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

NCT ID: NCT04321031

Last Updated: 2025-03-21

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

256 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-06-15

Study Completion Date

2024-02-21

Brief Summary

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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).

Detailed Description

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Conditions

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Nonalcoholic Fatty Liver Disease Nonalcoholic Steatohepatitis With Liver Fibrosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

dose ranging, dose finding
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors
Double blind, double dummy, placebo controlled

Study Groups

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Placebo

participants will receive medication for 48 weeks

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Tablet

PF-06865571 25 milligrams (mg) twice daily (BID)

participants will receive medication for 48 weeks

Group Type EXPERIMENTAL

PF-06865571

Intervention Type DRUG

Tablet

PF-06865571 75 mg BID

participants will receive medication for 48 weeks

Group Type EXPERIMENTAL

PF-06865571

Intervention Type DRUG

Tablet

PF-06865571 150 mg BID

participants will receive medication for 48 weeks

Group Type EXPERIMENTAL

PF-06865571

Intervention Type DRUG

Tablet

PF-06865571 300 mg BID

participants will receive medication for 48 weeks

Group Type EXPERIMENTAL

PF-06865571

Intervention Type DRUG

Tablet

PF-06865571 (150 mg BID) + PF-05221304 (5 mg BID)

participants will receive medication for 48 weeks

Group Type EXPERIMENTAL

PF-06865571

Intervention Type DRUG

Tablet

PF-05221304

Intervention Type DRUG

Tablet

PF-06865771 (300 mg BID) + PF-05221304 (10 mg BID)

participants will receive medication for 48 weeks

Group Type EXPERIMENTAL

PF-06865571

Intervention Type DRUG

Tablet

PF-05221304

Intervention Type DRUG

Tablet

Interventions

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Placebo

Tablet

Intervention Type DRUG

PF-06865571

Tablet

Intervention Type DRUG

PF-05221304

Tablet

Intervention Type DRUG

Eligibility Criteria

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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,
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Institute for Liver Health dba Arizona Liver Health

Chandler, Arizona, United States

Site Status

Comprehensive Interventional Care Centers (CICC)

Gilbert, Arizona, United States

Site Status

The Institute for Liver Health

Glendale, Arizona, United States

Site Status

The Institute for Liver Health

Peoria, Arizona, United States

Site Status

Comprehensive Interventional Care Centers (CICC)

Sun City, Arizona, United States

Site Status

Institute for Liver Health DBA Arizona Liver Health

Tucson, Arizona, United States

Site Status

Hope Clinical Research

Canoga Park, California, United States

Site Status

Sharp Coronado Hospital

Coronado, California, United States

Site Status

Southern California Research Center

Coronado, California, United States

Site Status

Magnolia Surgery Center

El Cajon, California, United States

Site Status

Encino Hospital Medical Center

Encino, California, United States

Site Status

National Research Institute

Huntington Park, California, United States

Site Status

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

La Jolla, California, United States

Site Status

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

La Jolla, California, United States

Site Status

UCSD Altman Clinical and Transitional Research Institute

La Jolla, California, United States

Site Status

A V Pediatrics, Allergy & Family Medicine

Lancaster, California, United States

Site Status

Jatinder S. Pruthi, M.D. FACG CPI

Lancaster, California, United States

Site Status

Om Research LLC

Lancaster, California, United States

Site Status

Kaiser Permanente Los Angeles Medical Center

Los Angeles, California, United States

Site Status

Cedars-Sinai Advanced Health Sciences Pavilion (Imaging)

Los Angeles, California, United States

Site Status

Cedars-Sinai Comprehensive Transplant Center

Los Angeles, California, United States

Site Status

Cedars-Sinai Medical Center Investigational Drug Services (Pharmacy)

Los Angeles, California, United States

Site Status

S. Mark Taper Foundation Imaging Center (Liver Biopsy)

Los Angeles, California, United States

Site Status

Providence Facey Medical Foundation

Mission Hills, California, United States

Site Status

Providence Holy Cross Medical Center

Mission Hills, California, United States

Site Status

ART Vascular

Montebello, California, United States

Site Status

United Medical Doctors

Murrieta, California, United States

Site Status

Back Bay Imaging (Liver Biopsy)

Newport Beach, California, United States

Site Status

Advanced Imaging Center

Palmdale, California, United States

Site Status

Blake Wilbur Outpatient Clinic (MRI)

Palo Alto, California, United States

Site Status

Stanford Hospital and Clinics

Palo Alto, California, United States

Site Status

California Liver Research Institute

Pasadena, California, United States

Site Status

HMRI

Pasadena, California, United States

Site Status

Stanford Medicine Outpatient Center (Liver clinic/MRI)

Redwood City, California, United States

Site Status

Inland Empire Clinical Trials, LLC

Rialto, California, United States

Site Status

Clinical Trials Research

Sacramento, California, United States

Site Status

Precision Research Institute

San Diego, California, United States

Site Status

WR-MCCR

San Diego, California, United States

Site Status

Sharp and Children's MRI Center, LLC

San Diego, California, United States

Site Status

Stanford Cancer Center South Bay (MRI)

San Jose, California, United States

Site Status

Liberty Pacific Advanced Imaging

Tarzana, California, United States

Site Status

Orange County Research Center

Tustin, California, United States

Site Status

Upland Clinical Research

Upland, California, United States

Site Status

Bristol Hospital

Bristol, Connecticut, United States

Site Status

Bristol Radiology Center

Bristol, Connecticut, United States

Site Status

Connecticut Clinical Research Institute, LLC

Bristol, Connecticut, United States

Site Status

Yale New Haven Hospital

New Haven, Connecticut, United States

Site Status

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

New Haven, Connecticut, United States

Site Status

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

New Haven, Connecticut, United States

Site Status

Yale Digestive Diseases (Fibroscan location)

New Haven, Connecticut, United States

Site Status

Tower Radiology (MRI-PDFF)

Brandon, Florida, United States

Site Status

Tower Radiology - Parsons

Brandon, Florida, United States

Site Status

Gastro Florida

Clearwater, Florida, United States

Site Status

Gastro Florida

Clearwater, Florida, United States

Site Status

Integrity Clinical Research, LLC

Doral, Florida, United States

Site Status

Mayo Clinic Florida

Jacksonville, Florida, United States

Site Status

Florida Research Institute

Lakewood Rch, Florida, United States

Site Status

Center for Advanced Gastroenterology

Maitland, Florida, United States

Site Status

Sandlake Imaging

Maitland, Florida, United States

Site Status

Optimus U Corporation

Miami, Florida, United States

Site Status

Unique Imaging (Biscayne Imaging Center)

Miami, Florida, United States

Site Status

Acevedo Clinical Research Associates

Miami, Florida, United States

Site Status

Ivetmar Medical Group LLC

Miami, Florida, United States

Site Status

Vascular and Interventional Specialists of Florida (Liver Biopsy)

Miami, Florida, United States

Site Status

Care Research Center Inc

Miami, Florida, United States

Site Status

San Marcus Research Clinic, Inc.

Miami Lakes, Florida, United States

Site Status

TGH Imaging Powered by Tower Radiology Center (MRI)

Oldsmar, Florida, United States

Site Status

Clinical Neuroscience Solutions, Inc

Orlando, Florida, United States

Site Status

Omega Research Maitland, LLC

Orlando, Florida, United States

Site Status

Innovation Medical Research Center, Inc

Palmetto Bay, Florida, United States

Site Status

Partners Imaging Center

Sarasota, Florida, United States

Site Status

GCP, Global Clinical Professionals

St. Petersburg, Florida, United States

Site Status

Gateway (Ultrasound)

St. Petersburg, Florida, United States

Site Status

Radiology Associates

Tampa, Florida, United States

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ForCare Clinical Research

Tampa, Florida, United States

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AdventHealth Zephyrhills

Zephyrhills, Florida, United States

Site Status

Florida Medical Clinic, LLC

Zephyrhills, Florida, United States

Site Status

Digestive Healthcare of Georgia

Atlanta, Georgia, United States

Site Status

Piedmont Atlanta Hospital/Piedmont Transplant Institute

Atlanta, Georgia, United States

Site Status

Piedmont Atlanta Hospital

Atlanta, Georgia, United States

Site Status

Columbus Regional Research Institute

Columbus, Georgia, United States

Site Status

WR-Mount Vernon Clinical Research, LLC

Sandy Springs, Georgia, United States

Site Status

Tekton Research, Inc.

Snellville, Georgia, United States

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Rush University Medical Center

Chicago, Illinois, United States

Site Status

Investigators Research Group, LLC

Brownsburg, Indiana, United States

Site Status

Hendricks Regional Health

Hendricks, Indiana, United States

Site Status

Heartland Medical Research, Inc. (Administrative Only)

Clive, Iowa, United States

Site Status

Iowa Digestive Disease Center

Clive, Iowa, United States

Site Status

Iowa Radiology

Clive, Iowa, United States

Site Status

MercyOne Des Moines Medical Center (Mercy Medical Center)

Des Moines, Iowa, United States

Site Status

University of Iowa Hospitals and Clinics

Iowa City, Iowa, United States

Site Status

University of Iowa Magnetic Resonance Research Facility

Iowa City, Iowa, United States

Site Status

Kansas Medical Clinic PA

Topeka, Kansas, United States

Site Status

Alliance for Multispecialty Research, LLC

Wichita, Kansas, United States

Site Status

Cypress Interventional

Wichita, Kansas, United States

Site Status

Centex Studies, Inc.

Lake Charles, Louisiana, United States

Site Status

Lake Charles Memorial Hospital

Lake Charles, Louisiana, United States

Site Status

Metropolitan Gastroenterology Associates

Marrero, Louisiana, United States

Site Status

Tandem Clinical Research GI, LLC

Marrero, Louisiana, United States

Site Status

Ochsner Clinic Foundation

New Orleans, Louisiana, United States

Site Status

Louisiana Research Center, LLC

Shreveport, Louisiana, United States

Site Status

Gastro Health Research

Catonsville, Maryland, United States

Site Status

Gastro Center of Maryland

Columbia, Maryland, United States

Site Status

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

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Michigan Clinical Research Unit (MCRU)

Ann Arbor, Michigan, United States

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University of Michigan

Ann Arbor, Michigan, United States

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Henry Ford Health System

Detroit, Michigan, United States

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Aa Mrc Llc

Flint, Michigan, United States

Site Status

Mercy Health

Grand Rapids, Michigan, United States

Site Status

M1 Imaging Center

Grand Rapids, Michigan, United States

Site Status

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

Wyoming, Michigan, United States

Site Status

Mayo Clinic

Rochester, Minnesota, United States

Site Status

Jefferson City Medical Group, P.C.

Jefferson City, Missouri, United States

Site Status

Desert Radiology

Las Vegas, Nevada, United States

Site Status

Machuca Family Medicine

Las Vegas, Nevada, United States

Site Status

The Machuca Foundation, Inc.

Las Vegas, Nevada, United States

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Sierra Clinical Research

Las Vegas, Nevada, United States

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Las Vegas Medical Research

Las Vegas, Nevada, United States

Site Status

Pueblo Medical Imaging

Las Vegas, Nevada, United States

Site Status

Digestive Healthcare Associates

Hillsborough, New Jersey, United States

Site Status

University Radiology

Hillsborough, New Jersey, United States

Site Status

Amici Clinical Research

Raritan, New Jersey, United States

Site Status

Northwell Health Center for Liver Diseases

Manhasset, New York, United States

Site Status

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

New York, New York, United States

Site Status

M3 - Wake Research, Inc.

Raleigh, North Carolina, United States

Site Status

Gastroenterology Associates of the Piedmont, PA

Winston-Salem, North Carolina, United States

Site Status

Novant Health Medical Center

Winston-Salem, North Carolina, United States

Site Status

PMG Research of Winston-Salem, LLC

Winston-Salem, North Carolina, United States

Site Status

Paramount Medical Research & Consulting, LLC

Middleburg Heights, Ohio, United States

Site Status

Comprehensive Diagnostic Imaging

Oklahoma City, Oklahoma, United States

Site Status

Digestive Disease Specialists, Inc. Endoscopy Lab

Oklahoma City, Oklahoma, United States

Site Status

Digestive Disease Specialists, Inc.

Oklahoma City, Oklahoma, United States

Site Status

Oklahoma Spine Hospital

Oklahoma City, Oklahoma, United States

Site Status

Thomas Jefferson University

Philadelphia, Pennsylvania, United States

Site Status

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

Pittsburgh, Pennsylvania, United States

Site Status

UPMC - Center for Liver Diseases in the Digestive Disorders Clinic

Pittsburgh, Pennsylvania, United States

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UPMC - Translational Research Center

Pittsburgh, Pennsylvania, United States

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UPMC Presbyterian Shadyside; Presbyterian Campus Pharmacy

Pittsburgh, Pennsylvania, United States

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UPMC

Pittsburgh, Pennsylvania, United States

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University Gastroenterology

Providence, Rhode Island, United States

Site Status

Roger Williams Hospital

Providence, Rhode Island, United States

Site Status

Medical University of South Carolina

Charleston, South Carolina, United States

Site Status

MUSC- Ashley River Tower

Charleston, South Carolina, United States

Site Status

Chattanooga Imaging Center

Chattanooga, Tennessee, United States

Site Status

WR-Clinsearch, LLC

Chattanooga, Tennessee, United States

Site Status

Quality Medical Research, PLLC

Nashville, Tennessee, United States

Site Status

Vanderbilt Hepatology and Liver Transplant

Nashville, Tennessee, United States

Site Status

Vanderbilt University Medical Center - GI Research Office

Nashville, Tennessee, United States

Site Status

Vanderbilt University Medical Center - Digestive Disease Center

Nashville, Tennessee, United States

Site Status

Vanderbilt University Medical Center - Heart Station

Nashville, Tennessee, United States

Site Status

Vanderbilt University Medical Center - Interventional Radiology

Nashville, Tennessee, United States

Site Status

Texas Center for Interventional Surgery (Liver Biopsy Facility)

Addison, Texas, United States

Site Status

Texas Clinical Research Institute

Arlington, Texas, United States

Site Status

Methodist Dallas Medical Center (MRI-PDFF)

Dallas, Texas, United States

Site Status

The Liver Institute at Methodist Dallas Medical Center

Dallas, Texas, United States

Site Status

Touchstone Imaging

Dallas, Texas, United States

Site Status

Center For Diagnostic Imaging

DeSoto, Texas, United States

Site Status

GI Alliance

Fort Worth, Texas, United States

Site Status

Therapeutic Concepts, PA

Houston, Texas, United States

Site Status

Centex Studies, Inc.

Houston, Texas, United States

Site Status

Biopharma Informatic, LLC

Houston, Texas, United States

Site Status

Premier Vein and Vascular

Houston, Texas, United States

Site Status

Centex Studies, Inc

McAllen, Texas, United States

Site Status

HCA Houston Healthcare Pearland

Pearland, Texas, United States

Site Status

American Research Corporation at the Texas Liver Institute

San Antonio, Texas, United States

Site Status

Clinical Trials of Texas, Inc.

San Antonio, Texas, United States

Site Status

Diabetes and Glandular Disease Clinic, P.A.

San Antonio, Texas, United States

Site Status

Reddy Cardiac Wellness

Sugar Land, Texas, United States

Site Status

Impact Research Institute

Waco, Texas, United States

Site Status

Gastro Health Research

Fairfax, Virginia, United States

Site Status

Gastro Health, LLC

Fairfax, Virginia, United States

Site Status

Manassas Clinical Research Center

Manassas, Virginia, United States

Site Status

Digestive and Liver Disease Specialists

Norfolk, Virginia, United States

Site Status

Sentara Leigh Hospital

Norfolk, Virginia, United States

Site Status

McGuire VA Medical Center

Richmond, Virginia, United States

Site Status

VCU Medical Center Investigational Drug Service

Richmond, Virginia, United States

Site Status

Virginia Commonwealth University

Richmond, Virginia, United States

Site Status

Virginia Gastroenterology Clinical Research

Suffolk, Virginia, United States

Site Status

Harborview Medical Center Investigational Drug Services

Seattle, Washington, United States

Site Status

Harborview Medical Center

Seattle, Washington, United States

Site Status

Seattle Radiology

Seattle, Washington, United States

Site Status

Liver Institute Northwest

Seattle, Washington, United States

Site Status

Swedish Medical Center

Seattle, Washington, United States

Site Status

University of Washington Medical Center

Seattle, Washington, United States

Site Status

MHAT Dr. Tota Venkova AD

Gabrovo, , Bulgaria

Site Status

MHAT Medline Clinic AD

Plovdiv, , Bulgaria

Site Status

Acibadem City Clinic MHAT Tokuda EAD

Sofia, , Bulgaria

Site Status

DCC Alexandrovska EOOD

Sofia, , Bulgaria

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UMHAT Sv. Ivan Rilski EAD

Sofia, , Bulgaria

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UMHAT Sofiamed OOD

Sofia, , Bulgaria

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MC New Rehabilitation Center EOOD

Stara Zagora, , Bulgaria

Site Status

DCC Mladost-M Varna OOD

Varna, , Bulgaria

Site Status

MC Leo Clinic EOOD

Varna, , Bulgaria

Site Status

University of Calgary - Heritage Medical Research Clinic (HMRC)

Calgary, Alberta, Canada

Site Status

University of Alberta Hospital

Edmonton, Alberta, Canada

Site Status

University of Alberta

Edmonton, Alberta, Canada

Site Status

Gordon and Leslie Diamond Health Care Centre

Vancouver, British Columbia, Canada

Site Status

(G.I.R.I.) GI Research Institute

Vancouver, British Columbia, Canada

Site Status

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

Halifax, Nova Scotia, Canada

Site Status

Manna Research (London)

London, Ontario, Canada

Site Status

Toronto Liver Centre

Toronto, Ontario, Canada

Site Status

Resonance Magnetique du Saguenay-Lac-Saint-Jean

Chicoutimi, Quebec, Canada

Site Status

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

Chicoutimi, Quebec, Canada

Site Status

Ecogene-21

Chicoutimi, Quebec, Canada

Site Status

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

Montreal, Quebec, Canada

Site Status

McGill University Health Centre (MUHC)

Montreal, Quebec, Canada

Site Status

Philips Radiation Oncology

Montreal, Quebec, Canada

Site Status

Research Institute of the MUHC

Montreal, Quebec, Canada

Site Status

Diex Recherche Quebec Inc.

Québec, , Canada

Site Status

Beijing Friendship Hospital, Capital Medical University

Beijing, Beijing Municipality, China

Site Status

The First Affiliated Hospital, Sun Yat-sen University

Guangzhou, Guangdong, China

Site Status

The Third Hospital of Hebei Medical University

Shijiazhuang, Hebei, China

Site Status

Hunan Provincial People's Hospital

Changsha, Hunan, China

Site Status

The First Bethune Hospital of Jilin University

Changchun, Jilin, China

Site Status

General Hospital of Ningxia Medical University

Yinchuan, Ningxia, China

Site Status

Qingdao Central Hospital

Qingdao, Shandong, China

Site Status

The Affiliated Hospital of Hangzhou Normal University

Hangzhou, Zhejiang, China

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The First Affiliated Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, China

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Peking University People's Hospital

Beijing, , China

Site Status

Beijing YouAn Hosptial,Capital Medical University

Beijing, , China

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Beijing Tsinghua Changgung Hospital

Beijing, , China

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Tianjin Third Central Hospital

Tianjin, , China

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Tianjin Second People's Hospital

Tianjin, , China

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Queen Mary Hospital

Hong Kong, , Hong Kong

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Prince of Wales Hospital

Shatin, , Hong Kong

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Alice Ho Miu Ling Nethersole Hospital

Tai Po, , Hong Kong

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Surat Institute of Digestive Sciences

Surat, Gujarat, India

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Gujarat Hospital - Gastro and Vascular Centre

Surat, Gujarat, India

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Global Hospital - Super Speciality & Transplant Centre

Mumbai, Maharashtra, India

Site Status

Max Smart Super Speciality Hospital

Sāket, NEW Delhi, India

Site Status

S.M.S. Medical College & Hospital

Jaipur, Rajasthan, India

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Institute of Post Graduate Medical Education and Research & SSKM Hospital

Kolkata, West Bengal, India

Site Status

Medanta - The Medicity

Gurugram, , India

Site Status

Institute of Liver and Biliary Sciences (ILBS)

New Delhi, , India

Site Status

All India Institute of Medical Sciences (AIIMS)

New Delhi, , India

Site Status

Aichi Medical University Hospital

Nagakute, Aichi-ken, Japan

Site Status

Ehime University Hospital

Tōon, Ehime, Japan

Site Status

Ogaki Municipal Hospital

Ōgaki, Gifu, Japan

Site Status

Tokyo Medical University Ibaraki Medical Center

Inashiki-gun, Ibaraki, Japan

Site Status

Kagawa Prefectural Central Hospital

Takamatsu, Kagawa-ken, Japan

Site Status

Yokohama City University Hospital

Yokohama, Kanagawa, Japan

Site Status

Shinshu University Hospital

Matsumoto, Nagano, Japan

Site Status

National Hospital Organization Nagasaki Medical Center

Ohmura, Nagasaki, Japan

Site Status

Osaka Rosai Hospital

Sakai, Osaka, Japan

Site Status

Saiseikai Suita Hospital

Suita, Osaka, Japan

Site Status

Juntendo University Shizuoka Hospital

Izunokuni, Shizuoka, Japan

Site Status

Chiba University Hospital

Chiba, , Japan

Site Status

Fukui-Ken Saiseikai Hospital

Fukui, , Japan

Site Status

Gifu Municipal Hospital

Gifu, , Japan

Site Status

Kagoshima University Hospital

Kagoshima, , Japan

Site Status

University Hospital, Kyoto Prefectural University of Medicine

Kyoto, , Japan

Site Status

Miyazaki Medical Center Hospital

Miyazaki, , Japan

Site Status

Saga University Hospital

Saga, , Japan

Site Status

Yamagata University Hospital

Yamagata, , Japan

Site Status

Szpital Zakonu Bonifratrow

Katowice, , Poland

Site Status

NZOZ Vita Longa Sp. z o.o.

Katowice, , Poland

Site Status

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

Katowice, , Poland

Site Status

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

Komorowice, , Poland

Site Status

SPZOZ Szpital Uniwersytecki w Krakowie

Krakow, , Poland

Site Status

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

Krakow, , Poland

Site Status

Krakowskie Centrum Medyczne

Krakow, , Poland

Site Status

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

Lodz, , Poland

Site Status

ID Clinic

Mysłowice, , Poland

Site Status

WIP Warsaw IBD Point Profesor Kierkus

Warsaw, , Poland

Site Status

Futuremeds Sp. z o.o.

Wroclaw, , Poland

Site Status

ETG Zamosc

Zamość, , Poland

Site Status

Samodzielny Publiczny Szpital Wojewodzki im. Papieza Jana Pawla II

Zamość, , Poland

Site Status

Clinical Research Puerto Rico

San Juan, , Puerto Rico

Site Status

Latin Clinical Trial Center

San Juan, , Puerto Rico

Site Status

GCM Medical Group PSC

San Juan, , Puerto Rico

Site Status

FDI Clinical Research

San Juan, , Puerto Rico

Site Status

Fakultna nemocnica s poliklinikou F. D. Roosevelta Banska Bystrica

Banská Bystrica, , Slovakia

Site Status

Medispektrum, s.r.o

Bratislava, , Slovakia

Site Status

SUMMIT CLINICAL RESEARCH, s.r.o.

Bratislava - Mestska Cast Nove Mesto, , Slovakia

Site Status

Lama Medical Care s.r.o.

Bratislava - Mestska Cast Ruzinov, , Slovakia

Site Status

Univerzitna nemocnica L. Pasteura Kosice

Kosice - Mestska Cast Zapad, , Slovakia

Site Status

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

Nitra, , Slovakia

Site Status

Fakultna nemocnica Nitra

Nitra, , Slovakia

Site Status

JAL, s.r.o.

Trnava, , Slovakia

Site Status

SMG-SNU Boramae Medical Center

Dongjak-gu, Seoul, South Korea

Site Status

Pusan National University Hospital

Busan, , South Korea

Site Status

Kyungpook National University Hospital

Daegu, , South Korea

Site Status

Yeungnam University Hospital

Daegu, , South Korea

Site Status

Severance Hospital Yonsei University Health System

Seoul, , South Korea

Site Status

Changhua Christian Hospital

Changhua, Changhua County, Taiwan

Site Status

Ditmanson Medical Foundation Chia-Yi Christian Hospital

Chiayi City, , Taiwan

Site Status

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, , Taiwan

Site Status

National Cheng Kung University (NCKU) Hospital

Tainan City, , Taiwan

Site Status

National Taiwan University Hospital

Taipei, , Taiwan

Site Status

Taipei Veterans General Hospital

Taipei, , Taiwan

Site Status

Chang Gung Medical Foundation Linkou Chang Gung Memorial Hospital

Taoyuan District, , Taiwan

Site Status

Countries

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United States Bulgaria Canada China Hong Kong India Japan Poland Puerto Rico Slovakia South Korea Taiwan

References

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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.

Reference Type DERIVED
PMID: 40753985 (View on PubMed)

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.

Reference Type DERIVED
PMID: 35354614 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

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https://pmiform.com/clinical-trial-info-request?StudyID=C2541013

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Other Identifiers

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2019-004775-39

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

C2541013

Identifier Type: -

Identifier Source: org_study_id

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