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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

Primary Purpose

Non-alcoholic Steatohepatitis

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Placebo
PF-06835919
PF-06835919
Sponsored by
Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Non-alcoholic Steatohepatitis focused on measuring Non-alcoholic steatohepatitis; Type 2 Diabetes Mellitus

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Horizon Clinical Research Associates, PLLC
  • Clinical Research Consortium an AMR company
  • Anaheim Clinical Trials LLC-Clinical Research
  • Anaheim Clinical Trials, LLC
  • Hope Clinical Research
  • San Diego Imaging SDI
  • Sharp Coronado Hospital
  • Southern California Research Center
  • Holy Trinity Medical Clinic
  • Innovative Clinical Research, Inc.
  • ICM Medical Group
  • eStudySite
  • Clinical Trials Research
  • National Research Institute
  • Renaissance Imaging Medical Associates
  • Huntington Medical Research Institute
  • Inland Empire Clinical Trials, LLC
  • Diagnostic Radiological Imaging Sacramento
  • Precision Research Institute
  • Sharp and Children's MRI Center, LLC
  • Sharp & Children's MRI Center, LLC
  • West Coast Radiology
  • Encompass Clinical Research
  • Liberty Pacific Advanced Imaging
  • Advanced Gastroenterology
  • University Clinical Investigators, Incorporated
  • Independant Imaging
  • Twin Lakes Imaging
  • Life Radiology
  • MD Clinical LLC
  • Borland Groover
  • Multi-Specialty Research Associates, Inc.
  • Panax Clinical Research
  • Health Care Family Rehab and Research Center
  • Clinical Research of Miami
  • Finlay Medical Research
  • Suncoast Research Group, LLC
  • Unique Imaging
  • Y & L Advance Health Care, Inc D/B/A Elite Clinical Research
  • Stand Up MRI of Miami
  • Vital Imaging Center
  • Vital Imaging
  • Unique Imaging
  • International Research Associates
  • Advanced Gastroenterology Associates, LLC
  • Rose Radiology
  • Castillo & Torres MD PA
  • Ctmd Research Inc
  • Progressive Medical Research
  • Qps-Mra, Llc
  • Physicians Research Associates , LLC
  • East-West Medical Research Institute
  • Alliance Multispecialty Research, LLC
  • AA MRC
  • Nebraska Medicine
  • University of Nebraska Medical Center
  • Excel Clinical Research
  • Alliance for Multispecialty, LLC
  • Desert Radiology
  • Pueblo Imaging
  • Northwell Imaging of Garden City
  • Northwell Health - Center for Liver Diseases and Transplantation
  • PMG Research of Wilmington
  • Gastroenterology Associates of the Piedmont, PA
  • PMG Research of Winston Salem
  • CTI Clinical Research Center
  • ProScan
  • RAS Health
  • Dallas Diabetes and Endocrine Research Center
  • Southwest Diagnostics Imaging Center
  • PrimeCare Medical Group
  • Endocrine IPS, PLLC
  • The Endocrine Center
  • Texas Center for Drug Development
  • Houston Medical Imaging
  • South Texas Radiology Imaging Centers
  • Clinical Trials of Texas
  • STRIC Northeast Imaging Center
  • Northeast Clinical Research of San Antonio, LLC (NECRSA, LLC)
  • Clinical Research Partners, LLC
  • Virginia Endoscopy Group
  • VCU Gateway Building Basement
  • Salem VA Medical Center
  • Harborview Medical Center Investigational Drug Services
  • Harborview Medical Center
  • University of Washington Medical Center
  • Discovery Clinical Services Ltd.
  • West Coast Medical Imaging
  • Nova Scotia Health Authority QE II Health Sciences Centre
  • Nova Scotia Health Authority QE II Health Sciences Centre
  • Nova Scotia Health Authority - Queen Elizabeth II Health Sciences Centre
  • Aggarwal and Associates Limited
  • The Western Centre for Functional and Metabolic Mapping
  • Oxford Medical Imaging
  • Bluewater Clinical Research Group, Inc.
  • St. Michael's Hospital
  • Toronto Liver Centre
  • Resonance Magnetique du Saguenay-Lac-Saint-Jean
  • Ecogene-21
  • Clinique de Medecine Urbaine du Quartier Latin
  • McGill University Health Centre (MUHC)
  • MRI TTT Philips Radiation Oncology
  • Radiologie Varad
  • IRM Quebec
  • Centre de Recherche Saint-Louis
  • ALPHA Recherche Clinique Lebourgneuf

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Experimental

Experimental

Arm Label

Placebo

Low Dose

High Dose

Arm Description

Palacebo

150 mg

300 mg

Outcomes

Primary Outcome Measures

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).
Change From Baseline in Hemoglobin A1c (HbA1c) at Week 16
A sufficient amount of blood was collected for the analysis of plasma HbA1c.

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.
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).
Change From Baseline in Fasting Glucose Over 16 Weeks
A sufficient amount of blood was collected for the analysis of plasma glucose.
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.
Percent Change From Baseline in Alanine Aminotransferase (ALT) Over 16 Weeks
ALT was assessed as one of the clinical laboratory chemistry tests.
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.

Full Information

First Posted
May 28, 2019
Last Updated
April 18, 2022
Sponsor
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT03969719
Brief 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
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

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
July 18, 2019 (Actual)
Primary Completion Date
March 2, 2021 (Actual)
Study Completion Date
March 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-alcoholic Steatohepatitis
Keywords
Non-alcoholic steatohepatitis; Type 2 Diabetes Mellitus

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
164 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Palacebo
Arm Title
Low Dose
Arm Type
Experimental
Arm Description
150 mg
Arm Title
High Dose
Arm Type
Experimental
Arm Description
300 mg
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo
Intervention Type
Drug
Intervention Name(s)
PF-06835919
Intervention Description
150 mg once daily
Intervention Type
Drug
Intervention Name(s)
PF-06835919
Intervention Description
300 mg once daily
Primary Outcome Measure Information:
Title
Percent Change From Baseline in Whole Liver Fat at Week 16
Description
Whole liver fat was measured by Magnetic Resonance Imaging-Proton Density Fat Fraction (MRI-PDFF).
Time Frame
Baseline, Week 16.
Title
Change From Baseline in Hemoglobin A1c (HbA1c) at Week 16
Description
A sufficient amount of blood was collected for the analysis of plasma HbA1c.
Time Frame
Baseline, Week 16.
Secondary Outcome Measure Information:
Title
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Description
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.
Time Frame
Up to 21 weeks.
Title
Number of Participants With Hypoglycemia TEAEs
Description
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.
Time Frame
Up to 21 weeks.
Title
Cumulative Number of Participants With Clinical Laboratory Abnormalities
Description
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.
Time Frame
Up to 21 weeks.
Title
Number of Participants With Vital Signs Data Meeting Pre-Specified Criteria
Description
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.
Time Frame
Up to 21 weeks.
Title
Number of Participants With Electrocardiogram (ECG) Data Meeting Pre-Specified Criteria
Description
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.
Time Frame
Up to 21 weeks.
Title
Percent Change From Baseline in High-Sensitivity C-Reactive Protein (Hs-CRP) Over 16 Weeks
Description
Blood samples were collected to ensure sufficient serum for the analysis of hs-CRP.
Time Frame
From Baseline to Week 2, Week, 4, Week 8, Week 12 and Week 16.
Title
Change From Baseline in Fasting Insulin Over 16 Weeks
Description
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).
Time Frame
From Baseline to Week 2, Week, 4, Week 8, Week 12 and Week 16.
Title
Change From Baseline in Fasting Glucose Over 16 Weeks
Description
A sufficient amount of blood was collected for the analysis of plasma glucose.
Time Frame
From Baseline to Week 2, Week, 4, Week 8, Week 12 and Week 16.
Title
Change From Baseline in Fasting Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) Over 16 Weeks
Description
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.
Time Frame
From Baseline to Week 2, Week, 4, Week 8, Week 12 and Week 16.
Title
Percent Change From Baseline in Alanine Aminotransferase (ALT) Over 16 Weeks
Description
ALT was assessed as one of the clinical laboratory chemistry tests.
Time Frame
From Baseline to Week 2, Week, 4, Week 8, Week 12 and Week 16.
Title
Change From Baseline in HbA1c at All Timepoints Other Than Week 16
Description
A sufficient amount of blood was collected for the analysis of plasma HbA1c.
Time Frame
From Baseline to Week 2, Week, 4, Week 8, and Week 12.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Horizon Clinical Research Associates, PLLC
City
Gilbert
State/Province
Arizona
ZIP/Postal Code
85295
Country
United States
Facility Name
Clinical Research Consortium an AMR company
City
Tempe
State/Province
Arizona
ZIP/Postal Code
85207
Country
United States
Facility Name
Anaheim Clinical Trials LLC-Clinical Research
City
Anaheim
State/Province
California
ZIP/Postal Code
92801
Country
United States
Facility Name
Anaheim Clinical Trials, LLC
City
Anaheim
State/Province
California
ZIP/Postal Code
92801
Country
United States
Facility Name
Hope Clinical Research
City
Canoga Park
State/Province
California
ZIP/Postal Code
91303
Country
United States
Facility Name
San Diego Imaging SDI
City
Chula Vista
State/Province
California
ZIP/Postal Code
91911
Country
United States
Facility Name
Sharp Coronado Hospital
City
Coronado
State/Province
California
ZIP/Postal Code
92118
Country
United States
Facility Name
Southern California Research Center
City
Coronado
State/Province
California
ZIP/Postal Code
92118
Country
United States
Facility Name
Holy Trinity Medical Clinic
City
Harbor City
State/Province
California
ZIP/Postal Code
90710
Country
United States
Facility Name
Innovative Clinical Research, Inc.
City
Harbor City
State/Province
California
ZIP/Postal Code
90710
Country
United States
Facility Name
ICM Medical Group
City
Inglewood
State/Province
California
ZIP/Postal Code
90301
Country
United States
Facility Name
eStudySite
City
La Mesa
State/Province
California
ZIP/Postal Code
91942
Country
United States
Facility Name
Clinical Trials Research
City
Lincoln
State/Province
California
ZIP/Postal Code
95648
Country
United States
Facility Name
National Research Institute
City
Los Angeles
State/Province
California
ZIP/Postal Code
90057
Country
United States
Facility Name
Renaissance Imaging Medical Associates
City
Northridge
State/Province
California
ZIP/Postal Code
91328
Country
United States
Facility Name
Huntington Medical Research Institute
City
Pasadena
State/Province
California
ZIP/Postal Code
91105
Country
United States
Facility Name
Inland Empire Clinical Trials, LLC
City
Rialto
State/Province
California
ZIP/Postal Code
92377
Country
United States
Facility Name
Diagnostic Radiological Imaging Sacramento
City
Sacramento
State/Province
California
ZIP/Postal Code
95825
Country
United States
Facility Name
Precision Research Institute
City
San Diego
State/Province
California
ZIP/Postal Code
92114
Country
United States
Facility Name
Sharp and Children's MRI Center, LLC
City
San Diego
State/Province
California
ZIP/Postal Code
92123-2731
Country
United States
Facility Name
Sharp & Children's MRI Center, LLC
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
West Coast Radiology
City
Santa Ana
State/Province
California
ZIP/Postal Code
92705
Country
United States
Facility Name
Encompass Clinical Research
City
Spring Valley
State/Province
California
ZIP/Postal Code
91978
Country
United States
Facility Name
Liberty Pacific Advanced Imaging
City
Tarzana
State/Province
California
ZIP/Postal Code
91356
Country
United States
Facility Name
Advanced Gastroenterology
City
Thousand Oaks
State/Province
California
ZIP/Postal Code
91360
Country
United States
Facility Name
University Clinical Investigators, Incorporated
City
Tustin
State/Province
California
ZIP/Postal Code
92780
Country
United States
Facility Name
Independant Imaging
City
Atlantis
State/Province
Florida
ZIP/Postal Code
33461
Country
United States
Facility Name
Twin Lakes Imaging
City
Daytona Beach
State/Province
Florida
ZIP/Postal Code
32117
Country
United States
Facility Name
Life Radiology
City
Doral
State/Province
Florida
ZIP/Postal Code
33122
Country
United States
Facility Name
MD Clinical LLC
City
Hallandale Beach
State/Province
Florida
ZIP/Postal Code
33009
Country
United States
Facility Name
Borland Groover
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32256
Country
United States
Facility Name
Multi-Specialty Research Associates, Inc.
City
Lake City
State/Province
Florida
ZIP/Postal Code
32055
Country
United States
Facility Name
Panax Clinical Research
City
Miami Lakes
State/Province
Florida
ZIP/Postal Code
33014
Country
United States
Facility Name
Health Care Family Rehab and Research Center
City
Miami
State/Province
Florida
ZIP/Postal Code
33015
Country
United States
Facility Name
Clinical Research of Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33126
Country
United States
Facility Name
Finlay Medical Research
City
Miami
State/Province
Florida
ZIP/Postal Code
33126
Country
United States
Facility Name
Suncoast Research Group, LLC
City
Miami
State/Province
Florida
ZIP/Postal Code
33135
Country
United States
Facility Name
Unique Imaging
City
Miami
State/Province
Florida
ZIP/Postal Code
33137
Country
United States
Facility Name
Y & L Advance Health Care, Inc D/B/A Elite Clinical Research
City
Miami
State/Province
Florida
ZIP/Postal Code
33144
Country
United States
Facility Name
Stand Up MRI of Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33145
Country
United States
Facility Name
Vital Imaging Center
City
Miami
State/Province
Florida
ZIP/Postal Code
33173
Country
United States
Facility Name
Vital Imaging
City
Miami
State/Province
Florida
ZIP/Postal Code
33173
Country
United States
Facility Name
Unique Imaging
City
Miami
State/Province
Florida
ZIP/Postal Code
33180
Country
United States
Facility Name
International Research Associates
City
Miami
State/Province
Florida
ZIP/Postal Code
33183
Country
United States
Facility Name
Advanced Gastroenterology Associates, LLC
City
Palm Harbor
State/Province
Florida
ZIP/Postal Code
34684
Country
United States
Facility Name
Rose Radiology
City
Palm Harbor
State/Province
Florida
ZIP/Postal Code
34685
Country
United States
Facility Name
Castillo & Torres MD PA
City
Palm Springs
State/Province
Florida
ZIP/Postal Code
33406
Country
United States
Facility Name
Ctmd Research Inc
City
Palm Springs
State/Province
Florida
ZIP/Postal Code
33406
Country
United States
Facility Name
Progressive Medical Research
City
Port Orange
State/Province
Florida
ZIP/Postal Code
32127
Country
United States
Facility Name
Qps-Mra, Llc
City
South Miami
State/Province
Florida
ZIP/Postal Code
33143
Country
United States
Facility Name
Physicians Research Associates , LLC
City
Lawrenceville
State/Province
Georgia
ZIP/Postal Code
30046
Country
United States
Facility Name
East-West Medical Research Institute
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96814
Country
United States
Facility Name
Alliance Multispecialty Research, LLC
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67207
Country
United States
Facility Name
AA MRC
City
Flint
State/Province
Michigan
ZIP/Postal Code
48504
Country
United States
Facility Name
Nebraska Medicine
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68198
Country
United States
Facility Name
University of Nebraska Medical Center
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68198
Country
United States
Facility Name
Excel Clinical Research
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89109
Country
United States
Facility Name
Alliance for Multispecialty, LLC
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89119
Country
United States
Facility Name
Desert Radiology
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89128
Country
United States
Facility Name
Pueblo Imaging
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89128
Country
United States
Facility Name
Northwell Imaging of Garden City
City
Garden City
State/Province
New York
ZIP/Postal Code
11530
Country
United States
Facility Name
Northwell Health - Center for Liver Diseases and Transplantation
City
Manhasset
State/Province
New York
ZIP/Postal Code
11030
Country
United States
Facility Name
PMG Research of Wilmington
City
Wilmington
State/Province
North Carolina
ZIP/Postal Code
28401
Country
United States
Facility Name
Gastroenterology Associates of the Piedmont, PA
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
PMG Research of Winston Salem
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
CTI Clinical Research Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45212
Country
United States
Facility Name
ProScan
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45227
Country
United States
Facility Name
RAS Health
City
Marion
State/Province
Ohio
ZIP/Postal Code
43302
Country
United States
Facility Name
Dallas Diabetes and Endocrine Research Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75230
Country
United States
Facility Name
Southwest Diagnostics Imaging Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
PrimeCare Medical Group
City
Houston
State/Province
Texas
ZIP/Postal Code
77024
Country
United States
Facility Name
Endocrine IPS, PLLC
City
Houston
State/Province
Texas
ZIP/Postal Code
77079
Country
United States
Facility Name
The Endocrine Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77079
Country
United States
Facility Name
Texas Center for Drug Development
City
Houston
State/Province
Texas
ZIP/Postal Code
77081
Country
United States
Facility Name
Houston Medical Imaging
City
Houston
State/Province
Texas
ZIP/Postal Code
77098
Country
United States
Facility Name
South Texas Radiology Imaging Centers
City
Live Oak
State/Province
Texas
ZIP/Postal Code
78233
Country
United States
Facility Name
Clinical Trials of Texas
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
STRIC Northeast Imaging Center
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78233
Country
United States
Facility Name
Northeast Clinical Research of San Antonio, LLC (NECRSA, LLC)
City
Schertz
State/Province
Texas
ZIP/Postal Code
78154
Country
United States
Facility Name
Clinical Research Partners, LLC
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23236
Country
United States
Facility Name
Virginia Endoscopy Group
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23236
Country
United States
Facility Name
VCU Gateway Building Basement
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
Country
United States
Facility Name
Salem VA Medical Center
City
Salem
State/Province
Virginia
ZIP/Postal Code
24153
Country
United States
Facility Name
Harborview Medical Center Investigational Drug Services
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
Facility Name
Harborview Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
Facility Name
University of Washington Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195
Country
United States
Facility Name
Discovery Clinical Services Ltd.
City
Victoria
State/Province
British Columbia
ZIP/Postal Code
V8T 5G4
Country
Canada
Facility Name
West Coast Medical Imaging
City
Victoria
State/Province
British Columbia
ZIP/Postal Code
V8Z0B9
Country
Canada
Facility Name
Nova Scotia Health Authority QE II Health Sciences Centre
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H 1V7
Country
Canada
Facility Name
Nova Scotia Health Authority QE II Health Sciences Centre
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H 2Y9
Country
Canada
Facility Name
Nova Scotia Health Authority - Queen Elizabeth II Health Sciences Centre
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3K 4N1
Country
Canada
Facility Name
Aggarwal and Associates Limited
City
Brampton
State/Province
Ontario
ZIP/Postal Code
L6T 0G1
Country
Canada
Facility Name
The Western Centre for Functional and Metabolic Mapping
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 5B7
Country
Canada
Facility Name
Oxford Medical Imaging
City
Mississauga
State/Province
Ontario
ZIP/Postal Code
L5R 3K7
Country
Canada
Facility Name
Bluewater Clinical Research Group, Inc.
City
Sarnia
State/Province
Ontario
ZIP/Postal Code
N7T 4X3
Country
Canada
Facility Name
St. Michael's Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5B 1W8
Country
Canada
Facility Name
Toronto Liver Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M6H 3M1
Country
Canada
Facility Name
Resonance Magnetique du Saguenay-Lac-Saint-Jean
City
Chicoutimi
State/Province
Quebec
ZIP/Postal Code
G7H 4J1
Country
Canada
Facility Name
Ecogene-21
City
Chicoutimi
State/Province
Quebec
ZIP/Postal Code
G7H 7K9
Country
Canada
Facility Name
Clinique de Medecine Urbaine du Quartier Latin
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2L 4E9
Country
Canada
Facility Name
McGill University Health Centre (MUHC)
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H4A 3J1
Country
Canada
Facility Name
MRI TTT Philips Radiation Oncology
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H4A 3J1
Country
Canada
Facility Name
Radiologie Varad
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H5B1B2
Country
Canada
Facility Name
IRM Quebec
City
Quebec
ZIP/Postal Code
G1J 0H4
Country
Canada
Facility Name
Centre de Recherche Saint-Louis
City
Quebec
ZIP/Postal Code
G1W4R4
Country
Canada
Facility Name
ALPHA Recherche Clinique Lebourgneuf
City
Quebec
ZIP/Postal Code
G2J 0C4
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
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.
IPD Sharing URL
https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests
Links:
URL
https://pmiform.com/clinical-trial-info-request?StudyID=C1061011
Description
To obtain contact information for a study center near you, click here.

Learn more about this trial

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

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