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Phase 2a, Dose-ranging Study With PF-05221304 in Nonalcoholic Fatty Liver Disease (NAFLD)

Primary Purpose

Nonalcoholic Fatty Liver Disease, Nonalcoholic Steatohepatitis

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Placebo
PF-05221304
Sponsored by
Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Nonalcoholic Fatty Liver Disease focused on measuring PF-05221304, NAFLD, NASH, features of metabolic syndrome, Dose-Ranging Study

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Body Mass Index >= 25 kg/m2
  • Body Weight > 50 kg
  • Liver fat (assessed via MRI-PDFF) >= 8%
  • Biopsy-proven NASH - diagnosed in previous 24-months
  • Presumed NASH - per Sponsor's definition
  • NAFLD with minimal inflammation/fibrosis
  • Features of Metabolic Syndrome

Exclusion Criteria:

  • Alcohol-induced steatohepatitis or other forms of chronic liver disease
  • Positive for Hepatitis B, Hepatitis C, or Human Deficiency Virus
  • Severe Renal Impairment
  • Contraindications for MRI

Sites / Locations

  • Franco Felizarta MD
  • eStudySite
  • San Diego Imaging Chula Vista
  • University of California, San Diego (Altman Clinical and Translational Research Institute)
  • University of California, San Diego
  • eStudySite
  • Clinical Trials Research
  • National Research Institute
  • Stanford University Medical Center, Blake wilbur Building
  • Stanford University Medical Center
  • Huntington Medical Research Institute
  • Inland Empire Liver Foundation
  • Precision Research Institute
  • Quest Clinical Research
  • South Denver Gastroenterology, P.C.
  • Jacksonville Center for Clinical Research
  • Borland-Groover Clinic
  • Ocean Blue Medical Research Center, Inc
  • Schiff Center for Liver Diseases/University of Miami
  • Stand Up MRI of Miami
  • Avail Clinical Research, LLC
  • Bioclinica Research
  • Advanced Gastroenterology Associates, LLC
  • Qps-Mra, Llc
  • Tampa General Medical Group
  • University of South Florida
  • South Florida Center Of Gastroenterology, PA
  • Independent Imaging
  • East-West Medical Research Institute
  • Invision Imaging
  • Midwest Institute for Clinical Research
  • Heartland Research Associates, LLC
  • Ascension Via Christi Imaging at St. Francis
  • Tulane University Health Sciences Center
  • Ochsner Medical Center
  • Mercy Medical Center
  • Digestive Disease Associates, PA
  • University of Michigan
  • Henry Ford Health System
  • Mayo Clinic- Main Campus
  • Gastrointestinal Associates, PA
  • Colonnades at Baptist
  • BioTelemetry Research
  • Investigational Drug Service, University of North Carolina Hospitals
  • The University of NC at Chapel Hill, Clinical and Translational Research Center (CTRC)
  • The University of North Carolina at Chapel Hill, Biomedical Research Imaging Center (MRI Facility)
  • Wake Research Associates, LLC
  • PMG Research of Wilmington, LLC
  • PMG Research, Inc.
  • Sterling Research Group, Ltd.
  • Prime Imaging (Chattanooga Outpatient Center)
  • ClinSearch
  • Touchstone
  • Baylor College of Medicine - Advanced Liver Therapies
  • Pinnacle Clinical Research
  • Clinical Trials of Texas, Inc.
  • Pinnacle Clinical Research, PLLC
  • Clinical Research Advantage, Inc./Wasatch Peak Family Practice
  • National Clinical Research - Richmond, Inc.
  • Harborview Medical Center
  • Australian Clinical Research Network
  • Spectrum Medical Imaging
  • Castlereagh Imaging
  • Storr Liver Centre, Westmead Hospital
  • Dr. Jones & Partners Medical Imaging
  • Royal Adelaide Hospital, Department of Gastroenterology and Hepatology
  • Flinders Medical Centre/Department of Gastroenterology & Hepatology
  • Radiology SA
  • Royal Melbourne Hospital
  • Dr TG Elliott Inc - BC Diabetes
  • False Creek Healthcare Centre
  • False Creek Healthcare
  • LAIR Centre
  • Discovery Clinical Services Ltd.
  • West Coast Medical Imaging
  • Nova Scotia Health Authority, QEII Health Sciences Centre
  • Nova Scotia Health Authority, QEII Health Sciences Centre
  • Nova Scotia Health Authority - QEII Health Sciences Centre
  • Aggarwal and Associates Limited
  • St. Joseph's Health Care London
  • London Health Sciences Centre - University Hospital
  • Oxford Medical Imaging
  • LMC Clinical Research Inc. (Bayview)
  • St. Michael's Hospital - MRI Research Centre
  • St. Michael's Hospital
  • University Health Network (UHN) - Toronto General Hospital - Toronto Centre for Liver Disease (TCLD)
  • University of Toronto - Toronto General Hospital
  • University Health Network (UHN)
  • Toronto Liver Centre - Liver Care Centre Corporation
  • Resonance Magnetique du Saguenay-Lac-Saint-Jean
  • Ecogene-21
  • Medpharmgene Inc
  • Clinique de Medecine Urbaine du Quartier Latin
  • Centre de recherche du CHUM
  • Cedar Cancer Center - McGill University Health Centre
  • Chronic Viral Illness Service - Royal Victoria Hospital - McGill University Health Centre (MUHC)
  • McGill University Health Centre
  • Research Institute of the MUHC
  • Radiologie Varad
  • Centre Intégré Universitaire de Santé et de Services Sociaux (CIUSSS) de l'Estrie
  • Recherche Medicale St-Jerome Inc
  • IRM Quebec
  • IRM Quebec
  • CHU de Quebec - Universite Laval - site Centre Hospitalier de l'Universite Laval (CHUL)
  • Centre de recherche de l'Institut Universitaire de Cardiologie et de pneumologie de Quebec
  • Centre de recherche Saint-Louis
  • IRM Québec - Clinique St-Louis
  • Alpha Recherche Clinique
  • Clinix
  • Hillel Yaffe Medical Center
  • Rambam Health Care Campus
  • Lady Davis Carmel Medical Center
  • Shaare Zedek Medical Center
  • Hadassah Hebrew University Medical Center - Ein Kerem
  • Galilee Medical Center
  • Holy Family Hospital
  • Rabin Medical Center
  • The Chaim Sheba Medical Center
  • Tel-Aviv Sourasky Medical Center
  • ClinicMed Badurski i wspolnicy Spolka Jawna
  • Synexus Polska Sp. z o.o. Oddzial w Gdansku
  • Centrum Badan Klinicznych PI-House Sp. z o.o.
  • Synexus Polska Sp. z o.o. Oddzial w Gdyni
  • Osrodek Badan Klinicznych
  • Synexus Polska Sp. z o.o. Oddzial w Katowicach
  • Silmedic Sp. z o.o. Oddzial w Katowicach
  • Centrum Medyczne A-Z Clinic
  • Krakowskie Centrum Medyczne sp. z o.o.
  • Gabinet Lekarski Malgorzata Saryusz-Wolska
  • Synexus Polska Sp. z o.o Oddzial w Poznaniu
  • Centrum Medyczne Medyk
  • Synexus Polska Sp. z o. o. Oddzial w Warszawie
  • Niepubliczny Zaklad Opieki Zdrowotnej Centrum Badan Klinicznych
  • Synexus Polska Sp. z o.o. Oddzial we Wroclawiu
  • DOBROSTAN - Gabinety Lekarskie
  • Changhua Christian Hospital
  • Chung-Ho Memorial Hospital, Kaohsiung Medical University
  • National Cheng-Kung University Hospital
  • National Taiwan University Hospital
  • Taipei Veterans General Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Placebo Comparator

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

Placebo

PF-05221304 - 2 mg

PF-05221304 - 10 mg

PF-05221304 - 25 mg

PF-05221304 - 50 mg

Arm Description

Double-Blind, PF-05221304-matching Placebo

PF-05221304 - 2 mg, once-daily

PF-05221304 - 10 mg, once-daily

PF-05221304 - 25 mg, once-daily

PF-05221304 - 50 mg, once-daily

Outcomes

Primary Outcome Measures

Percent Change From Baseline in Liver Fat by Magnetic Resonance Imaging-Proton Density Fat Fraction (MRI- PDFF) at Week 16
MRI-PDFF utilized a gradient echo sequence with low flip angle (FA) to minimize T1 bias, corrected T2* decay (due to iron overload) via modeling of the fat signal as a superposition of multiple frequency components from 5 different lipid types, and was applied in each of the 9 Couinaud segments. This technique improved fat quantification accuracy for the entire liver permitting quantification of small differences/changes following pharmacological intervention.

Secondary Outcome Measures

Percent Change From Baseline in Alanine Aminotransferase at Week 16
Potential improvement in liver function was denoted by reduction in alanine transaminase (ALT)
Number of Participants With Treatment-Emergent Adverse Events
An AE was any untoward medical occurrence in a study subject administered a product or medical device. A serious AE (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; life-threatening; initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect. Any such events with initial onset or increasing in severity after the first dose of study treatment were counted as treatment-emergent.
Number of Participants With Laboratory Abnormalities
Following laboratory parameters were assessed against pre-defined abnormality criteria: hematology (hemoglobin, hematocrit, erythrocytes, reticulocytes, platelets, leukocytes, lymphocytes, neutrophils, basophils, eosinophils, monocytes, activated partial thromboplastin time, prothrombin time [PT], PT/international normalized ratio, reticulocytes); chemistry (indirect bilirubin, direct bilirubin, protein, albumin, blood urea nitrogen, creatinine, creatine kinase, urate, calcium, sodium, potassium, chloride, bicarbonate, urine urobilinogen); urinalysis (pH, urine glucose, urine ketones, urine protein, urine hemoglobin, nitrites, leukocyte esterase, urine erythrocytes, urine leukocytes, urine hyaline casts, urine bilirubin, granular casts).
Number of Participants With Vital Signs Data Meeting Predefined Criteria
Vital signs categorical summarization criteria: 1) sitting systolic blood pressure (SBP) <90 or >180 millimeters of mercury (mmHg); 2) sitting diastolic blood pressure (DBP) <50 mmHg or >110 mmHg; 3) sitting pulse rate <40 or >120 beats per minute (bpm); 4) change from baseline (increase or decrease) in sitting DBP greater than or equal to (>=) 20 mmHg; 5) change from baseline (increase or decrease) in sitting SBP >=30 mmHg.
Number of Participants With 12-Lead Electrocardiogram (ECG) Data Meeting Predefined Criteria
ECG categorical summarization criteria: 1) QRS interval (time from ECG Q wave to the end of the S wave corresponding to ventricle depolarization) >=140 milliseconds (msec); 2) QRS interval >=50% change from baseline; 3) PR interval (the interval between the start of the P wave and the start of the QRS complex, corresponding to the time between the onset of the atrial depolarization and onset of ventricular depolarization) >=300 msec; 4) PR interval >=25% change when baseline is >200 msec or >=50% change when baseline is <=200 msec; 5) QT interval (time from ECG Q wave to the end of the T wave corresponding to electrical systole): absolute value of >=500 msec; 6) QTcF interval (QT corrected for heart rate using Fridericia's formula) absolute value of 450 to <480 msec; 7) QTcF interval: absolute value of 480 to <500 msec; 8) QTcF interval: absolute value >=500 msec; 9) QTcF interval: a change from baseline of 30 to <60 msec; 10) QTcF interval: a change from baseline >=60 msec.

Full Information

First Posted
August 10, 2017
Last Updated
December 7, 2020
Sponsor
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT03248882
Brief Title
Phase 2a, Dose-ranging Study With PF-05221304 in Nonalcoholic Fatty Liver Disease (NAFLD)
Official Title
A PHASE 2A, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, DOSE-RANGING, PARALLEL GROUP STUDY TO EVALUATE SAFETY, TOLERABILITY, AND PHARMACODYNAMICS OF PF-05221304 ADMINISTERED DAILY FOR 16-WEEKS TO ADULT SUBJECTS WITH NONALCOHOLIC FATTY LIVER DISEASE
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
August 22, 2017 (Actual)
Primary Completion Date
February 26, 2019 (Actual)
Study Completion Date
March 27, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Phase 2a, dose-ranging Study with PF-05221304 in Nonalcoholic Fatty Liver Disease (NAFLD)
Detailed Description
A Phase 2a, Randomized, Double-blind, Placebo-controlled, Dose-ranging, Parallel Group Study To Evaluate Safety, Tolerability, And Pharmacodynamics Of PF-05221304 Administered Daily For 16-weeks To Adult Subjects With Nonalcoholic Fatty Liver Disease

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nonalcoholic Fatty Liver Disease, Nonalcoholic Steatohepatitis
Keywords
PF-05221304, NAFLD, NASH, features of metabolic syndrome, Dose-Ranging Study

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
C1171002 is a randomized, double blind, placebo controlled, 5 arm (placebo, plus 4 active doses of PF 05221304), parallel group study.
Masking
ParticipantInvestigator
Masking Description
Double-Blind
Allocation
Randomized
Enrollment
305 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Double-Blind, PF-05221304-matching Placebo
Arm Title
PF-05221304 - 2 mg
Arm Type
Active Comparator
Arm Description
PF-05221304 - 2 mg, once-daily
Arm Title
PF-05221304 - 10 mg
Arm Type
Active Comparator
Arm Description
PF-05221304 - 10 mg, once-daily
Arm Title
PF-05221304 - 25 mg
Arm Type
Active Comparator
Arm Description
PF-05221304 - 25 mg, once-daily
Arm Title
PF-05221304 - 50 mg
Arm Type
Active Comparator
Arm Description
PF-05221304 - 50 mg, once-daily
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo
Intervention Type
Drug
Intervention Name(s)
PF-05221304
Intervention Description
PF-05221304, Experimental Drug
Primary Outcome Measure Information:
Title
Percent Change From Baseline in Liver Fat by Magnetic Resonance Imaging-Proton Density Fat Fraction (MRI- PDFF) at Week 16
Description
MRI-PDFF utilized a gradient echo sequence with low flip angle (FA) to minimize T1 bias, corrected T2* decay (due to iron overload) via modeling of the fat signal as a superposition of multiple frequency components from 5 different lipid types, and was applied in each of the 9 Couinaud segments. This technique improved fat quantification accuracy for the entire liver permitting quantification of small differences/changes following pharmacological intervention.
Time Frame
Baseline (between Day -14 and Day 1), Week 16
Secondary Outcome Measure Information:
Title
Percent Change From Baseline in Alanine Aminotransferase at Week 16
Description
Potential improvement in liver function was denoted by reduction in alanine transaminase (ALT)
Time Frame
Baseline (Day 1 pre-dose), Week 16
Title
Number of Participants With Treatment-Emergent Adverse Events
Description
An AE was any untoward medical occurrence in a study subject administered a product or medical device. A serious AE (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; life-threatening; initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect. Any such events with initial onset or increasing in severity after the first dose of study treatment were counted as treatment-emergent.
Time Frame
From first dose of study treatment (Day 1) up to Week 20
Title
Number of Participants With Laboratory Abnormalities
Description
Following laboratory parameters were assessed against pre-defined abnormality criteria: hematology (hemoglobin, hematocrit, erythrocytes, reticulocytes, platelets, leukocytes, lymphocytes, neutrophils, basophils, eosinophils, monocytes, activated partial thromboplastin time, prothrombin time [PT], PT/international normalized ratio, reticulocytes); chemistry (indirect bilirubin, direct bilirubin, protein, albumin, blood urea nitrogen, creatinine, creatine kinase, urate, calcium, sodium, potassium, chloride, bicarbonate, urine urobilinogen); urinalysis (pH, urine glucose, urine ketones, urine protein, urine hemoglobin, nitrites, leukocyte esterase, urine erythrocytes, urine leukocytes, urine hyaline casts, urine bilirubin, granular casts).
Time Frame
From first dose of study treatment (Day 1) up to Week 20
Title
Number of Participants With Vital Signs Data Meeting Predefined Criteria
Description
Vital signs categorical summarization criteria: 1) sitting systolic blood pressure (SBP) <90 or >180 millimeters of mercury (mmHg); 2) sitting diastolic blood pressure (DBP) <50 mmHg or >110 mmHg; 3) sitting pulse rate <40 or >120 beats per minute (bpm); 4) change from baseline (increase or decrease) in sitting DBP greater than or equal to (>=) 20 mmHg; 5) change from baseline (increase or decrease) in sitting SBP >=30 mmHg.
Time Frame
From first dose of study treatment (Day 1) up to Week 18
Title
Number of Participants With 12-Lead Electrocardiogram (ECG) Data Meeting Predefined Criteria
Description
ECG categorical summarization criteria: 1) QRS interval (time from ECG Q wave to the end of the S wave corresponding to ventricle depolarization) >=140 milliseconds (msec); 2) QRS interval >=50% change from baseline; 3) PR interval (the interval between the start of the P wave and the start of the QRS complex, corresponding to the time between the onset of the atrial depolarization and onset of ventricular depolarization) >=300 msec; 4) PR interval >=25% change when baseline is >200 msec or >=50% change when baseline is <=200 msec; 5) QT interval (time from ECG Q wave to the end of the T wave corresponding to electrical systole): absolute value of >=500 msec; 6) QTcF interval (QT corrected for heart rate using Fridericia's formula) absolute value of 450 to <480 msec; 7) QTcF interval: absolute value of 480 to <500 msec; 8) QTcF interval: absolute value >=500 msec; 9) QTcF interval: a change from baseline of 30 to <60 msec; 10) QTcF interval: a change from baseline >=60 msec.
Time Frame
From first dose of study treatment (Day 1) up to Week 18

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Body Mass Index >= 25 kg/m2 Body Weight > 50 kg Liver fat (assessed via MRI-PDFF) >= 8% Biopsy-proven NASH - diagnosed in previous 24-months Presumed NASH - per Sponsor's definition NAFLD with minimal inflammation/fibrosis Features of Metabolic Syndrome Exclusion Criteria: Alcohol-induced steatohepatitis or other forms of chronic liver disease Positive for Hepatitis B, Hepatitis C, or Human Deficiency Virus Severe Renal Impairment Contraindications for MRI
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Franco Felizarta MD
City
Bakersfield
State/Province
California
ZIP/Postal Code
93301
Country
United States
Facility Name
eStudySite
City
Chula Vista
State/Province
California
ZIP/Postal Code
91911
Country
United States
Facility Name
San Diego Imaging Chula Vista
City
Chula Vista
State/Province
California
ZIP/Postal Code
91911
Country
United States
Facility Name
University of California, San Diego (Altman Clinical and Translational Research Institute)
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
Facility Name
University of California, San Diego
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
Facility Name
eStudySite
City
La Mesa
State/Province
California
ZIP/Postal Code
91942
Country
United States
Facility Name
Clinical Trials Research
City
Lincoln
State/Province
California
ZIP/Postal Code
95648
Country
United States
Facility Name
National Research Institute
City
Los Angeles
State/Province
California
ZIP/Postal Code
90057
Country
United States
Facility Name
Stanford University Medical Center, Blake wilbur Building
City
Palo Alto
State/Province
California
ZIP/Postal Code
04304
Country
United States
Facility Name
Stanford University Medical Center
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States
Facility Name
Huntington Medical Research Institute
City
Pasadena
State/Province
California
ZIP/Postal Code
91105
Country
United States
Facility Name
Inland Empire Liver Foundation
City
Rialto
State/Province
California
ZIP/Postal Code
92377
Country
United States
Facility Name
Precision Research Institute
City
San Diego
State/Province
California
ZIP/Postal Code
92114
Country
United States
Facility Name
Quest Clinical Research
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Facility Name
South Denver Gastroenterology, P.C.
City
Englewood
State/Province
Colorado
ZIP/Postal Code
80113
Country
United States
Facility Name
Jacksonville Center for Clinical Research
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32216
Country
United States
Facility Name
Borland-Groover Clinic
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32256
Country
United States
Facility Name
Ocean Blue Medical Research Center, Inc
City
Miami Springs
State/Province
Florida
ZIP/Postal Code
33166
Country
United States
Facility Name
Schiff Center for Liver Diseases/University of Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Stand Up MRI of Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33145
Country
United States
Facility Name
Avail Clinical Research, LLC
City
Orange City
State/Province
Florida
ZIP/Postal Code
32763
Country
United States
Facility Name
Bioclinica Research
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
Advanced Gastroenterology Associates, LLC
City
Palm Harbor
State/Province
Florida
ZIP/Postal Code
34684
Country
United States
Facility Name
Qps-Mra, Llc
City
South Miami
State/Province
Florida
ZIP/Postal Code
33143
Country
United States
Facility Name
Tampa General Medical Group
City
Tampa
State/Province
Florida
ZIP/Postal Code
33606
Country
United States
Facility Name
University of South Florida
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Facility Name
South Florida Center Of Gastroenterology, PA
City
Wellington
State/Province
Florida
ZIP/Postal Code
33414
Country
United States
Facility Name
Independent Imaging
City
Wellington
State/Province
Florida
ZIP/Postal Code
33449
Country
United States
Facility Name
East-West Medical Research Institute
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96814
Country
United States
Facility Name
Invision Imaging
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96814
Country
United States
Facility Name
Midwest Institute for Clinical Research
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46260
Country
United States
Facility Name
Heartland Research Associates, LLC
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67207
Country
United States
Facility Name
Ascension Via Christi Imaging at St. Francis
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67214
Country
United States
Facility Name
Tulane University Health Sciences Center
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Facility Name
Ochsner Medical Center
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70121
Country
United States
Facility Name
Mercy Medical Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21202
Country
United States
Facility Name
Digestive Disease Associates, PA
City
Catonsville
State/Province
Maryland
ZIP/Postal Code
21228
Country
United States
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
Henry Ford Health System
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
Mayo Clinic- Main Campus
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Gastrointestinal Associates, PA
City
Flowood
State/Province
Mississippi
ZIP/Postal Code
39232
Country
United States
Facility Name
Colonnades at Baptist
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39202
Country
United States
Facility Name
BioTelemetry Research
City
Rochester
State/Province
New York
ZIP/Postal Code
14623
Country
United States
Facility Name
Investigational Drug Service, University of North Carolina Hospitals
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27514
Country
United States
Facility Name
The University of NC at Chapel Hill, Clinical and Translational Research Center (CTRC)
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
Facility Name
The University of North Carolina at Chapel Hill, Biomedical Research Imaging Center (MRI Facility)
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
Facility Name
Wake Research Associates, LLC
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27612
Country
United States
Facility Name
PMG Research of Wilmington, LLC
City
Wilmington
State/Province
North Carolina
ZIP/Postal Code
28401
Country
United States
Facility Name
PMG Research, Inc.
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
Sterling Research Group, Ltd.
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
Prime Imaging (Chattanooga Outpatient Center)
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37404
Country
United States
Facility Name
ClinSearch
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37421
Country
United States
Facility Name
Touchstone
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Facility Name
Baylor College of Medicine - Advanced Liver Therapies
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Pinnacle Clinical Research
City
Rollingwood
State/Province
Texas
ZIP/Postal Code
78746
Country
United States
Facility Name
Clinical Trials of Texas, Inc.
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Pinnacle Clinical Research, PLLC
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Clinical Research Advantage, Inc./Wasatch Peak Family Practice
City
Layton
State/Province
Utah
ZIP/Postal Code
84041
Country
United States
Facility Name
National Clinical Research - Richmond, Inc.
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23294
Country
United States
Facility Name
Harborview Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
Facility Name
Australian Clinical Research Network
City
Maroubra
State/Province
New South Wales
ZIP/Postal Code
2035
Country
Australia
Facility Name
Spectrum Medical Imaging
City
Randwick
State/Province
New South Wales
ZIP/Postal Code
2013
Country
Australia
Facility Name
Castlereagh Imaging
City
Westmead
State/Province
New South Wales
ZIP/Postal Code
2145
Country
Australia
Facility Name
Storr Liver Centre, Westmead Hospital
City
Westmead
State/Province
New South Wales
ZIP/Postal Code
2145
Country
Australia
Facility Name
Dr. Jones & Partners Medical Imaging
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5000
Country
Australia
Facility Name
Royal Adelaide Hospital, Department of Gastroenterology and Hepatology
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5000
Country
Australia
Facility Name
Flinders Medical Centre/Department of Gastroenterology & Hepatology
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5042
Country
Australia
Facility Name
Radiology SA
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5067
Country
Australia
Facility Name
Royal Melbourne Hospital
City
Parkville
State/Province
Victoria
ZIP/Postal Code
3050
Country
Australia
Facility Name
Dr TG Elliott Inc - BC Diabetes
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Y 3W2
Country
Canada
Facility Name
False Creek Healthcare Centre
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 1C6
Country
Canada
Facility Name
False Creek Healthcare
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 1C6
Country
Canada
Facility Name
LAIR Centre
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 1H2
Country
Canada
Facility Name
Discovery Clinical Services Ltd.
City
Victoria
State/Province
British Columbia
ZIP/Postal Code
V8T 5G4
Country
Canada
Facility Name
West Coast Medical Imaging
City
Victoria
State/Province
British Columbia
ZIP/Postal Code
V8Z 0B9
Country
Canada
Facility Name
Nova Scotia Health Authority, QEII Health Sciences Centre
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H 1V7
Country
Canada
Facility Name
Nova Scotia Health Authority, QEII Health Sciences Centre
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H 2Y9
Country
Canada
Facility Name
Nova Scotia Health Authority - QEII Health Sciences Centre
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H 3A7
Country
Canada
Facility Name
Aggarwal and Associates Limited
City
Brampton
State/Province
Ontario
ZIP/Postal Code
L6T 0G1
Country
Canada
Facility Name
St. Joseph's Health Care London
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 4V2
Country
Canada
Facility Name
London Health Sciences Centre - University Hospital
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 5A5
Country
Canada
Facility Name
Oxford Medical Imaging
City
Mississauga
State/Province
Ontario
ZIP/Postal Code
L5R 3K7
Country
Canada
Facility Name
LMC Clinical Research Inc. (Bayview)
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4G 3E8
Country
Canada
Facility Name
St. Michael's Hospital - MRI Research Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5B 1W8
Country
Canada
Facility Name
St. Michael's Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5B 1W8
Country
Canada
Facility Name
University Health Network (UHN) - Toronto General Hospital - Toronto Centre for Liver Disease (TCLD)
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2C4
Country
Canada
Facility Name
University of Toronto - Toronto General Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2C4
Country
Canada
Facility Name
University Health Network (UHN)
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada
Facility Name
Toronto Liver Centre - Liver Care Centre Corporation
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M6H 3M1
Country
Canada
Facility Name
Resonance Magnetique du Saguenay-Lac-Saint-Jean
City
Chicoutimi
State/Province
Quebec
ZIP/Postal Code
G7H 4J1
Country
Canada
Facility Name
Ecogene-21
City
Chicoutimi
State/Province
Quebec
ZIP/Postal Code
G7H 7K9
Country
Canada
Facility Name
Medpharmgene Inc
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2K 1H2
Country
Canada
Facility Name
Clinique de Medecine Urbaine du Quartier Latin
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2L 4E9
Country
Canada
Facility Name
Centre de recherche du CHUM
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2X 0A9
Country
Canada
Facility Name
Cedar Cancer Center - McGill University Health Centre
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H4A 3J1
Country
Canada
Facility Name
Chronic Viral Illness Service - Royal Victoria Hospital - McGill University Health Centre (MUHC)
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H4A 3J1
Country
Canada
Facility Name
McGill University Health Centre
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H4A 3J1
Country
Canada
Facility Name
Research Institute of the MUHC
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H4A 3J1
Country
Canada
Facility Name
Radiologie Varad
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H5B 1B2
Country
Canada
Facility Name
Centre Intégré Universitaire de Santé et de Services Sociaux (CIUSSS) de l'Estrie
City
Sherbrooke
State/Province
Quebec
ZIP/Postal Code
J1G 2E8
Country
Canada
Facility Name
Recherche Medicale St-Jerome Inc
City
St-Jerome
State/Province
Quebec
ZIP/Postal Code
J7Z 5T3
Country
Canada
Facility Name
IRM Quebec
City
Quebec
ZIP/Postal Code
G1J0H4
Country
Canada
Facility Name
IRM Quebec
City
Quebec
ZIP/Postal Code
G1J5B9
Country
Canada
Facility Name
CHU de Quebec - Universite Laval - site Centre Hospitalier de l'Universite Laval (CHUL)
City
Quebec
ZIP/Postal Code
G1V 4G2
Country
Canada
Facility Name
Centre de recherche de l'Institut Universitaire de Cardiologie et de pneumologie de Quebec
City
Quebec
ZIP/Postal Code
G1V 4G5
Country
Canada
Facility Name
Centre de recherche Saint-Louis
City
Quebec
ZIP/Postal Code
G1W 4R4
Country
Canada
Facility Name
IRM Québec - Clinique St-Louis
City
Quebec
ZIP/Postal Code
G1W 4R4
Country
Canada
Facility Name
Alpha Recherche Clinique
City
Quebec
ZIP/Postal Code
G3K 2P8
Country
Canada
Facility Name
Clinix
City
Quebec
ZIP/Postal Code
G3K 2P8
Country
Canada
Facility Name
Hillel Yaffe Medical Center
City
Hadera
ZIP/Postal Code
3810101
Country
Israel
Facility Name
Rambam Health Care Campus
City
Haifa
ZIP/Postal Code
3109601
Country
Israel
Facility Name
Lady Davis Carmel Medical Center
City
Haifa
ZIP/Postal Code
3434104
Country
Israel
Facility Name
Shaare Zedek Medical Center
City
Jerusalem
ZIP/Postal Code
9103102
Country
Israel
Facility Name
Hadassah Hebrew University Medical Center - Ein Kerem
City
Jerusalem
ZIP/Postal Code
9112001
Country
Israel
Facility Name
Galilee Medical Center
City
Nahariya
ZIP/Postal Code
2210001
Country
Israel
Facility Name
Holy Family Hospital
City
Nazareth
ZIP/Postal Code
1610001
Country
Israel
Facility Name
Rabin Medical Center
City
Petah Tikva
ZIP/Postal Code
4941492
Country
Israel
Facility Name
The Chaim Sheba Medical Center
City
Ramat-Gan
ZIP/Postal Code
5265601
Country
Israel
Facility Name
Tel-Aviv Sourasky Medical Center
City
Tel-Aviv
ZIP/Postal Code
6423906
Country
Israel
Facility Name
ClinicMed Badurski i wspolnicy Spolka Jawna
City
Bialystok
ZIP/Postal Code
15-879
Country
Poland
Facility Name
Synexus Polska Sp. z o.o. Oddzial w Gdansku
City
Gdansk
ZIP/Postal Code
80-382
Country
Poland
Facility Name
Centrum Badan Klinicznych PI-House Sp. z o.o.
City
Gdansk
ZIP/Postal Code
80-546
Country
Poland
Facility Name
Synexus Polska Sp. z o.o. Oddzial w Gdyni
City
Gdynia
ZIP/Postal Code
81-537
Country
Poland
Facility Name
Osrodek Badan Klinicznych
City
Jaworze
ZIP/Postal Code
43-384
Country
Poland
Facility Name
Synexus Polska Sp. z o.o. Oddzial w Katowicach
City
Katowice
ZIP/Postal Code
40-040
Country
Poland
Facility Name
Silmedic Sp. z o.o. Oddzial w Katowicach
City
Katowice
ZIP/Postal Code
40-282
Country
Poland
Facility Name
Centrum Medyczne A-Z Clinic
City
Krakow
ZIP/Postal Code
31-315
Country
Poland
Facility Name
Krakowskie Centrum Medyczne sp. z o.o.
City
Krakow
ZIP/Postal Code
31-501
Country
Poland
Facility Name
Gabinet Lekarski Malgorzata Saryusz-Wolska
City
Lodz
ZIP/Postal Code
90-132
Country
Poland
Facility Name
Synexus Polska Sp. z o.o Oddzial w Poznaniu
City
Poznan
ZIP/Postal Code
60-702
Country
Poland
Facility Name
Centrum Medyczne Medyk
City
Rzeszow
ZIP/Postal Code
35-326
Country
Poland
Facility Name
Synexus Polska Sp. z o. o. Oddzial w Warszawie
City
Warszawa
ZIP/Postal Code
01-192
Country
Poland
Facility Name
Niepubliczny Zaklad Opieki Zdrowotnej Centrum Badan Klinicznych
City
Wroclaw
ZIP/Postal Code
50-349
Country
Poland
Facility Name
Synexus Polska Sp. z o.o. Oddzial we Wroclawiu
City
Wroclaw
ZIP/Postal Code
50-381
Country
Poland
Facility Name
DOBROSTAN - Gabinety Lekarskie
City
Wroclaw
ZIP/Postal Code
53-301
Country
Poland
Facility Name
Changhua Christian Hospital
City
Changhua city
State/Province
Changhua County
ZIP/Postal Code
500
Country
Taiwan
Facility Name
Chung-Ho Memorial Hospital, Kaohsiung Medical University
City
Kaohsiung
ZIP/Postal Code
807
Country
Taiwan
Facility Name
National Cheng-Kung University Hospital
City
Tainan
ZIP/Postal Code
704
Country
Taiwan
Facility Name
National Taiwan University Hospital
City
Taipei
ZIP/Postal Code
100
Country
Taiwan
Facility Name
Taipei Veterans General Hospital
City
Taipei
ZIP/Postal Code
11217
Country
Taiwan

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
IPD Sharing URL
https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests
Citations:
PubMed Identifier
34635855
Citation
Calle RA, Amin NB, Carvajal-Gonzalez S, Ross TT, Bergman A, Aggarwal S, Crowley C, Rinaldi A, Mancuso J, Aggarwal N, Somayaji V, Inglot M, Tuthill TA, Kou K, Boucher M, Tesz G, Dullea R, Bence KK, Kim AM, Pfefferkorn JA, Esler WP. ACC inhibitor alone or co-administered with a DGAT2 inhibitor in patients with non-alcoholic fatty liver disease: two parallel, placebo-controlled, randomized phase 2a trials. Nat Med. 2021 Oct;27(10):1836-1848. doi: 10.1038/s41591-021-01489-1. Epub 2021 Oct 11.
Results Reference
derived
Links:
URL
https://pmiform.com/clinical-trial-info-request?StudyID=C1171002
Description
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Learn more about this trial

Phase 2a, Dose-ranging Study With PF-05221304 in Nonalcoholic Fatty Liver Disease (NAFLD)

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