Clinical trial NCT03248882: Phase 2a, Dose-ranging Study With PF-05221304 in Nonalcoholic Fatty Liver Disease (NAFLD)
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Nonalcoholic Fatty Liver Disease
Nonalcoholic Steatohepatitis
Keywords: PF-05221304
NAFLD
NASH
features of metabolic syndrome
Dose-Ranging Study
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2017-08-14
Enrollment: 305
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: C1171002 is a randomized, double blind, placebo controlled, 5 arm (placebo, plus 4 active doses of PF 05221304), parallel group study.
Primary purpose: TREATMENT

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

Detailed 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

Eligibility criteria: 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

Primary outcomes:
measure: Percent Change From Baseline in Liver Fat by Magnetic Resonance Imaging-Proton Density Fat Fraction (MRI- PDFF) at Week 16
timeFrame: Baseline (between Day -14 and Day 1), Week 16
Secondary outcomes:
measure: Percent Change From Baseline in Alanine Aminotransferase at Week 16
timeFrame: Baseline (Day 1 pre-dose), Week 16
measure: Number of Participants With Treatment-Emergent Adverse Events
timeFrame: From first dose of study treatment (Day 1) up to Week 20
measure: Number of Participants With Laboratory Abnormalities
timeFrame: From first dose of study treatment (Day 1) up to Week 20
measure: Number of Participants With Vital Signs Data Meeting Predefined Criteria
timeFrame: From first dose of study treatment (Day 1) up to Week 18
measure: Number of Participants With 12-Lead Electrocardiogram (ECG) Data Meeting Predefined Criteria
timeFrame: From first dose of study treatment (Day 1) up to Week 18
Other outcomes:
Locations:
city: Bakersfield
country: United States
facility: Franco Felizarta MD
state: California
city: Chula Vista
country: United States
facility: eStudySite
state: California
city: Chula Vista
country: United States
facility: San Diego Imaging Chula Vista
state: California
city: La Jolla
country: United States
facility: University of California, San Diego (Altman Clinical and Translational Research Institute)
state: California
city: La Jolla
country: United States
facility: University of California, San Diego
state: California
city: La Mesa
country: United States
facility: eStudySite
state: California
city: Lincoln
country: United States
facility: Clinical Trials Research
state: California
city: Los Angeles
country: United States
facility: National Research Institute
state: California
city: Palo Alto
country: United States
facility: Stanford University Medical Center, Blake wilbur Building
state: California
city: Palo Alto
country: United States
facility: Stanford University Medical Center
state: California
city: Pasadena
country: United States
facility: Huntington Medical Research Institute
state: California
city: Rialto
country: United States
facility: Inland Empire Liver Foundation
state: California
city: San Diego
country: United States
facility: Precision Research Institute
state: California
city: San Francisco
country: United States
facility: Quest Clinical Research
state: California
city: Englewood
country: United States
facility: South Denver Gastroenterology, P.C.
state: Colorado
city: Jacksonville
country: United States
facility: Jacksonville Center for Clinical Research
state: Florida
city: Jacksonville
country: United States
facility: Borland-Groover Clinic
state: Florida
city: Miami Springs
country: United States
facility: Ocean Blue Medical Research Center, Inc
state: Florida
city: Miami
country: United States
facility: Schiff Center for Liver Diseases/University of Miami
state: Florida
city: Miami
country: United States
facility: Stand Up MRI of Miami
state: Florida
city: Orange City
country: United States
facility: Avail Clinical Research, LLC
state: Florida
city: Orlando
country: United States
facility: Bioclinica Research
state: Florida
city: Palm Harbor
country: United States
facility: Advanced Gastroenterology Associates, LLC
state: Florida
city: South Miami
country: United States
facility: Qps-Mra, Llc
state: Florida
city: Tampa
country: United States
facility: Tampa General Medical Group
state: Florida
city: Tampa
country: United States
facility: University of South Florida
state: Florida
city: Wellington
country: United States
facility: South Florida Center Of Gastroenterology, PA
state: Florida
city: Wellington
country: United States
facility: Independent Imaging
state: Florida
city: Honolulu
country: United States
facility: East-West Medical Research Institute
state: Hawaii
city: Honolulu
country: United States
facility: Invision Imaging
state: Hawaii
city: Indianapolis
country: United States
facility: Midwest Institute for Clinical Research
state: Indiana
city: Wichita
country: United States
facility: Heartland Research Associates, LLC
state: Kansas
city: Wichita
country: United States
facility: Ascension Via Christi Imaging at St. Francis
state: Kansas
city: New Orleans
country: United States
facility: Tulane University Health Sciences Center
state: Louisiana
city: New Orleans
country: United States
facility: Ochsner Medical Center
state: Louisiana
city: Baltimore
country: United States
facility: Mercy Medical Center
state: Maryland
city: Catonsville
country: United States
facility: Digestive Disease Associates, PA
state: Maryland
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Detroit
country: United States
facility: Henry Ford Health System
state: Michigan
city: Rochester
country: United States
facility: Mayo Clinic- Main Campus
state: Minnesota
city: Flowood
country: United States
facility: Gastrointestinal Associates, PA
state: Mississippi
city: Jackson
country: United States
facility: Colonnades at Baptist
state: Mississippi
city: Rochester
country: United States
facility: BioTelemetry Research
state: New York
city: Chapel Hill
country: United States
facility: Investigational Drug Service, University of North Carolina Hospitals
state: North Carolina
city: Chapel Hill
country: United States
facility: The University of NC at Chapel Hill, Clinical and Translational Research Center (CTRC)
state: North Carolina
city: Chapel Hill
country: United States
facility: The University of North Carolina at Chapel Hill, Biomedical Research Imaging Center (MRI Facility)
state: North Carolina
city: Raleigh
country: United States
facility: Wake Research Associates, LLC
state: North Carolina
city: Wilmington
country: United States
facility: PMG Research of Wilmington, LLC
state: North Carolina
city: Winston-Salem
country: United States
facility: PMG Research, Inc.
state: North Carolina
city: Cincinnati
country: United States
facility: Sterling Research Group, Ltd.
state: Ohio
city: Chattanooga
country: United States
facility: Prime Imaging (Chattanooga Outpatient Center)
state: Tennessee
city: Chattanooga
country: United States
facility: ClinSearch
state: Tennessee
city: Austin
country: United States
facility: Touchstone
state: Texas
city: Houston
country: United States
facility: Baylor College of Medicine - Advanced Liver Therapies
state: Texas
city: Rollingwood
country: United States
facility: Pinnacle Clinical Research
state: Texas
city: San Antonio
country: United States
facility: Clinical Trials of Texas, Inc.
state: Texas
city: San Antonio
country: United States
facility: Pinnacle Clinical Research, PLLC
state: Texas
city: Layton
country: United States
facility: Clinical Research Advantage, Inc./Wasatch Peak Family Practice
state: Utah
city: Richmond
country: United States
facility: National Clinical Research - Richmond, Inc.
state: Virginia
city: Seattle
country: United States
facility: Harborview Medical Center
state: Washington
city: Maroubra
country: Australia
facility: Australian Clinical Research Network
state: New South Wales
city: Randwick
country: Australia
facility: Spectrum Medical Imaging
state: New South Wales
city: Westmead
country: Australia
facility: Castlereagh Imaging
state: New South Wales
city: Westmead
country: Australia
facility: Storr Liver Centre, Westmead Hospital
state: New South Wales
city: Adelaide
country: Australia
facility: Dr. Jones & Partners Medical Imaging
state: South Australia
city: Adelaide
country: Australia
facility: Royal Adelaide Hospital, Department of Gastroenterology and Hepatology
state: South Australia
city: Adelaide
country: Australia
facility: Flinders Medical Centre/Department of Gastroenterology & Hepatology
state: South Australia
city: Adelaide
country: Australia
facility: Radiology SA
state: South Australia
city: Parkville
country: Australia
facility: Royal Melbourne Hospital
state: Victoria
city: Vancouver
country: Canada
facility: Dr TG Elliott Inc - BC Diabetes
state: British Columbia
city: Vancouver
country: Canada
facility: False Creek Healthcare Centre
state: British Columbia
city: Vancouver
country: Canada
facility: False Creek Healthcare
state: British Columbia
city: Vancouver
country: Canada
facility: LAIR Centre
state: British Columbia
city: Victoria
country: Canada
facility: Discovery Clinical Services Ltd.
state: British Columbia
city: Victoria
country: Canada
facility: West Coast Medical Imaging
state: British Columbia
city: Halifax
country: Canada
facility: Nova Scotia Health Authority, QEII Health Sciences Centre
state: Nova Scotia
city: Halifax
country: Canada
facility: Nova Scotia Health Authority, QEII Health Sciences Centre
state: Nova Scotia
city: Halifax
country: Canada
facility: Nova Scotia Health Authority - QEII Health Sciences Centre
state: Nova Scotia
city: Brampton
country: Canada
facility: Aggarwal and Associates Limited
state: Ontario
city: London
country: Canada
facility: St. Joseph's Health Care London
state: Ontario
city: London
country: Canada
facility: London Health Sciences Centre - University Hospital
state: Ontario
city: Mississauga
country: Canada
facility: Oxford Medical Imaging
state: Ontario
city: Toronto
country: Canada
facility: LMC Clinical Research Inc. (Bayview)
state: Ontario
city: Toronto
country: Canada
facility: St. Michael's Hospital - MRI Research Centre
state: Ontario
city: Toronto
country: Canada
facility: St. Michael's Hospital
state: Ontario
city: Toronto
country: Canada
facility: University Health Network (UHN) - Toronto General Hospital - Toronto Centre for Liver Disease (TCLD)
state: Ontario
city: Toronto
country: Canada
facility: University of Toronto - Toronto General Hospital
state: Ontario
city: Toronto
country: Canada
facility: University Health Network (UHN)
state: Ontario
city: Toronto
country: Canada
facility: Toronto Liver Centre - Liver Care Centre Corporation
state: Ontario
city: Chicoutimi
country: Canada
facility: Resonance Magnetique du Saguenay-Lac-Saint-Jean
state: Quebec
city: Chicoutimi
country: Canada
facility: Ecogene-21
state: Quebec
city: Montreal
country: Canada
facility: Medpharmgene Inc
state: Quebec
city: Montreal
country: Canada
facility: Clinique de Medecine Urbaine du Quartier Latin
state: Quebec
city: Montreal
country: Canada
facility: Centre de recherche du CHUM
state: Quebec
city: Montreal
country: Canada
facility: Cedar Cancer Center - McGill University Health Centre
state: Quebec
city: Montreal
country: Canada
facility: Chronic Viral Illness Service - Royal Victoria Hospital - McGill University Health Centre (MUHC)
state: Quebec
city: Montreal
country: Canada
facility: McGill University Health Centre
state: Quebec
city: Montreal
country: Canada
facility: Research Institute of the MUHC
state: Quebec
city: Montreal
country: Canada
facility: Radiologie Varad
state: Quebec
city: Sherbrooke
country: Canada
facility: Centre Intégré Universitaire de Santé et de Services Sociaux (CIUSSS) de l'Estrie
state: Quebec
city: St-Jerome
country: Canada
facility: Recherche Medicale St-Jerome Inc
state: Quebec
city: Quebec
country: Canada
facility: IRM Quebec
city: Quebec
country: Canada
facility: IRM Quebec
city: Quebec
country: Canada
facility: CHU de Quebec - Universite Laval - site Centre Hospitalier de l'Universite Laval (CHUL)
city: Quebec
country: Canada
facility: Centre de recherche de l'Institut Universitaire de Cardiologie et de pneumologie de Quebec
city: Quebec
country: Canada
facility: Centre de recherche Saint-Louis
city: Quebec
country: Canada
facility: IRM Québec - Clinique St-Louis
city: Quebec
country: Canada
facility: Alpha Recherche Clinique
city: Quebec
country: Canada
facility: Clinix
city: Hadera
country: Israel
facility: Hillel Yaffe Medical Center
city: Haifa
country: Israel
facility: Rambam Health Care Campus
city: Haifa
country: Israel
facility: Lady Davis Carmel Medical Center
city: Jerusalem
country: Israel
facility: Shaare Zedek Medical Center
city: Jerusalem
country: Israel
facility: Hadassah Hebrew University Medical Center - Ein Kerem
city: Nahariya
country: Israel
facility: Galilee Medical Center
city: Nazareth
country: Israel
facility: Holy Family Hospital
city: Petah Tikva
country: Israel
facility: Rabin Medical Center
city: Ramat-Gan
country: Israel
facility: The Chaim Sheba Medical Center
city: Tel-Aviv
country: Israel
facility: Tel-Aviv Sourasky Medical Center
city: Bialystok
country: Poland
facility: ClinicMed Badurski i wspolnicy Spolka Jawna
city: Gdansk
country: Poland
facility: Synexus Polska Sp. z o.o. Oddzial w Gdansku
city: Gdansk
country: Poland
facility: Centrum Badan Klinicznych PI-House Sp. z o.o.
city: Gdynia
country: Poland
facility: Synexus Polska Sp. z o.o. Oddzial w Gdyni
city: Jaworze
country: Poland
facility: Osrodek Badan Klinicznych
city: Katowice
country: Poland
facility: Synexus Polska Sp. z o.o. Oddzial w Katowicach
city: Katowice
country: Poland
facility: Silmedic Sp. z o.o. Oddzial w Katowicach
city: Krakow
country: Poland
facility: Centrum Medyczne A-Z Clinic
city: Krakow
country: Poland
facility: Krakowskie Centrum Medyczne sp. z o.o.
city: Lodz
country: Poland
facility: Gabinet Lekarski Malgorzata Saryusz-Wolska
city: Poznan
country: Poland
facility: Synexus Polska Sp. z o.o Oddzial w Poznaniu
city: Rzeszow
country: Poland
facility: Centrum Medyczne Medyk
city: Warszawa
country: Poland
facility: Synexus Polska Sp. z o. o. Oddzial w Warszawie
city: Wroclaw
country: Poland
facility: Niepubliczny Zaklad Opieki Zdrowotnej Centrum Badan Klinicznych
city: Wroclaw
country: Poland
facility: Synexus Polska Sp. z o.o. Oddzial we Wroclawiu
city: Wroclaw
country: Poland
facility: DOBROSTAN - Gabinety Lekarskie
city: Changhua city
country: Taiwan
facility: Changhua Christian Hospital
state: Changhua County
city: Kaohsiung
country: Taiwan
facility: Chung-Ho Memorial Hospital, Kaohsiung Medical University
city: Tainan
country: Taiwan
facility: National Cheng-Kung University Hospital
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: 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.