Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2017-001156-55 | EudraCT Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Phase 2a, dose-ranging Study with PF-05221304 in Nonalcoholic Fatty Liver Disease (NAFLD)
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
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Double-Blind, PF-05221304-matching Placebo |
|
| PF-05221304 - 2 mg | Active Comparator | PF-05221304 - 2 mg, once-daily |
|
| PF-05221304 - 10 mg | Active Comparator | PF-05221304 - 10 mg, once-daily |
|
| PF-05221304 - 25 mg | Active Comparator | PF-05221304 - 25 mg, once-daily |
|
| PF-05221304 - 50 mg | Active Comparator | PF-05221304 - 50 mg, once-daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | Placebo |
| |
| PF-05221304 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline (between Day -14 and Day 1), Week 16 |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change From Baseline in Alanine Aminotransferase at Week 16 | Potential improvement in liver function was denoted by reduction in alanine transaminase (ALT) | Baseline (Day 1 pre-dose), Week 16 |
| Number of Participants With Treatment-Emergent Adverse Events |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Franco Felizarta MD | Bakersfield | California | 93301 | United States | ||
| eStudySite |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39048608 | Derived | Sivakumar P, Saul M, Robinson D, King LE, Amin NB. SomaLogic proteomics reveals new biomarkers and provides mechanistic, clinical insights into Acetyl coA Carboxylase (ACC) inhibition in Non-alcoholic Steatohepatitis (NASH). Sci Rep. 2024 Jul 24;14(1):17072. doi: 10.1038/s41598-024-67843-8. | |
| 34635855 | Derived |
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Placebo matched to PF-05221304 tablet was administered orally once daily (QD) for up to 16 weeks. |
| FG001 | PF-05221304 2 mg | PF-05221304 tablet was administered orally at 2 mg QD for up to 16 weeks. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 3, 2017 | Feb 25, 2020 |
Not provided
C1171002 is a randomized, double blind, placebo controlled, 5 arm (placebo, plus 4 active doses of PF 05221304), parallel group study.
Not provided
Not provided
Double-Blind
| Drug |
PF-05221304, Experimental Drug |
|
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. |
| From first dose of study treatment (Day 1) up to Week 20 |
| 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). | From first dose of study treatment (Day 1) up to Week 20 |
| 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. | From first dose of study treatment (Day 1) up to Week 18 |
| 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. | From first dose of study treatment (Day 1) up to Week 18 |
| 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 |
| Schiff Center for Liver Diseases/University of Miami | Miami | Florida | 33136 | United States |
| Stand Up MRI of Miami | Miami | Florida | 33145 | United States |
| Ocean Blue Medical Research Center, Inc | Miami Springs | Florida | 33166 | 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 |
| IRM Quebec | Québec | Quebec | G1J0H4 | Canada |
| IRM Quebec | Québec | Quebec | G1J5B9 | Canada |
| CHU de Quebec - Universite Laval - site Centre Hospitalier de l'Universite Laval (CHUL) | Québec | Quebec | G1V 4G2 | Canada |
| Centre de recherche de l'Institut Universitaire de Cardiologie et de pneumologie de Quebec | Québec | Quebec | G1V 4G5 | Canada |
| Centre de recherche Saint-Louis | Québec | Quebec | G1W 4R4 | Canada |
| IRM Québec - Clinique St-Louis | Québec | Quebec | G1W 4R4 | Canada |
| Alpha Recherche Clinique | Québec | Quebec | G3K 2P8 | Canada |
| Clinix | Québec | Quebec | G3K 2P8 | Canada |
| Recherche Medicale St-Jerome Inc | Saint-Jérôme | Quebec | J7Z 5T3 | Canada |
| Centre Intégré Universitaire de Santé et de Services Sociaux (CIUSSS) de l'Estrie | Sherbrooke | Quebec | J1G 2E8 | Canada |
| Hillel Yaffe Medical Center | Hadera | 3810101 | Israel |
| Rambam Health Care Campus | Haifa | 3109601 | Israel |
| Lady Davis Carmel Medical Center | Haifa | 3434104 | Israel |
| Shaare Zedek Medical Center | Jerusalem | 9103102 | Israel |
| Hadassah Hebrew University Medical Center - Ein Kerem | Jerusalem | 9112001 | Israel |
| Galilee Medical Center | Nahariya | 2210001 | Israel |
| Holy Family Hospital | Nazareth | 1610001 | Israel |
| Rabin Medical Center | Petah Tikva | 4941492 | Israel |
| The Chaim Sheba Medical Center | Ramat Gan | 5265601 | Israel |
| Tel-Aviv Sourasky Medical Center | Tel Aviv | 6423906 | Israel |
| ClinicMed Badurski i wspolnicy Spolka Jawna | Bialystok | 15-879 | Poland |
| Synexus Polska Sp. z o.o. Oddzial w Gdansku | Gdansk | 80-382 | Poland |
| Centrum Badan Klinicznych PI-House Sp. z o.o. | Gdansk | 80-546 | Poland |
| Synexus Polska Sp. z o.o. Oddzial w Gdyni | Gdynia | 81-537 | Poland |
| Osrodek Badan Klinicznych | Jaworze | 43-384 | Poland |
| Synexus Polska Sp. z o.o. Oddzial w Katowicach | Katowice | 40-040 | Poland |
| Silmedic Sp. z o.o. Oddzial w Katowicach | Katowice | 40-282 | Poland |
| Centrum Medyczne A-Z Clinic | Krakow | 31-315 | Poland |
| Krakowskie Centrum Medyczne sp. z o.o. | Krakow | 31-501 | Poland |
| Gabinet Lekarski Malgorzata Saryusz-Wolska | Lodz | 90-132 | Poland |
| Synexus Polska Sp. z o.o Oddzial w Poznaniu | Poznan | 60-702 | Poland |
| Centrum Medyczne Medyk | Rzeszów | 35-326 | Poland |
| Synexus Polska Sp. z o. o. Oddzial w Warszawie | Warsaw | 01-192 | Poland |
| Niepubliczny Zaklad Opieki Zdrowotnej Centrum Badan Klinicznych | Wroclaw | 50-349 | Poland |
| Synexus Polska Sp. z o.o. Oddzial we Wroclawiu | Wroclaw | 50-381 | Poland |
| DOBROSTAN - Gabinety Lekarskie | Wroclaw | 53-301 | Poland |
| Changhua Christian Hospital | Changhua | Changhua County | 500 | Taiwan |
| Chung-Ho Memorial Hospital, Kaohsiung Medical University | Kaohsiung City | 807 | Taiwan |
| National Cheng-Kung University Hospital | Tainan | 704 | Taiwan |
| National Taiwan University Hospital | Taipei | 100 | Taiwan |
| Taipei Veterans General Hospital | Taipei | 11217 | Taiwan |
| 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. |
| FG002 | PF-05221304 10 mg | PF-05221304 tablet was administered orally at 10 mg QD for up to 16 weeks. |
| FG003 | PF-05221304 25 mg | PF-05221304 tablet was administered orally at 25 mg QD for up to 16 weeks. |
| FG004 | PF-05221304 50 mg | PF-05221304 tablet was administered orally at 50 mg QD for up to 16 weeks. |
| Received Treatment |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
All randomized participants who received at least 1 dose of randomized study treatment.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Placebo matched to PF-05221304 tablet was administered orally once daily (QD) for up to 16 weeks. |
| BG001 | PF-05221304 2 mg | PF-05221304 tablet was administered orally at 2 mg QD for up to 16 weeks. |
| BG002 | PF-05221304 10 mg | PF-05221304 tablet was administered orally at 10 mg QD for up to 16 weeks. |
| BG003 | PF-05221304 25 mg | PF-05221304 tablet was administered orally at 25 mg QD for up to 16 weeks. |
| BG004 | PF-05221304 50 mg | PF-05221304 tablet was administered orally at 50 mg QD for up to 16 weeks. |
| BG005 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | All randomized participants who received at least 1 dose of randomized study treatment and with non-missing baseline and post-baseline endpoint. | Posted | Least Squares Mean | 80% Confidence Interval | Percent change | Baseline (between Day -14 and Day 1), Week 16 |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percent Change From Baseline in Alanine Aminotransferase at Week 16 | Potential improvement in liver function was denoted by reduction in alanine transaminase (ALT) | All randomized participants who received at least 1 dose of randomized study treatment and diagnosed/presumed with nonalcoholic steatohepatitis. | Posted | Least Squares Mean | 80% Confidence Interval | Percent change | Baseline (Day 1 pre-dose), Week 16 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | All randomized participants who received at least 1 dose of randomized study treatment. | Posted | Count of Participants | Participants | From first dose of study treatment (Day 1) up to Week 20 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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). | All randomized participants who received at least 1 dose of randomized study treatment and had laboratory data. | Posted | Count of Participants | Participants | From first dose of study treatment (Day 1) up to Week 20 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | All randomized participants who received at least 1 dose of randomized study treatment and had vital signs data. | Posted | Count of Participants | Participants | From first dose of study treatment (Day 1) up to Week 18 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | All randomized participants who received at least 1 dose of randomized study treatment and had ECG data. | Posted | Count of Participants | Participants | From first dose of study treatment (Day 1) up to Week 18 |
|
From first dose of study treatment up to 20 weeks
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Placebo matched to PF-05221304 tablet was administered orally once daily (QD) for up to 16 weeks. | 0 | 61 | 0 | 61 | 27 | 61 |
| EG001 | PF-05221304 2 mg | PF-05221304 tablet was administered orally at 2 mg QD for up to 16 weeks. | 0 | 63 | 1 | 63 | 21 | 63 |
| EG002 | PF-05221304 10 mg | PF-05221304 tablet was administered orally at 10 mg QD for up to 16 weeks. | 0 | 62 | 1 | 62 | 25 | 62 |
| EG003 | PF-05221304 25 mg | PF-05221304 tablet was administered orally at 25 mg QD for up to 16 weeks. | 0 | 58 | 2 | 58 | 31 | 58 |
| EG004 | PF-05221304 50 mg | PF-05221304 tablet was administered orally at 50 mg QD for up to 16 weeks. | 0 | 61 | 2 | 61 | 29 | 61 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Angina unstable | Cardiac disorders | MedDRA v22.0 | Non-systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA v22.0 | Non-systematic Assessment |
| |
| Myocardial ischaemia | Cardiac disorders | MedDRA v22.0 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA v22.0 | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA v22.0 | Non-systematic Assessment |
| |
| Rib fracture | Injury, poisoning and procedural complications | MedDRA v22.0 | Non-systematic Assessment |
| |
| Renal colic | Renal and urinary disorders | MedDRA v22.0 | Non-systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA v22.0 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA v22.0 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA v22.0 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA v22.0 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA v22.0 | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA v22.0 | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA v22.0 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA v22.0 | Non-systematic Assessment |
| |
| Blood triglycerides increased | Investigations | MedDRA v22.0 | Non-systematic Assessment |
| |
| Hypertriglyceridaemia | Metabolism and nutrition disorders | MedDRA v22.0 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA v22.0 | Non-systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA v22.0 | Non-systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA v22.0 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA v22.0 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA v22.0 | Non-systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA v22.0 | Non-systematic Assessment |
|
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 14, 2019 | Feb 25, 2020 | SAP_001.pdf |
| ID | Term |
|---|---|
| D065626 | Non-alcoholic Fatty Liver Disease |
| ID | Term |
|---|---|
| D005234 | Fatty Liver |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
Not provided
Not provided
| Male |
|
| Black or African American |
|
| Asian |
|
| American Indian or Alaska Native |
|
| Native Hawaiian or Other Pacific Islander |
|
| Not Reported |
|
| Mean Difference (Net) |
| -46.0 |
| 2-Sided |
| 80 |
| -51.3 |
| -40.1 |
| Superiority |
| Mean Difference (Net) | -52.4 | 2-Sided | 80 | -57.2 | -47.1 | Superiority |
| Mean Difference (Net) | -62.1 | 2-Sided | 80 | -66.0 | -57.8 | Superiority |
| OG004 |
| PF-05221304 50 mg |
PF-05221304 tablet was administered orally at 50 mg QD for up to 16 weeks. |
|
|
|
| OG003 |
| PF-05221304 25 mg |
PF-05221304 tablet was administered orally at 25 mg QD for up to 16 weeks. |
| OG004 | PF-05221304 50 mg | PF-05221304 tablet was administered orally at 50 mg QD for up to 16 weeks. |
|
|
PF-05221304 tablet was administered orally at 10 mg QD for up to 16 weeks. |
| OG003 | PF-05221304 25 mg | PF-05221304 tablet was administered orally at 25 mg QD for up to 16 weeks. |
| OG004 | PF-05221304 50 mg | PF-05221304 tablet was administered orally at 50 mg QD for up to 16 weeks. |
|
|
| PF-05221304 25 mg |
PF-05221304 tablet was administered orally at 25 mg QD for up to 16 weeks. |
| OG004 | PF-05221304 50 mg | PF-05221304 tablet was administered orally at 50 mg QD for up to 16 weeks. |
|
|
PF-05221304 tablet was administered orally at 2 mg QD for up to 16 weeks.
| OG002 | PF-05221304 10 mg | PF-05221304 tablet was administered orally at 10 mg QD for up to 16 weeks. |
| OG003 | PF-05221304 25 mg | PF-05221304 tablet was administered orally at 25 mg QD for up to 16 weeks. |
| OG004 | PF-05221304 50 mg | PF-05221304 tablet was administered orally at 50 mg QD for up to 16 weeks. |
|
|