Clinical trial NCT03969719: 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
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Non-alcoholic Steatohepatitis
Keywords: Non-alcoholic steatohepatitis; Type 2 Diabetes Mellitus
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2019-05-31
Enrollment: 164
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: Inclusion Criteria:

* 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)

Exclusion Criteria:

* 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

Primary outcomes:
measure: Percent Change From Baseline in Whole Liver Fat at Week 16
timeFrame: Baseline, Week 16.
measure: Change From Baseline in Hemoglobin A1c (HbA1c) at Week 16
timeFrame: Baseline, Week 16.
Secondary outcomes:
measure: Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
timeFrame: Up to 21 weeks.
measure: Number of Participants With Hypoglycemia TEAEs
timeFrame: Up to 21 weeks.
measure: Cumulative Number of Participants With Clinical Laboratory Abnormalities
timeFrame: Up to 21 weeks.
measure: Number of Participants With Vital Signs Data Meeting Pre-Specified Criteria
timeFrame: Up to 21 weeks.
measure: Number of Participants With Electrocardiogram (ECG) Data Meeting Pre-Specified Criteria
timeFrame: Up to 21 weeks.
measure: Percent Change From Baseline in High-Sensitivity C-Reactive Protein (Hs-CRP) Over 16 Weeks
timeFrame: From Baseline to Week 2, Week, 4, Week 8, Week 12 and Week 16.
measure: Change From Baseline in Fasting Insulin Over 16 Weeks
timeFrame: From Baseline to Week 2, Week, 4, Week 8, Week 12 and Week 16.
measure: Change From Baseline in Fasting Glucose Over 16 Weeks
timeFrame: From Baseline to Week 2, Week, 4, Week 8, Week 12 and Week 16.
measure: Change From Baseline in Fasting Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) Over 16 Weeks
timeFrame: From Baseline to Week 2, Week, 4, Week 8, Week 12 and Week 16.
measure: Percent Change From Baseline in Alanine Aminotransferase (ALT) Over 16 Weeks
timeFrame: From Baseline to Week 2, Week, 4, Week 8, Week 12 and Week 16.
measure: Change From Baseline in HbA1c at All Timepoints Other Than Week 16
timeFrame: From Baseline to Week 2, Week, 4, Week 8, and Week 12.
Other outcomes:
Locations:
city: Gilbert
country: United States
facility: Horizon Clinical Research Associates, PLLC
state: Arizona
city: Tempe
country: United States
facility: Clinical Research Consortium an AMR company
state: Arizona
city: Anaheim
country: United States
facility: Anaheim Clinical Trials LLC-Clinical Research
state: California
city: Anaheim
country: United States
facility: Anaheim Clinical Trials, LLC
state: California
city: Canoga Park
country: United States
facility: Hope Clinical Research
state: California
city: Chula Vista
country: United States
facility: San Diego Imaging SDI
state: California
city: Coronado
country: United States
facility: Sharp Coronado Hospital
state: California
city: Coronado
country: United States
facility: Southern California Research Center
state: California
city: Harbor City
country: United States
facility: Holy Trinity Medical Clinic
state: California
city: Harbor City
country: United States
facility: Innovative Clinical Research, Inc.
state: California
city: Inglewood
country: United States
facility: ICM Medical Group
state: California
city: La Mesa
country: United States
facility: eStudySite
state: California
city: Lincoln
country: United States
facility: Clinical Trials Research
state: California
city: Los Angeles
country: United States
facility: National Research Institute
state: California
city: Northridge
country: United States
facility: Renaissance Imaging Medical Associates
state: California
city: Pasadena
country: United States
facility: Huntington Medical Research Institute
state: California
city: Rialto
country: United States
facility: Inland Empire Clinical Trials, LLC
state: California
city: Sacramento
country: United States
facility: Diagnostic Radiological Imaging Sacramento
state: California
city: San Diego
country: United States
facility: Precision Research Institute
state: California
city: San Diego
country: United States
facility: Sharp and Children's MRI Center, LLC
state: California
city: San Diego
country: United States
facility: Sharp & Children's MRI Center, LLC
state: California
city: Santa Ana
country: United States
facility: West Coast Radiology
state: California
city: Spring Valley
country: United States
facility: Encompass Clinical Research
state: California
city: Tarzana
country: United States
facility: Liberty Pacific Advanced Imaging
state: California
city: Thousand Oaks
country: United States
facility: Advanced Gastroenterology
state: California
city: Tustin
country: United States
facility: University Clinical Investigators, Incorporated
state: California
city: Atlantis
country: United States
facility: Independant Imaging
state: Florida
city: Daytona Beach
country: United States
facility: Twin Lakes Imaging
state: Florida
city: Doral
country: United States
facility: Life Radiology
state: Florida
city: Hallandale Beach
country: United States
facility: MD Clinical LLC
state: Florida
city: Jacksonville
country: United States
facility: Borland Groover
state: Florida
city: Lake City
country: United States
facility: Multi-Specialty Research Associates, Inc.
state: Florida
city: Miami Lakes
country: United States
facility: Panax Clinical Research
state: Florida
city: Miami
country: United States
facility: Health Care Family Rehab and Research Center
state: Florida
city: Miami
country: United States
facility: Clinical Research of Miami
state: Florida
city: Miami
country: United States
facility: Finlay Medical Research
state: Florida
city: Miami
country: United States
facility: Suncoast Research Group, LLC
state: Florida
city: Miami
country: United States
facility: Unique Imaging
state: Florida
city: Miami
country: United States
facility: Y & L Advance Health Care, Inc D/B/A Elite Clinical Research
state: Florida
city: Miami
country: United States
facility: Stand Up MRI of Miami
state: Florida
city: Miami
country: United States
facility: Vital Imaging Center
state: Florida
city: Miami
country: United States
facility: Vital Imaging
state: Florida
city: Miami
country: United States
facility: Unique Imaging
state: Florida
city: Miami
country: United States
facility: International Research Associates
state: Florida
city: Palm Harbor
country: United States
facility: Advanced Gastroenterology Associates, LLC
state: Florida
city: Palm Harbor
country: United States
facility: Rose Radiology
state: Florida
city: Palm Springs
country: United States
facility: Castillo & Torres MD PA
state: Florida
city: Palm Springs
country: United States
facility: Ctmd Research Inc
state: Florida
city: Port Orange
country: United States
facility: Progressive Medical Research
state: Florida
city: South Miami
country: United States
facility: Qps-Mra, Llc
state: Florida
city: Lawrenceville
country: United States
facility: Physicians Research Associates , LLC
state: Georgia
city: Honolulu
country: United States
facility: East-West Medical Research Institute
state: Hawaii
city: Wichita
country: United States
facility: Alliance Multispecialty Research, LLC
state: Kansas
city: Flint
country: United States
facility: AA MRC
state: Michigan
city: Omaha
country: United States
facility: Nebraska Medicine
state: Nebraska
city: Omaha
country: United States
facility: University of Nebraska Medical Center
state: Nebraska
city: Las Vegas
country: United States
facility: Excel Clinical Research
state: Nevada
city: Las Vegas
country: United States
facility: Alliance for Multispecialty, LLC
state: Nevada
city: Las Vegas
country: United States
facility: Desert Radiology
state: Nevada
city: Las Vegas
country: United States
facility: Pueblo Imaging
state: Nevada
city: Garden City
country: United States
facility: Northwell Imaging of Garden City
state: New York
city: Manhasset
country: United States
facility: Northwell Health - Center for Liver Diseases and Transplantation
state: New York
city: Wilmington
country: United States
facility: PMG Research of Wilmington
state: North Carolina
city: Winston-Salem
country: United States
facility: Gastroenterology Associates of the Piedmont, PA
state: North Carolina
city: Winston-Salem
country: United States
facility: PMG Research of Winston Salem
state: North Carolina
city: Cincinnati
country: United States
facility: CTI Clinical Research Center
state: Ohio
city: Cincinnati
country: United States
facility: ProScan
state: Ohio
city: Marion
country: United States
facility: RAS Health
state: Ohio
city: Dallas
country: United States
facility: Dallas Diabetes and Endocrine Research Center
state: Texas
city: Dallas
country: United States
facility: Southwest Diagnostics Imaging Center
state: Texas
city: Houston
country: United States
facility: PrimeCare Medical Group
state: Texas
city: Houston
country: United States
facility: Endocrine IPS, PLLC
state: Texas
city: Houston
country: United States
facility: The Endocrine Center
state: Texas
city: Houston
country: United States
facility: Texas Center for Drug Development
state: Texas
city: Houston
country: United States
facility: Houston Medical Imaging
state: Texas
city: Live Oak
country: United States
facility: South Texas Radiology Imaging Centers
state: Texas
city: San Antonio
country: United States
facility: Clinical Trials of Texas
state: Texas
city: San Antonio
country: United States
facility: STRIC Northeast Imaging Center
state: Texas
city: Schertz
country: United States
facility: Northeast Clinical Research of San Antonio, LLC (NECRSA, LLC)
state: Texas
city: Richmond
country: United States
facility: Clinical Research Partners, LLC
state: Virginia
city: Richmond
country: United States
facility: Virginia Endoscopy Group
state: Virginia
city: Richmond
country: United States
facility: VCU Gateway Building Basement
state: Virginia
city: Salem
country: United States
facility: Salem VA Medical Center
state: Virginia
city: Seattle
country: United States
facility: Harborview Medical Center Investigational Drug Services
state: Washington
city: Seattle
country: United States
facility: Harborview Medical Center
state: Washington
city: Seattle
country: United States
facility: University of Washington Medical Center
state: Washington
city: Victoria
country: Canada
facility: Discovery Clinical Services Ltd.
state: British Columbia
city: Victoria
country: Canada
facility: West Coast Medical Imaging
state: British Columbia
city: Halifax
country: Canada
facility: Nova Scotia Health Authority QE II Health Sciences Centre
state: Nova Scotia
city: Halifax
country: Canada
facility: Nova Scotia Health Authority QE II Health Sciences Centre
state: Nova Scotia
city: Halifax
country: Canada
facility: Nova Scotia Health Authority - Queen Elizabeth II Health Sciences Centre
state: Nova Scotia
city: Brampton
country: Canada
facility: Aggarwal and Associates Limited
state: Ontario
city: London
country: Canada
facility: The Western Centre for Functional and Metabolic Mapping
state: Ontario
city: Mississauga
country: Canada
facility: Oxford Medical Imaging
state: Ontario
city: Sarnia
country: Canada
facility: Bluewater Clinical Research Group, Inc.
state: Ontario
city: Toronto
country: Canada
facility: St. Michael's Hospital
state: Ontario
city: Toronto
country: Canada
facility: Toronto Liver Centre
state: Ontario
city: Chicoutimi
country: Canada
facility: Resonance Magnetique du Saguenay-Lac-Saint-Jean
state: Quebec
city: Chicoutimi
country: Canada
facility: Ecogene-21
state: Quebec
city: Montreal
country: Canada
facility: Clinique de Medecine Urbaine du Quartier Latin
state: Quebec
city: Montreal
country: Canada
facility: McGill University Health Centre (MUHC)
state: Quebec
city: Montreal
country: Canada
facility: MRI TTT Philips Radiation Oncology
state: Quebec
city: Montreal
country: Canada
facility: Radiologie Varad
state: Quebec
city: Quebec
country: Canada
facility: IRM Quebec
city: Quebec
country: Canada
facility: Centre de Recherche Saint-Louis
city: Quebec
country: Canada
facility: ALPHA Recherche Clinique Lebourgneuf
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: