AzTrials
AzTrials

Nonalcoholic Fatty Liver DiseasePhase 2MIRNANCT04321031

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

A Phase 2 study testing PF-06865571 and PF-05221304 in people with Nonalcoholic Fatty Liver Disease and Nonalcoholic Steatohepatitis With Liver Fibrosis, run by Pfizer at 291 sites in 12 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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). Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
PF-06865571 and PF-05221304
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
256 participants
Where
291 sitesin 12 countries
Study dates
15 Jun 2020to 21 Feb 2024
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Biopsy proven NASH with either F2 or F3 fibrosis, per NASH CRN definition
  • BMI >/= 22.5kg/m2

Who cannot join

  • 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,

Trial locations and contacts

291 sites in 12 countries.

291 sites in 12 countries

United States184 sites

  • Texas Center for Interventional Surgery (Liver Biopsy Facility)

    Addison, Texas, 75001

  • Michigan Clinical Research Unit (MCRU)

    Ann Arbor, Michigan, 48109

  • University of Michigan

    Ann Arbor, Michigan, 48109

  • Texas Clinical Research Institute

    Arlington, Texas, 76012

  • Digestive Healthcare of Georgia

    Atlanta, Georgia, 30309

  • Piedmont Atlanta Hospital/Piedmont Transplant Institute

    Atlanta, Georgia, 30309

  • Piedmont Atlanta Hospital

    Atlanta, Georgia, 30309

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215

  • Tower Radiology (MRI-PDFF)

    Brandon, Florida, 33511

  • Tower Radiology - Parsons

    Brandon, Florida, 33511

  • Bristol Hospital

    Bristol, Connecticut, 06010

  • Bristol Radiology Center

    Bristol, Connecticut, 06010

  • Connecticut Clinical Research Institute, LLC

    Bristol, Connecticut, 06010

  • Investigators Research Group, LLC

    Brownsburg, Indiana, 46112

  • Hope Clinical Research

    Canoga Park, California, 91303

  • Gastro Health Research

    Catonsville, Maryland, 21228

  • Institute for Liver Health dba Arizona Liver Health

    Chandler, Arizona, 85224

  • Medical University of South Carolina

    Charleston, South Carolina, 29425

  • MUSC- Ashley River Tower

    Charleston, South Carolina, 29425

  • Chattanooga Imaging Center

    Chattanooga, Tennessee, 37421

  • WR-Clinsearch, LLC

    Chattanooga, Tennessee, 37421

  • Rush University Medical Center

    Chicago, Illinois, 60612

  • Gastro Florida

    Clearwater, Florida, 33756

  • Gastro Florida

    Clearwater, Florida, 33762

  • Heartland Medical Research, Inc. (Administrative Only)

    Clive, Iowa, 50325

  • Iowa Digestive Disease Center

    Clive, Iowa, 50325

  • Iowa Radiology

    Clive, Iowa, 50325

  • Gastro Center of Maryland

    Columbia, Maryland, 21045

  • Columbus Regional Research Institute

    Columbus, Georgia, 31904

  • Sharp Coronado Hospital

    Coronado, California, 92118

  • Southern California Research Center

    Coronado, California, 92118

  • Methodist Dallas Medical Center (MRI-PDFF)

    Dallas, Texas, 75203

  • The Liver Institute at Methodist Dallas Medical Center

    Dallas, Texas, 75203

  • Touchstone Imaging

    Dallas, Texas, 75246

  • MercyOne Des Moines Medical Center (Mercy Medical Center)

    Des Moines, Iowa, 50314

  • Center For Diagnostic Imaging

    DeSoto, Texas, 75115

  • Henry Ford Health System

    Detroit, Michigan, 48202

  • Integrity Clinical Research, LLC

    Doral, Florida, 33122

  • Magnolia Surgery Center

    El Cajon, California, 92020

  • Encino Hospital Medical Center

    Encino, California, 91436

  • Gastro Health Research

    Fairfax, Virginia, 22031

  • Gastro Health, LLC

    Fairfax, Virginia, 22031

  • Aa Mrc Llc

    Flint, Michigan, 48504

  • GI Alliance

    Fort Worth, Texas, 76104

  • Comprehensive Interventional Care Centers (CICC)

    Gilbert, Arizona, 85233

  • The Institute for Liver Health

    Glendale, Arizona, 85306

  • Mercy Health

    Grand Rapids, Michigan, 49503

  • M1 Imaging Center

    Grand Rapids, Michigan, 49505

  • Hendricks Regional Health

    Hendricks, Indiana, 46122

  • Digestive Healthcare Associates

    Hillsborough, New Jersey, 08844

  • University Radiology

    Hillsborough, New Jersey, 08844

  • Therapeutic Concepts, PA

    Houston, Texas, 77004

  • Centex Studies, Inc.

    Houston, Texas, 77058

  • Biopharma Informatic, LLC

    Houston, Texas, 77084

  • Premier Vein and Vascular

    Houston, Texas, 77084

  • National Research Institute

    Huntington Park, California, 90255

  • University of Iowa Hospitals and Clinics

    Iowa City, Iowa, 52242

  • University of Iowa Magnetic Resonance Research Facility

    Iowa City, Iowa, 52242

  • Mayo Clinic Florida

    Jacksonville, Florida, 32224

  • Jefferson City Medical Group, P.C.

    Jefferson City, Missouri, 65109

  • Investigational Drug Service, Altman Clinical and Translational Research Institute (ACTRI)

    La Jolla, California, 92037

  • University of California San Diego, Altman Clinical and Translational Research Institute Clinic

    La Jolla, California, 92037

  • UCSD Altman Clinical and Transitional Research Institute

    La Jolla, California, 92093

  • Centex Studies, Inc.

    Lake Charles, Louisiana, 70601

  • Lake Charles Memorial Hospital

    Lake Charles, Louisiana, 70601

  • Florida Research Institute

    Lakewood Rch, Florida, 34211

  • A V Pediatrics, Allergy & Family Medicine

    Lancaster, California, 93534

  • Jatinder S. Pruthi, M.D. FACG CPI

    Lancaster, California, 93534

  • Om Research LLC

    Lancaster, California, 93534

  • Desert Radiology

    Las Vegas, Nevada, 89104

  • Machuca Family Medicine

    Las Vegas, Nevada, 89104

  • The Machuca Foundation, Inc.

    Las Vegas, Nevada, 89104

  • Sierra Clinical Research

    Las Vegas, Nevada, 89106

  • Las Vegas Medical Research

    Las Vegas, Nevada, 89113

  • Pueblo Medical Imaging

    Las Vegas, Nevada, 89118

  • Kaiser Permanente Los Angeles Medical Center

    Los Angeles, California, 90027

  • Cedars-Sinai Advanced Health Sciences Pavilion (Imaging)

    Los Angeles, California, 90048

  • Cedars-Sinai Comprehensive Transplant Center

    Los Angeles, California, 90048

  • Cedars-Sinai Medical Center Investigational Drug Services (Pharmacy)

    Los Angeles, California, 90048

  • S. Mark Taper Foundation Imaging Center (Liver Biopsy)

    Los Angeles, California, 90048

  • Center for Advanced Gastroenterology

    Maitland, Florida, 32751

  • Sandlake Imaging

    Maitland, Florida, 32751

  • Manassas Clinical Research Center

    Manassas, Virginia, 20110

  • Northwell Health Center for Liver Diseases

    Manhasset, New York, 11030

  • Metropolitan Gastroenterology Associates

    Marrero, Louisiana, 70072

  • Tandem Clinical Research GI, LLC

    Marrero, Louisiana, 70072

  • Centex Studies, Inc

    McAllen, Texas, 78504

  • Optimus U Corporation

    Miami, Florida, 33125

  • Unique Imaging (Biscayne Imaging Center)

    Miami, Florida, 33137

  • Acevedo Clinical Research Associates

    Miami, Florida, 33142

  • Ivetmar Medical Group LLC

    Miami, Florida, 33155

  • Vascular and Interventional Specialists of Florida (Liver Biopsy)

    Miami, Florida, 33156

  • Care Research Center Inc

    Miami, Florida, 33175

  • San Marcus Research Clinic, Inc.

    Miami Lakes, Florida, 33014

  • Paramount Medical Research & Consulting, LLC

    Middleburg Heights, Ohio, 44130

  • Providence Facey Medical Foundation

    Mission Hills, California, 91345

  • Providence Holy Cross Medical Center

    Mission Hills, California, 91345

  • ART Vascular

    Montebello, California, 90640

  • United Medical Doctors

    Murrieta, California, 92563

  • Quality Medical Research, PLLC

    Nashville, Tennessee, 37211

  • Vanderbilt Hepatology and Liver Transplant

    Nashville, Tennessee, 37212

  • Vanderbilt University Medical Center - GI Research Office

    Nashville, Tennessee, 37212

  • Vanderbilt University Medical Center - Digestive Disease Center

    Nashville, Tennessee, 37232

  • Vanderbilt University Medical Center - Heart Station

    Nashville, Tennessee, 37232

  • Vanderbilt University Medical Center - Interventional Radiology

    Nashville, Tennessee, 37232

  • Yale New Haven Hospital

    New Haven, Connecticut, 06510

  • Yale New Haven Hospital, Saint Raphael Campus (MRE location)

    New Haven, Connecticut, 06511

  • Yale Center for Clinical Investigators, Church Street South Research Unit (CSRU)

    New Haven, Connecticut, 06519

  • Yale Digestive Diseases (Fibroscan location)

    New Haven, Connecticut, 06520

  • Ochsner Clinic Foundation

    New Orleans, Louisiana, 70121

  • Icahn School of Medicine at Mount Sinai/The Mount Sinai Hospital

    New York, New York, 10029

  • Back Bay Imaging (Liver Biopsy)

    Newport Beach, California, 92660

  • Digestive and Liver Disease Specialists

    Norfolk, Virginia, 23502

  • Sentara Leigh Hospital

    Norfolk, Virginia, 23502

  • Comprehensive Diagnostic Imaging

    Oklahoma City, Oklahoma, 73112

  • Digestive Disease Specialists, Inc. Endoscopy Lab

    Oklahoma City, Oklahoma, 73112

  • Digestive Disease Specialists, Inc.

    Oklahoma City, Oklahoma, 73112

  • Oklahoma Spine Hospital

    Oklahoma City, Oklahoma, 73134

  • TGH Imaging Powered by Tower Radiology Center (MRI)

    Oldsmar, Florida, 34677

  • Clinical Neuroscience Solutions, Inc

    Orlando, Florida, 32801

  • Omega Research Maitland, LLC

    Orlando, Florida, 32808

  • Advanced Imaging Center

    Palmdale, California, 93551

  • Innovation Medical Research Center, Inc

    Palmetto Bay, Florida, 33157

  • Blake Wilbur Outpatient Clinic (MRI)

    Palo Alto, California, 94304

  • Stanford Hospital and Clinics

    Palo Alto, California, 94305

  • California Liver Research Institute

    Pasadena, California, 91105

  • HMRI

    Pasadena, California, 91105

  • HCA Houston Healthcare Pearland

    Pearland, Texas, 77584

  • The Institute for Liver Health

    Peoria, Arizona, 85381

  • Thomas Jefferson University

    Philadelphia, Pennsylvania, 19107

  • UPMC - Center for Liver Diseases at the Thomas E. Starzl Institute

    Pittsburgh, Pennsylvania, 15213

  • UPMC - Center for Liver Diseases in the Digestive Disorders Clinic

    Pittsburgh, Pennsylvania, 15213

  • UPMC - Translational Research Center

    Pittsburgh, Pennsylvania, 15213

  • UPMC Presbyterian Shadyside; Presbyterian Campus Pharmacy

    Pittsburgh, Pennsylvania, 15213

  • UPMC

    Pittsburgh, Pennsylvania, 15213

  • University Gastroenterology

    Providence, Rhode Island, 02905

  • Roger Williams Hospital

    Providence, Rhode Island, 02908

  • M3 - Wake Research, Inc.

    Raleigh, North Carolina, 27612

  • Amici Clinical Research

    Raritan, New Jersey, 08869

  • Stanford Medicine Outpatient Center (Liver clinic/MRI)

    Redwood City, California, 94063

  • Inland Empire Clinical Trials, LLC

    Rialto, California, 92377

  • McGuire VA Medical Center

    Richmond, Virginia, 23249

  • VCU Medical Center Investigational Drug Service

    Richmond, Virginia, 23298

  • Virginia Commonwealth University

    Richmond, Virginia, 23298

  • Mayo Clinic

    Rochester, Minnesota, 55905

  • Clinical Trials Research

    Sacramento, California, 95821

  • American Research Corporation at the Texas Liver Institute

    San Antonio, Texas, 78215

  • Clinical Trials of Texas, Inc.

    San Antonio, Texas, 78229

  • Diabetes and Glandular Disease Clinic, P.A.

    San Antonio, Texas, 78229

  • Precision Research Institute

    San Diego, California, 92114

  • WR-MCCR

    San Diego, California, 92120

  • Sharp and Children's MRI Center, LLC

    San Diego, California, 92123

  • Stanford Cancer Center South Bay (MRI)

    San Jose, California, 95124

  • WR-Mount Vernon Clinical Research, LLC

    Sandy Springs, Georgia, 30328

  • Partners Imaging Center

    Sarasota, Florida, 34239

  • Harborview Medical Center Investigational Drug Services

    Seattle, Washington, 98104

  • Harborview Medical Center

    Seattle, Washington, 98104

  • Seattle Radiology

    Seattle, Washington, 98104

  • Liver Institute Northwest

    Seattle, Washington, 98105

  • Swedish Medical Center

    Seattle, Washington, 98122

  • University of Washington Medical Center

    Seattle, Washington, 98195

  • Louisiana Research Center, LLC

    Shreveport, Louisiana, 71105

  • Tekton Research, Inc.

    Snellville, Georgia, 30078

  • GCP, Global Clinical Professionals

    St. Petersburg, Florida, 33702

  • Gateway (Ultrasound)

    St. Petersburg, Florida, 33712

  • Virginia Gastroenterology Clinical Research

    Suffolk, Virginia, 23435

  • Reddy Cardiac Wellness

    Sugar Land, Texas, 77479

  • Comprehensive Interventional Care Centers (CICC)

    Sun City, Arizona, 85351

  • Radiology Associates

    Tampa, Florida, 33606

  • ForCare Clinical Research

    Tampa, Florida, 33613

  • Liberty Pacific Advanced Imaging

    Tarzana, California, 91356

  • Kansas Medical Clinic PA

    Topeka, Kansas, 66606

  • Institute for Liver Health DBA Arizona Liver Health

    Tucson, Arizona, 85712

  • Orange County Research Center

    Tustin, California, 92780

  • Upland Clinical Research

    Upland, California, 91786

  • Impact Research Institute

    Waco, Texas, 76710

  • Alliance for Multispecialty Research, LLC

    Wichita, Kansas, 67205

  • Cypress Interventional

    Wichita, Kansas, 67226

  • Gastroenterology Associates of the Piedmont, PA

    Winston-Salem, North Carolina, 27103

  • Novant Health Medical Center

    Winston-Salem, North Carolina, 27103

  • PMG Research of Winston-Salem, LLC

    Winston-Salem, North Carolina, 27103

  • Gastroenterology Associates of Western Michigan, PLC d.b.a. West Michigan Clinical Research Center

    Wyoming, Michigan, 49519

  • AdventHealth Zephyrhills

    Zephyrhills, Florida, 33541

  • Florida Medical Clinic, LLC

    Zephyrhills, Florida, 33542

Other trials in United States

Japan19 sites

  • Chiba University Hospital

    Chiba, 260-8677

  • Fukui-Ken Saiseikai Hospital

    Fukui, 918-8503

  • Gifu Municipal Hospital

    Gifu, 500-8513

  • Tokyo Medical University Ibaraki Medical Center

    Inashiki-gun, Ibaraki, 300-0395

  • Juntendo University Shizuoka Hospital

    Izunokuni, Shizuoka, 410-2295

  • Kagoshima University Hospital

    Kagoshima, 890-8520

  • University Hospital, Kyoto Prefectural University of Medicine

    Kyoto, 602-8566

  • Shinshu University Hospital

    Matsumoto, Nagano, 3908621

  • Miyazaki Medical Center Hospital

    Miyazaki, 880-0003

  • Aichi Medical University Hospital

    Nagakute, Aichi-ken, 480-1195

  • Ogaki Municipal Hospital

    Ōgaki, Gifu, 503-8502

  • National Hospital Organization Nagasaki Medical Center

    Ohmura, Nagasaki, 856-8562

  • Saga University Hospital

    Saga, 849-8501

  • Osaka Rosai Hospital

    Sakai, Osaka, 591-8025

  • Saiseikai Suita Hospital

    Suita, Osaka, 564-0013

  • Kagawa Prefectural Central Hospital

    Takamatsu, Kagawa-ken, 760-8557

  • Ehime University Hospital

    Tōon, Ehime, 791-0295

  • Yamagata University Hospital

    Yamagata, 990-9585

  • Yokohama City University Hospital

    Yokohama, Kanagawa, 236-0004

Other trials in Japan

Canada16 sites

  • University of Calgary - Heritage Medical Research Clinic (HMRC)

    Calgary, Alberta, T2N 4Z6

  • Resonance Magnetique du Saguenay-Lac-Saint-Jean

    Chicoutimi, Quebec, G7H 4J1

  • Centre integre universitaire de sante et de services sociaux du Saguenay-Lac-Saint-Jean

    Chicoutimi, Quebec, G7H 5H6

  • Ecogene-21

    Chicoutimi, Quebec, G7H 7K9

  • University of Alberta Hospital

    Edmonton, Alberta, T6G 2B7

  • University of Alberta

    Edmonton, Alberta, T6G 2X8

  • Nova Scotia Health Authority QEII (Queen Elizabeth II) Health Sciences Centre

    Halifax, Nova Scotia, B3H 1V7

  • Manna Research (London)

    London, Ontario, N6A 2C2

  • Centre de recherche du Centre hospitalier de l'Université de Montréal (CRCHUM)

    Montreal, Quebec, H2X 0A9

  • McGill University Health Centre (MUHC)

    Montreal, Quebec, H4A 3J1

  • Philips Radiation Oncology

    Montreal, Quebec, H4A 3J1

  • Research Institute of the MUHC

    Montreal, Quebec, H4A 3J1

  • Diex Recherche Quebec Inc.

    Québec, G1V 4T3

  • Toronto Liver Centre

    Toronto, Ontario, M6H 3M1

  • Gordon and Leslie Diamond Health Care Centre

    Vancouver, British Columbia, V5Z 1M9

  • (G.I.R.I.) GI Research Institute

    Vancouver, British Columbia, V6Z 2K5

Other trials in Canada

China14 sites

  • Beijing Friendship Hospital, Capital Medical University

    Beijing, Beijing Municipality, 100050

  • Peking University People's Hospital

    Beijing, 100044

  • Beijing YouAn Hosptial,Capital Medical University

    Beijing, 100069

  • Beijing Tsinghua Changgung Hospital

    Beijing, 102218

  • The First Bethune Hospital of Jilin University

    Changchun, Jilin, 130021

  • Hunan Provincial People's Hospital

    Changsha, Hunan, 410005

  • The First Affiliated Hospital, Sun Yat-sen University

    Guangzhou, Guangdong, 510080

  • The Affiliated Hospital of Hangzhou Normal University

    Hangzhou, Zhejiang, 310000

  • Qingdao Central Hospital

    Qingdao, Shandong, 266042

  • The Third Hospital of Hebei Medical University

    Shijiazhuang, Hebei, 050051

  • Tianjin Third Central Hospital

    Tianjin, 300170

  • Tianjin Second People's Hospital

    Tianjin, 300192

  • The First Affiliated Hospital of Wenzhou Medical University

    Wenzhou, Zhejiang, 325000

  • General Hospital of Ningxia Medical University

    Yinchuan, Ningxia, 750004

Other trials in China

Poland13 sites

  • Szpital Zakonu Bonifratrow

    Katowice, 40-211

  • NZOZ Vita Longa Sp. z o.o.

    Katowice, 40-748

  • Uniwersyteckie Centrum Kliniczne im. prof. K. Gibinskiego Slaskiego Uniwersytetu Medycznego

    Katowice, 40-752

  • Orthos Szpital Wielospecjalistyczny Sp. z o.o. (Liver Biopsy)

    Komorowice, 52-229

  • SPZOZ Szpital Uniwersytecki w Krakowie

    Krakow, 30-688

  • Szpital Zakonu Bonifratrów św. Jana Grandego w Krakowie sp. z o.o. (Liver Biopsy)

    Krakow, 31-061

  • Krakowskie Centrum Medyczne

    Krakow, 31-501

  • Wojewodzki Specjalistyczny Szpital im. Dr. Wl. Bieganskiego w Lodzi

    Lodz, 91-347

  • ID Clinic

    Mysłowice, 41-400

  • WIP Warsaw IBD Point Profesor Kierkus

    Warsaw, 00-728

  • Futuremeds Sp. z o.o.

    Wroclaw, 50-088

  • ETG Zamosc

    Zamość, 22-400

  • Samodzielny Publiczny Szpital Wojewodzki im. Papieza Jana Pawla II

    Zamość, 22-400

Other trials in Poland

Bulgaria9 sites

  • MHAT Dr. Tota Venkova AD

    Gabrovo, 5300

  • MHAT Medline Clinic AD

    Plovdiv, 4002

  • Acibadem City Clinic MHAT Tokuda EAD

    Sofia, 1407

  • DCC Alexandrovska EOOD

    Sofia, 1431

  • UMHAT Sv. Ivan Rilski EAD

    Sofia, 1431

  • UMHAT Sofiamed OOD

    Sofia, 1797

  • MC New Rehabilitation Center EOOD

    Stara Zagora, 6001

  • DCC Mladost-M Varna OOD

    Varna, 9020

  • MC Leo Clinic EOOD

    Varna, 9020

Other trials in Bulgaria

India9 sites

  • Medanta - The Medicity

    Gurugram, 122001

  • S.M.S. Medical College & Hospital

    Jaipur, Rajasthan, 302004

  • Institute of Post Graduate Medical Education and Research & SSKM Hospital

    Kolkata, West Bengal, 700020

  • Global Hospital - Super Speciality & Transplant Centre

    Mumbai, Maharashtra, 400012

  • Institute of Liver and Biliary Sciences (ILBS)

    New Delhi, 110 070

  • All India Institute of Medical Sciences (AIIMS)

    New Delhi, 110029

  • Max Smart Super Speciality Hospital

    Sāket, NEW Delhi, 110017

  • Surat Institute of Digestive Sciences

    Surat, Gujarat, 395002

  • Gujarat Hospital - Gastro and Vascular Centre

    Surat, Gujarat, 395009

Other trials in India

Slovakia8 sites

  • Fakultna nemocnica s poliklinikou F. D. Roosevelta Banska Bystrica

    Banská Bystrica, 974 01

  • Medispektrum, s.r.o

    Bratislava, 851 01

  • SUMMIT CLINICAL RESEARCH, s.r.o.

    Bratislava - Mestska Cast Nove Mesto, 831 01

  • Lama Medical Care s.r.o.

    Bratislava - Mestska Cast Ruzinov, 831 04

  • Univerzitna nemocnica L. Pasteura Kosice

    Kosice - Mestska Cast Zapad, 040 11

  • KM Management spol. s.r.o., Gastroenterologicke a hepatologicke centrum Nitra

    Nitra, 949 01

  • Fakultna nemocnica Nitra

    Nitra, 950 01

  • JAL, s.r.o.

    Trnava, 917 01

Other trials in Slovakia

Taiwan7 sites

  • Changhua Christian Hospital

    Changhua, Changhua County, 500

  • Ditmanson Medical Foundation Chia-Yi Christian Hospital

    Chiayi City, 600

  • Kaohsiung Medical University Chung-Ho Memorial Hospital

    Kaohsiung City, 807

  • National Cheng Kung University (NCKU) Hospital

    Tainan, 704

  • National Taiwan University Hospital

    Taipei, 100

  • Taipei Veterans General Hospital

    Taipei, 11217

  • Chang Gung Medical Foundation Linkou Chang Gung Memorial Hospital

    Taoyuan, 333

Other trials in Taiwan

South Korea5 sites

  • Pusan National University Hospital

    Busan, 49241

  • Kyungpook National University Hospital

    Daegu, 41944

  • Yeungnam University Hospital

    Daegu, 42415

  • SMG-SNU Boramae Medical Center

    Dongjak-gu, Seoul, 07061

  • Severance Hospital Yonsei University Health System

    Seoul, 03722

Other trials in South Korea

Puerto Rico4 sites

  • Clinical Research Puerto Rico

    San Juan, 00909

  • Latin Clinical Trial Center

    San Juan, 00909

  • GCM Medical Group PSC

    San Juan, 00917

  • FDI Clinical Research

    San Juan, 00927

Other trials in Puerto Rico

Hong Kong3 sites

  • Queen Mary Hospital

    Hong Kong

  • Prince of Wales Hospital

    Shatin

  • Alice Ho Miu Ling Nethersole Hospital

    Tai Po

Other trials in Hong Kong

About this study

Official title: 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).

Being tested
Placebo, PF-06865571, PF-05221304
Medical subject headings
Non-alcoholic Fatty Liver Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PlaceboDrug

    Tablet

  • PF-06865571Drug

    Tablet

  • PF-05221304Drug

    Tablet

Study groups in NCT04321031
Study groupRoleWhat they receive
PlaceboPlacebo comparatorparticipants will receive medication for 48 weeks
Receives: Drug: Placebo
PF-06865571 25 milligrams (mg) twice daily (BID)Experimentalparticipants will receive medication for 48 weeks
Receives: Drug: PF-06865571
PF-06865571 75 mg BIDExperimentalparticipants will receive medication for 48 weeks
Receives: Drug: PF-06865571
PF-06865571 150 mg BIDExperimentalparticipants will receive medication for 48 weeks
Receives: Drug: PF-06865571
PF-06865571 300 mg BIDExperimentalparticipants will receive medication for 48 weeks
Receives: Drug: PF-06865571
PF-06865571 (150 mg BID) + PF-05221304 (5 mg BID)Experimentalparticipants will receive medication for 48 weeks
Receives: Drug: PF-06865571; Drug: PF-05221304
PF-06865771 (300 mg BID) + PF-05221304 (10 mg BID)Experimentalparticipants will receive medication for 48 weeks
Receives: Drug: PF-06865571; Drug: PF-05221304

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Mean Proportion of Participants Achieving Resolution of NASH Without Worsening/Improvement of Fibrosis by >=1 Stage Without Worsening of NASH/Both Based on Assessment by Sponsor-Identified Central Pathologist at Week 48:Bayesian Dose Response Model (BDRM)

    NASH resolution: disappearance of ballooning (Nonalcoholic Fatty Liver Disease [NAFLD] Activity Score [NAS] ballooning score=0;0=no ballooning,1=few balloon cells,2=many cells with prominent ballooning; higher scores(HS)=more disease activity [DA]),residual/no lobular inflammation(NAS lobular inflammation score 0/1,0=no foci,1= <2 foci, 2=2-4 foci,3= >4 foci; HS=more DA),NAS steatosis score 0,1,2,3; 0= <5% hepatocytes involved (HI),1=5-33% HI ,2= 34-66% HI, 3= >66% HI; HS=more DA. No worsening of fibrosis: no change/decrease of at least 1 stage in Brunt-Kleiner scale (BKS) compared to baseline (CTB). Improvement in fibrosis by >=1 stage: decrease of at least 1 stage in BKS CTB. No worsening of NASH: no change/increase in NAS for ballooning, inflammation, steatosis CTB. BDRM utilized to characterize dose response across BID treatment groups, estimate posterior mean proportion (\& 90% credible interval [CI], indicated as 'confidence interval' below) for placebo and each BID dose studied.

    Measured: Week 48

  2. Number of Participants Achieving Resolution of NASH Without Worsening or Improvement in Fibrosis by >= 1 Stage Without Worsening of NASH or Both Based on Assessment by Sponsor-Identified Central Pathologist at Week 48: Logistic Regression Model

    Resolution of NASH: disappearance of ballooning (NAS ballooning score= 0; where 0= no ballooning, 1= few balloon cells, 2= many cells with prominent ballooning; higher scores= more disease activity), residual or no lobular inflammation (NAS lobular inflammation score 0 or 1, where 0= no foci, 1= <2 foci, 2= 2-4 foci, 3= >4 foci; higher scores= more disease activity), NAS steatosis score 0, 1, 2, or 3, where 0= <5% hepatocytes involved, 1= 5-33% hepatocytes involved, 2= 34-66% hepatocytes involved, 3= >66% hepatocytes involved; higher scores= more disease activity. No worsening of fibrosis: no change or decrease of at least 1 stage in BKS compared to baseline. Improvement in fibrosis by >=1 stage: decrease of at least 1 stage in BKS compared to baseline. No worsening of NASH: no change or increase in NAS for ballooning, inflammation, steatosis compared to baseline.

    Measured: Week 48

Secondary outcomes (14)

  1. Percent Change From Baseline in Liver Fat at Week 48: Bayesian Dose Response Model

    Magnetic resonance imaging proton density fat fraction (MRI-PDFF) is an established method that enables quantification of fat content in the liver.

    Measured: Baseline, Week 48

  2. Percent Change From Baseline in Liver Fat at Week 48: Pairwise Comparisons With Analysis of Covariance (ANCOVA)

    MRI-PDFF is an established method that enables quantification of fat content in the liver.

    Measured: Baseline, Week 48

  3. Mean Proportion of Participants Achieving Resolution of NASH, Without Worsening of Fibrosis Based on Assessment by Sponsor-Identified Central Pathologist(s) at Week 48: Bayesian Dose Response Model

    Resolution of NASH: disappearance of ballooning (NAS ballooning score= 0; where 0= no ballooning, 1= few balloon cells, 2= many cells with prominent ballooning; higher scores= more disease activity), residual or no lobular inflammation (NAS lobular inflammation score 0 or 1, where 0= no foci, 1= <2 foci, 2= 2-4 foci, 3= >4 foci; higher scores= more disease activity), NAS steatosis score 0, 1, 2 or 3, where 0= <5% HI, 1= 5-33% HI, 2= 34-66% HI, 3= >66% HI; higher scores= more disease activity. No worsening of fibrosis: no change or decrease of at least 1 stage in BKS compared to baseline. BKS: scaling for fibrosis (0= none, 1= perisinusoidal/ periportal, 2= perisinusoidal, portal/ periportal, 3= bridging, 4= cirrhosis; higher scores= more disease activity). BDRM utilized to characterize dose response across BID treatment groups, estimate posterior mean proportion (\& 90% credible interval [CI], indicated as 'confidence interval' below) for placebo and each BID dose studied.

    Measured: Week 48

  4. Number of Participants Achieving Resolution of NASH, Without Worsening of Fibrosis Based on Assessment by Sponsor-Identified Central Pathologist(s) at Week 48: Pairwise Comparisons With Logistic Regression Model

    Resolution of NASH: disappearance of ballooning (NAS ballooning score= 0; where 0= no ballooning, 1= few balloon cells, 2= many cells with prominent ballooning; higher scores= more disease activity), residual or no lobular inflammation (NAS lobular inflammation score 0 or 1, where 0= no foci, 1= <2 foci, 2= 2-4 foci, 3= >4 foci; higher scores= more disease activity), NAS steatosis score 0, 1, 2 or 3, where 0= <5% hepatocytes involved, 1= 5-33% hepatocytes involved, 2= 34-66% hepatocytes involved, 3= >66% hepatocytes involved; higher scores= more disease activity. No worsening of fibrosis: no change or decrease of at least 1 stage in Brunt-Kleiner scale compared to baseline. Brunt-Kleiner scale included scaling for fibrosis (0= none, 1= perisinusoidal/ periportal, 2= perisinusoidal, portal/ periportal, 3= bridging, 4= cirrhosis; higher scores = more disease activity). Logistic Regression model included treatment and baseline fibrosis stage (F2/F3) as factors.

    Measured: Week 48

  5. Mean Proportion of Participants Achieving Improvement in Fibrosis by >=1 Stage, Without Worsening of NASH Based on Assessment by Sponsor-Identified Central Pathologist(s) at Week 48: Bayesian Dose Response Model

    Improvement in fibrosis by >=1 stage: decrease of at least 1 stage in Brunt-Kleiner scale compared to baseline. No worsening of fibrosis: no change or decrease of at least 1 stage in Brunt-Kleiner scale compared to baseline. Brunt-Kleiner scale included scaling for fibrosis (0= none, 1= perisinusoidal/ periportal, 2= perisinusoidal, portal/ periportal, 3= bridging, 4= cirrhosis; higher scores = more disease activity). BDRM utilized to characterize dose response across BID treatment groups, estimate posterior mean proportion (\& 90% credible interval [CI], indicated as 'confidence interval' below) for placebo and each BID dose studied.

    Measured: Week 48

  6. Number of Participants Achieving Improvement in Fibrosis by >=1 Stage, Without Worsening of NASH Based on Assessment by Sponsor-Identified Central Pathologist(s) at Week 48: Pairwise Comparisons With Logistic Regression Model

    Improvement in fibrosis by >=1 stage: decrease of at least 1 stage in Brunt-Kleiner scale compared to baseline. No worsening of fibrosis: no change/decrease of at least 1 stage in Brunt-Kleiner scale compared to baseline. Brunt-Kleiner scale included scaling for fibrosis (0= none, 1= perisinusoidal/ periportal, 2= perisinusoidal, portal/ periportal, 3= bridging, 4= cirrhosis; higher scores = more DA). Logistic Regression model included treatment and baseline fibrosis stage (F2/F3) as factors.

    Measured: Week 48

  7. Mean Proportion of Participants Achieving Improvement in Fibrosis by >=2 Stage, Without Worsening of NASH Based on Assessment by Sponsor-Identified Central Pathologist(s) at Week 48: Bayesian Dose Response Model

    Improvement in fibrosis by >=2 stage: decrease of at least 2 points in total NAS compared to baseline, without progression of fibrosis. No worsening of NASH: no change or no increase in NAS for ballooning (NAS ballooning score= 0; where 0= no ballooning, 1= few balloon cells, 2= many cells with prominent ballooning; higher scores= more disease activity), inflammation (NAS lobular inflammation score 0 or 1, where 0= no foci, 1= <2 foci, 2= 2-4 foci, 3= >4 foci; higher scores= more disease activity), steatosis (NAS steatosis score 0, 1, 2, or 3, where 0= <5% hepatocytes involved, 1= 5-33% hepatocytes involved, 2= 34-66% hepatocytes involved, 3= >66% hepatocytes involved; higher scores=more disease activity) compared to baseline. BDRM utilized to characterize dose response across BID treatment groups, estimate posterior mean proportion (\& 90% credible interval [CI], indicated as 'confidence interval' below) for placebo and each BID dose studied.

    Measured: Week 48

  8. Number of Participants Achieving Improvement in Fibrosis by >=2 Stage, Without Worsening of NASH Based on Assessment by Sponsor-Identified Central Pathologist(s) at Week 48: Pairwise Comparisons With Logistic Regression Model

    Improvement in fibrosis by >=2 stage: decrease of at least 2 points in total NAS compared to baseline, without progression of fibrosis. No worsening of NASH: no change or no increase in NAS for ballooning (NAS ballooning score= 0; where 0= no ballooning, 1= few balloon cells, 2= many cells with prominent ballooning; higher scores= more disease activity), inflammation (NAS lobular inflammation score 0 or 1, where 0= no foci, 1= <2 foci, 2= 2-4 foci, 3= >4 foci; higher scores= more disease activity), steatosis (NAS steatosis score 0, 1, 2 or 3, where 0= <5% hepatocytes involved, 1= 5-33% hepatocytes involved, 2= 34-66% hepatocytes involved, 3= >66% hepatocytes involved; higher scores= more disease activity) compared to baseline. Logistic Regression model included treatment and baseline fibrosis stage (F2/F3) as factors.

    Measured: Week 48

  9. Mean Proportion of Participants Achieving Improvement of >=2 Points in Total NAS, Without Progression of Fibrosis Based on Assessment by Sponsor-Identified Central Pathologist(s) at Week 48: Bayesian Dose Response Model

    Improvement of >=2 points in Total NAS: decrease of at least 2 points in Total NAS compared to baseline, without progression of fibrosis. Total NAS ranged 0 to 8, higher scores= more disease activity and calculated as sum of scores of steatosis (0= <5% hepatocytes involved, 1=5-33% hepatocytes involved, 2=34-66% hepatocytes involved, 3= >66% hepatocytes involved; higher scores= more disease activity), lobular inflammation (0= no foci, 1= <2 foci, 2= 2-4 foci, 3= >4 foci; higher scores= more disease activity), ballooning (0= no ballooning, 1= few balloon cells, 2= many cells with prominent ballooning; higher scores= more disease activity). If sub-scale scores non evaluable or missing, total score was derived as missing. BDRM utilized to characterize dose response across BID treatment groups, estimate posterior mean proportion (\& 90% credible interval [CI], indicated as 'confidence interval' below) for placebo and each BID dose studied.

    Measured: Week 48

  10. Number of Participants Achieving Improvement of >=2 Points in Total NAS Without Progression of Fibrosis Based on Assessment by Sponsor-Identified Central Pathologist(s) at Week 48: Pairwise Comparisons With Logistic Regression Model

    Improvement of >=2 points in Total NAS: decrease of at least 2 points in Total NAS compared to baseline, without progression of fibrosis. Total NAS ranged from 0 to 8, higher scores= more DA and calculated as sum of scores of steatosis (0= <5% hepatocytes involved, 1= 5-33% hepatocytes involved, 2= 34-66% hepatocytes involved, 3= >66% hepatocytes involved; higher scores= more DA), lobular inflammation (0= no foci, 1= <2 foci, 2= 2-4 foci, 3= >4 foci; higher scores= more DA), ballooning (0= no ballooning, 1= few balloon cells, 2= many cells with prominent ballooning; higher scores= more DA). If any of the sub-scale scores were non evaluable/missing, then the total score was derived as missing. Logistic Regression model included treatment and baseline fibrosis stage (F2/F3) as factors.

    Measured: Week 48

  11. Number of Participants With Treatment-Emergent Adverse Events (TEAEs)

    An adverse event (AE) was any untoward medical occurrence in a participant/ clinical investigational participant administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Serious adverse events (SAE) was any untoward medical occurrence at any dose that: resulted in death, was life threatening (risk of death), required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions), resulted in congenital anomaly/birth defect. AEs included both serious and all non-serious AEs. TEAEs were defined as newly occurring or worsening AE after the first dose of study drug.

    Measured: From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)

  12. Number of Participants With Laboratory Test Abnormalities

    Laboratory abnormalities included: Hematology (Hemoglobin [hgb], hematocrit, erythrocytes [ery]: <0.8*lower limit of normal [LLN]; reticulocytes, reticulocytes/ery: <0.5*LLN, >1.5*upper LN [ULN]; ery mean corpuscular volume [EMC], EMC hgb: <0.9*LLN, >1.1*ULN; platelet: >1.75 ULN; lymphocytes, neutrophils, basophils, eosinophils: <0.8* LLN, >1.2*ULN; monocytes: >1.2*ULN; activated partial thromboplastin time, prothrombin time: >1.1*ULN); Clinical chemistry (Total/direct bilirubin, glucose:>1.5*ULN; aspartate aminotransferase [AT], alanine AT, gamma glutamyl transferase: >3.0*ULN; HDL cholesterol: <0.8*LLN; urea nitrogen, creatinine, triglyceride, cholesterol, hgb A1C: >1.3*ULN; urate: >1.2*ULN; potassium: <0.9*LLN, >1.1*ULN; sodium: <0.95*LLN; calcium, bicarbonate: <0.9*LLN; creatine kinase: >2.0*ULN); Urinalysis (glucose, protein, hgb, ketones, nitrite, leukocyte esterase, urobilinogen, bilirubin: >=1; ery, leukocytes: >=20; granular, hyaline casts: >1).

    Measured: From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)

  13. Number of Participants With Clinically Significant Abnormalities in Vital Signs

    Number of participants with clinically significant vital signs were reported in this outcome measure. Vital signs included blood pressure, and heart rate. Clinical significance in vital signs abnormalities was judged by investigator.

    Measured: From first dose of study drug (Day 1) upto Week 48 (maximum up to approximately 50 weeks)

  14. Number of Participants With Clinically Significant Abnormalities in Electrocardiograms (ECG) Parameters

    Number of participants with clinically significant ECG abnormalities were reported in this outcome measure. ECG parameters included heart rate, PR interval, QRS interval and QTcF interval.

    Measured: From first dose of study drug (Day 1) upto Week 48 (maximum up to approximately 50 weeks)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Mar 2020
  2. Study start15 Jun 2020
  3. Primary completion23 Jan 2024
  4. Study completion21 Feb 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Parallel groups
Model description
dose ranging, dose finding
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
256 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04321031
Sponsor's protocol ID
C2541013
Other IDs
2019-004775-39, 2019
Acronym
MIRNA
Status last verified
Mar 2025
First submitted
23 Mar 2020
Last updated
21 Mar 2025
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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.

Publications

  • Wong VW, Amin NB, Takahashi H, Darekar A, Tacke F, Kiszko J, Rodriguez H, Nakajima A, Alkhouri N, Charlton M, Anstee QM. Efficacy and safety of ervogastat alone and in combination with clesacostat in patients with biopsy-confirmed metabolic dysfunction-associated steatohepatitis and F2-F3 fibrosis (MIRNA): results from a phase 2, randomised, double-blind, double-dummy study. Lancet Gastroenterol Hepatol. 2025 Oct;10(10):924-940. doi: 10.1016/S2468-1253(25)00128-1. Epub 2025 Jul 31.

    PubMed 40753985

  • 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.

    PubMed 35354614

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing PF-06865571 and PF-05221304 in people with Nonalcoholic Fatty Liver Disease and Nonalcoholic Steatohepatitis With Liver Fibrosis, run by Pfizer at 291 sites in 12 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 291 sites in United States, Japan, Canada, China, Poland and 7 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 21 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean Proportion of Participants Achieving Resolution of NASH Without Worsening/Improvement of Fibrosis by >=1 Stage Without Worsening of NASH/Both Based on Assessment by Sponsor-Identified Central Pathologist at Week 48:Bayesian Dose Response Model (BDRM) (time frame: Week 48). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04321031, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2025.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in