Clinical Trial Details

Trial ID: L0119
Source ID: NCT03969719
Associated Drug: PF-06835919
Title: 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
Acronym: --
Status: Completed
Study Results: No Results Available
Results: --
Conditions: Non-alcoholic Steatohepatitis
Interventions: Drug: Placebo|Drug: PF-06835919
Outcome Measures: Percent change from baseline in whole liver fat at Week 16|Change from baseline in glycosylated hemoglobin (HbA1c) at Week 16|Number of Participants With Treatment Emergent Treatment-Related Adverse Events (AEs)|Number of Participants With Treatment Emergent Treatment-Related Hypoglycemia Adverse Events (HAEs)|Number of Participants With Clinical Laboratory Abnormalities|Change from Baseline in Blood Pressure|Number of Participants With Abnormal Electrocardiogram (ECG)|Percent change from baseline in high-sensitivity C-Reactive Protein (hs-CRP)|Change from baseline in fasting insulin|Change from baseline in fasting glucose|Change from baseline in HOMA-IR|Percent change from baseline in alanine aminotransferse (ALT)|Change from baseline in glycosylated hemoglobin (HbA1c)
Sponsor/Collaborators: Pfizer
Gender: All
Age: 18 Years to 70 Years ?? (Adult, Older Adult)
Phases: Phase 2
Enrollment: 164
Study Type: Interventional
Study Designs: Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Double (Participant, Investigator)|Primary Purpose: Basic Science
Start Date: July 18, 2019
Completion Date: March 30, 2021
Results First Posted: --
Last Update Posted: August 5, 2021
Locations: 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 Beach, Florida, United States|Borland Groover, Jacksonville, Florida, United States|Multi-Specialty Research Associates, Inc., Lake City, Florida, United States|Panax Clinical Research, Miami Lakes, 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|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, 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, Quebec, Canada|Centre de Recherche Saint-Louis, Quebec, Canada|ALPHA Recherche Clinique Lebourgneuf, Quebec, Canada
URL: https://ClinicalTrials.gov/show/NCT03969719

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress
D269 PF-06835919 Chemical drug -- Ketohexokinase inhibitor Enhance lipid metabolism Under clinical trials Details
D182 Insulin Biological drug DB00030 INSR agonist; CPE modulator&product of -- Under clinical trials Details
D199 L-alanine Chemical drug DB00160 KYNU -- Failed in clinical trials Details
D248 Obeticholic Acid Chemical drug DB05990 NR1H4 activator; NR1H4 agonist; FXR agonist Enhance lipid metabolism Approval rejected Details