    - Univerzitna nemocnica L. Pasteura Kosice
  - Nitra, Slovakia, 949 01
    - KM Management spol. s.r.o., Gastroenterologicke a hepatologicke centrum Nitra
  - Nitra, Slovakia, 950 01
    - Fakultná nemocnica Nitra
  - Trnava, Slovakia, 917 01
    - JAL, s.r.o.
Taiwan
- - Chia-Yi, Taiwan, 600
    - Ditmanson Medical Foundation Chia-Yi Christian Hospital
  - Kaohsiung, Taiwan, 807
    - Kaohsiung Medical University Chung-Ho Memorial Hospital
  - Tainan, Taiwan, 704
    - National Cheng Kung University (NCKU) Hospital
  - Taipei, Taiwan, 100
    - National Taiwan University Hospital
  - Taipei, Taiwan, 11217
    - Taipei Veterans General Hospital
  - Taoyuan, Taiwan, 333
    - Chang Gung Medical Foundation Linkou Chang Gung Memorial Hospital
- Changhua County
  - Changhua City, Changhua County, Taiwan, 500
    - Changhua Christian Hospital
United States
- Arizona
  - Chandler, Arizona, United States, 85224
    - Institute for Liver Health DBA Arizona Liver Health
  - Gilbert, Arizona, United States, 85233
    - Comprehensive Interventional Care Centers (CICC)
  - Glendale, Arizona, United States, 85306
    - The Institute for Liver Health
  - Peoria, Arizona, United States, 85381
    - The Institute for Liver Health
  - Sun City, Arizona, United States, 85351
    - Comprehensive Interventional Care Centers (CICC)
  - Tucson, Arizona, United States, 85712
    - Institute for Liver Health DBA Arizona Liver Health
- California
  - Canoga Park, California, United States, 91303
    - Hope Clinical Research
  - Coronado, California, United States, 92118
    - Southern California Research Center
  - Coronado, California, United States, 92118
    - Sharp Coronado Hospital
  - El Cajon, California, United States, 92020
    - Magnolia Surgery Center
  - Encino, California, United States, 91436
    - Encino Hospital Medical Center
  - Huntington Park, California, United States, 90255
    - National Research Institute
  - La Jolla, California, United States, 92037
    - Altman Clinical and Translational Research Institute (ACTRI)
  - La Jolla, California, United States, 92037
    - Investigational Drug Service, Altman Clinical and Translational Research Institute (ACTRI)
  - La Jolla, California, United States, 92037
    - University of California San Diego, Altman Clinical and Translational Research Institute Clinic
  - La Jolla, California, United States, 92093
    - UCSD Altman Clinical and Transitional Research Institute
  - Lancaster, California, United States, 93534
    - Om Research LLC
  - Lancaster, California, United States, 93534
    - A V Pediatrics, Allergy & Family Medicine
  - Lancaster, California, United States, 93534
    - Jatinder S. Pruthi, M.D. FACG CPI
  - Los Angeles, California, United States, 90027
    - Kaiser Permanente Los Angeles Medical Center
  - Los Angeles, California, United States, 90048
    - Cedars-Sinai Advanced Health Sciences Pavilion (Imaging)
  - Los Angeles, California, United States, 90048
    - Cedars-Sinai Comprehensive Transplant Center
  - Los Angeles, California, United States, 90048
    - Cedars-Sinai Medical Center Investigational Drug Services (Pharmacy)
  - Los Angeles, California, United States, 90048
    - S. Mark Taper Foundation Imaging Center (Liver Biopsy)
  - Mission Hills, California, United States, 91345
    - Providence Facey Medical Foundation
  - Mission Hills, California, United States, 91345
    - Providence Holy Cross Medical Center
  - Montebello, California, United States, 90640
    - ART Vascular
  - Monterey Park, California, United States, 91754
    - ART Vascular
  - Murrieta, California, United States, 92563
    - United Medical Doctors
  - Newport Beach, California, United States, 92660
    - Back Bay Imaging (Liver Biopsy)
  - Palmdale, California, United States, 93551
    - Advanced Imaging Center
  - Palo Alto, California, United States, 94305
    - Stanford Hospital and Clinics
  - Palo Alto, California, United States, 94304
    - Blake Wilbur Outpatient Clinic (MRI)
  - Pasadena, California, United States, 91105
    - California Liver Research Institute
  - Pasadena, California, United States, 91101
    - Huntington-Hill Imaging Center, Cordova
  - Pasadena, California, United States, 91105
    - HMRI
  - Pasadena, California, United States, 91105
    - Huntington Medical Research Institute
  - Pasadena, California, United States, 91105
    - Huntington-Hill Imaging Center, Fair Oaks
  - Redwood City, California, United States, 94063
    - Stanford Medicine Outpatient Center (Liver clinic/MRI)
  - Rialto, California, United States, 92377
    - Inland Empire Clinical Trials, LLC
  - Sacramento, California, United States, 95821
    - Clinical Trials Research
  - San Diego, California, United States, 92114
    - Precision Research Institute
  - San Diego, California, United States, 92120
    - WR-MCCR
  - San Diego, California, United States, 92123-2731
    - Sharp and Children's MRI Center, LLC
  - San Jose, California, United States, 95124
    - Stanford Cancer Center South Bay (MRI)
  - Tarzana, California, United States, 91356
    - Liberty Pacific Advanced Imaging
  - Tustin, California, United States, 92780
    - Orange County Research Center
  - Upland, California, United States, 91786
    - Upland Clinical Research
- Connecticut
  - Bristol, Connecticut, United States, 06010
    - Bristol Hospital
  - Bristol, Connecticut, United States, 06010
    - Bristol Radiology Center
  - Bristol, Connecticut, United States, 06010
    - Connecticut Clinical Research Institute, LLC
  - New Haven, Connecticut, United States, 06510
    - Yale New Haven Hospital
  - New Haven, Connecticut, United States, 06511
    - Yale New Haven Hospital, Saint Raphael Campus (MRE location)
  - New Haven, Connecticut, United States, 06519
    - Yale Center for Clinical Investigators, Church Street South Research Unit (CSRU)
  - New Haven, Connecticut, United States, 06520
    - Yale Digestive Diseases (Fibroscan location)
- Florida
  - Brandon, Florida, United States, 33511
    - Tower Radiology (MRI-PDFF)
  - Brandon, Florida, United States, 33511
    - Tower Radiology - Parsons
  - Clearwater, Florida, United States, 33756
    - Gastro Florida
  - Clearwater, Florida, United States, 33762
    - Gastro Florida
  - Doral, Florida, United States, 33122
    - Integrity Clinical Research, LLC
  - Jacksonville, Florida, United States, 32224
    - Mayo Clinic Florida
  - Lakewood Ranch, Florida, United States, 34211
    - Florida Research Institute
  - Lakewood Ranch, Florida, United States, 34202
    - FDHS Pathology Lab
  - Maitland, Florida, United States, 32751
    - Center for Advanced Gastroenterology
  - Maitland, Florida, United States, 32751
    - Sandlake Imaging
  - Miami, Florida, United States, 33142
    - Acevedo Clinical Research Associates
  - Miami, Florida, United States, 33125
    - Optimus U Corporation
  - Miami, Florida, United States, 33137
    - Unique Imaging (Biscayne Imaging Center)
  - Miami, Florida, United States, 33155
    - Ivetmar Medical Group LLC
  - Miami, Florida, United States, 33156
    - Vascular and Interventional Specialists of Florida (Liver Biopsy)
  - Miami, Florida, United States, 33175
    - Care Research Center Inc
  - Miami Lakes, Florida, United States, 33014
    - San Marcus Research Clinic, Inc.
  - Oldsmar, Florida, United States, 34677
    - TGH Imaging Powered by Tower Radiology Center (MRI)
  - Orlando, Florida, United States, 32801
    - Clinical Neuroscience Solutions, Inc
  - Orlando, Florida, United States, 32808
    - Omega Research Maitland, LLC
  - Palmetto Bay, Florida, United States, 33157
    - Innovation Medical Research Center, Inc
  - Saint Petersburg, Florida, United States, 33702
    - GCP, Global Clinical Professionals
  - Saint Petersburg, Florida, United States, 33712
    - Gateway (Ultrasound)
  - Sarasota, Florida, United States, 34239
    - Partners Imaging Center
  - Tampa, Florida, United States, 33606
    - Radiology Associates
  - Tampa, Florida, United States, 33613
    - Center For Clinical Studies
  - Zephyrhills, Florida, United States, 33541
    - AdventHealth Zephyrhills
  - Zephyrhills, Florida, United States, 33542
    - Florida Medical Clinic, LLC
- Georgia
  - Atlanta, Georgia, United States, 30309
    - Digestive Healthcare of Georgia
  - Atlanta, Georgia, United States, 30309
    - Piedmont Atlanta Hospital
  - Atlanta, Georgia, United States, 30309
    - Piedmont Atlanta Hospital/Piedmont Transplant Institute
  - Columbus, Georgia, United States, 31904
    - Columbus Regional Research Institute
  - Sandy Springs, Georgia, United States, 30328
    - WR-Mount Vernon Clinical Research, LLC
  - Snellville, Georgia, United States, 30078
    - Tekton Research, Inc.
- Illinois
  - Chicago, Illinois, United States, 60612
    - Rush University Medical Center
- Indiana
  - Brownsburg, Indiana, United States, 46112
    - Investigators Research Group, LLC
  - Hendricks, Indiana, United States, 46122
    - Hendricks Regional Health
- Iowa
  - Clive, Iowa, United States, 50325
    - Iowa Digestive Disease Center
  - Clive, Iowa, United States, 50325
    - Heartland Medical Research, Inc. (Administrative Only)
  - Clive, Iowa, United States, 50325
    - Iowa Radiology
  - Des Moines, Iowa, United States, 50314
    - MercyOne Des Moines Medical Center (Mercy Medical Center)
  - Iowa City, Iowa, United States, 52242
    - University of Iowa Hospitals and Clinics
  - Iowa City, Iowa, United States, 52242
    - University of Iowa Magnetic Resonance Research Facility
- Kansas
  - Topeka, Kansas, United States, 66606
    - Kansas Medical Clinic PA
  - Wichita, Kansas, United States, 67205-1138
    - Alliance for Multispecialty Research, LLC
  - Wichita, Kansas, United States, 67226
    - Cypress Interventional
- Louisiana
  - Lake Charles, Louisiana, United States, 70601
    - Centex Studies, Inc.
  - Lake Charles, Louisiana, United States, 70601
    - Lake Charles Memorial Hospital
  - Marrero, Louisiana, United States, 70072
    - Metropolitan Gastroenterology Associates
  - Marrero, Louisiana, United States, 70072
    - Tandem Clinical Research GI, LLC
  - New Orleans, Louisiana, United States, 70121
    - Ochsner Clinic Foundation
  - Shreveport, Louisiana, United States, 71105
    - Louisiana Research Center, LLC
- Maryland
  - Catonsville, Maryland, United States, 21228
    - Gastro Health Research
  - Columbia, Maryland, United States, 21045
    - Gastro Center of Maryland
- Massachusetts
  - Boston, Massachusetts, United States, 02215
    - Beth Israel Deaconess Medical Center
- Michigan
  - Ann Arbor, Michigan, United States, 48109
    - University of Michigan
  - Ann Arbor, Michigan, United States, 48109
    - Michigan Clinical Research Unit (MCRU)
  - Detroit, Michigan, United States, 48202
    - Henry Ford Health System
  - Flint, Michigan, United States, 48504
    - Aa Mrc Llc
  - Grand Rapids, Michigan, United States, 49503
    - Mercy Health
  - Grand Rapids, Michigan, United States, 49505
    - M1 Imaging Center
  - Wyoming, Michigan, United States, 49519
    - Gastroenterology Associates of Western Michigan, PLC d.b.a. West Michigan Clinical Research Center
- Minnesota
  - Rochester, Minnesota, United States, 55905
    - Mayo Clinic
- Missouri
  - Jefferson City, Missouri, United States, 65109
    - Jefferson City Medical Group, P.C.
- Nevada
  - Las Vegas, Nevada, United States, 89106
    - Sierra Clinical Research
  - Las Vegas, Nevada, United States, 89113
    - Las Vegas Medical Research
  - Las Vegas, Nevada, United States, 89104
    - Desert Radiology
  - Las Vegas, Nevada, United States, 89104
    - Machuca Family Medicine
  - Las Vegas, Nevada, United States, 89104
    - The Machuca Foundation, Inc.
  - Las Vegas, Nevada, United States, 89118
    - Pueblo Medical Imaging
- New Jersey
  - Hillsborough, New Jersey, United States, 08844
    - Digestive Healthcare Associates
  - Hillsborough, New Jersey, United States, 08844
    - University Radiology
  - Raritan, New Jersey, United States, 08869
    - Amici Clinical Research
- New York
  - Manhasset, New York, United States, 11030
    - Northwell Health Center for Liver Diseases
  - New York, New York, United States, 10003
    - Mount Sinai Downtown Union Square
  - New York, New York, United States, 10003
    - Icahn School of Medicine at Mount Sinai Beth Israel
  - New York, New York, United States, 10029
    - Hess Building- CMS
  - New York, New York, United States, 10029
    - Icahn School of Medicine at Mount Sinai/The Mount Sinai Hospital
  - New York, New York, United States, 10029
    - The Mount Sinai Hospital: Department of Pharmacy
- North Carolina
  - Raleigh, North Carolina, United States, 26712
    - M3-Wake Research, Inc.
  - Winston-Salem, North Carolina, United States, 27103
    - PMG Research of Winston-Salem, LLC
  - Winston-Salem, North Carolina, United States, 27103
    - Gastroenterology Associates of the Piedmont, PA
  - Winston-Salem, North Carolina, United States, 27103
    - Novant Health Medical Center
- Ohio
  - Middleburg Heights, Ohio, United States, 44130
    - Paramount Medical Research & Consulting, LLC
- Oklahoma
  - Oklahoma City, Oklahoma, United States, 73112
    - Digestive Disease Specialists, Inc.
  - Oklahoma City, Oklahoma, United States, 73112
    - Comprehensive Diagnostic Imaging
  - Oklahoma City, Oklahoma, United States, 73112
    - Digestive Disease Specialists, Inc. Endoscopy Lab
  - Oklahoma City, Oklahoma, United States, 73134
    - Oklahoma Spine Hospital
- Pennsylvania
  - Philadelphia, Pennsylvania, United States, 19107
    - Thomas Jefferson University
  - Pittsburgh, Pennsylvania, United States, 15213
    - UPMC
  - Pittsburgh, Pennsylvania, United States, 15213
    - UPMC - Center for Liver Diseases at the Thomas E. Starzl Institute
  - Pittsburgh, Pennsylvania, United States, 15213
    - UPMC - Center for Liver Diseases in the Digestive Disorders Clinic
  - Pittsburgh, Pennsylvania, United States, 15213
    - UPMC - Translational Research Center
  - Pittsburgh, Pennsylvania, United States, 15213
    - UPMC Presbyterian Shadyside; Presbyterian Campus Pharmacy
- Rhode Island
  - Providence, Rhode Island, United States, 02905
    - University Gastroenterology
  - Providence, Rhode Island, United States, 02908
    - Roger Williams Hospital
- South Carolina
  - Charleston, South Carolina, United States, 29425
    - Medical University of South Carolina
  - Charleston, South Carolina, United States, 29425
    - MUSC- Ashley River Tower
- Tennessee
  - Chattanooga, Tennessee, United States, 37421
    - WR-Clinsearch, LLC
  - Chattanooga, Tennessee, United States, 37421
    - Chattanooga Imaging Center
  - Nashville, Tennessee, United States, 37232
    - Vanderbilt University Medical Center - Digestive Disease Center
  - Nashville, Tennessee, United States, 37211
    - Quality Medical Research, PLLC
  - Nashville, Tennessee, United States, 37212-1610
    - Vanderbilt University Medical Center - GI Research Office
  - Nashville, Tennessee, United States, 37212
    - Vanderbilt Hepatology and Liver Transplant
  - Nashville, Tennessee, United States, 37232
    - Vanderbilt University Medical Center - Heart Station
  - Nashville, Tennessee, United States, 37232
    - Vanderbilt University Medical Center - Interventional Radiology
- Texas
  - Addison, Texas, United States, 75001
    - Texas Center for Interventional Surgery (Liver Biopsy Facility)
  - Arlington, Texas, United States, 76012
    - Texas Clinical Research Institute
  - Dallas, Texas, United States, 75203
    - The Liver Institute At Methodist Dallas Medical Center
  - Dallas, Texas, United States, 75203
    - Methodist Dallas Medical Center (Liver Biopsy)
  - Dallas, Texas, United States, 75203
    - Methodist Dallas Medical Center (MRI-PDFF)
  - Dallas, Texas, United States, 75246
    - Touchstone Imaging
  - DeSoto, Texas, United States, 75115
    - Center For Diagnostic Imaging
  - Fort Worth, Texas, United States, 76104
    - GI Alliance
  - Houston, Texas, United States, 77084
    - Biopharma Informatic, Llc
  - Houston, Texas, United States, 77058
    - Centex Studies, Inc.
  - Houston, Texas, United States, 77004
    - Therapeutic Concepts, PA
  - Houston, Texas, United States, 77084
    - Premier Vein and Vascular
  - McAllen, Texas, United States, 78504
    - Centex Studies, Inc
  - Pearland, Texas, United States, 77584
    - HCA Houston Healthcare Pearland
  - San Antonio, Texas, United States, 78229
    - Clinical Trials of Texas, Inc.
  - San Antonio, Texas, United States, 78215
    - American Research Corporation at the Texas Liver Institute
  - San Antonio, Texas, United States, 78229
    - Diabetes and Glandular Disease Clinic, P.A.
  - Sugar Land, Texas, United States, 77479
    - Reddy Cardiac Wellness
  - Waco, Texas, United States, 76710
    - Impact Research Institute
- Virginia
  - Fairfax, Virginia, United States, 22031
    - Gastro Health Research
  - Manassas, Virginia, United States, 20110
    - Manassas Clinical Research Center
  - Norfolk, Virginia, United States, 23502
    - Digestive and Liver Disease Specialists
  - Norfolk, Virginia, United States, 23502
    - Sentara Leigh Hospital
  - Richmond, Virginia, United States, 23298
    - Virginia Commonwealth University
  - Richmond, Virginia, United States, 23249
    - McGuire VA Medical Center
  - Richmond, Virginia, United States, 23298-5051
    - VCU Medical Center Investigational Drug Service
  - Suffolk, Virginia, United States, 23435
    - Virginia Gastroenterology Clinical Research
- Washington
  - Seattle, Washington, United States, 98195
    - University of Washington Medical Center
  - Seattle, Washington, United States, 98104
    - Harborview Medical Center
  - Seattle, Washington, United States, 98105
    - Liver Institute Northwest
  - Seattle, Washington, United States, 98122
    - Swedish Medical Center
  - Seattle, Washington, United States, 98104
    - Harborview Medical Center Investigational Drug Services
  - Seattle, Washington, United States, 98104
    - Seattle Radiology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

Description

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,

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: Quadruple

Number of Arms

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo participants will receive medication for 48 weeks	Drug: Placebo Tablet
Experimental: PF-06865571 25 milligrams (mg) twice daily (BID) participants will receive medication for 48 weeks	Drug: PF-06865571 Tablet
Experimental: PF-06865571 75 mg BID participants will receive medication for 48 weeks	Drug: PF-06865571 Tablet
Experimental: PF-06865571 150 mg BID participants will receive medication for 48 weeks	Drug: PF-06865571 Tablet
Experimental: PF-06865571 300 mg BID participants will receive medication for 48 weeks	Drug: PF-06865571 Tablet
Experimental: PF-06865571 (150 mg BID) + PF-05221304 (5 mg BID) participants will receive medication for 48 weeks	Drug: PF-06865571 Tablet Drug: PF-05221304 Tablet
Experimental: PF-06865771 (300 mg BID) + PF-05221304 (10 mg BID) participants will receive medication for 48 weeks	Drug: PF-06865571 Tablet Drug: PF-05221304 Tablet

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Resolution of NASH without worsening of fibrosis or improvement in fibrosis by 1>/= or both Time Frame: Week 48	Proportion of participants achieving resolution of NASH without worsening of fibrosis or improvement in fibrosis by ≥1 stage without worsening of NASH or both	Week 48

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent change in liver fat Time Frame: Week 48	Percent change in liver fat (assessed via MRI-PDFF)	Week 48
Proportion of participants achieving Resolution of NASH, without worsening of fibrosis Time Frame: Week 48		Week 48
Proportion of participants achieving improvement in fibrosis by ≥1stage, without worsening of NASH Time Frame: Week 48		Week 48
Proportion of participants with Improvement in fibrosis by ≥2 stages, without worsening of NASH Time Frame: Week 48		Week 48
Proportion of participants with Improvement of ≥2 points in Total NASH Time Frame: Week 48		Week 48
Proportion of participants with a clinically significant change from baseline in vital signs Time Frame: Baseline to Week 50		Baseline to Week 50
Proportion of participants with a clinically significant change from baseline in laboratory values Time Frame: Baseline to Week 50		Baseline to Week 50
Proportion of participants with a clinically significant change from baseline in electrocardiograms (ECG) parameters Time Frame: Baseline to Week 50		Baseline to Week 50
Proportion of participants with treatment-emergent adverse events (TEAE) Time Frame: Baseline to Week 52		Baseline to Week 52

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer

Investigators

Study Director: Pfizer CT.gov Call Center, Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Amin NB, Darekar A, Anstee QM, Wong VW, Tacke F, Vourvahis M, Lee DS, Charlton M, Alkhouri N, Nakajima A, Yunis C. Efficacy and safety of an orally administered DGAT2 inhibitor alone or coadministered with a liver-targeted ACC inhibitor in adults with non-alcoholic steatohepatitis (NASH): rationale and design of the phase II, dose-ranging, dose-finding, randomised, placebo-controlled MIRNA (Metabolic Interventions to Resolve NASH with fibrosis) study. BMJ Open. 2022 Mar 30;12(3):e056159. doi: 10.1136/bmjopen-2021-056159.

Helpful Links

To obtain contact information for a study center near you, click here.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 15, 2020

Primary Completion (Actual)

January 23, 2024

Study Completion (Actual)

February 21, 2024

Study Registration Dates

First Submitted

March 23, 2020

First Submitted That Met QC Criteria

March 23, 2020

First Posted (Actual)

March 25, 2020

Study Record Updates

Last Update Posted (Actual)

April 4, 2024

Last Update Submitted That Met QC Criteria

April 2, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

C2541013
2019-004775-39 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Study Overview

Status

Conditions

Intervention / Treatment

Study Type

Enrollment (Actual)

Phase

Contacts and Locations

Study Locations

Participation Criteria

Eligibility Criteria

Ages Eligible for Study

Accepts Healthy Volunteers

Description

Study Plan

How is the study designed?

Design Details

Number of Arms

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Secondary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Collaborators and Investigators

Sponsor

Investigators

Publications and helpful links

General Publications

Helpful Links

Study record dates

Study Major Dates

Study Start (Actual)

Primary Completion (Actual)

Study Completion (Actual)

Study Registration Dates

First Submitted

First Submitted That Met QC Criteria

First Posted (Actual)

Study Record Updates

Last Update Posted (Actual)

Last Update Submitted That Met QC Criteria

Last Verified

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

IPD Plan Description

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Studies a U.S. FDA-regulated device product

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