Trial · NCT03248882

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

NCT03248882, Phase 2, Completed, Pfizer; results first posted 2020-03-10

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Phase 2a, Dose-ranging Study With PF-05221304 in Nonalcoholic Fatty Liver Disease (NAFLD). Trials, record NCT03248882. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03248882

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Phase 2a, Dose-ranging Study With PF-05221304 in Nonalcoholic Fatty Liver Disease (NAFLD)
NCT number: NCT03248882
Status: Completed
Phases: Phase 2
Enrollment: 305 participants, actual
Lead sponsor: Pfizer
Conditions: Nonalcoholic Fatty Liver Disease, Nonalcoholic Steatohepatitis
Interventions: Placebo, PF-05221304
First posted: 2017-08-14
Last updated: 2020-12-09
Other registries' IDs: eudract:2017-001156-55
Results first posted: 2020-03-10

Source ClinicalTrials.gov

Registered outcomes6

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Percent Change From Baseline in Liver Fat by Magnetic Resonance Imaging-Proton Density Fat Fraction (MRI- PDFF) at Week 16	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.
Secondary	Percent Change From Baseline in Alanine Aminotransferase at Week 16	Baseline (Day 1 pre-dose), Week 16	Potential improvement in liver function was denoted by reduction in alanine transaminase (ALT)
Secondary	Number of Participants With Treatment-Emergent Adverse Events	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.
Secondary	Number of Participants With Laboratory Abnormalities	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 protein, urine hemoglobin, nitrites, leukocyte esterase, urine erythrocytes, urine leukocytes, urine hyaline casts, urine bilirubin, granular casts).
Secondary	Number of Participants With Vital Signs Data Meeting Predefined Criteria	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.
Secondary	Number of Participants With 12-Lead Electrocardiogram (ECG) Data Meeting Predefined Criteria	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 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.

Source ClinicalTrials.gov

Outcomes6

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Percent Change From Baseline in Liver Fat by Magnetic Resonance Imaging-Proton Density Fat Fraction (MRI- PDFF) at Week 16	Baseline (between Day -14 and Day 1), Week 16	All randomized participants who received at least 1 dose of randomized study treatment and with non-missing baseline and post-baseline endpoint.	Percent change	LEAST_SQUARES_MEAN
SECONDARY	Percent Change From Baseline in Alanine Aminotransferase at Week 16	Baseline (Day 1 pre-dose), Week 16	All randomized participants who received at least 1 dose of randomized study treatment and diagnosed/presumed with nonalcoholic steatohepatitis.	Percent change	LEAST_SQUARES_MEAN
SECONDARY	Number of Participants With Treatment-Emergent Adverse Events	From first dose of study treatment (Day 1) up to Week 20	All randomized participants who received at least 1 dose of randomized study treatment.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Number of Participants With Laboratory Abnormalities	From first dose of study treatment (Day 1) up to Week 20	All randomized participants who received at least 1 dose of randomized study treatment and had laboratory data.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Number of Participants With Vital Signs Data Meeting Predefined Criteria	From first dose of study treatment (Day 1) up to Week 18	All randomized participants who received at least 1 dose of randomized study treatment and had vital signs data.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Number of Participants With 12-Lead Electrocardiogram (ECG) Data Meeting Predefined Criteria	From first dose of study treatment (Day 1) up to Week 18	All randomized participants who received at least 1 dose of randomized study treatment and had ECG data.	Participants	COUNT_OF_PARTICIPANTS

Source ClinicalTrials.gov

Results by group135

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Percent Change From Baseline in Liver Fat by Magnetic Resonance Imaging-Proton Density Fat Fraction (MRI- PDFF) at Week 16	Placebo	-7.2	80% Confidence Interval -13.9 to 0.0	Percent change
Percent Change From Baseline in Liver Fat by Magnetic Resonance Imaging-Proton Density Fat Fraction (MRI- PDFF) at Week 16	PF-05221304 2 mg	-17.1	80% Confidence Interval -22.7 to -11.1	Percent change
Percent Change From Baseline in Liver Fat by Magnetic Resonance Imaging-Proton Density Fat Fraction (MRI- PDFF) at Week 16	PF-05221304 10 mg	-49.9	80% Confidence Interval -53.3 to -46.2	Percent change
Percent Change From Baseline in Liver Fat by Magnetic Resonance Imaging-Proton Density Fat Fraction (MRI- PDFF) at Week 16	PF-05221304 25 mg	-55.9	80% Confidence Interval -59.0 to -52.4	Percent change
Percent Change From Baseline in Liver Fat by Magnetic Resonance Imaging-Proton Density Fat Fraction (MRI- PDFF) at Week 16	PF-05221304 50 mg	-64.8	80% Confidence Interval -67.5 to -62.0	Percent change
Percent Change From Baseline in Alanine Aminotransferase at Week 16	Placebo	-8.5	80% Confidence Interval -15.2 to -1.2	Percent change
Percent Change From Baseline in Alanine Aminotransferase at Week 16	PF-05221304 2 mg	-12.5	80% Confidence Interval -18.7 to -5.8	Percent change
Percent Change From Baseline in Alanine Aminotransferase at Week 16	PF-05221304 10 mg	-27.7	80% Confidence Interval -32.9 to -22.2	Percent change
Percent Change From Baseline in Alanine Aminotransferase at Week 16	PF-05221304 25 mg	-31.3	80% Confidence Interval -36.6 to -25.5	Percent change
Percent Change From Baseline in Alanine Aminotransferase at Week 16	PF-05221304 50 mg	-46.8	80% Confidence Interval -50.8 to -42.4	Percent change

1 to 10 of 135Source ClinicalTrials.gov

See all 135 results by group

Participant flow20

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Placebo	61
Overall Study	STARTED	PF-05221304 2 mg	63
Overall Study	STARTED	PF-05221304 10 mg	62
Overall Study	STARTED	PF-05221304 25 mg	58
Overall Study	STARTED	PF-05221304 50 mg	61
Overall Study	Received Treatment	Placebo	61
Overall Study	Received Treatment	PF-05221304 2 mg	63
Overall Study	Received Treatment	PF-05221304 10 mg	62
Overall Study	Received Treatment	PF-05221304 25 mg	58
Overall Study	Received Treatment	PF-05221304 50 mg	61

1 to 10 of 20Source ClinicalTrials.gov

See all 20 participant flow

Adverse events115

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Abdominal pain upper	Gastrointestinal disorders	Placebo	1	61
other	Abdominal pain upper	Gastrointestinal disorders	PF-05221304 2 mg	0	63
other	Abdominal pain upper	Gastrointestinal disorders	PF-05221304 10 mg	1	62
other	Abdominal pain upper	Gastrointestinal disorders	PF-05221304 25 mg	6	58
other	Abdominal pain upper	Gastrointestinal disorders	PF-05221304 50 mg	1	61
other	Diarrhoea	Gastrointestinal disorders	Placebo	3	61
other	Diarrhoea	Gastrointestinal disorders	PF-05221304 2 mg	3	63
other	Diarrhoea	Gastrointestinal disorders	PF-05221304 10 mg	8	62
other	Diarrhoea	Gastrointestinal disorders	PF-05221304 25 mg	2	58
other	Diarrhoea	Gastrointestinal disorders	PF-05221304 50 mg	4	61

1 to 10 of 115Source ClinicalTrials.gov

See all 115 adverse events

Adverse event totals15

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Placebo	0	61
Total, all-cause mortality	PF-05221304 2 mg	0	63
Total, all-cause mortality	PF-05221304 10 mg	0	62
Total, all-cause mortality	PF-05221304 25 mg	0	58
Total, all-cause mortality	PF-05221304 50 mg	0	61
Total, other adverse events	Placebo	27	61
Total, other adverse events	PF-05221304 2 mg	21	63
Total, other adverse events	PF-05221304 10 mg	25	62
Total, other adverse events	PF-05221304 25 mg	31	58
Total, other adverse events	PF-05221304 50 mg	29	61

1 to 10 of 15Source ClinicalTrials.gov

See all 15 adverse event totals

Papers2

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
34635855	DERIVED	PubMed
39048608	DERIVED	PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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