Adults 18 to 70, any sex, with Nonalcoholic Fatty Liver Disease or Nonalcoholic Steatohepatitis. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Percent Change From Baseline in Liver Fat by Magnetic Resonance Imaging-Proton Density Fat Fraction (MRI- PDFF) at Week 16Primary· Baseline (between Day -14 and Day 1), 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.
Group
Value
95% CI
Placebo
-7.2
-13.9 – 0.0
PF-05221304 2 mg
-17.1
-22.7 – -11.1
PF-05221304 10 mg
-49.9
-53.3 – -46.2
PF-05221304 25 mg
-55.9
-59.0 – -52.4
PF-05221304 50 mg
-64.8
-67.5 – -62.0
Percent Change From Baseline in Alanine Aminotransferase at Week 16Secondary· Baseline (Day 1 pre-dose), Week 16
Potential improvement in liver function was denoted by reduction in alanine transaminase (ALT)
Group
Value
95% CI
Placebo
-8.5
-15.2 – -1.2
PF-05221304 2 mg
-12.5
-18.7 – -5.8
PF-05221304 10 mg
-27.7
-32.9 – -22.2
PF-05221304 25 mg
-31.3
-36.6 – -25.5
PF-05221304 50 mg
-46.8
-50.8 – -42.4
Number of Participants With Treatment-Emergent Adverse EventsSecondary· From first dose of study treatment (Day 1) up to Week 20
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.
All-causality AE
Group
Value
95% CI
Placebo
41
PF-05221304 2 mg
40
PF-05221304 10 mg
42
PF-05221304 25 mg
45
PF-05221304 50 mg
40
All-causality SAE
Group
Value
95% CI
Placebo
0
PF-05221304 2 mg
1
PF-05221304 10 mg
1
PF-05221304 25 mg
2
PF-05221304 50 mg
2
Treatment-related AE
Group
Value
95% CI
Placebo
16
PF-05221304 2 mg
9
PF-05221304 10 mg
12
PF-05221304 25 mg
16
PF-05221304 50 mg
23
Treatment-related SAE
Group
Value
95% CI
Placebo
0
PF-05221304 2 mg
0
PF-05221304 10 mg
0
PF-05221304 25 mg
0
PF-05221304 50 mg
0
Number of Participants With Laboratory AbnormalitiesSecondary· From first dose of study treatment (Day 1) up to Week 20
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
Group
Value
95% CI
Placebo
39
PF-05221304 2 mg
44
PF-05221304 10 mg
36
PF-05221304 25 mg
33
PF-05221304 50 mg
40
Number of Participants With Vital Signs Data Meeting Predefined CriteriaSecondary· From first dose of study treatment (Day 1) up to Week 18
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.
Sitting SBP <90 mmHg
Group
Value
95% CI
Placebo
0
PF-05221304 2 mg
0
PF-05221304 10 mg
0
PF-05221304 25 mg
0
PF-05221304 50 mg
2
Sitting SBP >180 mmHg
Group
Value
95% CI
Placebo
0
PF-05221304 2 mg
0
PF-05221304 10 mg
0
PF-05221304 25 mg
1
PF-05221304 50 mg
0
Sitting SBP increase >=30 mmHg
Group
Value
95% CI
Placebo
5
PF-05221304 2 mg
6
PF-05221304 10 mg
2
PF-05221304 25 mg
2
PF-05221304 50 mg
0
Sitting SBP decrease >=30 mmHg
Group
Value
95% CI
Placebo
2
PF-05221304 2 mg
1
PF-05221304 10 mg
5
PF-05221304 25 mg
7
PF-05221304 50 mg
6
Sitting DBP <50 mmHg
Group
Value
95% CI
Placebo
1
PF-05221304 2 mg
0
PF-05221304 10 mg
0
PF-05221304 25 mg
0
PF-05221304 50 mg
0
Sitting DBP >110 mmHg
Group
Value
95% CI
Placebo
0
PF-05221304 2 mg
0
PF-05221304 10 mg
0
PF-05221304 25 mg
0
PF-05221304 50 mg
1
Sitting DBP increase >=20 mmHg
Group
Value
95% CI
Placebo
1
PF-05221304 2 mg
4
PF-05221304 10 mg
2
PF-05221304 25 mg
2
PF-05221304 50 mg
3
Sitting DBP decrease >=20 mmHg
Group
Value
95% CI
Placebo
0
PF-05221304 2 mg
4
PF-05221304 10 mg
3
PF-05221304 25 mg
4
PF-05221304 50 mg
4
Number of Participants With 12-Lead Electrocardiogram (ECG) Data Meeting Predefined CriteriaSecondary· From first dose of study treatment (Day 1) up to Week 18
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
PR interval >=300 msec
Group
Value
95% CI
Placebo
0
PF-05221304 2 mg
0
PF-05221304 10 mg
0
PF-05221304 25 mg
0
PF-05221304 50 mg
0
%Change in PR interval >=25/50%
Group
Value
95% CI
Placebo
0
PF-05221304 2 mg
1
PF-05221304 10 mg
0
PF-05221304 25 mg
1
PF-05221304 50 mg
1
QRS interval >=140 msec
Group
Value
95% CI
Placebo
0
PF-05221304 2 mg
0
PF-05221304 10 mg
1
PF-05221304 25 mg
0
PF-05221304 50 mg
0
%Change in QRS interval >=50%
Group
Value
95% CI
Placebo
0
PF-05221304 2 mg
0
PF-05221304 10 mg
0
PF-05221304 25 mg
0
PF-05221304 50 mg
0
QT interval >=500 msec
Group
Value
95% CI
Placebo
0
PF-05221304 2 mg
0
PF-05221304 10 mg
0
PF-05221304 25 mg
1
PF-05221304 50 mg
0
QTcF interval >=450 to <480 msec
Group
Value
95% CI
Placebo
6
PF-05221304 2 mg
10
PF-05221304 10 mg
7
PF-05221304 25 mg
9
PF-05221304 50 mg
3
QTcF interval >=480 to <500 msec
Group
Value
95% CI
Placebo
0
PF-05221304 2 mg
1
PF-05221304 10 mg
0
PF-05221304 25 mg
1
PF-05221304 50 mg
1
QTcF interval >=500 msec
Group
Value
95% CI
Placebo
0
PF-05221304 2 mg
0
PF-05221304 10 mg
0
PF-05221304 25 mg
0
PF-05221304 50 mg
0
Adverse events — posted to ClinicalTrials.gov
Time frame: From first dose of study treatment up to 20 weeks.
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Pfizer
Last refreshed: 9 December 2020
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03248882.