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NCT03248882 Clinical Trial

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

Nonalcoholic Steatohepatitis Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03248882
Other study ID # C1171002
Secondary ID 2017-001156-55
Status Completed
Phase Phase 2
First received
Last updated
Start date August 22, 2017
Est. completion date March 27, 2019

Study information
Verified date February 2020
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility
Status Completed
Enrollment 305
Est. completion date March 27, 2019
Est. primary completion date February 26, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility 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: - 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Placebo
Placebo
• PF-05221304
PF-05221304, Experimental Drug

Locations
Country Name City State
Australia Dr. Jones & Partners Medical Imaging Adelaide South Australia
Australia Flinders Medical Centre/Department of Gastroenterology & Hepatology Adelaide South Australia
Australia Radiology SA Adelaide South Australia
Australia Royal Adelaide Hospital, Department of Gastroenterology and Hepatology Adelaide South Australia
Australia Australian Clinical Research Network Maroubra New South Wales
Australia Royal Melbourne Hospital Parkville Victoria
Australia Spectrum Medical Imaging Randwick New South Wales
Australia Castlereagh Imaging Westmead New South Wales
Australia Storr Liver Centre, Westmead Hospital Westmead New South Wales
Canada Aggarwal and Associates Limited Brampton Ontario
Canada Ecogene-21 Chicoutimi Quebec
Canada Resonance Magnetique du Saguenay-Lac-Saint-Jean Chicoutimi Quebec
Canada Nova Scotia Health Authority - QEII Health Sciences Centre Halifax Nova Scotia
Canada Nova Scotia Health Authority, QEII Health Sciences Centre Halifax Nova Scotia
Canada Nova Scotia Health Authority, QEII Health Sciences Centre Halifax Nova Scotia
Canada London Health Sciences Centre - University Hospital London Ontario
Canada St. Joseph's Health Care London London Ontario
Canada Oxford Medical Imaging Mississauga Ontario
Canada Cedar Cancer Center - McGill University Health Centre Montreal Quebec
Canada Centre de recherche du CHUM Montreal Quebec
Canada Chronic Viral Illness Service - Royal Victoria Hospital - McGill University Health Centre (MUHC) Montreal Quebec
Canada Clinique de Medecine Urbaine du Quartier Latin Montreal Quebec
Canada McGill University Health Centre Montreal Quebec
Canada Medpharmgene Inc Montreal Quebec
Canada Radiologie Varad Montreal Quebec
Canada Research Institute of the MUHC Montreal Quebec
Canada Alpha Recherche Clinique Quebec
Canada Centre de recherche de l'Institut Universitaire de Cardiologie et de pneumologie de Quebec Quebec
Canada Centre de recherche Saint-Louis Quebec
Canada CHU de Quebec - Universite Laval - site Centre Hospitalier de l'Universite Laval (CHUL) Quebec
Canada Clinix Quebec
Canada IRM Quebec Quebec
Canada IRM Quebec Quebec
Canada IRM Québec - Clinique St-Louis Quebec
Canada Centre Intégré Universitaire de Santé et de Services Sociaux (CIUSSS) de l'Estrie Sherbrooke Quebec
Canada Recherche Medicale St-Jerome Inc St-Jerome Quebec
Canada LMC Clinical Research Inc. (Bayview) Toronto Ontario
Canada St. Michael's Hospital Toronto Ontario
Canada St. Michael's Hospital - MRI Research Centre Toronto Ontario
Canada Toronto Liver Centre - Liver Care Centre Corporation Toronto Ontario
Canada University Health Network (UHN) Toronto Ontario
Canada University Health Network (UHN) - Toronto General Hospital - Toronto Centre for Liver Disease (TCLD) Toronto Ontario
Canada University of Toronto - Toronto General Hospital Toronto Ontario
Canada Dr TG Elliott Inc - BC Diabetes Vancouver British Columbia
Canada False Creek Healthcare Vancouver British Columbia
Canada False Creek Healthcare Centre Vancouver British Columbia
Canada LAIR Centre Vancouver British Columbia
Canada Discovery Clinical Services Ltd. Victoria British Columbia
Canada West Coast Medical Imaging Victoria British Columbia
Israel Hillel Yaffe Medical Center Hadera
Israel Lady Davis Carmel Medical Center Haifa
Israel Rambam Health Care Campus Haifa
Israel Hadassah Hebrew University Medical Center - Ein Kerem Jerusalem
Israel Shaare Zedek Medical Center Jerusalem
Israel Galilee Medical Center Nahariya
Israel Holy Family Hospital Nazareth
Israel Rabin Medical Center Petah Tikva
Israel The Chaim Sheba Medical Center Ramat-Gan
Israel Tel-Aviv Sourasky Medical Center Tel-Aviv
Poland ClinicMed Badurski i wspolnicy Spolka Jawna Bialystok
Poland Centrum Badan Klinicznych PI-House Sp. z o.o. Gdansk
Poland Synexus Polska Sp. z o.o. Oddzial w Gdansku Gdansk
Poland Synexus Polska Sp. z o.o. Oddzial w Gdyni Gdynia
Poland Osrodek Badan Klinicznych Jaworze
Poland Silmedic Sp. z o.o. Oddzial w Katowicach Katowice
Poland Synexus Polska Sp. z o.o. Oddzial w Katowicach Katowice
Poland Centrum Medyczne A-Z Clinic Krakow
Poland Krakowskie Centrum Medyczne sp. z o.o. Krakow
Poland Gabinet Lekarski Malgorzata Saryusz-Wolska Lodz
Poland Synexus Polska Sp. z o.o Oddzial w Poznaniu Poznan
Poland Centrum Medyczne Medyk Rzeszow
Poland Synexus Polska Sp. z o. o. Oddzial w Warszawie Warszawa
Poland DOBROSTAN - Gabinety Lekarskie Wroclaw
Poland Niepubliczny Zaklad Opieki Zdrowotnej Centrum Badan Klinicznych Wroclaw
Poland Synexus Polska Sp. z o.o. Oddzial we Wroclawiu Wroclaw
Taiwan Changhua Christian Hospital Changhua city Changhua County
Taiwan Chung-Ho Memorial Hospital, Kaohsiung Medical University Kaohsiung
Taiwan National Cheng-Kung University Hospital Tainan
Taiwan National Taiwan University Hospital Taipei
Taiwan Taipei Veterans General Hospital Taipei
United States University of Michigan Ann Arbor Michigan
United States Touchstone Austin Texas
United States Franco Felizarta MD Bakersfield California
United States Mercy Medical Center Baltimore Maryland
United States Digestive Disease Associates, PA Catonsville Maryland
United States Investigational Drug Service, University of North Carolina Hospitals Chapel Hill North Carolina
United States The University of NC at Chapel Hill, Clinical and Translational Research Center (CTRC) Chapel Hill North Carolina
United States The University of North Carolina at Chapel Hill, Biomedical Research Imaging Center (MRI Facility) Chapel Hill North Carolina
United States ClinSearch Chattanooga Tennessee
United States Prime Imaging (Chattanooga Outpatient Center) Chattanooga Tennessee
United States eStudySite Chula Vista California
United States San Diego Imaging Chula Vista Chula Vista California
United States Sterling Research Group, Ltd. Cincinnati Ohio
United States Henry Ford Health System Detroit Michigan
United States South Denver Gastroenterology, P.C. Englewood Colorado
United States Gastrointestinal Associates, PA Flowood Mississippi
United States East-West Medical Research Institute Honolulu Hawaii
United States Invision Imaging Honolulu Hawaii
United States Baylor College of Medicine - Advanced Liver Therapies Houston Texas
United States Midwest Institute for Clinical Research Indianapolis Indiana
United States Colonnades at Baptist Jackson Mississippi
United States Borland-Groover Clinic Jacksonville Florida
United States Jacksonville Center for Clinical Research Jacksonville Florida
United States University of California, San Diego La Jolla California
United States University of California, San Diego (Altman Clinical and Translational Research Institute) La Jolla California
United States eStudySite La Mesa California
United States Clinical Research Advantage, Inc./Wasatch Peak Family Practice Layton Utah
United States Clinical Trials Research Lincoln California
United States National Research Institute Los Angeles California
United States Schiff Center for Liver Diseases/University of Miami Miami Florida
United States Stand Up MRI of Miami Miami Florida
United States Ocean Blue Medical Research Center, Inc Miami Springs Florida
United States Ochsner Medical Center New Orleans Louisiana
United States Tulane University Health Sciences Center New Orleans Louisiana
United States Avail Clinical Research, LLC Orange City Florida
United States Bioclinica Research Orlando Florida
United States Advanced Gastroenterology Associates, LLC Palm Harbor Florida
United States Stanford University Medical Center Palo Alto California
United States Stanford University Medical Center, Blake wilbur Building Palo Alto California
United States Huntington Medical Research Institute Pasadena California
United States Wake Research Associates, LLC Raleigh North Carolina
United States Inland Empire Liver Foundation Rialto California
United States National Clinical Research - Richmond, Inc. Richmond Virginia
United States BioTelemetry Research Rochester New York
United States Mayo Clinic- Main Campus Rochester Minnesota
United States Pinnacle Clinical Research Rollingwood Texas
United States Clinical Trials of Texas, Inc. San Antonio Texas
United States Pinnacle Clinical Research, PLLC San Antonio Texas
United States Precision Research Institute San Diego California
United States Quest Clinical Research San Francisco California
United States Harborview Medical Center Seattle Washington
United States Qps-Mra, Llc South Miami Florida
United States Tampa General Medical Group Tampa Florida
United States University of South Florida Tampa Florida
United States Independent Imaging Wellington Florida
United States South Florida Center Of Gastroenterology, PA Wellington Florida
United States Ascension Via Christi Imaging at St. Francis Wichita Kansas
United States Heartland Research Associates, LLC Wichita Kansas
United States PMG Research of Wilmington, LLC Wilmington North Carolina
United States PMG Research, Inc. Winston-Salem North Carolina

Sponsors (1)
Lead Sponsor Collaborator
Pfizer

Countries where clinical trial is conducted

United States,  Australia,  Canada,  Israel,  Poland,  Taiwan, 

Outcome
Type Measure Description Time frame Safety issue
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. 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) 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. 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). 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. 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. From first dose of study treatment (Day 1) up to Week 18
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