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
NCT ID: NCT03969719
Last Updated: 2022-05-11
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
164 participants
INTERVENTIONAL
2019-07-18
2021-03-30
Brief Summary
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A 12-WEEK TITRATE STUDY TO EVALUATE SAFETY, TOLERABILITY AND PHARMACODYNAMICS OF PF-06882961 IN ADULTS WITH TYPE 2 DIABETES MELLITUS AND IN NON-DIABETIC ADULTS WITH OBESITY
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A 12-week Study To Evaluate PF-06291874 Once a Day in Adults With T2DM Inadequately Controlled On Metformin
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
DOUBLE
Study Groups
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Placebo
Palacebo
Placebo
Placebo
Low Dose
150 mg
PF-06835919
150 mg once daily
High Dose
300 mg
PF-06835919
300 mg once daily
Interventions
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Placebo
Placebo
PF-06835919
150 mg once daily
PF-06835919
300 mg once daily
Eligibility Criteria
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Inclusion Criteria
* 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)
Exclusion Criteria
* 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
18 Years
70 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Horizon Clinical Research Associates, PLLC
Gilbert, Arizona, United States
Clinical Research Consortium an AMR company
Tempe, Arizona, United States
Anaheim Clinical Trials LLC-Clinical Research
Anaheim, California, United States
Anaheim Clinical Trials, LLC
Anaheim, California, United States
Hope Clinical Research
Canoga Park, California, United States
San Diego Imaging SDI
Chula Vista, California, United States
Sharp Coronado Hospital
Coronado, California, United States
Southern California Research Center
Coronado, California, United States
Holy Trinity Medical Clinic
Harbor City, California, United States
Innovative Clinical Research, Inc.
Harbor City, California, United States
ICM Medical Group
Inglewood, California, United States
eStudySite
La Mesa, California, United States
Clinical Trials Research
Lincoln, California, United States
National Research Institute
Los Angeles, California, United States
Renaissance Imaging Medical Associates
Northridge, California, United States
Huntington Medical Research Institute
Pasadena, California, United States
Inland Empire Clinical Trials, LLC
Rialto, California, United States
Diagnostic Radiological Imaging Sacramento
Sacramento, California, United States
Precision Research Institute
San Diego, California, United States
Sharp and Children's MRI Center, LLC
San Diego, California, United States
Sharp & Children's MRI Center, LLC
San Diego, California, United States
West Coast Radiology
Santa Ana, California, United States
Encompass Clinical Research
Spring Valley, California, United States
Liberty Pacific Advanced Imaging
Tarzana, California, United States
Advanced Gastroenterology
Thousand Oaks, California, United States
University Clinical Investigators, Incorporated
Tustin, California, United States
Independant Imaging
Atlantis, Florida, United States
Twin Lakes Imaging
Daytona Beach, Florida, United States
Life Radiology
Doral, Florida, United States
MD Clinical LLC
Hallandale, Florida, United States
Borland Groover
Jacksonville, Florida, United States
Multi-Specialty Research Associates, Inc.
Lake City, Florida, United States
Health Care Family Rehab and Research Center
Miami, Florida, United States
Clinical Research of Miami
Miami, Florida, United States
Finlay Medical Research
Miami, Florida, United States
Suncoast Research Group, LLC
Miami, Florida, United States
Unique Imaging
Miami, Florida, United States
Y & L Advance Health Care, Inc D/B/A Elite Clinical Research
Miami, Florida, United States
Stand Up MRI of Miami
Miami, Florida, United States
Vital Imaging Center
Miami, Florida, United States
Vital Imaging
Miami, Florida, United States
Unique Imaging
Miami, Florida, United States
International Research Associates
Miami, Florida, United States
Panax Clinical Research
Miami Lakes, Florida, United States
Advanced Gastroenterology Associates, LLC
Palm Harbor, Florida, United States
Rose Radiology
Palm Harbor, Florida, United States
Castillo & Torres MD PA
Palm Springs, Florida, United States
Ctmd Research Inc
Palm Springs, Florida, United States
Progressive Medical Research
Port Orange, Florida, United States
Qps-Mra, Llc
South Miami, Florida, United States
Physicians Research Associates , LLC
Lawrenceville, Georgia, United States
East-West Medical Research Institute
Honolulu, Hawaii, United States
Alliance Multispecialty Research, LLC
Wichita, Kansas, United States
AA MRC
Flint, Michigan, United States
Nebraska Medicine
Omaha, Nebraska, United States
University of Nebraska Medical Center
Omaha, Nebraska, United States
Excel Clinical Research
Las Vegas, Nevada, United States
Alliance for Multispecialty, LLC
Las Vegas, Nevada, United States
Desert Radiology
Las Vegas, Nevada, United States
Pueblo Imaging
Las Vegas, Nevada, United States
Northwell Imaging of Garden City
Garden City, New York, United States
Northwell Health - Center for Liver Diseases and Transplantation
Manhasset, New York, United States
PMG Research of Wilmington
Wilmington, North Carolina, United States
Gastroenterology Associates of the Piedmont, PA
Winston-Salem, North Carolina, United States
PMG Research of Winston Salem
Winston-Salem, North Carolina, United States
CTI Clinical Research Center
Cincinnati, Ohio, United States
ProScan
Cincinnati, Ohio, United States
RAS Health
Marion, Ohio, United States
Dallas Diabetes and Endocrine Research Center
Dallas, Texas, United States
Southwest Diagnostics Imaging Center
Dallas, Texas, United States
PrimeCare Medical Group
Houston, Texas, United States
Endocrine IPS, PLLC
Houston, Texas, United States
The Endocrine Center
Houston, Texas, United States
Texas Center for Drug Development
Houston, Texas, United States
Houston Medical Imaging
Houston, Texas, United States
South Texas Radiology Imaging Centers
Live Oak, Texas, United States
Clinical Trials of Texas
San Antonio, Texas, United States
STRIC Northeast Imaging Center
San Antonio, Texas, United States
Northeast Clinical Research of San Antonio, LLC (NECRSA, LLC)
Schertz, Texas, United States
Clinical Research Partners, LLC
Richmond, Virginia, United States
Virginia Endoscopy Group
Richmond, Virginia, United States
VCU Gateway Building Basement
Richmond, Virginia, United States
Salem VA Medical Center
Salem, Virginia, United States
Harborview Medical Center Investigational Drug Services
Seattle, Washington, United States
Harborview Medical Center
Seattle, Washington, United States
University of Washington Medical Center
Seattle, Washington, United States
Discovery Clinical Services Ltd.
Victoria, British Columbia, Canada
West Coast Medical Imaging
Victoria, British Columbia, Canada
Nova Scotia Health Authority QE II Health Sciences Centre
Halifax, Nova Scotia, Canada
Nova Scotia Health Authority QE II Health Sciences Centre
Halifax, Nova Scotia, Canada
Nova Scotia Health Authority - Queen Elizabeth II Health Sciences Centre
Halifax, Nova Scotia, Canada
Aggarwal and Associates Limited
Brampton, Ontario, Canada
The Western Centre for Functional and Metabolic Mapping
London, Ontario, Canada
Oxford Medical Imaging
Mississauga, Ontario, Canada
Bluewater Clinical Research Group, Inc.
Sarnia, Ontario, Canada
St. Michael's Hospital
Toronto, Ontario, Canada
Toronto Liver Centre
Toronto, Ontario, Canada
Resonance Magnetique du Saguenay-Lac-Saint-Jean
Chicoutimi, Quebec, Canada
Ecogene-21
Chicoutimi, Quebec, Canada
Clinique de Medecine Urbaine du Quartier Latin
Montreal, Quebec, Canada
McGill University Health Centre (MUHC)
Montreal, Quebec, Canada
MRI TTT Philips Radiation Oncology
Montreal, Quebec, Canada
Radiologie Varad
Montreal, Quebec, Canada
IRM Quebec
Québec, , Canada
Centre de Recherche Saint-Louis
Québec, , Canada
ALPHA Recherche Clinique Lebourgneuf
Québec, , Canada
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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DOSE RESPONSE IN PATIENTS
Identifier Type: OTHER
Identifier Source: secondary_id
C1061011
Identifier Type: -
Identifier Source: org_study_id
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