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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT03248882
Registration number
NCT03248882
Ethics application status
Date submitted
10/08/2017
Date registered
14/08/2017
Titles & IDs
Public title
Phase 2a, Dose-ranging Study With PF-05221304 in Nonalcoholic Fatty Liver Disease (NAFLD)
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Scientific 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
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Secondary ID [1]
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2017-001156-55
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Secondary ID [2]
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C1171002
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Nonalcoholic Fatty Liver Disease
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Nonalcoholic Steatohepatitis
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Condition category
Condition code
Oral and Gastrointestinal
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Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
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Cancer
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Liver
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Metabolic and Endocrine
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Metabolic disorders
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Diet and Nutrition
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Obesity
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Placebo
Treatment: Drugs - PF-05221304
Placebo comparator: Placebo - Double-Blind, PF-05221304-matching Placebo
Active comparator: PF-05221304 - 2 mg - PF-05221304 - 2 mg, once-daily
Active comparator: PF-05221304 - 10 mg - PF-05221304 - 10 mg, once-daily
Active comparator: PF-05221304 - 25 mg - PF-05221304 - 25 mg, once-daily
Active comparator: PF-05221304 - 50 mg - PF-05221304 - 50 mg, once-daily
Treatment: Drugs: Placebo
Placebo
Treatment: Drugs: PF-05221304
PF-05221304, Experimental Drug
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Percent Change From Baseline in Liver Fat by Magnetic Resonance Imaging-Proton Density Fat Fraction (MRI- PDFF) at Week 16
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Assessment method [1]
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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.
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Timepoint [1]
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Baseline (between Day -14 and Day 1), Week 16
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Secondary outcome [1]
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Percent Change From Baseline in Alanine Aminotransferase at Week 16
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Assessment method [1]
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Potential improvement in liver function was denoted by reduction in alanine transaminase (ALT)
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Timepoint [1]
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Baseline (Day 1 pre-dose), Week 16
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Secondary outcome [2]
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Number of Participants With Treatment-Emergent Adverse Events
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Assessment method [2]
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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.
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Timepoint [2]
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From first dose of study treatment (Day 1) up to Week 20
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Secondary outcome [3]
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Number of Participants With Laboratory Abnormalities
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Assessment method [3]
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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).
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Timepoint [3]
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From first dose of study treatment (Day 1) up to Week 20
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Secondary outcome [4]
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Number of Participants With Vital Signs Data Meeting Predefined Criteria
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Assessment method [4]
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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.
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Timepoint [4]
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From first dose of study treatment (Day 1) up to Week 18
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Secondary outcome [5]
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Number of Participants With 12-Lead Electrocardiogram (ECG) Data Meeting Predefined Criteria
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Assessment method [5]
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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.
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Timepoint [5]
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From first dose of study treatment (Day 1) up to Week 18
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Eligibility
Key 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
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Minimum age
18
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Maximum age
70
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
22/08/2017
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
27/03/2019
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Sample size
Target
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Accrual to date
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Final
305
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Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC
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Recruitment hospital [1]
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Australian Clinical Research Network - Maroubra
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Recruitment hospital [2]
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Spectrum Medical Imaging - Randwick
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Recruitment hospital [3]
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Castlereagh Imaging - Westmead
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Recruitment hospital [4]
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Storr Liver Centre, Westmead Hospital - Westmead
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Recruitment hospital [5]
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Dr. Jones & Partners Medical Imaging - Adelaide
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Recruitment hospital [6]
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Royal Adelaide Hospital, Department of Gastroenterology and Hepatology - Adelaide
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Recruitment hospital [7]
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Flinders Medical Centre/Department of Gastroenterology & Hepatology - Adelaide
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Recruitment hospital [8]
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Radiology SA - Adelaide
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Recruitment hospital [9]
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Royal Melbourne Hospital - Parkville
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Recruitment postcode(s) [1]
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2035 - Maroubra
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Recruitment postcode(s) [2]
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2013 - Randwick
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Recruitment postcode(s) [3]
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2145 - Westmead
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Recruitment postcode(s) [4]
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5000 - Adelaide
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Recruitment postcode(s) [5]
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5042 - Adelaide
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Recruitment postcode(s) [6]
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5067 - Adelaide
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Recruitment postcode(s) [7]
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3050 - Parkville
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Recruitment outside Australia
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United States of America
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California
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Colorado
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United States of America
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Florida
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Hawaii
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Indiana
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Kansas
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Ontario
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Israel
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Hadera
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Israel
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Haifa
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Israel
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Jerusalem
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Israel
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Nahariya
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Israel
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Nazareth
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Israel
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Petah Tikva
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Israel
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Taiwan
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Kaohsiung
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Tainan
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Taiwan
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Taipei
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Pfizer
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
Phase 2a, dose-ranging Study with PF-05221304 in Nonalcoholic Fatty Liver Disease (NAFLD)
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Trial website
https://clinicaltrials.gov/study/NCT03248882
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Trial related presentations / 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.
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Public notes
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Contacts
Principal investigator
Name
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Pfizer CT.gov Call Center
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Address
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Pfizer
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Fax
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Contact person for public queries
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
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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When will data be available (start and end dates)?
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Available to whom?
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Available for what types of analyses?
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How or where can data be obtained?
IPD available at link: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests
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What supporting documents are/will be available?
No Supporting Document Provided
Type
Other Details
Attachment
Study protocol
https://cdn.clinicaltrials.gov/large-docs/82/NCT03248882/Prot_000.pdf
Statistical analysis plan
https://cdn.clinicaltrials.gov/large-docs/82/NCT03248882/SAP_001.pdf
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT03248882