Clinical trial NCT04321031: Metabolic Interventions to Resolve Non-alcoholic Steatohepatitis (NASH) With Fibrosis (MIRNA)
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Nonalcoholic Fatty Liver Disease
Nonalcoholic Steatohepatitis With Liver Fibrosis
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2020-03-25
Enrollment: 256
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: dose ranging, dose finding
Primary purpose: BASIC_SCIENCE

Brief 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). 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).


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Evidence of other causes of liver disease such as Alcoholic steatohepatitis, (de)compensated cirrhosis, active viral hepatitis
* Any condition possibly affecting drug absorption -Unstable concomitant medical conditions, based on medical history or screening laboratory results including-
* unstable liver function tests, recent cardiovascular event(s) significant malignancies,

Primary outcomes:
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)
timeFrame: Week 48
measure: 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
timeFrame: Week 48
Secondary outcomes:
measure: Percent Change From Baseline in Liver Fat at Week 48: Bayesian Dose Response Model
timeFrame: Baseline, Week 48
measure: Percent Change From Baseline in Liver Fat at Week 48: Pairwise Comparisons With Analysis of Covariance (ANCOVA)
timeFrame: Baseline, Week 48
measure: 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
timeFrame: Week 48
measure: 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
timeFrame: Week 48
measure: 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
timeFrame: Week 48
measure: 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
timeFrame: Week 48
measure: 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
timeFrame: Week 48
measure: 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
timeFrame: Week 48
measure: 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
timeFrame: Week 48
measure: 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
timeFrame: Week 48
measure: Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
timeFrame: From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
measure: Number of Participants With Laboratory Test Abnormalities
timeFrame: From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
measure: Number of Participants With Clinically Significant Abnormalities in Vital Signs
timeFrame: From first dose of study drug (Day 1) upto Week 48 (maximum up to approximately 50 weeks)
measure: Number of Participants With Clinically Significant Abnormalities in Electrocardiograms (ECG) Parameters
timeFrame: From first dose of study drug (Day 1) upto Week 48 (maximum up to approximately 50 weeks)
Other outcomes:
Locations:
city: Chandler
country: United States
facility: Institute for Liver Health dba Arizona Liver Health
state: Arizona
city: Gilbert
country: United States
facility: Comprehensive Interventional Care Centers (CICC)
state: Arizona
city: Glendale
country: United States
facility: The Institute for Liver Health
state: Arizona
city: Peoria
country: United States
facility: The Institute for Liver Health
state: Arizona
city: Sun City
country: United States
facility: Comprehensive Interventional Care Centers (CICC)
state: Arizona
city: Tucson
country: United States
facility: Institute for Liver Health DBA Arizona Liver Health
state: Arizona
city: Canoga Park
country: United States
facility: Hope Clinical Research
state: California
city: Coronado
country: United States
facility: Sharp Coronado Hospital
state: California
city: Coronado
country: United States
facility: Southern California Research Center
state: California
city: El Cajon
country: United States
facility: Magnolia Surgery Center
state: California
city: Encino
country: United States
facility: Encino Hospital Medical Center
state: California
city: Huntington Park
country: United States
facility: National Research Institute
state: California
city: La Jolla
country: United States
facility: Investigational Drug Service, Altman Clinical and Translational Research Institute (ACTRI)
state: California
city: La Jolla
country: United States
facility: University of California San Diego, Altman Clinical and Translational Research Institute Clinic
state: California
city: La Jolla
country: United States
facility: UCSD Altman Clinical and Transitional Research Institute
state: California
city: Lancaster
country: United States
facility: A V Pediatrics, Allergy & Family Medicine
state: California
city: Lancaster
country: United States
facility: Jatinder S. Pruthi, M.D. FACG CPI
state: California
city: Lancaster
country: United States
facility: Om Research LLC
state: California
city: Los Angeles
country: United States
facility: Kaiser Permanente Los Angeles Medical Center
state: California
city: Los Angeles
country: United States
facility: Cedars-Sinai Advanced Health Sciences Pavilion (Imaging)
state: California
city: Los Angeles
country: United States
facility: Cedars-Sinai Comprehensive Transplant Center
state: California
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center Investigational Drug Services (Pharmacy)
state: California
city: Los Angeles
country: United States
facility: S. Mark Taper Foundation Imaging Center (Liver Biopsy)
state: California
city: Mission Hills
country: United States
facility: Providence Facey Medical Foundation
state: California
city: Mission Hills
country: United States
facility: Providence Holy Cross Medical Center
state: California
city: Montebello
country: United States
facility: ART Vascular
state: California
city: Murrieta
country: United States
facility: United Medical Doctors
state: California
city: Newport Beach
country: United States
facility: Back Bay Imaging (Liver Biopsy)
state: California
city: Palmdale
country: United States
facility: Advanced Imaging Center
state: California
city: Palo Alto
country: United States
facility: Blake Wilbur Outpatient Clinic (MRI)
state: California
city: Palo Alto
country: United States
facility: Stanford Hospital and Clinics
state: California
city: Pasadena
country: United States
facility: California Liver Research Institute
state: California
city: Pasadena
country: United States
facility: HMRI
state: California
city: Redwood City
country: United States
facility: Stanford Medicine Outpatient Center (Liver clinic/MRI)
state: California
city: Rialto
country: United States
facility: Inland Empire Clinical Trials, LLC
state: California
city: Sacramento
country: United States
facility: Clinical Trials Research
state: California
city: San Diego
country: United States
facility: Precision Research Institute
state: California
city: San Diego
country: United States
facility: WR-MCCR
state: California
city: San Diego
country: United States
facility: Sharp and Children's MRI Center, LLC
state: California
city: San Jose
country: United States
facility: Stanford Cancer Center South Bay (MRI)
state: California
city: Tarzana
country: United States
facility: Liberty Pacific Advanced Imaging
state: California
city: Tustin
country: United States
facility: Orange County Research Center
state: California
city: Upland
country: United States
facility: Upland Clinical Research
state: California
city: Bristol
country: United States
facility: Bristol Hospital
state: Connecticut
city: Bristol
country: United States
facility: Bristol Radiology Center
state: Connecticut
city: Bristol
country: United States
facility: Connecticut Clinical Research Institute, LLC
state: Connecticut
city: New Haven
country: United States
facility: Yale New Haven Hospital
state: Connecticut
city: New Haven
country: United States
facility: Yale New Haven Hospital, Saint Raphael Campus (MRE location)
state: Connecticut
city: New Haven
country: United States
facility: Yale Center for Clinical Investigators, Church Street South Research Unit (CSRU)
state: Connecticut
city: New Haven
country: United States
facility: Yale Digestive Diseases (Fibroscan location)
state: Connecticut
city: Brandon
country: United States
facility: Tower Radiology (MRI-PDFF)
state: Florida
city: Brandon
country: United States
facility: Tower Radiology - Parsons
state: Florida
city: Clearwater
country: United States
facility: Gastro Florida
state: Florida
city: Clearwater
country: United States
facility: Gastro Florida
state: Florida
city: Doral
country: United States
facility: Integrity Clinical Research, LLC
state: Florida
city: Jacksonville
country: United States
facility: Mayo Clinic Florida
state: Florida
city: Lakewood Ranch
country: United States
facility: Florida Research Institute
state: Florida
city: Maitland
country: United States
facility: Center for Advanced Gastroenterology
state: Florida
city: Maitland
country: United States
facility: Sandlake Imaging
state: Florida
city: Miami Lakes
country: United States
facility: San Marcus Research Clinic, Inc.
state: Florida
city: Miami
country: United States
facility: Optimus U Corporation
state: Florida
city: Miami
country: United States
facility: Unique Imaging (Biscayne Imaging Center)
state: Florida
city: Miami
country: United States
facility: Acevedo Clinical Research Associates
state: Florida
city: Miami
country: United States
facility: Ivetmar Medical Group LLC
state: Florida
city: Miami
country: United States
facility: Vascular and Interventional Specialists of Florida (Liver Biopsy)
state: Florida
city: Miami
country: United States
facility: Care Research Center Inc
state: Florida
city: Oldsmar
country: United States
facility: TGH Imaging Powered by Tower Radiology Center (MRI)
state: Florida
city: Orlando
country: United States
facility: Clinical Neuroscience Solutions, Inc
state: Florida
city: Orlando
country: United States
facility: Omega Research Maitland, LLC
state: Florida
city: Palmetto Bay
country: United States
facility: Innovation Medical Research Center, Inc
state: Florida
city: Saint Petersburg
country: United States
facility: GCP, Global Clinical Professionals
state: Florida
city: Saint Petersburg
country: United States
facility: Gateway (Ultrasound)
state: Florida
city: Sarasota
country: United States
facility: Partners Imaging Center
state: Florida
city: Tampa
country: United States
facility: Radiology Associates
state: Florida
city: Tampa
country: United States
facility: ForCare Clinical Research
state: Florida
city: Zephyrhills
country: United States
facility: AdventHealth Zephyrhills
state: Florida
city: Zephyrhills
country: United States
facility: Florida Medical Clinic, LLC
state: Florida
city: Atlanta
country: United States
facility: Digestive Healthcare of Georgia
state: Georgia
city: Atlanta
country: United States
facility: Piedmont Atlanta Hospital/Piedmont Transplant Institute
state: Georgia
city: Atlanta
country: United States
facility: Piedmont Atlanta Hospital
state: Georgia
city: Columbus
country: United States
facility: Columbus Regional Research Institute
state: Georgia
city: Sandy Springs
country: United States
facility: WR-Mount Vernon Clinical Research, LLC
state: Georgia
city: Snellville
country: United States
facility: Tekton Research, Inc.
state: Georgia
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: Brownsburg
country: United States
facility: Investigators Research Group, LLC
state: Indiana
city: Hendricks
country: United States
facility: Hendricks Regional Health
state: Indiana
city: Clive
country: United States
facility: Heartland Medical Research, Inc. (Administrative Only)
state: Iowa
city: Clive
country: United States
facility: Iowa Digestive Disease Center
state: Iowa
city: Clive
country: United States
facility: Iowa Radiology
state: Iowa
city: Des Moines
country: United States
facility: MercyOne Des Moines Medical Center (Mercy Medical Center)
state: Iowa
city: Iowa City
country: United States
facility: University of Iowa Hospitals and Clinics
state: Iowa
city: Iowa City
country: United States
facility: University of Iowa Magnetic Resonance Research Facility
state: Iowa
city: Topeka
country: United States
facility: Kansas Medical Clinic PA
state: Kansas
city: Wichita
country: United States
facility: Alliance for Multispecialty Research, LLC
state: Kansas
city: Wichita
country: United States
facility: Cypress Interventional
state: Kansas
city: Lake Charles
country: United States
facility: Centex Studies, Inc.
state: Louisiana
city: Lake Charles
country: United States
facility: Lake Charles Memorial Hospital
state: Louisiana
city: Marrero
country: United States
facility: Metropolitan Gastroenterology Associates
state: Louisiana
city: Marrero
country: United States
facility: Tandem Clinical Research GI, LLC
state: Louisiana
city: New Orleans
country: United States
facility: Ochsner Clinic Foundation
state: Louisiana
city: Shreveport
country: United States
facility: Louisiana Research Center, LLC
state: Louisiana
city: Catonsville
country: United States
facility: Gastro Health Research
state: Maryland
city: Columbia
country: United States
facility: Gastro Center of Maryland
state: Maryland
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Ann Arbor
country: United States
facility: Michigan Clinical Research Unit (MCRU)
state: Michigan
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Detroit
country: United States
facility: Henry Ford Health System
state: Michigan
city: Flint
country: United States
facility: Aa Mrc Llc
state: Michigan
city: Grand Rapids
country: United States
facility: Mercy Health
state: Michigan
city: Grand Rapids
country: United States
facility: M1 Imaging Center
state: Michigan
city: Wyoming
country: United States
facility: Gastroenterology Associates of Western Michigan, PLC d.b.a. West Michigan Clinical Research Center
state: Michigan
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Jefferson City
country: United States
facility: Jefferson City Medical Group, P.C.
state: Missouri
city: Las Vegas
country: United States
facility: Desert Radiology
state: Nevada
city: Las Vegas
country: United States
facility: Machuca Family Medicine
state: Nevada
city: Las Vegas
country: United States
facility: The Machuca Foundation, Inc.
state: Nevada
city: Las Vegas
country: United States
facility: Sierra Clinical Research
state: Nevada
city: Las Vegas
country: United States
facility: Las Vegas Medical Research
state: Nevada
city: Las Vegas
country: United States
facility: Pueblo Medical Imaging
state: Nevada
city: Hillsborough
country: United States
facility: Digestive Healthcare Associates
state: New Jersey
city: Hillsborough
country: United States
facility: University Radiology
state: New Jersey
city: Raritan
country: United States
facility: Amici Clinical Research
state: New Jersey
city: Manhasset
country: United States
facility: Northwell Health Center for Liver Diseases
state: New York
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai/The Mount Sinai Hospital
state: New York
city: Raleigh
country: United States
facility: M3 - Wake Research, Inc.
state: North Carolina
city: Winston-Salem
country: United States
facility: Gastroenterology Associates of the Piedmont, PA
state: North Carolina
city: Winston-Salem
country: United States
facility: Novant Health Medical Center
state: North Carolina
city: Winston-Salem
country: United States
facility: PMG Research of Winston-Salem, LLC
state: North Carolina
city: Middleburg Heights
country: United States
facility: Paramount Medical Research & Consulting, LLC
state: Ohio
city: Oklahoma City
country: United States
facility: Comprehensive Diagnostic Imaging
state: Oklahoma
city: Oklahoma City
country: United States
facility: Digestive Disease Specialists, Inc. Endoscopy Lab
state: Oklahoma
city: Oklahoma City
country: United States
facility: Digestive Disease Specialists, Inc.
state: Oklahoma
city: Oklahoma City
country: United States
facility: Oklahoma Spine Hospital
state: Oklahoma
city: Philadelphia
country: United States
facility: Thomas Jefferson University
state: Pennsylvania
city: Pittsburgh
country: United States
facility: UPMC - Center for Liver Diseases at the Thomas E. Starzl Institute
state: Pennsylvania
city: Pittsburgh
country: United States
facility: UPMC - Center for Liver Diseases in the Digestive Disorders Clinic
state: Pennsylvania
city: Pittsburgh
country: United States
facility: UPMC - Translational Research Center
state: Pennsylvania
city: Pittsburgh
country: United States
facility: UPMC Presbyterian Shadyside; Presbyterian Campus Pharmacy
state: Pennsylvania
city: Pittsburgh
country: United States
facility: UPMC
state: Pennsylvania
city: Providence
country: United States
facility: University Gastroenterology
state: Rhode Island
city: Providence
country: United States
facility: Roger Williams Hospital
state: Rhode Island
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Charleston
country: United States
facility: MUSC- Ashley River Tower
state: South Carolina
city: Chattanooga
country: United States
facility: Chattanooga Imaging Center
state: Tennessee
city: Chattanooga
country: United States
facility: WR-Clinsearch, LLC
state: Tennessee
city: Nashville
country: United States
facility: Quality Medical Research, PLLC
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt Hepatology and Liver Transplant
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt University Medical Center - GI Research Office
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt University Medical Center - Digestive Disease Center
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt University Medical Center - Heart Station
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt University Medical Center - Interventional Radiology
state: Tennessee
city: Addison
country: United States
facility: Texas Center for Interventional Surgery (Liver Biopsy Facility)
state: Texas
city: Arlington
country: United States
facility: Texas Clinical Research Institute
state: Texas
city: Dallas
country: United States
facility: Methodist Dallas Medical Center (MRI-PDFF)
state: Texas
city: Dallas
country: United States
facility: The Liver Institute at Methodist Dallas Medical Center
state: Texas
city: Dallas
country: United States
facility: Touchstone Imaging
state: Texas
city: DeSoto
country: United States
facility: Center For Diagnostic Imaging
state: Texas
city: Fort Worth
country: United States
facility: GI Alliance
state: Texas
city: Houston
country: United States
facility: Therapeutic Concepts, PA
state: Texas
city: Houston
country: United States
facility: Centex Studies, Inc.
state: Texas
city: Houston
country: United States
facility: Biopharma Informatic, LLC
state: Texas
city: Houston
country: United States
facility: Premier Vein and Vascular
state: Texas
city: McAllen
country: United States
facility: Centex Studies, Inc
state: Texas
city: Pearland
country: United States
facility: HCA Houston Healthcare Pearland
state: Texas
city: San Antonio
country: United States
facility: American Research Corporation at the Texas Liver Institute
state: Texas
city: San Antonio
country: United States
facility: Clinical Trials of Texas, Inc.
state: Texas
city: San Antonio
country: United States
facility: Diabetes and Glandular Disease Clinic, P.A.
state: Texas
city: Sugar Land
country: United States
facility: Reddy Cardiac Wellness
state: Texas
city: Waco
country: United States
facility: Impact Research Institute
state: Texas
city: Fairfax
country: United States
facility: Gastro Health Research
state: Virginia
city: Fairfax
country: United States
facility: Gastro Health, LLC
state: Virginia
city: Manassas
country: United States
facility: Manassas Clinical Research Center
state: Virginia
city: Norfolk
country: United States
facility: Digestive and Liver Disease Specialists
state: Virginia
city: Norfolk
country: United States
facility: Sentara Leigh Hospital
state: Virginia
city: Richmond
country: United States
facility: McGuire VA Medical Center
state: Virginia
city: Richmond
country: United States
facility: VCU Medical Center Investigational Drug Service
state: Virginia
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
city: Suffolk
country: United States
facility: Virginia Gastroenterology Clinical Research
state: Virginia
city: Seattle
country: United States
facility: Harborview Medical Center Investigational Drug Services
state: Washington
city: Seattle
country: United States
facility: Harborview Medical Center
state: Washington
city: Seattle
country: United States
facility: Seattle Radiology
state: Washington
city: Seattle
country: United States
facility: Liver Institute Northwest
state: Washington
city: Seattle
country: United States
facility: Swedish Medical Center
state: Washington
city: Seattle
country: United States
facility: University of Washington Medical Center
state: Washington
city: Gabrovo
country: Bulgaria
facility: MHAT Dr. Tota Venkova AD
city: Plovdiv
country: Bulgaria
facility: MHAT Medline Clinic AD
city: Sofia
country: Bulgaria
facility: Acibadem City Clinic MHAT Tokuda EAD
city: Sofia
country: Bulgaria
facility: DCC Alexandrovska EOOD
city: Sofia
country: Bulgaria
facility: UMHAT Sv. Ivan Rilski EAD
city: Sofia
country: Bulgaria
facility: UMHAT Sofiamed OOD
city: Stara Zagora
country: Bulgaria
facility: MC New Rehabilitation Center EOOD
city: Varna
country: Bulgaria
facility: DCC Mladost-M Varna OOD
city: Varna
country: Bulgaria
facility: MC Leo Clinic EOOD
city: Calgary
country: Canada
facility: University of Calgary - Heritage Medical Research Clinic (HMRC)
state: Alberta
city: Edmonton
country: Canada
facility: University of Alberta Hospital
state: Alberta
city: Edmonton
country: Canada
facility: University of Alberta
state: Alberta
city: Vancouver
country: Canada
facility: Gordon and Leslie Diamond Health Care Centre
state: British Columbia
city: Vancouver
country: Canada
facility: (G.I.R.I.) GI Research Institute
state: British Columbia
city: Halifax
country: Canada
facility: Nova Scotia Health Authority QEII (Queen Elizabeth II) Health Sciences Centre
state: Nova Scotia
city: London
country: Canada
facility: Manna Research (London)
state: Ontario
city: Toronto
country: Canada
facility: Toronto Liver Centre
state: Ontario
city: Chicoutimi
country: Canada
facility: Resonance Magnetique du Saguenay-Lac-Saint-Jean
state: Quebec
city: Chicoutimi
country: Canada
facility: Centre integre universitaire de sante et de services sociaux du Saguenay-Lac-Saint-Jean
state: Quebec
city: Chicoutimi
country: Canada
facility: Ecogene-21
state: Quebec
city: Montreal
country: Canada
facility: McGill University Health Centre (MUHC)
state: Quebec
city: Montreal
country: Canada
facility: Philips Radiation Oncology
state: Quebec
city: Montreal
country: Canada
facility: Research Institute of the MUHC
state: Quebec
city: Montréal
country: Canada
facility: Centre de recherche du Centre hospitalier de l'Université de Montréal (CRCHUM)
state: Quebec
city: Quebec
country: Canada
facility: Diex Recherche Quebec Inc.
city: Beijing
country: China
facility: Beijing Friendship Hospital, Capital Medical University
state: Beijing
city: Guangzhou
country: China
facility: The First Affiliated Hospital, Sun Yat-sen University
state: Guangdong
city: Shijiazhuang
country: China
facility: The Third Hospital of Hebei Medical University
state: Hebei
city: Changsha
country: China
facility: Hunan Provincial People's Hospital
state: Hunan
city: Changchun
country: China
facility: The First Bethune Hospital of Jilin University
state: Jilin
city: Yinchuan
country: China
facility: General Hospital of Ningxia Medical University
state: Ningxia
city: Qingdao
country: China
facility: Qingdao Central Hospital
state: Shandong
city: Hangzhou
country: China
facility: The Affiliated Hospital of Hangzhou Normal University
state: Zhejiang
city: Wenzhou
country: China
facility: The First Affiliated Hospital of Wenzhou Medical University
state: Zhejiang
city: Beijing
country: China
facility: Peking University People's Hospital
city: Beijing
country: China
facility: Beijing YouAn Hosptial,Capital Medical University
city: Beijing
country: China
facility: Beijing Tsinghua Changgung Hospital
city: Tianjin
country: China
facility: Tianjin Third Central Hospital
city: Tianjin
country: China
facility: Tianjin Second People's Hospital
city: Hong Kong
country: Hong Kong
facility: Queen Mary Hospital
city: Shatin
country: Hong Kong
facility: Prince of Wales Hospital
city: Tai Po
country: Hong Kong
facility: Alice Ho Miu Ling Nethersole Hospital
city: Surat
country: India
facility: Surat Institute of Digestive Sciences
state: Gujarat
city: Surat
country: India
facility: Gujarat Hospital - Gastro and Vascular Centre
state: Gujarat
city: Mumbai
country: India
facility: Global Hospital - Super Speciality & Transplant Centre
state: Maharashtra
city: Saket
country: India
facility: Max Smart Super Speciality Hospital
state: NEW Delhi
city: Jaipur
country: India
facility: S.M.S. Medical College & Hospital
state: Rajasthan
city: Kolkata
country: India
facility: Institute of Post Graduate Medical Education and Research & SSKM Hospital
state: WEST Bengal
city: Gurugram
country: India
facility: Medanta - The Medicity
city: New Delhi
country: India
facility: Institute of Liver and Biliary Sciences (ILBS)
city: New Delhi
country: India
facility: All India Institute of Medical Sciences (AIIMS)
city: Nagakute
country: Japan
facility: Aichi Medical University Hospital
state: Aichi
city: Toon
country: Japan
facility: Ehime University Hospital
state: Ehime
city: Ogaki
country: Japan
facility: Ogaki Municipal Hospital
state: Gifu
city: Inashiki-gun
country: Japan
facility: Tokyo Medical University Ibaraki Medical Center
state: Ibaraki
city: Takamatsu
country: Japan
facility: Kagawa Prefectural Central Hospital
state: Kagawa
city: Yokohama
country: Japan
facility: Yokohama City University Hospital
state: Kanagawa
city: Matsumoto
country: Japan
facility: Shinshu University Hospital
state: Nagano
city: Ohmura
country: Japan
facility: National Hospital Organization Nagasaki Medical Center
state: Nagasaki
city: Sakai
country: Japan
facility: Osaka Rosai Hospital
state: Osaka
city: Suita
country: Japan
facility: Saiseikai Suita Hospital
state: Osaka
city: Izunokuni
country: Japan
facility: Juntendo University Shizuoka Hospital
state: Shizuoka
city: Chiba
country: Japan
facility: Chiba University Hospital
city: Fukui
country: Japan
facility: Fukui-Ken Saiseikai Hospital
city: Gifu
country: Japan
facility: Gifu Municipal Hospital
city: Kagoshima
country: Japan
facility: Kagoshima University Hospital
city: Kyoto
country: Japan
facility: University Hospital, Kyoto Prefectural University of Medicine
city: Miyazaki
country: Japan
facility: Miyazaki Medical Center Hospital
city: Saga
country: Japan
facility: Saga University Hospital
city: Yamagata
country: Japan
facility: Yamagata University Hospital
city: Dongjak-gu
country: Korea, Republic of
facility: SMG-SNU Boramae Medical Center
state: Seoul
city: Busan
country: Korea, Republic of
facility: Pusan National University Hospital
city: Daegu
country: Korea, Republic of
facility: Kyungpook National University Hospital
city: Daegu
country: Korea, Republic of
facility: Yeungnam University Hospital
city: Seoul
country: Korea, Republic of
facility: Severance Hospital Yonsei University Health System
city: Katowice
country: Poland
facility: Szpital Zakonu Bonifratrow
city: Katowice
country: Poland
facility: NZOZ Vita Longa Sp. z o.o.
city: Katowice
country: Poland
facility: Uniwersyteckie Centrum Kliniczne im. prof. K. Gibinskiego Slaskiego Uniwersytetu Medycznego
city: Komorowice
country: Poland
facility: Orthos Szpital Wielospecjalistyczny Sp. z o.o. (Liver Biopsy)
city: Krakow
country: Poland
facility: SPZOZ Szpital Uniwersytecki w Krakowie
city: Krakow
country: Poland
facility: Szpital Zakonu Bonifratrów św. Jana Grandego w Krakowie sp. z o.o. (Liver Biopsy)
city: Krakow
country: Poland
facility: Krakowskie Centrum Medyczne
city: Lodz
country: Poland
facility: Wojewodzki Specjalistyczny Szpital im. Dr. Wl. Bieganskiego w Lodzi
city: Myslowice
country: Poland
facility: ID Clinic
city: Warszawa
country: Poland
facility: WIP Warsaw IBD Point Profesor Kierkus
city: Wroclaw
country: Poland
facility: Futuremeds Sp. z o.o.
city: Zamosc
country: Poland
facility: ETG Zamosc
city: Zamosc
country: Poland
facility: Samodzielny Publiczny Szpital Wojewodzki im. Papieza Jana Pawla II
city: San Juan
country: Puerto Rico
facility: Clinical Research Puerto Rico
city: San Juan
country: Puerto Rico
facility: Latin Clinical Trial Center
city: San Juan
country: Puerto Rico
facility: GCM Medical Group PSC
city: San Juan
country: Puerto Rico
facility: FDI Clinical Research
city: Banska Bystrica
country: Slovakia
facility: Fakultna nemocnica s poliklinikou F. D. Roosevelta Banska Bystrica
city: Bratislava - Mestska Cast Nove Mesto
country: Slovakia
facility: SUMMIT CLINICAL RESEARCH, s.r.o.
city: Bratislava - Mestska Cast Ruzinov
country: Slovakia
facility: Lama Medical Care s.r.o.
city: Bratislava
country: Slovakia
facility: Medispektrum, s.r.o
city: Kosice - Mestska Cast Zapad
country: Slovakia
facility: Univerzitna nemocnica L. Pasteura Kosice
city: Nitra
country: Slovakia
facility: KM Management spol. s.r.o., Gastroenterologicke a hepatologicke centrum Nitra
city: Nitra
country: Slovakia
facility: Fakultna nemocnica Nitra
city: Trnava
country: Slovakia
facility: JAL, s.r.o.
city: Changhua City
country: Taiwan
facility: Changhua Christian Hospital
state: Changhua County
city: Chia-Yi
country: Taiwan
facility: Ditmanson Medical Foundation Chia-Yi Christian Hospital
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Medical University Chung-Ho Memorial Hospital
city: Tainan
country: Taiwan
facility: National Cheng Kung University (NCKU) Hospital
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital
city: Taoyuan
country: Taiwan
facility: Chang Gung Medical Foundation Linkou Chang Gung Memorial Hospital
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: 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.