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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04321031
Other study ID # C2541013
Secondary ID 2019-004775-39
Status Completed
Phase Phase 2
First received
Last updated
Start date June 15, 2020
Est. completion date February 21, 2024

Study information

Verified date April 2024
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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). 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).


Recruitment information / eligibility

Status Completed
Enrollment 258
Est. completion date February 21, 2024
Est. primary completion date January 23, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria: - Biopsy proven NASH with either F2 or F3 fibrosis, per NASH CRN definition - BMI >/= 22.5kg/m2 Exclusion Criteria: - Evidence of other causes of liver disease such as Alcoholic steatohepatitis, (de)compensated cirrhosis, active viral hepatitis - Any condition possibly affecting drug absorption -Unstable concomitant medical conditions, based on medical history or screening laboratory results including- - unstable liver function tests, recent cardiovascular event(s) significant malignancies,

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Placebo
Tablet
PF-06865571
Tablet
PF-05221304
Tablet

Locations

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

Sponsors (1)

Lead Sponsor Collaborator
Pfizer

Countries where clinical trial is conducted

United States,  Bulgaria,  Canada,  China,  Hong Kong,  India,  Japan,  Korea, Republic of,  Poland,  Puerto Rico,  Slovakia,  Taiwan, 

Outcome

Type Measure Description Time frame Safety issue
Primary Resolution of NASH without worsening of fibrosis or improvement in fibrosis by 1>/= or both Proportion of participants achieving resolution of NASH without worsening of fibrosis or improvement in fibrosis by =1 stage without worsening of NASH or both Week 48
Secondary Percent change in liver fat Percent change in liver fat (assessed via MRI-PDFF) Week 48
Secondary Proportion of participants achieving Resolution of NASH, without worsening of fibrosis Week 48
Secondary Proportion of participants achieving improvement in fibrosis by =1stage, without worsening of NASH Week 48
Secondary Proportion of participants with Improvement in fibrosis by =2 stages, without worsening of NASH Week 48
Secondary Proportion of participants with Improvement of =2 points in Total NASH Week 48
Secondary Proportion of participants with a clinically significant change from baseline in vital signs Baseline to Week 50
Secondary Proportion of participants with a clinically significant change from baseline in laboratory values Baseline to Week 50
Secondary Proportion of participants with a clinically significant change from baseline in electrocardiograms (ECG) parameters Baseline to Week 50
Secondary Proportion of participants with treatment-emergent adverse events (TEAE) Baseline to Week 52
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