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CompletedNCT03248882Updated Dec 9, 2020Results posted

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

A Phase 2 interventional study of Placebo and PF-05221304 in Nonalcoholic Fatty Liver Disease and Nonalcoholic Steatohepatitis, sponsored by Pfizer. Completed at 140 sites in 6 countries. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2020-12-09.

Sponsored by Pfizer · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
305
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Study summary

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

Read the 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

02

Conditions studied

  • Nonalcoholic Fatty Liver Disease
  • Nonalcoholic Steatohepatitis

Keywords

  • PF-05221304
  • NAFLD
  • NASH
  • features of metabolic syndrome
  • Dose-Ranging Study
03

In context

Liver Diseases

2,081 studies on the registry are indexed under Liver Diseases; 390 are open to participants now.

This study's enrollment of 305 is above the median of 50 across 1,323 interventional studies indexed under Liver Diseases.

Browse Liver Diseases studies →

Lead sponsor

Pfizer is the lead sponsor of 3,244 studies on the registry; 139 are open to participants now.

Of its 582 completed or terminated interventional studies of FDA-regulated products, 381 (65%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
305 participants (actual)

Study arms

  • Placebo comparator
    Placebo

    Double-Blind, PF-05221304-matching Placebo

    Drug: Placebo

  • Active comparator
    PF-05221304 - 2 mg

    PF-05221304 - 2 mg, once-daily

    Drug: PF-05221304

  • Active comparator
    PF-05221304 - 10 mg

    PF-05221304 - 10 mg, once-daily

    Drug: PF-05221304

  • Active comparator
    PF-05221304 - 25 mg

    PF-05221304 - 25 mg, once-daily

    Drug: PF-05221304

  • Active comparator
    PF-05221304 - 50 mg

    PF-05221304 - 50 mg, once-daily

    Drug: PF-05221304

Interventions

  • DrugPlacebo

    Placebo

  • DrugPF-05221304

    PF-05221304, Experimental Drug

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Baseline (between Day -14 and Day 1), Week 16

Secondary outcomes

  1. Percent Change From Baseline in Alanine Aminotransferase at Week 16

    Potential improvement in liver function was denoted by reduction in alanine transaminase (ALT)

    Time frame: Baseline (Day 1 pre-dose), Week 16

  2. 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.

    Time frame: From first dose of study treatment (Day 1) up to Week 20

  3. 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).

    Time frame: From first dose of study treatment (Day 1) up to Week 20

  4. 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.

    Time frame: From first dose of study treatment (Day 1) up to Week 18

  5. 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.

    Time frame: From first dose of study treatment (Day 1) up to Week 18

07

Results

Posted Mar 10, 2020

Participant flow

Participant flow — Overall Study
MilestonePlaceboPF-05221304 2 mgPF-05221304 10 mgPF-05221304 25 mgPF-05221304 50 mg
Started6163625861
Received treatment6163625861
Completed5458554848
Not completed7571013
Withdrew: Adverse event33269
Withdrew: Lost to follow-up00001
Withdrew: Protocol violation20201
Withdrew: Withdrawal by subject22342

Outcome measures

PrimaryPercent 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.

Time frame:
Baseline (between Day -14 and Day 1), Week 16
Reported as:
Least squares mean · Percent change
Percent Change From Baseline in Liver Fat by Magnetic Resonance Imaging-Proton Density Fat Fraction (MRI- PDFF) at Week 16
Percent changePlaceboPF-05221304 2 mgPF-05221304 10 mgPF-05221304 25 mgPF-05221304 50 mg
Percent Change From Baseline in Liver Fat by Magnetic Resonance Imaging-Proton Density Fat Fraction (MRI- PDFF) at Week 16-7.2 (-13.9 to 0.0)-17.1 (-22.7 to -11.1)-49.9 (-53.3 to -46.2)-55.9 (-59.0 to -52.4)-64.8 (-67.5 to -62.0)
Statistical analysis
  • Placebo vs PF-05221304 2 mg · Mean difference (net): -10.7 · 80% CI -19.4 to -1.1
  • Placebo vs PF-05221304 10 mg · Mean difference (net): -46.0 · 80% CI -51.3 to -40.1
  • Placebo vs PF-05221304 25 mg · Mean difference (net): -52.4 · 80% CI -57.2 to -47.1
  • Placebo vs PF-05221304 50 mg · Mean difference (net): -62.1 · 80% CI -66.0 to -57.8
SecondaryPercent Change From Baseline in Alanine Aminotransferase at Week 16

Potential improvement in liver function was denoted by reduction in alanine transaminase (ALT)

Time frame:
Baseline (Day 1 pre-dose), Week 16
Reported as:
Least squares mean · Percent change
Percent Change From Baseline in Alanine Aminotransferase at Week 16
Percent changePlaceboPF-05221304 2 mgPF-05221304 10 mgPF-05221304 25 mgPF-05221304 50 mg
Percent Change From Baseline in Alanine Aminotransferase at Week 16-8.5 (-15.2 to -1.2)-12.5 (-18.7 to -5.8)-27.7 (-32.9 to -22.2)-31.3 (-36.6 to -25.5)-46.8 (-50.8 to -42.4)
Statistical analysis
  • Placebo vs PF-05221304 2 mg · Mean difference (net): -4.4 · 80% CI -14.0 to 6.3
  • Placebo vs PF-05221304 10 mg · Mean difference (net): -21.0 · 80% CI -29.0 to -12.2
  • Placebo vs PF-05221304 25 mg · Mean difference (net): -25.0 · 80% CI -32.8 to -16.1
  • Placebo vs PF-05221304 50 mg · Mean difference (net): -41.8 · 80% CI -47.9 to -35.0
SecondaryNumber 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.

Time frame:
From first dose of study treatment (Day 1) up to Week 20
Reported as:
Count of participants · Participants
Number of Participants With Treatment-Emergent Adverse Events
ParticipantsPlaceboPF-05221304 2 mgPF-05221304 10 mgPF-05221304 25 mgPF-05221304 50 mg
All-causality AE4140424540
All-causality SAE01122
Treatment-related AE169121623
Treatment-related SAE00000
SecondaryNumber 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).

Time frame:
From first dose of study treatment (Day 1) up to Week 20
Reported as:
Count of participants · Participants
Number of Participants With Laboratory Abnormalities
ParticipantsPlaceboPF-05221304 2 mgPF-05221304 10 mgPF-05221304 25 mgPF-05221304 50 mg
Number of Participants With Laboratory Abnormalities3944363340
SecondaryNumber 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.

Time frame:
From first dose of study treatment (Day 1) up to Week 18
Reported as:
Count of participants · Participants
Number of Participants With Vital Signs Data Meeting Predefined Criteria
ParticipantsPlaceboPF-05221304 2 mgPF-05221304 10 mgPF-05221304 25 mgPF-05221304 50 mg
Sitting SBP <90 mmHg00002
Sitting SBP >180 mmHg00010
Sitting SBP increase >=30 mmHg56220
Sitting SBP decrease >=30 mmHg21576
Sitting DBP <50 mmHg10000
Sitting DBP >110 mmHg00001
Sitting DBP increase >=20 mmHg14223
Sitting DBP decrease >=20 mmHg04344
Sitting pulse rate <40 bpm00000
Sitting pulse rate >120 bpm00000
SecondaryNumber 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.

Time frame:
From first dose of study treatment (Day 1) up to Week 18
Reported as:
Count of participants · Participants
Number of Participants With 12-Lead Electrocardiogram (ECG) Data Meeting Predefined Criteria
ParticipantsPlaceboPF-05221304 2 mgPF-05221304 10 mgPF-05221304 25 mgPF-05221304 50 mg
PR interval >=300 msec00000
%Change in PR interval >=25/50%01011
QRS interval >=140 msec00100
%Change in QRS interval >=50%00000
QT interval >=500 msec00010
QTcF interval >=450 to <480 msec610793
QTcF interval >=480 to <500 msec01011
QTcF interval >=500 msec00000
QTcF interval increase >=30 to 60 msec568104
QTcF interval increase >=60 msec21000

Adverse events

Collected over From first dose of study treatment up to 20 weeks. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Placebo0/61 (0%)0/61 (0%)27/61 (44.3%)
PF-05221304 2 mg0/63 (0%)1/63 (1.6%)21/63 (33.3%)
PF-05221304 10 mg0/62 (0%)1/62 (1.6%)25/62 (40.3%)
PF-05221304 25 mg0/58 (0%)2/58 (3.4%)31/58 (53.4%)
PF-05221304 50 mg0/61 (0%)2/61 (3.3%)29/61 (47.5%)
Most frequent serious events
Most frequent serious events
EventPlaceboPF-05221304 2 mgPF-05221304 10 mgPF-05221304 25 mgPF-05221304 50 mg
Angina unstableCardiac disorders0/610/630/621/580/61
Myocardial ischaemiaCardiac disorders0/610/630/621/580/61
Renal colicRenal and urinary disorders0/610/630/620/581/61
AsthmaRespiratory, thoracic and mediastinal disorders0/610/630/620/581/61
Upper respiratory tract infectionInfections and infestations0/610/631/620/580/61
Rib fractureInjury, poisoning and procedural complications0/610/631/620/580/61
Myocardial infarctionCardiac disorders0/611/630/620/580/61
PneumoniaInfections and infestations0/611/630/620/580/61
Most frequent other events
Showing 10 of 15
Most frequent other events
EventPlaceboPF-05221304 2 mgPF-05221304 10 mgPF-05221304 25 mgPF-05221304 50 mg
HypertriglyceridaemiaMetabolism and nutrition disorders2/611/636/624/5810/61
HeadacheNervous system disorders8/613/633/627/584/61
DiarrhoeaGastrointestinal disorders3/613/638/622/584/61
Abdominal pain upperGastrointestinal disorders1/610/631/626/581/61
Upper respiratory tract infectionInfections and infestations2/616/633/623/582/61
NauseaGastrointestinal disorders3/610/633/625/584/61
Urinary tract infectionInfections and infestations1/611/632/625/584/61
FatigueGeneral disorders5/613/632/622/582/61
ArthralgiaMusculoskeletal and connective tissue disorders1/611/633/624/580/61
Muscle spasmsMusculoskeletal and connective tissue disorders4/610/632/621/580/61

Baseline characteristics

All randomized participants who received at least 1 dose of randomized study treatment.

Age, Continuous
Age, Continuous(Years)PlaceboPF-05221304 2 mgPF-05221304 10 mgPF-05221304 25 mgPF-05221304 50 mgTotal
Mean53.3 ± 10.854.1 ± 11.952.7 ± 12.854.0 ± 11.652.8 ± 13.153.38 ± 11.99
Sex: Female, Male
Sex: Female, Male(Participants)PlaceboPF-05221304 2 mgPF-05221304 10 mgPF-05221304 25 mgPF-05221304 50 mgTotal
Female3637333530171
Male2526292331134
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)PlaceboPF-05221304 2 mgPF-05221304 10 mgPF-05221304 25 mgPF-05221304 50 mgTotal
White5350524651252
Black or African American111104
Asian57791038
American Indian or Alaska Native010001
Native Hawaiian or Other Pacific Islander010001
Not Reported232209
08

Study locations

140 sites
  • Franco Felizarta MD
    Bakersfield, California 93301, United States
  • eStudySite
    Chula Vista, California 91911, United States
  • San Diego Imaging Chula Vista
    Chula Vista, California 91911, United States
  • University of California, San Diego (Altman Clinical and Translational Research Institute)
    La Jolla, California 92037, United States
  • University of California, San Diego
    La Jolla, California 92037, United States
  • eStudySite
    La Mesa, California 91942, United States
  • Clinical Trials Research
    Lincoln, California 95648, United States
  • National Research Institute
    Los Angeles, California 90057, United States
  • Stanford University Medical Center, Blake wilbur Building
    Palo Alto, California 04304, United States
  • Stanford University Medical Center
    Palo Alto, California 94304, United States
  • Huntington Medical Research Institute
    Pasadena, California 91105, United States
  • Inland Empire Liver Foundation
    Rialto, California 92377, United States
  • Precision Research Institute
    San Diego, California 92114, United States
  • Quest Clinical Research
    San Francisco, California 94115, United States
  • South Denver Gastroenterology, P.C.
    Englewood, Colorado 80113, United States
  • Jacksonville Center for Clinical Research
    Jacksonville, Florida 32216, United States
  • Borland-Groover Clinic
    Jacksonville, Florida 32256, United States
  • Ocean Blue Medical Research Center, Inc
    Miami Springs, Florida 33166, United States
  • Schiff Center for Liver Diseases/University of Miami
    Miami, Florida 33136, United States
  • Stand Up MRI of Miami
    Miami, Florida 33145, United States
  • Avail Clinical Research, LLC
    Orange City, Florida 32763, United States
  • Bioclinica Research
    Orlando, Florida 32806, United States
  • Advanced Gastroenterology Associates, LLC
    Palm Harbor, Florida 34684, United States
  • Qps-Mra, Llc
    South Miami, Florida 33143, United States
  • Tampa General Medical Group
    Tampa, Florida 33606, United States
  • University of South Florida
    Tampa, Florida 33612, United States
  • South Florida Center Of Gastroenterology, PA
    Wellington, Florida 33414, United States
  • Independent Imaging
    Wellington, Florida 33449, United States
  • East-West Medical Research Institute
    Honolulu, Hawaii 96814, United States
  • Invision Imaging
    Honolulu, Hawaii 96814, United States
  • Midwest Institute for Clinical Research
    Indianapolis, Indiana 46260, United States
  • Heartland Research Associates, LLC
    Wichita, Kansas 67207, United States
  • Ascension Via Christi Imaging at St. Francis
    Wichita, Kansas 67214, United States
  • Tulane University Health Sciences Center
    New Orleans, Louisiana 70112, United States
  • Ochsner Medical Center
    New Orleans, Louisiana 70121, United States
  • Mercy Medical Center
    Baltimore, Maryland 21202, United States
  • Digestive Disease Associates, PA
    Catonsville, Maryland 21228, United States
  • University of Michigan
    Ann Arbor, Michigan 48109, United States
  • Henry Ford Health System
    Detroit, Michigan 48202, United States
  • Mayo Clinic- Main Campus
    Rochester, Minnesota 55905, United States
  • Gastrointestinal Associates, PA
    Flowood, Mississippi 39232, United States
  • Colonnades at Baptist
    Jackson, Mississippi 39202, United States
  • BioTelemetry Research
    Rochester, New York 14623, United States
  • Investigational Drug Service, University of North Carolina Hospitals
    Chapel Hill, North Carolina 27514, United States
  • The University of NC at Chapel Hill, Clinical and Translational Research Center (CTRC)
    Chapel Hill, North Carolina 27599, United States
  • The University of North Carolina at Chapel Hill, Biomedical Research Imaging Center (MRI Facility)
    Chapel Hill, North Carolina 27599, United States
  • Wake Research Associates, LLC
    Raleigh, North Carolina 27612, United States
  • PMG Research of Wilmington, LLC
    Wilmington, North Carolina 28401, United States
  • PMG Research, Inc.
    Winston-Salem, North Carolina 27103, United States
  • Sterling Research Group, Ltd.
    Cincinnati, Ohio 45219, United States
  • Prime Imaging (Chattanooga Outpatient Center)
    Chattanooga, Tennessee 37404, United States
  • ClinSearch
    Chattanooga, Tennessee 37421, United States
  • Touchstone
    Austin, Texas 78705, United States
  • Baylor College of Medicine - Advanced Liver Therapies
    Houston, Texas 77030, United States
  • Pinnacle Clinical Research
    Rollingwood, Texas 78746, United States
  • Clinical Trials of Texas, Inc.
    San Antonio, Texas 78229, United States
  • Pinnacle Clinical Research, PLLC
    San Antonio, Texas 78229, United States
  • Clinical Research Advantage, Inc./Wasatch Peak Family Practice
    Layton, Utah 84041, United States
  • National Clinical Research - Richmond, Inc.
    Richmond, Virginia 23294, United States
  • Harborview Medical Center
    Seattle, Washington 98104, United States
  • Australian Clinical Research Network
    Maroubra, New South Wales 2035, Australia
  • Spectrum Medical Imaging
    Randwick, New South Wales 2013, Australia
  • Castlereagh Imaging
    Westmead, New South Wales 2145, Australia
  • Storr Liver Centre, Westmead Hospital
    Westmead, New South Wales 2145, Australia
  • Dr. Jones & Partners Medical Imaging
    Adelaide, South Australia 5000, Australia
  • Royal Adelaide Hospital, Department of Gastroenterology and Hepatology
    Adelaide, South Australia 5000, Australia
  • Flinders Medical Centre/Department of Gastroenterology & Hepatology
    Adelaide, South Australia 5042, Australia
  • Radiology SA
    Adelaide, South Australia 5067, Australia
  • Royal Melbourne Hospital
    Parkville, Victoria 3050, Australia
  • Dr TG Elliott Inc - BC Diabetes
    Vancouver, British Columbia V5Y 3W2, Canada
  • False Creek Healthcare Centre
    Vancouver, British Columbia V5Z 1C6, Canada
  • False Creek Healthcare
    Vancouver, British Columbia V5Z 1C6, Canada
  • LAIR Centre
    Vancouver, British Columbia V5Z 1H2, Canada
  • Discovery Clinical Services Ltd.
    Victoria, British Columbia V8T 5G4, Canada
  • West Coast Medical Imaging
    Victoria, British Columbia V8Z 0B9, Canada
  • Nova Scotia Health Authority, QEII Health Sciences Centre
    Halifax, Nova Scotia B3H 1V7, Canada
  • Nova Scotia Health Authority, QEII Health Sciences Centre
    Halifax, Nova Scotia B3H 2Y9, Canada
  • Nova Scotia Health Authority - QEII Health Sciences Centre
    Halifax, Nova Scotia B3H 3A7, Canada
  • Aggarwal and Associates Limited
    Brampton, Ontario L6T 0G1, Canada
  • St. Joseph's Health Care London
    London, Ontario N6A 4V2, Canada
  • London Health Sciences Centre - University Hospital
    London, Ontario N6A 5A5, Canada
  • Oxford Medical Imaging
    Mississauga, Ontario L5R 3K7, Canada
  • LMC Clinical Research Inc. (Bayview)
    Toronto, Ontario M4G 3E8, Canada
  • St. Michael's Hospital - MRI Research Centre
    Toronto, Ontario M5B 1W8, Canada
  • St. Michael's Hospital
    Toronto, Ontario M5B 1W8, Canada
  • University Health Network (UHN) - Toronto General Hospital - Toronto Centre for Liver Disease (TCLD)
    Toronto, Ontario M5G 2C4, Canada
  • University of Toronto - Toronto General Hospital
    Toronto, Ontario M5G 2C4, Canada
  • University Health Network (UHN)
    Toronto, Ontario M5G 2M9, Canada
  • Toronto Liver Centre - Liver Care Centre Corporation
    Toronto, Ontario M6H 3M1, Canada
  • Resonance Magnetique du Saguenay-Lac-Saint-Jean
    Chicoutimi, Quebec G7H 4J1, Canada
  • Ecogene-21
    Chicoutimi, Quebec G7H 7K9, Canada
  • Medpharmgene Inc
    Montreal, Quebec H2K 1H2, Canada
  • Clinique de Medecine Urbaine du Quartier Latin
    Montreal, Quebec H2L 4E9, Canada
  • Centre de recherche du CHUM
    Montreal, Quebec H2X 0A9, Canada
  • Cedar Cancer Center - McGill University Health Centre
    Montreal, Quebec H4A 3J1, Canada
  • Chronic Viral Illness Service - Royal Victoria Hospital - McGill University Health Centre (MUHC)
    Montreal, Quebec H4A 3J1, Canada
  • McGill University Health Centre
    Montreal, Quebec H4A 3J1, Canada
  • Research Institute of the MUHC
    Montreal, Quebec H4A 3J1, Canada
  • Radiologie Varad
    Montreal, Quebec H5B 1B2, Canada
  • Centre Intégré Universitaire de Santé et de Services Sociaux (CIUSSS) de l'Estrie
    Sherbrooke, Quebec J1G 2E8, Canada

Showing the first 100 of 140 sites across 6 countries.

09

References and documents

Publications

  • 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. PubMed 34635855 ↗

Study documents

  • Study protocol · Oct 3, 2017
  • Statistical analysis plan · Mar 14, 2019

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Yes — Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 9, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03248882
Lead sponsor
Pfizer
Responsible party
Sponsor
First posted
Aug 14, 2017
Start date
Aug 22, 2017
Primary completion
Feb 26, 2019
Completion
Mar 27, 2019
Results posted
Mar 10, 2020
Last update
Dec 9, 2020

Study contacts

Pfizer CT.gov Call Center
study director · Pfizer

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2020. You cannot join it, but the record below documents what was studied.

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