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Non-alcoholic SteatohepatitisPhase 2NCT03969719

A Double-blind Study to Assess 2 Doses of an Investigational Product for 16 Weeks in Participants With Non-alcoholic Fatty Liver Disease and Type 2 Diabetes Mellitus

A Phase 2 study testing PF-06835919 in people with Non-alcoholic Steatohepatitis, run by Pfizer at 106 sites in 2 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

This is a double-blind, placebo-controlled study in adults with non-alcoholic steatohepatitis and Type 2 Diabetes Mellitis on stable dose of metformin monotherapy. Participants will be treated for 16 weeks with placebo or 1 of 2 doses of investigational product to determine the effect on liver fat, HbA1c, safety… Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Non-alcoholic Steatohepatitis
What is being tested?
PF-06835919
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
164 participants
Where
106 sitesin 2 countries
Study dates
18 Jul 2019to 30 Mar 2021
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

  • Males, or females of nonchildbearing potential
  • 18 to 70 years of age
  • Type 2 Diabetes Mellitus
  • Liver fat >/=8% by MRI-PDFF
  • On stable dose of metformin monotherapy for at least 2 months (at a dose of at least 500 mg daily)

Who cannot join

  • History of other liver disease
  • Unable to have an MRI performed
  • Significant weight loss in the previous month and/or participant in current weight loss program
  • History of diabetic complications with end-organ damage

Trial locations and contacts

106 sites in 2 countries.

106 sites in 2 countries

United States86 sites

  • Anaheim Clinical Trials LLC-Clinical Research

    Anaheim, California, 92801

  • Anaheim Clinical Trials, LLC

    Anaheim, California, 92801

  • Independant Imaging

    Atlantis, Florida, 33461

  • Hope Clinical Research

    Canoga Park, California, 91303

  • San Diego Imaging SDI

    Chula Vista, California, 91911

  • CTI Clinical Research Center

    Cincinnati, Ohio, 45212

  • ProScan

    Cincinnati, Ohio, 45227

  • Sharp Coronado Hospital

    Coronado, California, 92118

  • Southern California Research Center

    Coronado, California, 92118

  • Dallas Diabetes and Endocrine Research Center

    Dallas, Texas, 75230

  • Southwest Diagnostics Imaging Center

    Dallas, Texas, 75231

  • Twin Lakes Imaging

    Daytona Beach, Florida, 32117

  • Life Radiology

    Doral, Florida, 33122

  • AA MRC

    Flint, Michigan, 48504

  • Northwell Imaging of Garden City

    Garden City, New York, 11530

  • Horizon Clinical Research Associates, PLLC

    Gilbert, Arizona, 85295

  • MD Clinical LLC

    Hallandale, Florida, 33009

  • Holy Trinity Medical Clinic

    Harbor City, California, 90710

  • Innovative Clinical Research, Inc.

    Harbor City, California, 90710

  • East-West Medical Research Institute

    Honolulu, Hawaii, 96814

  • PrimeCare Medical Group

    Houston, Texas, 77024

  • Endocrine IPS, PLLC

    Houston, Texas, 77079

  • The Endocrine Center

    Houston, Texas, 77079

  • Texas Center for Drug Development

    Houston, Texas, 77081

  • Houston Medical Imaging

    Houston, Texas, 77098

  • ICM Medical Group

    Inglewood, California, 90301

  • Borland Groover

    Jacksonville, Florida, 32256

  • eStudySite

    La Mesa, California, 91942

  • Multi-Specialty Research Associates, Inc.

    Lake City, Florida, 32055

  • Excel Clinical Research

    Las Vegas, Nevada, 89109

  • Alliance for Multispecialty, LLC

    Las Vegas, Nevada, 89119

  • Desert Radiology

    Las Vegas, Nevada, 89128

  • Pueblo Imaging

    Las Vegas, Nevada, 89128

  • Physicians Research Associates , LLC

    Lawrenceville, Georgia, 30046

  • Clinical Trials Research

    Lincoln, California, 95648

  • South Texas Radiology Imaging Centers

    Live Oak, Texas, 78233

  • National Research Institute

    Los Angeles, California, 90057

  • Northwell Health - Center for Liver Diseases and Transplantation

    Manhasset, New York, 11030

  • RAS Health

    Marion, Ohio, 43302

  • Health Care Family Rehab and Research Center

    Miami, Florida, 33015

  • Clinical Research of Miami

    Miami, Florida, 33126

  • Finlay Medical Research

    Miami, Florida, 33126

  • Suncoast Research Group, LLC

    Miami, Florida, 33135

  • Unique Imaging

    Miami, Florida, 33137

  • Y & L Advance Health Care, Inc D/B/A Elite Clinical Research

    Miami, Florida, 33144

  • Stand Up MRI of Miami

    Miami, Florida, 33145

  • Vital Imaging Center

    Miami, Florida, 33173

  • Vital Imaging

    Miami, Florida, 33173

  • Unique Imaging

    Miami, Florida, 33180

  • International Research Associates

    Miami, Florida, 33183

  • Panax Clinical Research

    Miami Lakes, Florida, 33014

  • Renaissance Imaging Medical Associates

    Northridge, California, 91328

  • Nebraska Medicine

    Omaha, Nebraska, 68198

  • University of Nebraska Medical Center

    Omaha, Nebraska, 68198

  • Advanced Gastroenterology Associates, LLC

    Palm Harbor, Florida, 34684

  • Rose Radiology

    Palm Harbor, Florida, 34685

  • Castillo & Torres MD PA

    Palm Springs, Florida, 33406

  • Ctmd Research Inc

    Palm Springs, Florida, 33406

  • Huntington Medical Research Institute

    Pasadena, California, 91105

  • Progressive Medical Research

    Port Orange, Florida, 32127

  • Inland Empire Clinical Trials, LLC

    Rialto, California, 92377

  • Clinical Research Partners, LLC

    Richmond, Virginia, 23236

  • Virginia Endoscopy Group

    Richmond, Virginia, 23236

  • VCU Gateway Building Basement

    Richmond, Virginia, 23298

  • Diagnostic Radiological Imaging Sacramento

    Sacramento, California, 95825

  • Salem VA Medical Center

    Salem, Virginia, 24153

  • Clinical Trials of Texas

    San Antonio, Texas, 78229

  • STRIC Northeast Imaging Center

    San Antonio, Texas, 78233

  • Precision Research Institute

    San Diego, California, 92114

  • Sharp and Children's MRI Center, LLC

    San Diego, California, 92123-2731

  • Sharp & Children's MRI Center, LLC

    San Diego, California, 92123

  • West Coast Radiology

    Santa Ana, California, 92705

  • Northeast Clinical Research of San Antonio, LLC (NECRSA, LLC)

    Schertz, Texas, 78154

  • Harborview Medical Center Investigational Drug Services

    Seattle, Washington, 98104

  • Harborview Medical Center

    Seattle, Washington, 98104

  • University of Washington Medical Center

    Seattle, Washington, 98195

  • Qps-Mra, Llc

    South Miami, Florida, 33143

  • Encompass Clinical Research

    Spring Valley, California, 91978

  • Liberty Pacific Advanced Imaging

    Tarzana, California, 91356

  • Clinical Research Consortium an AMR company

    Tempe, Arizona, 85207

  • Advanced Gastroenterology

    Thousand Oaks, California, 91360

  • University Clinical Investigators, Incorporated

    Tustin, California, 92780

  • Alliance Multispecialty Research, LLC

    Wichita, Kansas, 67207

  • PMG Research of Wilmington

    Wilmington, North Carolina, 28401

  • Gastroenterology Associates of the Piedmont, PA

    Winston-Salem, North Carolina, 27103

  • PMG Research of Winston Salem

    Winston-Salem, North Carolina, 27103

Other trials in United States

Canada20 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 QE II Health Sciences Centre

    Halifax, Nova Scotia, B3H 1V7

  • Nova Scotia Health Authority QE II Health Sciences Centre

    Halifax, Nova Scotia, B3H 2Y9

  • Nova Scotia Health Authority - Queen Elizabeth II Health Sciences Centre

    Halifax, Nova Scotia, B3K 4N1

  • The Western Centre for Functional and Metabolic Mapping

    London, Ontario, N6A 5B7

  • Oxford Medical Imaging

    Mississauga, Ontario, L5R 3K7

  • Clinique de Medecine Urbaine du Quartier Latin

    Montreal, Quebec, H2L 4E9

  • McGill University Health Centre (MUHC)

    Montreal, Quebec, H4A 3J1

  • MRI TTT Philips Radiation Oncology

    Montreal, Quebec, H4A 3J1

  • Radiologie Varad

    Montreal, Quebec, H5B1B2

  • IRM Quebec

    Québec, G1J 0H4

  • Centre de Recherche Saint-Louis

    Québec, G1W4R4

  • ALPHA Recherche Clinique Lebourgneuf

    Québec, G2J 0C4

  • Bluewater Clinical Research Group, Inc.

    Sarnia, Ontario, N7T 4X3

  • St. Michael's Hospital

    Toronto, Ontario, M5B 1W8

  • Toronto Liver Centre

    Toronto, Ontario, M6H 3M1

  • Discovery Clinical Services Ltd.

    Victoria, British Columbia, V8T 5G4

  • West Coast Medical Imaging

    Victoria, British Columbia, V8Z0B9

Other trials in Canada

About this study

Official title: A PHASE 2A, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, 3-ARM, PARALLEL GROUP STUDY TO EVALUATE SAFETY, TOLERABILITY AND PHARMACODYNAMICS OF PF-06835919 ADMINISTERED DAILY FOR 16 WEEKS IN ADULTS WITH NON-ALCOHOLIC FATTY LIVER DISEASE AND TYPE 2 DIABETES MELLITUS ON METFORMIN

This is a double-blind, placebo-controlled study in adults with non-alcoholic steatohepatitis and Type 2 Diabetes Mellitis on stable dose of metformin monotherapy. Participants will be treated for 16 weeks with placebo or 1 of 2 doses of investigational product to determine the effect on liver fat, HbA1c, safety, tolerability and pharmacodynamics.

Being tested
Placebo, PF-06835919
Keywords
Non-alcoholic steatohepatitis; Type 2 Diabetes Mellitus
Medical subject headings
Non-alcoholic Fatty Liver Disease, Diabetes Mellitus, Type 2

What participants receive

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

  • PlaceboDrug

    Placebo

  • PF-06835919Drug

    150 mg once daily

  • PF-06835919Drug

    300 mg once daily

Study groups in NCT03969719
Study groupRoleWhat they receive
PlaceboPlacebo comparatorPalacebo
Receives: Drug: Placebo
Low DoseExperimental150 mg
Receives: Drug: PF-06835919
High DoseExperimental300 mg
Receives: Drug: PF-06835919

What is being measured

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

  1. Percent Change From Baseline in Whole Liver Fat at Week 16

    Whole liver fat was measured by Magnetic Resonance Imaging-Proton Density Fat Fraction (MRI-PDFF).

    Measured: Baseline, Week 16.

  2. Change From Baseline in Hemoglobin A1c (HbA1c) at Week 16

    A sufficient amount of blood was collected for the analysis of plasma HbA1c.

    Measured: Baseline, Week 16.

Secondary outcomes (11)

  1. Number of Participants With Treatment-Emergent Adverse Events (TEAEs)

    An adverse event (AE) was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. A serious AE was any untoward medical occurrence at any dose that resulted in death; was life-threatening; required hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity; resulted in congenital anomaly/birth defect or that was considered to be an important medical event. An AE was considered TEAE if the event occurred during the on-treatment period. The causality of AEs were assessed by the investigator using clinical judgement. A severe AE was an event that prevents normal everyday activities.

    Measured: Up to 21 weeks.

  2. Number of Participants With Hypoglycemia TEAEs

    Hypoglycemic AEs were routinely monitored during participation in the study. Hypoglycemic AE was defined as 1 of the following: 1. Asymptomatic hypoglycemia: an event not accompanied by typical symptoms of hypoglycemic AE but a plasma glucose value of <70 milligram per deciliter (mg/dL) using glucometer; 2. Documented symptomatic hypoglycemia: an event during which typical symptoms of hypoglycemic AEs were accompanied with a glucose value of <70 mg/dL using glucometer and the clinical picture included prompt resolution with food intake, subcutaneous glucagon or intravenous (IV) glucose; 3. Probable symptomatic hypoglycemia: an event during which symptoms of hypoglycemic AEs were not accompanied by a plasma glucose determination but was presumably caused by a plasma glucose concentration of <70 mg/dL, and the clinical picture included prompt resolution with food intake, subcutaneous glucagon, or IV glucose.

    Measured: Up to 21 weeks.

  3. Cumulative Number of Participants With Clinical Laboratory Abnormalities

    Clinical laboratory tests included hematology (hemoglobin, hematocrit, red blood cell count, mean corpuscular volume, mean cell hemoglobin, mean corpuscular hemoglobin concentration, platelet count, white blood cell count, total neutrophils, eosinophils, monocytes, basophils, lymphocytes); blood chemistry (blood urea nitrogen, creatinine, glucose, calcium, sodium, potassium, chloride, total bicarbonate, aspartate aminotransferase, alanine aminotransferase, gamma glutamyl transferase, total bilirubin, alkaline phosphatase, uric acid, albumin, total protein); urinalysis (pH, glucose, protein, blood, ketones, nitrites, leukocyte esterase, urobilinogen, urine bilirubin, microscopy). The abnormality criteria were standard sponsor reporting criteria.

    Measured: Up to 21 weeks.

  4. Number of Participants With Vital Signs Data Meeting Pre-Specified Criteria

    Vital signs data meeting the following criteria were reported: sitting diastolic blood pressure (DBP) <50 mmHg or >= 20 mmHg increase or >= 20 mmHg decrease, sitting systolic blood pressure (SBP) blood pressure <90 mmHg or >=30 mmHg increase or >=30 mmHg decrease.

    Measured: Up to 21 weeks.

  5. Number of Participants With Electrocardiogram (ECG) Data Meeting Pre-Specified Criteria

    ECG data meeting the following criteria were reported: PR interval value >=300 msec, QRS interval percent change >= 50%, QTcF interval value >450 msec and <=480 msec, or change >30 msec and <=60 msec, or change >60 msec.

    Measured: Up to 21 weeks.

  6. Percent Change From Baseline in High-Sensitivity C-Reactive Protein (Hs-CRP) Over 16 Weeks

    Blood samples were collected to ensure sufficient serum for the analysis of hs-CRP.

    Measured: From Baseline to Week 2, Week, 4, Week 8, Week 12 and Week 16.

  7. Change From Baseline in Fasting Insulin Over 16 Weeks

    A sufficient amount of blood was collected for the analysis of plasma insulin. The unit of insulin is milli-international units per liter (mIU/L).

    Measured: From Baseline to Week 2, Week, 4, Week 8, Week 12 and Week 16.

  8. Change From Baseline in Fasting Glucose Over 16 Weeks

    A sufficient amount of blood was collected for the analysis of plasma glucose.

    Measured: From Baseline to Week 2, Week, 4, Week 8, Week 12 and Week 16.

  9. Change From Baseline in Fasting Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) Over 16 Weeks

    HOMA-IR values were derived from fasting plasma insulin and glucose values. Greater reduction from baseline in HOMA-IR scale values shows greater effects on glycemic metabolism.

    Measured: From Baseline to Week 2, Week, 4, Week 8, Week 12 and Week 16.

  10. Percent Change From Baseline in Alanine Aminotransferase (ALT) Over 16 Weeks

    ALT was assessed as one of the clinical laboratory chemistry tests.

    Measured: From Baseline to Week 2, Week, 4, Week 8, Week 12 and Week 16.

  11. Change From Baseline in HbA1c at All Timepoints Other Than Week 16

    A sufficient amount of blood was collected for the analysis of plasma HbA1c.

    Measured: From Baseline to Week 2, Week, 4, Week 8, and Week 12.

Timeline

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

  1. First posted31 May 2019
  2. Study start18 Jul 2019
  3. Primary completion2 Mar 2021
  4. Study completion30 Mar 2021

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
Basic science
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
164 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03969719
Sponsor's protocol ID
C1061011
Other IDs
DOSE RESPONSE IN PATIENTS
Status last verified
Apr 2022
First submitted
28 May 2019
Last updated
11 May 2022
Data monitoring committee
No
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

  • Hong JG, Trotman J, Carbajal Y, Dey P, Glass M, Sclar V, Alter IL, Zhang P, Wang L, Chen L, Petitjean M, Bhattacharya D, Wang S, Friedman SL, DeRossi C, Chu J. Mannose reduces fructose metabolism and reverses MASH in human liver slices and murine models in vivo. Hepatol Commun. 2025 Mar 21;9(4):e0671. doi: 10.1097/HC9.0000000000000671. eCollection 2025 Apr 1.

    PubMed 40116750

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing PF-06835919 in people with Non-alcoholic Steatohepatitis, run by Pfizer at 106 sites in 2 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 5 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 11 May 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 106 sites in United States, Canada. 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 11 May 2022). 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 Whole Liver Fat at Week 16 (time frame: Baseline, Week 16.). The study lists 2 primary outcomes in all. 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 NCT03969719, which also lists 1 linked publication.

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 11 May 2022; AzTrials last refreshed its copy on 6 Nov 2026.

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