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
2 other identifiers
interventional
305
6 countries
140
Brief Summary
Phase 2a, dose-ranging Study with PF-05221304 in Nonalcoholic Fatty Liver Disease (NAFLD)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Aug 2017
140 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 10, 2017
CompletedFirst Posted
Study publicly available on registry
August 14, 2017
CompletedStudy Start
First participant enrolled
August 22, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 26, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
March 27, 2019
CompletedResults Posted
Study results publicly available
March 10, 2020
CompletedDecember 9, 2020
February 1, 2020
1.5 years
August 10, 2017
February 25, 2020
December 7, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (5)
Percent Change From Baseline in Alanine Aminotransferase at Week 16
Baseline (Day 1 pre-dose), Week 16
Number of Participants With Treatment-Emergent Adverse Events
From first dose of study treatment (Day 1) up to Week 20
Number of Participants With Laboratory Abnormalities
From first dose of study treatment (Day 1) up to Week 20
Number of Participants With Vital Signs Data Meeting Predefined Criteria
From first dose of study treatment (Day 1) up to Week 18
Number of Participants With 12-Lead Electrocardiogram (ECG) Data Meeting Predefined Criteria
From first dose of study treatment (Day 1) up to Week 18
Study Arms (5)
Placebo
PLACEBO COMPARATORDouble-Blind, PF-05221304-matching Placebo
PF-05221304 - 2 mg
ACTIVE COMPARATORPF-05221304 - 2 mg, once-daily
PF-05221304 - 10 mg
ACTIVE COMPARATORPF-05221304 - 10 mg, once-daily
PF-05221304 - 25 mg
ACTIVE COMPARATORPF-05221304 - 25 mg, once-daily
PF-05221304 - 50 mg
ACTIVE COMPARATORPF-05221304 - 50 mg, once-daily
Interventions
PF-05221304, Experimental Drug
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (140)
Franco Felizarta MD
Bakersfield, California, 93301, United States
eStudySite
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
Related Publications (2)
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.
PMID: 39048608DERIVEDCalle 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.
PMID: 34635855DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Pfizer ClinicalTrials.gov Call Center
- Organization
- Pfizer, Inc
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Masking Details
- Double-Blind
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 10, 2017
First Posted
August 14, 2017
Study Start
August 22, 2017
Primary Completion
February 26, 2019
Study Completion
March 27, 2019
Last Updated
December 9, 2020
Results First Posted
March 10, 2020
Record last verified: 2020-02
Data Sharing
- IPD Sharing
- Will share
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.