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 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
2 other identifiers
interventional
164
2 countries
106
Brief 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, tolerability and pharmacodynamics.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jul 2019
106 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
May 28, 2019
CompletedFirst Posted
Study publicly available on registry
May 31, 2019
CompletedStudy Start
First participant enrolled
July 18, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 2, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
March 30, 2021
CompletedResults Posted
Study results publicly available
May 11, 2022
CompletedMay 11, 2022
April 1, 2022
1.6 years
May 28, 2019
February 24, 2022
April 18, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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).
Baseline, Week 16.
Change From Baseline in Hemoglobin A1c (HbA1c) at Week 16
A sufficient amount of blood was collected for the analysis of plasma HbA1c.
Baseline, Week 16.
Secondary Outcomes (11)
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Up to 21 weeks.
Number of Participants With Hypoglycemia TEAEs
Up to 21 weeks.
Cumulative Number of Participants With Clinical Laboratory Abnormalities
Up to 21 weeks.
Number of Participants With Vital Signs Data Meeting Pre-Specified Criteria
Up to 21 weeks.
Number of Participants With Electrocardiogram (ECG) Data Meeting Pre-Specified Criteria
Up to 21 weeks.
- +6 more secondary outcomes
Study Arms (3)
Placebo
PLACEBO COMPARATORPalacebo
Low Dose
EXPERIMENTAL150 mg
High Dose
EXPERIMENTAL300 mg
Interventions
Eligibility Criteria
You may qualify if:
- Males, or females of nonchildbearing potential
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (106)
Horizon Clinical Research Associates, PLLC
Gilbert, Arizona, 85295, United States
Clinical Research Consortium an AMR company
Tempe, Arizona, 85207, United States
Anaheim Clinical Trials LLC-Clinical Research
Anaheim, California, 92801, United States
Anaheim Clinical Trials, LLC
Anaheim, California, 92801, United States
Hope Clinical Research
Canoga Park, California, 91303, United States
San Diego Imaging SDI
Chula Vista, California, 91911, United States
Sharp Coronado Hospital
Coronado, California, 92118, United States
Southern California Research Center
Coronado, California, 92118, United States
Holy Trinity Medical Clinic
Harbor City, California, 90710, United States
Innovative Clinical Research, Inc.
Harbor City, California, 90710, United States
ICM Medical Group
Inglewood, California, 90301, 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
Renaissance Imaging Medical Associates
Northridge, California, 91328, United States
Huntington Medical Research Institute
Pasadena, California, 91105, United States
Inland Empire Clinical Trials, LLC
Rialto, California, 92377, United States
Diagnostic Radiological Imaging Sacramento
Sacramento, California, 95825, United States
Precision Research Institute
San Diego, California, 92114, United States
Sharp and Children's MRI Center, LLC
San Diego, California, 92123-2731, United States
Sharp & Children's MRI Center, LLC
San Diego, California, 92123, United States
West Coast Radiology
Santa Ana, California, 92705, United States
Encompass Clinical Research
Spring Valley, California, 91978, United States
Liberty Pacific Advanced Imaging
Tarzana, California, 91356, United States
Advanced Gastroenterology
Thousand Oaks, California, 91360, United States
University Clinical Investigators, Incorporated
Tustin, California, 92780, United States
Independant Imaging
Atlantis, Florida, 33461, United States
Twin Lakes Imaging
Daytona Beach, Florida, 32117, United States
Life Radiology
Doral, Florida, 33122, United States
MD Clinical LLC
Hallandale, Florida, 33009, United States
Borland Groover
Jacksonville, Florida, 32256, United States
Multi-Specialty Research Associates, Inc.
Lake City, Florida, 32055, United States
Health Care Family Rehab and Research Center
Miami, Florida, 33015, United States
Clinical Research of Miami
Miami, Florida, 33126, United States
Finlay Medical Research
Miami, Florida, 33126, United States
Suncoast Research Group, LLC
Miami, Florida, 33135, United States
Unique Imaging
Miami, Florida, 33137, United States
Y & L Advance Health Care, Inc D/B/A Elite Clinical Research
Miami, Florida, 33144, United States
Stand Up MRI of Miami
Miami, Florida, 33145, United States
Vital Imaging Center
Miami, Florida, 33173, United States
Vital Imaging
Miami, Florida, 33173, United States
Unique Imaging
Miami, Florida, 33180, United States
International Research Associates
Miami, Florida, 33183, United States
Panax Clinical Research
Miami Lakes, Florida, 33014, United States
Advanced Gastroenterology Associates, LLC
Palm Harbor, Florida, 34684, United States
Rose Radiology
Palm Harbor, Florida, 34685, United States
Castillo & Torres MD PA
Palm Springs, Florida, 33406, United States
Ctmd Research Inc
Palm Springs, Florida, 33406, United States
Progressive Medical Research
Port Orange, Florida, 32127, United States
Qps-Mra, Llc
South Miami, Florida, 33143, United States
Physicians Research Associates , LLC
Lawrenceville, Georgia, 30046, United States
East-West Medical Research Institute
Honolulu, Hawaii, 96814, United States
Alliance Multispecialty Research, LLC
Wichita, Kansas, 67207, United States
AA MRC
Flint, Michigan, 48504, United States
Nebraska Medicine
Omaha, Nebraska, 68198, United States
University of Nebraska Medical Center
Omaha, Nebraska, 68198, United States
Excel Clinical Research
Las Vegas, Nevada, 89109, United States
Alliance for Multispecialty, LLC
Las Vegas, Nevada, 89119, United States
Desert Radiology
Las Vegas, Nevada, 89128, United States
Pueblo Imaging
Las Vegas, Nevada, 89128, United States
Northwell Imaging of Garden City
Garden City, New York, 11530, United States
Northwell Health - Center for Liver Diseases and Transplantation
Manhasset, New York, 11030, United States
PMG Research of Wilmington
Wilmington, North Carolina, 28401, United States
Gastroenterology Associates of the Piedmont, PA
Winston-Salem, North Carolina, 27103, United States
PMG Research of Winston Salem
Winston-Salem, North Carolina, 27103, United States
CTI Clinical Research Center
Cincinnati, Ohio, 45212, United States
ProScan
Cincinnati, Ohio, 45227, United States
RAS Health
Marion, Ohio, 43302, United States
Dallas Diabetes and Endocrine Research Center
Dallas, Texas, 75230, United States
Southwest Diagnostics Imaging Center
Dallas, Texas, 75231, United States
PrimeCare Medical Group
Houston, Texas, 77024, United States
Endocrine IPS, PLLC
Houston, Texas, 77079, United States
The Endocrine Center
Houston, Texas, 77079, United States
Texas Center for Drug Development
Houston, Texas, 77081, United States
Houston Medical Imaging
Houston, Texas, 77098, United States
South Texas Radiology Imaging Centers
Live Oak, Texas, 78233, United States
Clinical Trials of Texas
San Antonio, Texas, 78229, United States
STRIC Northeast Imaging Center
San Antonio, Texas, 78233, United States
Northeast Clinical Research of San Antonio, LLC (NECRSA, LLC)
Schertz, Texas, 78154, United States
Clinical Research Partners, LLC
Richmond, Virginia, 23236, United States
Virginia Endoscopy Group
Richmond, Virginia, 23236, United States
VCU Gateway Building Basement
Richmond, Virginia, 23298, United States
Salem VA Medical Center
Salem, Virginia, 24153, United States
Harborview Medical Center Investigational Drug Services
Seattle, Washington, 98104, United States
Harborview Medical Center
Seattle, Washington, 98104, United States
University of Washington Medical Center
Seattle, Washington, 98195, United States
Discovery Clinical Services Ltd.
Victoria, British Columbia, V8T 5G4, Canada
West Coast Medical Imaging
Victoria, British Columbia, V8Z0B9, Canada
Nova Scotia Health Authority QE II Health Sciences Centre
Halifax, Nova Scotia, B3H 1V7, Canada
Nova Scotia Health Authority QE II Health Sciences Centre
Halifax, Nova Scotia, B3H 2Y9, Canada
Nova Scotia Health Authority - Queen Elizabeth II Health Sciences Centre
Halifax, Nova Scotia, B3K 4N1, Canada
Aggarwal and Associates Limited
Brampton, Ontario, L6T 0G1, Canada
The Western Centre for Functional and Metabolic Mapping
London, Ontario, N6A 5B7, Canada
Oxford Medical Imaging
Mississauga, Ontario, L5R 3K7, Canada
Bluewater Clinical Research Group, Inc.
Sarnia, Ontario, N7T 4X3, Canada
St. Michael's Hospital
Toronto, Ontario, M5B 1W8, Canada
Toronto Liver Centre
Toronto, Ontario, M6H 3M1, Canada
Resonance Magnetique du Saguenay-Lac-Saint-Jean
Chicoutimi, Quebec, G7H 4J1, Canada
Ecogene-21
Chicoutimi, Quebec, G7H 7K9, Canada
Clinique de Medecine Urbaine du Quartier Latin
Montreal, Quebec, H2L 4E9, Canada
McGill University Health Centre (MUHC)
Montreal, Quebec, H4A 3J1, Canada
MRI TTT Philips Radiation Oncology
Montreal, Quebec, H4A 3J1, Canada
Radiologie Varad
Montreal, Quebec, H5B1B2, Canada
IRM Quebec
Québec, G1J 0H4, Canada
Centre de Recherche Saint-Louis
Québec, G1W4R4, Canada
ALPHA Recherche Clinique Lebourgneuf
Québec, G2J 0C4, Canada
Related Links
MeSH Terms
Conditions
Interventions
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
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 28, 2019
First Posted
May 31, 2019
Study Start
July 18, 2019
Primary Completion
March 2, 2021
Study Completion
March 30, 2021
Last Updated
May 11, 2022
Results First Posted
May 11, 2022
Record last verified: 2022-04
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.