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Nonalcoholic Fatty Liver DiseasePhase 2NCT03248882

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

A Phase 2 study testing PF-05221304 in people with Nonalcoholic Fatty Liver Disease and Nonalcoholic Steatohepatitis, run by Pfizer at 140 sites in 6 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

Phase 2a, dose-ranging Study with PF-05221304 in Nonalcoholic Fatty Liver Disease (NAFLD) Read more about this study

Who is it for?
Ages 18 to 70 years
What is being tested?
PF-05221304
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
305 participants
Where
140 sitesin 6 countries
Study dates
22 Aug 2017to 27 Mar 2019
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

140 sites in 6 countries.

140 sites in 6 countries

United States60 sites

  • University of Michigan

    Ann Arbor, Michigan, 48109

  • Touchstone

    Austin, Texas, 78705

  • Franco Felizarta MD

    Bakersfield, California, 93301

  • Mercy Medical Center

    Baltimore, Maryland, 21202

  • Digestive Disease Associates, PA

    Catonsville, Maryland, 21228

  • Investigational Drug Service, University of North Carolina Hospitals

    Chapel Hill, North Carolina, 27514

  • The University of NC at Chapel Hill, Clinical and Translational Research Center (CTRC)

    Chapel Hill, North Carolina, 27599

  • The University of North Carolina at Chapel Hill, Biomedical Research Imaging Center (MRI Facility)

    Chapel Hill, North Carolina, 27599

  • Prime Imaging (Chattanooga Outpatient Center)

    Chattanooga, Tennessee, 37404

  • ClinSearch

    Chattanooga, Tennessee, 37421

  • eStudySite

    Chula Vista, California, 91911

  • San Diego Imaging Chula Vista

    Chula Vista, California, 91911

  • Sterling Research Group, Ltd.

    Cincinnati, Ohio, 45219

  • Henry Ford Health System

    Detroit, Michigan, 48202

  • South Denver Gastroenterology, P.C.

    Englewood, Colorado, 80113

  • Gastrointestinal Associates, PA

    Flowood, Mississippi, 39232

  • East-West Medical Research Institute

    Honolulu, Hawaii, 96814

  • Invision Imaging

    Honolulu, Hawaii, 96814

  • Baylor College of Medicine - Advanced Liver Therapies

    Houston, Texas, 77030

  • Midwest Institute for Clinical Research

    Indianapolis, Indiana, 46260

  • Colonnades at Baptist

    Jackson, Mississippi, 39202

  • Jacksonville Center for Clinical Research

    Jacksonville, Florida, 32216

  • Borland-Groover Clinic

    Jacksonville, Florida, 32256

  • University of California, San Diego (Altman Clinical and Translational Research Institute)

    La Jolla, California, 92037

  • University of California, San Diego

    La Jolla, California, 92037

  • eStudySite

    La Mesa, California, 91942

  • Clinical Research Advantage, Inc./Wasatch Peak Family Practice

    Layton, Utah, 84041

  • Clinical Trials Research

    Lincoln, California, 95648

  • National Research Institute

    Los Angeles, California, 90057

  • Schiff Center for Liver Diseases/University of Miami

    Miami, Florida, 33136

  • Stand Up MRI of Miami

    Miami, Florida, 33145

  • Ocean Blue Medical Research Center, Inc

    Miami Springs, Florida, 33166

  • Tulane University Health Sciences Center

    New Orleans, Louisiana, 70112

  • Ochsner Medical Center

    New Orleans, Louisiana, 70121

  • Avail Clinical Research, LLC

    Orange City, Florida, 32763

  • Bioclinica Research

    Orlando, Florida, 32806

  • Advanced Gastroenterology Associates, LLC

    Palm Harbor, Florida, 34684

  • Stanford University Medical Center, Blake wilbur Building

    Palo Alto, California, 04304

  • Stanford University Medical Center

    Palo Alto, California, 94304

  • Huntington Medical Research Institute

    Pasadena, California, 91105

  • Wake Research Associates, LLC

    Raleigh, North Carolina, 27612

  • Inland Empire Liver Foundation

    Rialto, California, 92377

  • National Clinical Research - Richmond, Inc.

    Richmond, Virginia, 23294

  • Mayo Clinic- Main Campus

    Rochester, Minnesota, 55905

  • BioTelemetry Research

    Rochester, New York, 14623

  • Pinnacle Clinical Research

    Rollingwood, Texas, 78746

  • Clinical Trials of Texas, Inc.

    San Antonio, Texas, 78229

  • Pinnacle Clinical Research, PLLC

    San Antonio, Texas, 78229

  • Precision Research Institute

    San Diego, California, 92114

  • Quest Clinical Research

    San Francisco, California, 94115

  • Harborview Medical Center

    Seattle, Washington, 98104

  • Qps-Mra, Llc

    South Miami, Florida, 33143

  • Tampa General Medical Group

    Tampa, Florida, 33606

  • University of South Florida

    Tampa, Florida, 33612

  • South Florida Center Of Gastroenterology, PA

    Wellington, Florida, 33414

  • Independent Imaging

    Wellington, Florida, 33449

  • Heartland Research Associates, LLC

    Wichita, Kansas, 67207

  • Ascension Via Christi Imaging at St. Francis

    Wichita, Kansas, 67214

  • PMG Research of Wilmington, LLC

    Wilmington, North Carolina, 28401

  • PMG Research, Inc.

    Winston-Salem, North Carolina, 27103

Other trials in United States

Canada40 sites

  • Aggarwal and Associates Limited

    Brampton, Ontario, L6T 0G1

  • Resonance Magnetique du Saguenay-Lac-Saint-Jean

    Chicoutimi, Quebec, G7H 4J1

  • Ecogene-21

    Chicoutimi, Quebec, G7H 7K9

  • Nova Scotia Health Authority, QEII Health Sciences Centre

    Halifax, Nova Scotia, B3H 1V7

  • Nova Scotia Health Authority, QEII Health Sciences Centre

    Halifax, Nova Scotia, B3H 2Y9

  • Nova Scotia Health Authority - QEII Health Sciences Centre

    Halifax, Nova Scotia, B3H 3A7

  • St. Joseph's Health Care London

    London, Ontario, N6A 4V2

  • London Health Sciences Centre - University Hospital

    London, Ontario, N6A 5A5

  • Oxford Medical Imaging

    Mississauga, Ontario, L5R 3K7

  • Medpharmgene Inc

    Montreal, Quebec, H2K 1H2

  • Clinique de Medecine Urbaine du Quartier Latin

    Montreal, Quebec, H2L 4E9

  • Centre de recherche du CHUM

    Montreal, Quebec, H2X 0A9

  • Cedar Cancer Center - McGill University Health Centre

    Montreal, Quebec, H4A 3J1

  • Chronic Viral Illness Service - Royal Victoria Hospital - McGill University Health Centre (MUHC)

    Montreal, Quebec, H4A 3J1

  • McGill University Health Centre

    Montreal, Quebec, H4A 3J1

  • Research Institute of the MUHC

    Montreal, Quebec, H4A 3J1

  • Radiologie Varad

    Montreal, Quebec, H5B 1B2

  • IRM Quebec

    Québec, Quebec, G1J0H4

  • IRM Quebec

    Québec, Quebec, G1J5B9

  • CHU de Quebec - Universite Laval - site Centre Hospitalier de l'Universite Laval (CHUL)

    Québec, Quebec, G1V 4G2

  • Centre de recherche de l'Institut Universitaire de Cardiologie et de pneumologie de Quebec

    Québec, Quebec, G1V 4G5

  • Centre de recherche Saint-Louis

    Québec, Quebec, G1W 4R4

  • IRM Québec - Clinique St-Louis

    Québec, Quebec, G1W 4R4

  • Alpha Recherche Clinique

    Québec, Quebec, G3K 2P8

  • Clinix

    Québec, Quebec, G3K 2P8

  • Recherche Medicale St-Jerome Inc

    Saint-Jérôme, Quebec, J7Z 5T3

  • Centre Intégré Universitaire de Santé et de Services Sociaux (CIUSSS) de l'Estrie

    Sherbrooke, Quebec, J1G 2E8

  • LMC Clinical Research Inc. (Bayview)

    Toronto, Ontario, M4G 3E8

  • St. Michael's Hospital - MRI Research Centre

    Toronto, Ontario, M5B 1W8

  • St. Michael's Hospital

    Toronto, Ontario, M5B 1W8

  • University Health Network (UHN) - Toronto General Hospital - Toronto Centre for Liver Disease (TCLD)

    Toronto, Ontario, M5G 2C4

  • University of Toronto - Toronto General Hospital

    Toronto, Ontario, M5G 2C4

  • University Health Network (UHN)

    Toronto, Ontario, M5G 2M9

  • Toronto Liver Centre - Liver Care Centre Corporation

    Toronto, Ontario, M6H 3M1

  • Dr TG Elliott Inc - BC Diabetes

    Vancouver, British Columbia, V5Y 3W2

  • False Creek Healthcare Centre

    Vancouver, British Columbia, V5Z 1C6

  • False Creek Healthcare

    Vancouver, British Columbia, V5Z 1C6

  • LAIR Centre

    Vancouver, British Columbia, V5Z 1H2

  • Discovery Clinical Services Ltd.

    Victoria, British Columbia, V8T 5G4

  • West Coast Medical Imaging

    Victoria, British Columbia, V8Z 0B9

Other trials in Canada

Poland16 sites

  • ClinicMed Badurski i wspolnicy Spolka Jawna

    Bialystok, 15-879

  • Synexus Polska Sp. z o.o. Oddzial w Gdansku

    Gdansk, 80-382

  • Centrum Badan Klinicznych PI-House Sp. z o.o.

    Gdansk, 80-546

  • Synexus Polska Sp. z o.o. Oddzial w Gdyni

    Gdynia, 81-537

  • Osrodek Badan Klinicznych

    Jaworze, 43-384

  • Synexus Polska Sp. z o.o. Oddzial w Katowicach

    Katowice, 40-040

  • Silmedic Sp. z o.o. Oddzial w Katowicach

    Katowice, 40-282

  • Centrum Medyczne A-Z Clinic

    Krakow, 31-315

  • Krakowskie Centrum Medyczne sp. z o.o.

    Krakow, 31-501

  • Gabinet Lekarski Malgorzata Saryusz-Wolska

    Lodz, 90-132

  • Synexus Polska Sp. z o.o Oddzial w Poznaniu

    Poznan, 60-702

  • Centrum Medyczne Medyk

    Rzeszów, 35-326

  • Synexus Polska Sp. z o. o. Oddzial w Warszawie

    Warsaw, 01-192

  • Niepubliczny Zaklad Opieki Zdrowotnej Centrum Badan Klinicznych

    Wroclaw, 50-349

  • Synexus Polska Sp. z o.o. Oddzial we Wroclawiu

    Wroclaw, 50-381

  • DOBROSTAN - Gabinety Lekarskie

    Wroclaw, 53-301

Other trials in Poland

Israel10 sites

  • Hillel Yaffe Medical Center

    Hadera, 3810101

  • Rambam Health Care Campus

    Haifa, 3109601

  • Lady Davis Carmel Medical Center

    Haifa, 3434104

  • Shaare Zedek Medical Center

    Jerusalem, 9103102

  • Hadassah Hebrew University Medical Center - Ein Kerem

    Jerusalem, 9112001

  • Galilee Medical Center

    Nahariya, 2210001

  • Holy Family Hospital

    Nazareth, 1610001

  • Rabin Medical Center

    Petah Tikva, 4941492

  • The Chaim Sheba Medical Center

    Ramat Gan, 5265601

  • Tel-Aviv Sourasky Medical Center

    Tel Aviv, 6423906

Other trials in Israel

Australia9 sites

  • Dr. Jones & Partners Medical Imaging

    Adelaide, South Australia, 5000

  • Royal Adelaide Hospital, Department of Gastroenterology and Hepatology

    Adelaide, South Australia, 5000

  • Flinders Medical Centre/Department of Gastroenterology & Hepatology

    Adelaide, South Australia, 5042

  • Radiology SA

    Adelaide, South Australia, 5067

  • Australian Clinical Research Network

    Maroubra, New South Wales, 2035

  • Royal Melbourne Hospital

    Parkville, Victoria, 3050

  • Spectrum Medical Imaging

    Randwick, New South Wales, 2013

  • Castlereagh Imaging

    Westmead, New South Wales, 2145

  • Storr Liver Centre, Westmead Hospital

    Westmead, New South Wales, 2145

Other trials in Australia

Taiwan5 sites

  • Changhua Christian Hospital

    Changhua, Changhua County, 500

  • Chung-Ho Memorial Hospital, Kaohsiung Medical University

    Kaohsiung City, 807

  • National Cheng-Kung University Hospital

    Tainan, 704

  • National Taiwan University Hospital

    Taipei, 100

  • Taipei Veterans General Hospital

    Taipei, 11217

Other trials in Taiwan

About this study

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

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

Read the 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

Being tested
Placebo, PF-05221304
Keywords
PF-05221304, NAFLD, NASH, features of metabolic syndrome, Dose-Ranging Study
Medical subject headings
Non-alcoholic Fatty Liver Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PlaceboDrug

    Placebo

  • PF-05221304Drug

    PF-05221304, Experimental Drug

Study groups in NCT03248882
Study groupRoleWhat they receive
PlaceboPlacebo comparatorDouble-Blind, PF-05221304-matching Placebo
Receives: Drug: Placebo
PF-05221304 - 2 mgActive comparatorPF-05221304 - 2 mg, once-daily
Receives: Drug: PF-05221304
PF-05221304 - 10 mgActive comparatorPF-05221304 - 10 mg, once-daily
Receives: Drug: PF-05221304
PF-05221304 - 25 mgActive comparatorPF-05221304 - 25 mg, once-daily
Receives: Drug: PF-05221304
PF-05221304 - 50 mgActive comparatorPF-05221304 - 50 mg, once-daily
Receives: Drug: PF-05221304

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Baseline (between Day -14 and Day 1), Week 16

Secondary outcomes (5)

  1. Percent Change From Baseline in Alanine Aminotransferase at Week 16

    Potential improvement in liver function was denoted by reduction in alanine transaminase (ALT)

    Measured: Baseline (Day 1 pre-dose), Week 16

  2. 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.

    Measured: From first dose of study treatment (Day 1) up to Week 20

  3. 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).

    Measured: From first dose of study treatment (Day 1) up to Week 20

  4. 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.

    Measured: From first dose of study treatment (Day 1) up to Week 18

  5. 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.

    Measured: From first dose of study treatment (Day 1) up to Week 18

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Aug 2017
  2. Study start22 Aug 2017
  3. Primary completion26 Feb 2019
  4. Study completion27 Mar 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
C1171002 is a randomized, double blind, placebo controlled, 5 arm (placebo, plus 4 active doses of PF 05221304), parallel group study.
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
305 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03248882
Sponsor's protocol ID
C1171002
Other IDs
2017-001156-55, 2017
Status last verified
Feb 2020
First submitted
10 Aug 2017
Last updated
9 Dec 2020
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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.

Publications

  • 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.

    PubMed 39048608

  • 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.

    PubMed 34635855

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing PF-05221304 in people with Nonalcoholic Fatty Liver Disease and Nonalcoholic Steatohepatitis, run by Pfizer at 140 sites in 6 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 140 sites in United States, Canada, Poland, Israel, Australia and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 10 Mar 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percent Change From Baseline in Liver Fat by Magnetic Resonance Imaging-Proton Density Fat Fraction (MRI- PDFF) at Week 16 (time frame: Baseline (between Day -14 and Day 1), Week 16). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03248882, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2020.

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