Metabolic Interventions to Resolve Non-alcoholic Steatohe... | NCT04321031 | Trialant
NCT04321031
Sponsor
Pfizer
Status
Completed
Last Update Posted
Mar 21, 2025Actual
Enrollment
256Actual
Phase
Phase 2
Conditions
Nonalcoholic Fatty Liver Disease
Nonalcoholic Steatohepatitis With Liver Fibrosis
Interventions
Placebo
PF-06865571
PF-05221304
Countries
United States
Bulgaria
Canada
China
Hong Kong
India
Japan
Poland
Puerto Rico
Slovakia
South Korea
Taiwan
Protocol Section
Identification Module
NCT ID
NCT04321031
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
C2541013
Secondary IDs
ID
Type
Description
Link
2019-004775-39
EudraCT Number
Brief Title
Metabolic Interventions to Resolve Non-alcoholic Steatohepatitis (NASH) With Fibrosis (MIRNA)
Official Title
A PHASE 2, RANDOMIZED, DOUBLE-BLIND, DOUBLE-DUMMY, PLACEBO-CONTROLLED, DOSE-RANGING, DOSE-FINDING, PARALLEL GROUP STUDY TO ASSESS EFFICACY AND SAFETY OF PF-06865571 (DGAT2I) ALONE AND WHEN COADMINISTERED WITH PF-05221304 (ACCI) IN ADULT PARTICIPANTS WITH BIOPSY-CONFIRMED NONALCOHOLIC STEATOHEPATITIS AND FIBROSIS STAGE 2 OR 3
Acronym
MIRNA
Organization
PfizerINDUSTRY
Status Module
Record Verification Date
Mar 2025
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Jun 15, 2020Actual
Primary Completion Date
Jan 23, 2024Actual
Completion Date
Feb 21, 2024Actual
First Submitted Date
Mar 23, 2020
First Submission Date that Met QC Criteria
Mar 23, 2020
First Posted Date
Mar 25, 2020Actual
Results Waived
Not provided
Results First Submitted Date
Jan 17, 2025
Results First Submitted that Met QC Criteria
Mar 4, 2025
Results First Posted Date
Mar 21, 2025Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Mar 4, 2025
Last Update Posted Date
Mar 21, 2025Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
PfizerINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
The study aims to evaluate two, orally administered, investigational agents - PF-06865571 (DGAT2 inhibitor) and the coadministration of PF-06865571 with PF-05221304 (ACC inhibitor). This study is specifically designed to evaluate the effect of a range of doses of DGAT2i alone, and DGAT2i + ACCi, on resolution of NASH or improvement in liver fibrosis, as assessed histologically (via liver biopsy).
Detailed Description
Not provided
Conditions Module
Conditions
Nonalcoholic Fatty Liver Disease
Nonalcoholic Steatohepatitis With Liver Fibrosis
Keywords
Not provided
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
256Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Placebo
Placebo Comparator
participants will receive medication for 48 weeks
Drug: Placebo
PF-06865571 25 milligrams (mg) twice daily (BID)
Experimental
participants will receive medication for 48 weeks
Drug: PF-06865571
PF-06865571 75 mg BID
Experimental
participants will receive medication for 48 weeks
Drug: PF-06865571
PF-06865571 150 mg BID
Experimental
participants will receive medication for 48 weeks
Drug: PF-06865571
PF-06865571 300 mg BID
Experimental
participants will receive medication for 48 weeks
Drug: PF-06865571
PF-06865571 (150 mg BID) + PF-05221304 (5 mg BID)
Experimental
participants will receive medication for 48 weeks
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Placebo
Drug
Tablet
Placebo
PF-06865571
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Mean Proportion of Participants Achieving Resolution of NASH Without Worsening/Improvement of Fibrosis by >=1 Stage Without Worsening of NASH/Both Based on Assessment by Sponsor-Identified Central Pathologist at Week 48:Bayesian Dose Response Model (BDRM)
NASH resolution: disappearance of ballooning (Nonalcoholic Fatty Liver Disease [NAFLD] Activity Score [NAS] ballooning score=0;0=no ballooning,1=few balloon cells,2=many cells with prominent ballooning; higher scores(HS)=more disease activity [DA]),residual/no lobular inflammation(NAS lobular inflammation score 0/1,0=no foci,1= <2 foci, 2=2-4 foci,3= >4 foci; HS=more DA),NAS steatosis score 0,1,2,3; 0= <5% hepatocytes involved (HI),1=5-33% HI ,2= 34-66% HI, 3= >66% HI; HS=more DA. No worsening of fibrosis: no change/decrease of at least 1 stage in Brunt-Kleiner scale (BKS) compared to baseline (CTB). Improvement in fibrosis by >=1 stage: decrease of at least 1 stage in BKS CTB. No worsening of NASH: no change/increase in NAS for ballooning, inflammation, steatosis CTB. BDRM utilized to characterize dose response across BID treatment groups, estimate posterior mean proportion (& 90% credible interval [CI], indicated as 'confidence interval' below) for placebo and each BID dose studied.
Week 48
Number of Participants Achieving Resolution of NASH Without Worsening or Improvement in Fibrosis by >= 1 Stage Without Worsening of NASH or Both Based on Assessment by Sponsor-Identified Central Pathologist at Week 48: Logistic Regression Model
Resolution of NASH: disappearance of ballooning (NAS ballooning score= 0; where 0= no ballooning, 1= few balloon cells, 2= many cells with prominent ballooning; higher scores= more disease activity), residual or no lobular inflammation (NAS lobular inflammation score 0 or 1, where 0= no foci, 1= <2 foci, 2= 2-4 foci, 3= >4 foci; higher scores= more disease activity), NAS steatosis score 0, 1, 2, or 3, where 0= <5% hepatocytes involved, 1= 5-33% hepatocytes involved, 2= 34-66% hepatocytes involved, 3= >66% hepatocytes involved; higher scores= more disease activity. No worsening of fibrosis: no change or decrease of at least 1 stage in BKS compared to baseline. Improvement in fibrosis by >=1 stage: decrease of at least 1 stage in BKS compared to baseline. No worsening of NASH: no change or increase in NAS for ballooning, inflammation, steatosis compared to baseline.
Week 48
Secondary Outcomes
Measure
Description
Time Frame
Percent Change From Baseline in Liver Fat at Week 48: Bayesian Dose Response Model
Magnetic resonance imaging proton density fat fraction (MRI-PDFF) is an established method that enables quantification of fat content in the liver.
Baseline, Week 48
Percent Change From Baseline in Liver Fat at Week 48: Pairwise Comparisons With Analysis of Covariance (ANCOVA)
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Biopsy proven NASH with either F2 or F3 fibrosis, per NASH CRN definition
BMI >/= 22.5kg/m2
Exclusion Criteria:
Evidence of other causes of liver disease such as Alcoholic steatohepatitis, (de)compensated cirrhosis, active viral hepatitis
Any condition possibly affecting drug absorption -Unstable concomitant medical conditions, based on medical history or screening laboratory results including-
unstable liver function tests, recent cardiovascular event(s) significant malignancies,
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
75 Years
Standard Ages
AdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
Pfizer CT.gov Call Center
Pfizer
Study Director
Locations
Facility
Status
City
State
ZIP
Country
Contacts
Institute for Liver Health dba Arizona Liver Health
Wong VW, Amin NB, Takahashi H, Darekar A, Tacke F, Kiszko J, Rodriguez H, Nakajima A, Alkhouri N, Charlton M, Anstee QM. Efficacy and safety of ervogastat alone and in combination with clesacostat in patients with biopsy-confirmed metabolic dysfunction-associated steatohepatitis and F2-F3 fibrosis (MIRNA): results from a phase 2, randomised, double-blind, double-dummy study. Lancet Gastroenterol Hepatol. 2025 Oct;10(10):924-940. doi: 10.1016/S2468-1253(25)00128-1. Epub 2025 Jul 31.
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.
F2: significant stage of fibrosis when scarring had occurred and extended outside liver area and F3: severe stage of fibrosis with spreading and forming bridges with other fibrotic liver areas.
Recruitment Details
A total of 256 participants with biopsy confirmed Non-alcoholic Steatohepatitis (NASH) with fibrosis state (F2-F3) were randomized, of which 255 were treated.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Placebo
Participants were randomized to receive 2 tablets of diacylglycerol acyltransferase 2 inhibitor (PF-06865571/DGAT2i) matching placebo and 1 tablet of acetyl-CoA carboxylase inhibitor (PF-05221304/ACCi) matching placebo twice a day (BID) for 48 weeks by oral administration. Participants were followed up to 52 weeks.
MRI-PDFF is an established method that enables quantification of fat content in the liver.
Baseline, Week 48
Mean Proportion of Participants Achieving Resolution of NASH, Without Worsening of Fibrosis Based on Assessment by Sponsor-Identified Central Pathologist(s) at Week 48: Bayesian Dose Response Model
Resolution of NASH: disappearance of ballooning (NAS ballooning score= 0; where 0= no ballooning, 1= few balloon cells, 2= many cells with prominent ballooning; higher scores= more disease activity), residual or no lobular inflammation (NAS lobular inflammation score 0 or 1, where 0= no foci, 1= <2 foci, 2= 2-4 foci, 3= >4 foci; higher scores= more disease activity), NAS steatosis score 0, 1, 2 or 3, where 0= <5% HI, 1= 5-33% HI, 2= 34-66% HI, 3= >66% HI; higher scores= more disease activity. No worsening of fibrosis: no change or decrease of at least 1 stage in BKS compared to baseline. BKS: scaling for fibrosis (0= none, 1= perisinusoidal/ periportal, 2= perisinusoidal, portal/ periportal, 3= bridging, 4= cirrhosis; higher scores= more disease activity). BDRM utilized to characterize dose response across BID treatment groups, estimate posterior mean proportion (& 90% credible interval [CI], indicated as 'confidence interval' below) for placebo and each BID dose studied.
Week 48
Number of Participants Achieving Resolution of NASH, Without Worsening of Fibrosis Based on Assessment by Sponsor-Identified Central Pathologist(s) at Week 48: Pairwise Comparisons With Logistic Regression Model
Resolution of NASH: disappearance of ballooning (NAS ballooning score= 0; where 0= no ballooning, 1= few balloon cells, 2= many cells with prominent ballooning; higher scores= more disease activity), residual or no lobular inflammation (NAS lobular inflammation score 0 or 1, where 0= no foci, 1= <2 foci, 2= 2-4 foci, 3= >4 foci; higher scores= more disease activity), NAS steatosis score 0, 1, 2 or 3, where 0= <5% hepatocytes involved, 1= 5-33% hepatocytes involved, 2= 34-66% hepatocytes involved, 3= >66% hepatocytes involved; higher scores= more disease activity. No worsening of fibrosis: no change or decrease of at least 1 stage in Brunt-Kleiner scale compared to baseline. Brunt-Kleiner scale included scaling for fibrosis (0= none, 1= perisinusoidal/ periportal, 2= perisinusoidal, portal/ periportal, 3= bridging, 4= cirrhosis; higher scores = more disease activity). Logistic Regression model included treatment and baseline fibrosis stage (F2/F3) as factors.
Week 48
Mean Proportion of Participants Achieving Improvement in Fibrosis by >=1 Stage, Without Worsening of NASH Based on Assessment by Sponsor-Identified Central Pathologist(s) at Week 48: Bayesian Dose Response Model
Improvement in fibrosis by >=1 stage: decrease of at least 1 stage in Brunt-Kleiner scale compared to baseline. No worsening of fibrosis: no change or decrease of at least 1 stage in Brunt-Kleiner scale compared to baseline. Brunt-Kleiner scale included scaling for fibrosis (0= none, 1= perisinusoidal/ periportal, 2= perisinusoidal, portal/ periportal, 3= bridging, 4= cirrhosis; higher scores = more disease activity). BDRM utilized to characterize dose response across BID treatment groups, estimate posterior mean proportion (& 90% credible interval [CI], indicated as 'confidence interval' below) for placebo and each BID dose studied.
Week 48
Number of Participants Achieving Improvement in Fibrosis by >=1 Stage, Without Worsening of NASH Based on Assessment by Sponsor-Identified Central Pathologist(s) at Week 48: Pairwise Comparisons With Logistic Regression Model
Improvement in fibrosis by >=1 stage: decrease of at least 1 stage in Brunt-Kleiner scale compared to baseline. No worsening of fibrosis: no change/decrease of at least 1 stage in Brunt-Kleiner scale compared to baseline. Brunt-Kleiner scale included scaling for fibrosis (0= none, 1= perisinusoidal/ periportal, 2= perisinusoidal, portal/ periportal, 3= bridging, 4= cirrhosis; higher scores = more DA). Logistic Regression model included treatment and baseline fibrosis stage (F2/F3) as factors.
Week 48
Mean Proportion of Participants Achieving Improvement in Fibrosis by >=2 Stage, Without Worsening of NASH Based on Assessment by Sponsor-Identified Central Pathologist(s) at Week 48: Bayesian Dose Response Model
Improvement in fibrosis by >=2 stage: decrease of at least 2 points in total NAS compared to baseline, without progression of fibrosis. No worsening of NASH: no change or no increase in NAS for ballooning (NAS ballooning score= 0; where 0= no ballooning, 1= few balloon cells, 2= many cells with prominent ballooning; higher scores= more disease activity), inflammation (NAS lobular inflammation score 0 or 1, where 0= no foci, 1= <2 foci, 2= 2-4 foci, 3= >4 foci; higher scores= more disease activity), steatosis (NAS steatosis score 0, 1, 2, or 3, where 0= <5% hepatocytes involved, 1= 5-33% hepatocytes involved, 2= 34-66% hepatocytes involved, 3= >66% hepatocytes involved; higher scores=more disease activity) compared to baseline. BDRM utilized to characterize dose response across BID treatment groups, estimate posterior mean proportion (& 90% credible interval [CI], indicated as 'confidence interval' below) for placebo and each BID dose studied.
Week 48
Number of Participants Achieving Improvement in Fibrosis by >=2 Stage, Without Worsening of NASH Based on Assessment by Sponsor-Identified Central Pathologist(s) at Week 48: Pairwise Comparisons With Logistic Regression Model
Improvement in fibrosis by >=2 stage: decrease of at least 2 points in total NAS compared to baseline, without progression of fibrosis. No worsening of NASH: no change or no increase in NAS for ballooning (NAS ballooning score= 0; where 0= no ballooning, 1= few balloon cells, 2= many cells with prominent ballooning; higher scores= more disease activity), inflammation (NAS lobular inflammation score 0 or 1, where 0= no foci, 1= <2 foci, 2= 2-4 foci, 3= >4 foci; higher scores= more disease activity), steatosis (NAS steatosis score 0, 1, 2 or 3, where 0= <5% hepatocytes involved, 1= 5-33% hepatocytes involved, 2= 34-66% hepatocytes involved, 3= >66% hepatocytes involved; higher scores= more disease activity) compared to baseline. Logistic Regression model included treatment and baseline fibrosis stage (F2/F3) as factors.
Week 48
Mean Proportion of Participants Achieving Improvement of >=2 Points in Total NAS, Without Progression of Fibrosis Based on Assessment by Sponsor-Identified Central Pathologist(s) at Week 48: Bayesian Dose Response Model
Improvement of >=2 points in Total NAS: decrease of at least 2 points in Total NAS compared to baseline, without progression of fibrosis. Total NAS ranged 0 to 8, higher scores= more disease activity and calculated as sum of scores of steatosis (0= <5% hepatocytes involved, 1=5-33% hepatocytes involved, 2=34-66% hepatocytes involved, 3= >66% hepatocytes involved; higher scores= more disease activity), lobular inflammation (0= no foci, 1= <2 foci, 2= 2-4 foci, 3= >4 foci; higher scores= more disease activity), ballooning (0= no ballooning, 1= few balloon cells, 2= many cells with prominent ballooning; higher scores= more disease activity). If sub-scale scores non evaluable or missing, total score was derived as missing. BDRM utilized to characterize dose response across BID treatment groups, estimate posterior mean proportion (& 90% credible interval [CI], indicated as 'confidence interval' below) for placebo and each BID dose studied.
Week 48
Number of Participants Achieving Improvement of >=2 Points in Total NAS Without Progression of Fibrosis Based on Assessment by Sponsor-Identified Central Pathologist(s) at Week 48: Pairwise Comparisons With Logistic Regression Model
Improvement of >=2 points in Total NAS: decrease of at least 2 points in Total NAS compared to baseline, without progression of fibrosis. Total NAS ranged from 0 to 8, higher scores= more DA and calculated as sum of scores of steatosis (0= <5% hepatocytes involved, 1= 5-33% hepatocytes involved, 2= 34-66% hepatocytes involved, 3= >66% hepatocytes involved; higher scores= more DA), lobular inflammation (0= no foci, 1= <2 foci, 2= 2-4 foci, 3= >4 foci; higher scores= more DA), ballooning (0= no ballooning, 1= few balloon cells, 2= many cells with prominent ballooning; higher scores= more DA). If any of the sub-scale scores were non evaluable/missing, then the total score was derived as missing. Logistic Regression model included treatment and baseline fibrosis stage (F2/F3) as factors.
Week 48
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
An adverse event (AE) was any untoward medical occurrence in a participant/ clinical investigational participant administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Serious adverse events (SAE) was any untoward medical occurrence at any dose that: resulted in death, was life threatening (risk of death), required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions), resulted in congenital anomaly/birth defect. AEs included both serious and all non-serious AEs. TEAEs were defined as newly occurring or worsening AE after the first dose of study drug.
From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Number of Participants With Laboratory Test Abnormalities
From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Number of Participants With Clinically Significant Abnormalities in Vital Signs
Number of participants with clinically significant vital signs were reported in this outcome measure. Vital signs included blood pressure, and heart rate. Clinical significance in vital signs abnormalities was judged by investigator.
From first dose of study drug (Day 1) upto Week 48 (maximum up to approximately 50 weeks)
Number of Participants With Clinically Significant Abnormalities in Electrocardiograms (ECG) Parameters
Number of participants with clinically significant ECG abnormalities were reported in this outcome measure. ECG parameters included heart rate, PR interval, QRS interval and QTcF interval.
From first dose of study drug (Day 1) upto Week 48 (maximum up to approximately 50 weeks)
Gilbert
Arizona
85233
United States
The Institute for Liver Health
Glendale
Arizona
85306
United States
The Institute for Liver Health
Peoria
Arizona
85381
United States
Comprehensive Interventional Care Centers (CICC)
Sun City
Arizona
85351
United States
Institute for Liver Health DBA Arizona Liver Health
Tucson
Arizona
85712
United States
Hope Clinical Research
Canoga Park
California
91303
United States
Sharp Coronado Hospital
Coronado
California
92118
United States
Southern California Research Center
Coronado
California
92118
United States
Magnolia Surgery Center
El Cajon
California
92020
United States
Encino Hospital Medical Center
Encino
California
91436
United States
National Research Institute
Huntington Park
California
90255
United States
Investigational Drug Service, Altman Clinical and Translational Research Institute (ACTRI)
La Jolla
California
92037
United States
University of California San Diego, Altman Clinical and Translational Research Institute Clinic
La Jolla
California
92037
United States
UCSD Altman Clinical and Transitional Research Institute
La Jolla
California
92093
United States
A V Pediatrics, Allergy & Family Medicine
Lancaster
California
93534
United States
Jatinder S. Pruthi, M.D. FACG CPI
Lancaster
California
93534
United States
Om Research LLC
Lancaster
California
93534
United States
Kaiser Permanente Los Angeles Medical Center
Los Angeles
California
90027
United States
Cedars-Sinai Advanced Health Sciences Pavilion (Imaging)
Los Angeles
California
90048
United States
Cedars-Sinai Comprehensive Transplant Center
Los Angeles
California
90048
United States
Cedars-Sinai Medical Center Investigational Drug Services (Pharmacy)
Los Angeles
California
90048
United States
S. Mark Taper Foundation Imaging Center (Liver Biopsy)
Los Angeles
California
90048
United States
Providence Facey Medical Foundation
Mission Hills
California
91345
United States
Providence Holy Cross Medical Center
Mission Hills
California
91345
United States
ART Vascular
Montebello
California
90640
United States
United Medical Doctors
Murrieta
California
92563
United States
Back Bay Imaging (Liver Biopsy)
Newport Beach
California
92660
United States
Advanced Imaging Center
Palmdale
California
93551
United States
Blake Wilbur Outpatient Clinic (MRI)
Palo Alto
California
94304
United States
Stanford Hospital and Clinics
Palo Alto
California
94305
United States
California Liver Research Institute
Pasadena
California
91105
United States
HMRI
Pasadena
California
91105
United States
Stanford Medicine Outpatient Center (Liver clinic/MRI)
Redwood City
California
94063
United States
Inland Empire Clinical Trials, LLC
Rialto
California
92377
United States
Clinical Trials Research
Sacramento
California
95821
United States
Precision Research Institute
San Diego
California
92114
United States
WR-MCCR
San Diego
California
92120
United States
Sharp and Children's MRI Center, LLC
San Diego
California
92123
United States
Stanford Cancer Center South Bay (MRI)
San Jose
California
95124
United States
Liberty Pacific Advanced Imaging
Tarzana
California
91356
United States
Orange County Research Center
Tustin
California
92780
United States
Upland Clinical Research
Upland
California
91786
United States
Bristol Hospital
Bristol
Connecticut
06010
United States
Bristol Radiology Center
Bristol
Connecticut
06010
United States
Connecticut Clinical Research Institute, LLC
Bristol
Connecticut
06010
United States
Yale New Haven Hospital
New Haven
Connecticut
06510
United States
Yale New Haven Hospital, Saint Raphael Campus (MRE location)
New Haven
Connecticut
06511
United States
Yale Center for Clinical Investigators, Church Street South Research Unit (CSRU)
New Haven
Connecticut
06519
United States
Yale Digestive Diseases (Fibroscan location)
New Haven
Connecticut
06520
United States
Tower Radiology (MRI-PDFF)
Brandon
Florida
33511
United States
Tower Radiology - Parsons
Brandon
Florida
33511
United States
Gastro Florida
Clearwater
Florida
33756
United States
Gastro Florida
Clearwater
Florida
33762
United States
Integrity Clinical Research, LLC
Doral
Florida
33122
United States
Mayo Clinic Florida
Jacksonville
Florida
32224
United States
Florida Research Institute
Lakewood Rch
Florida
34211
United States
Center for Advanced Gastroenterology
Maitland
Florida
32751
United States
Sandlake Imaging
Maitland
Florida
32751
United States
Optimus U Corporation
Miami
Florida
33125
United States
Unique Imaging (Biscayne Imaging Center)
Miami
Florida
33137
United States
Acevedo Clinical Research Associates
Miami
Florida
33142
United States
Ivetmar Medical Group LLC
Miami
Florida
33155
United States
Vascular and Interventional Specialists of Florida (Liver Biopsy)
Miami
Florida
33156
United States
Care Research Center Inc
Miami
Florida
33175
United States
San Marcus Research Clinic, Inc.
Miami Lakes
Florida
33014
United States
TGH Imaging Powered by Tower Radiology Center (MRI)
Oldsmar
Florida
34677
United States
Clinical Neuroscience Solutions, Inc
Orlando
Florida
32801
United States
Omega Research Maitland, LLC
Orlando
Florida
32808
United States
Innovation Medical Research Center, Inc
Palmetto Bay
Florida
33157
United States
Partners Imaging Center
Sarasota
Florida
34239
United States
GCP, Global Clinical Professionals
St. Petersburg
Florida
33702
United States
Gateway (Ultrasound)
St. Petersburg
Florida
33712
United States
Radiology Associates
Tampa
Florida
33606
United States
ForCare Clinical Research
Tampa
Florida
33613
United States
AdventHealth Zephyrhills
Zephyrhills
Florida
33541
United States
Florida Medical Clinic, LLC
Zephyrhills
Florida
33542
United States
Digestive Healthcare of Georgia
Atlanta
Georgia
30309
United States
Piedmont Atlanta Hospital/Piedmont Transplant Institute
Atlanta
Georgia
30309
United States
Piedmont Atlanta Hospital
Atlanta
Georgia
30309
United States
Columbus Regional Research Institute
Columbus
Georgia
31904
United States
WR-Mount Vernon Clinical Research, LLC
Sandy Springs
Georgia
30328
United States
Tekton Research, Inc.
Snellville
Georgia
30078
United States
Rush University Medical Center
Chicago
Illinois
60612
United States
Investigators Research Group, LLC
Brownsburg
Indiana
46112
United States
Hendricks Regional Health
Hendricks
Indiana
46122
United States
Heartland Medical Research, Inc. (Administrative Only)
Clive
Iowa
50325
United States
Iowa Digestive Disease Center
Clive
Iowa
50325
United States
Iowa Radiology
Clive
Iowa
50325
United States
MercyOne Des Moines Medical Center (Mercy Medical Center)
Des Moines
Iowa
50314
United States
University of Iowa Hospitals and Clinics
Iowa City
Iowa
52242
United States
University of Iowa Magnetic Resonance Research Facility
Iowa City
Iowa
52242
United States
Kansas Medical Clinic PA
Topeka
Kansas
66606
United States
Alliance for Multispecialty Research, LLC
Wichita
Kansas
67205
United States
Cypress Interventional
Wichita
Kansas
67226
United States
Centex Studies, Inc.
Lake Charles
Louisiana
70601
United States
Lake Charles Memorial Hospital
Lake Charles
Louisiana
70601
United States
Metropolitan Gastroenterology Associates
Marrero
Louisiana
70072
United States
Tandem Clinical Research GI, LLC
Marrero
Louisiana
70072
United States
Ochsner Clinic Foundation
New Orleans
Louisiana
70121
United States
Louisiana Research Center, LLC
Shreveport
Louisiana
71105
United States
Gastro Health Research
Catonsville
Maryland
21228
United States
Gastro Center of Maryland
Columbia
Maryland
21045
United States
Beth Israel Deaconess Medical Center
Boston
Massachusetts
02215
United States
Michigan Clinical Research Unit (MCRU)
Ann Arbor
Michigan
48109
United States
University of Michigan
Ann Arbor
Michigan
48109
United States
Henry Ford Health System
Detroit
Michigan
48202
United States
Aa Mrc Llc
Flint
Michigan
48504
United States
Mercy Health
Grand Rapids
Michigan
49503
United States
M1 Imaging Center
Grand Rapids
Michigan
49505
United States
Gastroenterology Associates of Western Michigan, PLC d.b.a. West Michigan Clinical Research Center
Wyoming
Michigan
49519
United States
Mayo Clinic
Rochester
Minnesota
55905
United States
Jefferson City Medical Group, P.C.
Jefferson City
Missouri
65109
United States
Desert Radiology
Las Vegas
Nevada
89104
United States
Machuca Family Medicine
Las Vegas
Nevada
89104
United States
The Machuca Foundation, Inc.
Las Vegas
Nevada
89104
United States
Sierra Clinical Research
Las Vegas
Nevada
89106
United States
Las Vegas Medical Research
Las Vegas
Nevada
89113
United States
Pueblo Medical Imaging
Las Vegas
Nevada
89118
United States
Digestive Healthcare Associates
Hillsborough
New Jersey
08844
United States
University Radiology
Hillsborough
New Jersey
08844
United States
Amici Clinical Research
Raritan
New Jersey
08869
United States
Northwell Health Center for Liver Diseases
Manhasset
New York
11030
United States
Icahn School of Medicine at Mount Sinai/The Mount Sinai Hospital
New York
New York
10029
United States
M3 - Wake Research, Inc.
Raleigh
North Carolina
27612
United States
Gastroenterology Associates of the Piedmont, PA
Winston-Salem
North Carolina
27103
United States
Novant Health Medical Center
Winston-Salem
North Carolina
27103
United States
PMG Research of Winston-Salem, LLC
Winston-Salem
North Carolina
27103
United States
Paramount Medical Research & Consulting, LLC
Middleburg Heights
Ohio
44130
United States
Comprehensive Diagnostic Imaging
Oklahoma City
Oklahoma
73112
United States
Digestive Disease Specialists, Inc. Endoscopy Lab
Oklahoma City
Oklahoma
73112
United States
Digestive Disease Specialists, Inc.
Oklahoma City
Oklahoma
73112
United States
Oklahoma Spine Hospital
Oklahoma City
Oklahoma
73134
United States
Thomas Jefferson University
Philadelphia
Pennsylvania
19107
United States
UPMC - Center for Liver Diseases at the Thomas E. Starzl Institute
Pittsburgh
Pennsylvania
15213
United States
UPMC - Center for Liver Diseases in the Digestive Disorders Clinic
Vanderbilt University Medical Center - GI Research Office
Nashville
Tennessee
37212
United States
Vanderbilt University Medical Center - Digestive Disease Center
Nashville
Tennessee
37232
United States
Vanderbilt University Medical Center - Heart Station
Nashville
Tennessee
37232
United States
Vanderbilt University Medical Center - Interventional Radiology
Nashville
Tennessee
37232
United States
Texas Center for Interventional Surgery (Liver Biopsy Facility)
Addison
Texas
75001
United States
Texas Clinical Research Institute
Arlington
Texas
76012
United States
Methodist Dallas Medical Center (MRI-PDFF)
Dallas
Texas
75203
United States
The Liver Institute at Methodist Dallas Medical Center
Dallas
Texas
75203
United States
Touchstone Imaging
Dallas
Texas
75246
United States
Center For Diagnostic Imaging
DeSoto
Texas
75115
United States
GI Alliance
Fort Worth
Texas
76104
United States
Therapeutic Concepts, PA
Houston
Texas
77004
United States
Centex Studies, Inc.
Houston
Texas
77058
United States
Biopharma Informatic, LLC
Houston
Texas
77084
United States
Premier Vein and Vascular
Houston
Texas
77084
United States
Centex Studies, Inc
McAllen
Texas
78504
United States
HCA Houston Healthcare Pearland
Pearland
Texas
77584
United States
American Research Corporation at the Texas Liver Institute
San Antonio
Texas
78215
United States
Clinical Trials of Texas, Inc.
San Antonio
Texas
78229
United States
Diabetes and Glandular Disease Clinic, P.A.
San Antonio
Texas
78229
United States
Reddy Cardiac Wellness
Sugar Land
Texas
77479
United States
Impact Research Institute
Waco
Texas
76710
United States
Gastro Health Research
Fairfax
Virginia
22031
United States
Gastro Health, LLC
Fairfax
Virginia
22031
United States
Manassas Clinical Research Center
Manassas
Virginia
20110
United States
Digestive and Liver Disease Specialists
Norfolk
Virginia
23502
United States
Sentara Leigh Hospital
Norfolk
Virginia
23502
United States
McGuire VA Medical Center
Richmond
Virginia
23249
United States
VCU Medical Center Investigational Drug Service
Richmond
Virginia
23298
United States
Virginia Commonwealth University
Richmond
Virginia
23298
United States
Virginia Gastroenterology Clinical Research
Suffolk
Virginia
23435
United States
Harborview Medical Center Investigational Drug Services
Seattle
Washington
98104
United States
Harborview Medical Center
Seattle
Washington
98104
United States
Seattle Radiology
Seattle
Washington
98104
United States
Liver Institute Northwest
Seattle
Washington
98105
United States
Swedish Medical Center
Seattle
Washington
98122
United States
University of Washington Medical Center
Seattle
Washington
98195
United States
MHAT Dr. Tota Venkova AD
Gabrovo
5300
Bulgaria
MHAT Medline Clinic AD
Plovdiv
4002
Bulgaria
Acibadem City Clinic MHAT Tokuda EAD
Sofia
1407
Bulgaria
DCC Alexandrovska EOOD
Sofia
1431
Bulgaria
UMHAT Sv. Ivan Rilski EAD
Sofia
1431
Bulgaria
UMHAT Sofiamed OOD
Sofia
1797
Bulgaria
MC New Rehabilitation Center EOOD
Stara Zagora
6001
Bulgaria
DCC Mladost-M Varna OOD
Varna
9020
Bulgaria
MC Leo Clinic EOOD
Varna
9020
Bulgaria
University of Calgary - Heritage Medical Research Clinic (HMRC)
Calgary
Alberta
T2N 4Z6
Canada
University of Alberta Hospital
Edmonton
Alberta
T6G 2B7
Canada
University of Alberta
Edmonton
Alberta
T6G 2X8
Canada
Gordon and Leslie Diamond Health Care Centre
Vancouver
British Columbia
V5Z 1M9
Canada
(G.I.R.I.) GI Research Institute
Vancouver
British Columbia
V6Z 2K5
Canada
Nova Scotia Health Authority QEII (Queen Elizabeth II) Health Sciences Centre
Halifax
Nova Scotia
B3H 1V7
Canada
Manna Research (London)
London
Ontario
N6A 2C2
Canada
Toronto Liver Centre
Toronto
Ontario
M6H 3M1
Canada
Resonance Magnetique du Saguenay-Lac-Saint-Jean
Chicoutimi
Quebec
G7H 4J1
Canada
Centre integre universitaire de sante et de services sociaux du Saguenay-Lac-Saint-Jean
Chicoutimi
Quebec
G7H 5H6
Canada
Ecogene-21
Chicoutimi
Quebec
G7H 7K9
Canada
Centre de recherche du Centre hospitalier de l'Université de Montréal (CRCHUM)
Montreal
Quebec
H2X 0A9
Canada
McGill University Health Centre (MUHC)
Montreal
Quebec
H4A 3J1
Canada
Philips Radiation Oncology
Montreal
Quebec
H4A 3J1
Canada
Research Institute of the MUHC
Montreal
Quebec
H4A 3J1
Canada
Diex Recherche Quebec Inc.
Québec
G1V 4T3
Canada
Beijing Friendship Hospital, Capital Medical University
Beijing
Beijing Municipality
100050
China
The First Affiliated Hospital, Sun Yat-sen University
Guangzhou
Guangdong
510080
China
The Third Hospital of Hebei Medical University
Shijiazhuang
Hebei
050051
China
Hunan Provincial People's Hospital
Changsha
Hunan
410005
China
The First Bethune Hospital of Jilin University
Changchun
Jilin
130021
China
General Hospital of Ningxia Medical University
Yinchuan
Ningxia
750004
China
Qingdao Central Hospital
Qingdao
Shandong
266042
China
The Affiliated Hospital of Hangzhou Normal University
Hangzhou
Zhejiang
310000
China
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou
Zhejiang
325000
China
Peking University People's Hospital
Beijing
100044
China
Beijing YouAn Hosptial,Capital Medical University
Beijing
100069
China
Beijing Tsinghua Changgung Hospital
Beijing
102218
China
Tianjin Third Central Hospital
Tianjin
300170
China
Tianjin Second People's Hospital
Tianjin
300192
China
Queen Mary Hospital
Hong Kong
Hong Kong
Prince of Wales Hospital
Shatin
Hong Kong
Alice Ho Miu Ling Nethersole Hospital
Tai Po
Hong Kong
Surat Institute of Digestive Sciences
Surat
Gujarat
395002
India
Gujarat Hospital - Gastro and Vascular Centre
Surat
Gujarat
395009
India
Global Hospital - Super Speciality & Transplant Centre
Mumbai
Maharashtra
400012
India
Max Smart Super Speciality Hospital
Sāket
NEW Delhi
110017
India
S.M.S. Medical College & Hospital
Jaipur
Rajasthan
302004
India
Institute of Post Graduate Medical Education and Research & SSKM Hospital
Kolkata
West Bengal
700020
India
Medanta - The Medicity
Gurugram
122001
India
Institute of Liver and Biliary Sciences (ILBS)
New Delhi
110 070
India
All India Institute of Medical Sciences (AIIMS)
New Delhi
110029
India
Aichi Medical University Hospital
Nagakute
Aichi-ken
480-1195
Japan
Ehime University Hospital
Tōon
Ehime
791-0295
Japan
Ogaki Municipal Hospital
Ōgaki
Gifu
503-8502
Japan
Tokyo Medical University Ibaraki Medical Center
Inashiki-gun
Ibaraki
300-0395
Japan
Kagawa Prefectural Central Hospital
Takamatsu
Kagawa-ken
760-8557
Japan
Yokohama City University Hospital
Yokohama
Kanagawa
236-0004
Japan
Shinshu University Hospital
Matsumoto
Nagano
3908621
Japan
National Hospital Organization Nagasaki Medical Center
Ohmura
Nagasaki
856-8562
Japan
Osaka Rosai Hospital
Sakai
Osaka
591-8025
Japan
Saiseikai Suita Hospital
Suita
Osaka
564-0013
Japan
Juntendo University Shizuoka Hospital
Izunokuni
Shizuoka
410-2295
Japan
Chiba University Hospital
Chiba
260-8677
Japan
Fukui-Ken Saiseikai Hospital
Fukui
918-8503
Japan
Gifu Municipal Hospital
Gifu
500-8513
Japan
Kagoshima University Hospital
Kagoshima
890-8520
Japan
University Hospital, Kyoto Prefectural University of Medicine
Kyoto
602-8566
Japan
Miyazaki Medical Center Hospital
Miyazaki
880-0003
Japan
Saga University Hospital
Saga
849-8501
Japan
Yamagata University Hospital
Yamagata
990-9585
Japan
Szpital Zakonu Bonifratrow
Katowice
40-211
Poland
NZOZ Vita Longa Sp. z o.o.
Katowice
40-748
Poland
Uniwersyteckie Centrum Kliniczne im. prof. K. Gibinskiego Slaskiego Uniwersytetu Medycznego
Katowice
40-752
Poland
Orthos Szpital Wielospecjalistyczny Sp. z o.o. (Liver Biopsy)
Komorowice
52-229
Poland
SPZOZ Szpital Uniwersytecki w Krakowie
Krakow
30-688
Poland
Szpital Zakonu Bonifratrów św. Jana Grandego w Krakowie sp. z o.o. (Liver Biopsy)
Krakow
31-061
Poland
Krakowskie Centrum Medyczne
Krakow
31-501
Poland
Wojewodzki Specjalistyczny Szpital im. Dr. Wl. Bieganskiego w Lodzi
Lodz
91-347
Poland
ID Clinic
Mysłowice
41-400
Poland
WIP Warsaw IBD Point Profesor Kierkus
Warsaw
00-728
Poland
Futuremeds Sp. z o.o.
Wroclaw
50-088
Poland
ETG Zamosc
Zamość
22-400
Poland
Samodzielny Publiczny Szpital Wojewodzki im. Papieza Jana Pawla II
Zamość
22-400
Poland
Clinical Research Puerto Rico
San Juan
00909
Puerto Rico
Latin Clinical Trial Center
San Juan
00909
Puerto Rico
GCM Medical Group PSC
San Juan
00917
Puerto Rico
FDI Clinical Research
San Juan
00927
Puerto Rico
Fakultna nemocnica s poliklinikou F. D. Roosevelta Banska Bystrica
Banská Bystrica
974 01
Slovakia
Medispektrum, s.r.o
Bratislava
851 01
Slovakia
SUMMIT CLINICAL RESEARCH, s.r.o.
Bratislava - Mestska Cast Nove Mesto
831 01
Slovakia
Lama Medical Care s.r.o.
Bratislava - Mestska Cast Ruzinov
831 04
Slovakia
Univerzitna nemocnica L. Pasteura Kosice
Kosice - Mestska Cast Zapad
040 11
Slovakia
KM Management spol. s.r.o., Gastroenterologicke a hepatologicke centrum Nitra
Nitra
949 01
Slovakia
Fakultna nemocnica Nitra
Nitra
950 01
Slovakia
JAL, s.r.o.
Trnava
917 01
Slovakia
SMG-SNU Boramae Medical Center
Dongjak-gu
Seoul
07061
South Korea
Pusan National University Hospital
Busan
49241
South Korea
Kyungpook National University Hospital
Daegu
41944
South Korea
Yeungnam University Hospital
Daegu
42415
South Korea
Severance Hospital Yonsei University Health System
Seoul
03722
South Korea
Changhua Christian Hospital
Changhua
Changhua County
500
Taiwan
Ditmanson Medical Foundation Chia-Yi Christian Hospital
Chiayi City
600
Taiwan
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City
807
Taiwan
National Cheng Kung University (NCKU) Hospital
Tainan
704
Taiwan
National Taiwan University Hospital
Taipei
100
Taiwan
Taipei Veterans General Hospital
Taipei
11217
Taiwan
Chang Gung Medical Foundation Linkou Chang Gung Memorial Hospital
Taoyuan
333
Taiwan
Derived
Amin NB, Darekar A, Anstee QM, Wong VW, Tacke F, Vourvahis M, Lee DS, Charlton M, Alkhouri N, Nakajima A, Yunis C. Efficacy and safety of an orally administered DGAT2 inhibitor alone or coadministered with a liver-targeted ACC inhibitor in adults with non-alcoholic steatohepatitis (NASH): rationale and design of the phase II, dose-ranging, dose-finding, randomised, placebo-controlled MIRNA (Metabolic Interventions to Resolve NASH with fibrosis) study. BMJ Open. 2022 Mar 30;12(3):e056159. doi: 10.1136/bmjopen-2021-056159.
DGAT2i/PF-06865571 25 mg BID
Participants were randomized to receive 1 tablet of DGAT2i 25 milligrams (mg) along with 1 tablet of DGAT2i and ACCi matching placebo BID for 48 weeks by oral administration. Participants were followed up to 52 weeks.
FG002
DGAT2i/PF-06865571 75 mg BID
Participants were randomized to receive 1 tablet of DGAT2i 25 mg, 1 tablet of DGAT2i 50 mg and 1 tablet of ACCi matching placebo BID for 48 weeks by oral administration. Participants were followed up to 52 weeks.
FG003
DGAT2i/PF-06865571 150 mg BID
Participants were randomized to receive 1 tablet of DGAT2i matching placebo, 1 tablet of DGAT2i 150 mg and 1 tablet of ACCi matching placebo BID for 48 weeks by oral administration. Participants were followed up to 52 weeks.
Participants were randomized to receive 1 tablet of DGAT2i matching placebo, 1 tablet of DGAT2i 150 mg and 1 tablet of ACCi 5 mg BID for 48 weeks by oral administration. Participants were followed up to 52 weeks.
FG005
DGAT2i/PF-06865571 300 mg BID
Participants were randomized to receive 2 tablets of DGAT2i 150 mg and 1 tablet of ACCi matching placebo BID for 48 weeks by oral administration. Participants were followed up to 52 weeks.
Participants were randomized to receive 2 tablets of DGAT2i 150 mg and 1 tablet of ACCi 10 mg BID for 48 weeks by oral administration. Participants were followed up to 52 weeks.
FG00034 subjects
FG00135 subjects
FG00248 subjects
FG00342 subjects
FG00435 subjects
FG00531 subjects
FG00630 subjects
COMPLETED
FG00032 subjects
FG00131 subjects
FG00245 subjects
FG00335 subjects
FG00432 subjects
FG00526 subjects
FG00628 subjects
NOT COMPLETED
FG0002 subjects
FG0014 subjects
FG0023 subjects
FG0037 subjects
FG0043 subjects
FG0055 subjects
FG0062 subjects
Type
Comment
Reasons
Adverse Event
FG0000 subjects
FG0012 subjects
FG0022 subjects
FG0032 subjects
FG0042 subjects
FG0052 subjects
FG0060 subjects
Lost to Follow-up
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG004
Withdrawal by Subject
FG0002 subjects
FG0012 subjects
FG0021 subjects
FG0033 subjects
FG004
Non-compliance with study drug
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Other
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG004
Safety population included all participants who took at least 1 dose of investigational product. Participants were analyzed according to the treatment they actually received.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Placebo
Participants were randomized to receive 2 tablets of diacylglycerol acyltransferase 2 inhibitor (PF-06865571/DGAT2i) matching placebo and 1 tablet of acetyl-CoA carboxylase inhibitor (PF-05221304/ACCi) matching placebo twice a day (BID) for 48 weeks by oral administration. Participants were followed up to 52 weeks.
BG001
DGAT2i/PF-06865571 25 mg BID
Participants were randomized to receive 1 tablet of DGAT2i 25 milligrams (mg) along with 1 tablet of DGAT2i and ACCi matching placebo BID for 48 weeks by oral administration. Participants were followed up to 52 weeks.
BG002
DGAT2i/PF-06865571 75 mg BID
Participants were randomized to receive 1 tablet of DGAT2i 25 mg, 1 tablet of DGAT2i 50 mg and 1 tablet of ACCi matching placebo BID for 48 weeks by oral administration. Participants were followed up to 52 weeks.
BG003
DGAT2i/PF-06865571 150 mg BID
Participants were randomized to receive 1 tablet of DGAT2i matching placebo, 1 tablet of DGAT2i 150 mg and 1 tablet of ACCi matching placebo BID for 48 weeks by oral administration. Participants were followed up to 52 weeks.
Participants were randomized to receive 1 tablet of DGAT2i matching placebo, 1 tablet of DGAT2i 150 mg and 1 tablet of ACCi 5 mg BID for 48 weeks by oral administration. Participants were followed up to 52 weeks.
BG005
DGAT2i/PF-06865571 300 mg BID
Participants were randomized to receive 2 tablets of DGAT2i 150 mg and 1 tablet of ACCi matching placebo BID for 48 weeks by oral administration. Participants were followed up to 52 weeks.
Participants were randomized to receive 2 tablets of DGAT2i 150 mg and 1 tablet of ACCi 10 mg BID for 48 weeks by oral administration. Participants were followed up to 52 weeks.
BG007
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00034
BG00135
BG00248
BG00342
BG00435
BG00531
BG00630
BG007255
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
Years
Title
Denominators
Categories
Title
Measurements
BG00055.21± 12.00
BG00156.54± 11.38
BG00256.02± 12.67
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00017
BG00119
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Ethnicity
Title
Measurements
Hispanic or Latino
BG0008
BG00115
BG002
Race (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Race
Title
Measurements
American Indian or Alaska Native
BG0000
BG0010
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Mean Proportion of Participants Achieving Resolution of NASH Without Worsening/Improvement of Fibrosis by >=1 Stage Without Worsening of NASH/Both Based on Assessment by Sponsor-Identified Central Pathologist at Week 48:Bayesian Dose Response Model (BDRM)
NASH resolution: disappearance of ballooning (Nonalcoholic Fatty Liver Disease [NAFLD] Activity Score [NAS] ballooning score=0;0=no ballooning,1=few balloon cells,2=many cells with prominent ballooning; higher scores(HS)=more disease activity [DA]),residual/no lobular inflammation(NAS lobular inflammation score 0/1,0=no foci,1= <2 foci, 2=2-4 foci,3= >4 foci; HS=more DA),NAS steatosis score 0,1,2,3; 0= <5% hepatocytes involved (HI),1=5-33% HI ,2= 34-66% HI, 3= >66% HI; HS=more DA. No worsening of fibrosis: no change/decrease of at least 1 stage in Brunt-Kleiner scale (BKS) compared to baseline (CTB). Improvement in fibrosis by >=1 stage: decrease of at least 1 stage in BKS CTB. No worsening of NASH: no change/increase in NAS for ballooning, inflammation, steatosis CTB. BDRM utilized to characterize dose response across BID treatment groups, estimate posterior mean proportion (& 90% credible interval [CI], indicated as 'confidence interval' below) for placebo and each BID dose studied.
BKS: scaling for fibrosis (0=none,1=perisinusoidal/ periportal,2=perisinusoidal, portal/ periportal,3=bridging,4=cirrhosis; higher scores=more DA). Full analysis set (FAS):all randomized participants who took at least 1 dose of investigational product who had provided baseline data for primary endpoint. This outcome measure was not planned to be analyzed in combination arms (DGAT2i/PF-06865571 150 mg BID + ACCi/PF-05221304 5 mg BID and DGAT2i/PF-06865571 300 mg BID + ACCi/PF-05221304 10 mg BID).
Posted
Mean
90% Confidence Interval
Proportion of participants
Week 48
ID
Title
Description
OG000
Placebo
Participants were randomized to receive 2 tablets of diacylglycerol acyltransferase 2 inhibitor (PF-06865571/DGAT2i) matching placebo and 1 tablet of acetyl-CoA carboxylase inhibitor (PF-05221304/ACCi) matching placebo twice a day (BID) for 48 weeks by oral administration. Participants were followed up to 52 weeks.
OG001
DGAT2i/PF-06865571 25 mg BID
Participants were randomized to receive 1 tablet of DGAT2i 25 milligrams (mg) along with 1 tablet of DGAT2i and ACCi matching placebo BID for 48 weeks by oral administration. Participants were followed up to 52 weeks.
OG002
DGAT2i/PF-06865571 75 mg BID
Participants were randomized to receive 1 tablet of DGAT2i 25 mg, 1 tablet of DGAT2i 50 mg and 1 tablet of ACCi matching placebo BID for 48 weeks by oral administration. Participants were followed up to 52 weeks.
OG003
DGAT2i/PF-06865571 150 mg BID
Participants were randomized to receive 1 tablet of DGAT2i matching placebo, 1 tablet of DGAT2i 150 mg and 1 tablet of ACCi matching placebo BID for 48 weeks by oral administration. Participants were followed up to 52 weeks.
OG004
DGAT2i/PF-06865571 300 mg BID
Participants were randomized to receive 2 tablets of DGAT2i 150 mg and 1 tablet of ACCi matching placebo BID for 48 weeks by oral administration. Participants were followed up to 52 weeks.
Units
Counts
Participants
OG00034
OG00135
OG00248
OG003
Title
Denominators
Categories
Title
Measurements
OG0000.38(0.26 to 0.50)
OG0010.45(0.38 to 0.53)
OG0020.48(0.42 to 0.55)
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
The model was applied to the raw number of responders and non-responders utilizing a Bayesian methodology approach with non-informative priors as described in the statistical analysis plan (SAP).
Risk Difference (RD)
0.08
2-Sided
90
-0.02
0.20
Reported values reflect a 90% Credible Interval rather than a 90% Confidence Interval.
Superiority
Primary
Number of Participants Achieving Resolution of NASH Without Worsening or Improvement in Fibrosis by >= 1 Stage Without Worsening of NASH or Both Based on Assessment by Sponsor-Identified Central Pathologist at Week 48: Logistic Regression Model
Resolution of NASH: disappearance of ballooning (NAS ballooning score= 0; where 0= no ballooning, 1= few balloon cells, 2= many cells with prominent ballooning; higher scores= more disease activity), residual or no lobular inflammation (NAS lobular inflammation score 0 or 1, where 0= no foci, 1= <2 foci, 2= 2-4 foci, 3= >4 foci; higher scores= more disease activity), NAS steatosis score 0, 1, 2, or 3, where 0= <5% hepatocytes involved, 1= 5-33% hepatocytes involved, 2= 34-66% hepatocytes involved, 3= >66% hepatocytes involved; higher scores= more disease activity. No worsening of fibrosis: no change or decrease of at least 1 stage in BKS compared to baseline. Improvement in fibrosis by >=1 stage: decrease of at least 1 stage in BKS compared to baseline. No worsening of NASH: no change or increase in NAS for ballooning, inflammation, steatosis compared to baseline.
BKS: scaling for fibrosis (0= none, 1= perisinusoidal/ periportal, 2= perisinusoidal, portal/periportal, 3= bridging, 4= cirrhosis; higher scores= more disease activity). Logistic Regression model included treatment and baseline F2/F3 as factors. Full analysis set included all randomized participants who took at least 1 dose of investigational product who had provided baseline data for the primary endpoint.
Posted
Count of Participants
Participants
Week 48
ID
Title
Description
OG000
Placebo
Participants were randomized to receive 2 tablets of diacylglycerol acyltransferase 2 inhibitor (PF-06865571/DGAT2i) matching placebo and 1 tablet of acetyl-CoA carboxylase inhibitor (PF-05221304/ACCi) matching placebo twice a day (BID) for 48 weeks by oral administration. Participants were followed up to 52 weeks.
Secondary
Percent Change From Baseline in Liver Fat at Week 48: Bayesian Dose Response Model
Magnetic resonance imaging proton density fat fraction (MRI-PDFF) is an established method that enables quantification of fat content in the liver.
Full analysis set: all randomized participants who took at least 1 dose of investigational product who had provided baseline data for primary endpoint. This outcome measure was not planned to be analyzed in combination arms (DGAT2i/PF-06865571 150 mg BID + ACCi/PF-05221304 5 mg BID and DGAT2i/PF-06865571 300 mg BID + ACCi/PF-05221304 10 mg BID). Here, ''Number of Participants Analyzed'' signifies participants evaluable for this outcome measure.
Posted
Mean
90% Confidence Interval
Percent change
Baseline, Week 48
ID
Title
Description
OG000
Placebo
Participants were randomized to receive 2 tablets of diacylglycerol acyltransferase 2 inhibitor (PF-06865571/DGAT2i) matching placebo and 1 tablet of acetyl-CoA carboxylase inhibitor (PF-05221304/ACCi) matching placebo twice a day (BID) for 48 weeks by oral administration. Participants were followed up to 52 weeks.
OG001
DGAT2i/PF-06865571 25 mg BID
Participants were randomized to receive 1 tablet of DGAT2i 25 milligrams (mg) along with 1 tablet of DGAT2i and ACCi matching placebo BID for 48 weeks by oral administration. Participants were followed up to 52 weeks.
Secondary
Percent Change From Baseline in Liver Fat at Week 48: Pairwise Comparisons With Analysis of Covariance (ANCOVA)
MRI-PDFF is an established method that enables quantification of fat content in the liver.
Full analysis set: all randomized participants who took at least 1 dose of investigational product who had provided baseline data for primary endpoint. Here, ''Number of Participants Analyzed'' signifies participants evaluable for this outcome measure.
Posted
Least Squares Mean
Standard Error
Percent change
Baseline, Week 48
ID
Title
Description
OG000
Placebo
Participants were randomized to receive 2 tablets of diacylglycerol acyltransferase 2 inhibitor (PF-06865571/DGAT2i) matching placebo and 1 tablet of acetyl-CoA carboxylase inhibitor (PF-05221304/ACCi) matching placebo twice a day (BID) for 48 weeks by oral administration. Participants were followed up to 52 weeks.
OG001
DGAT2i/PF-06865571 25 mg BID
Participants were randomized to receive 1 tablet of DGAT2i 25 milligrams (mg) along with 1 tablet of DGAT2i and ACCi matching placebo BID for 48 weeks by oral administration. Participants were followed up to 52 weeks.
OG002
DGAT2i/PF-06865571 75 mg BID
Participants were randomized to receive 1 tablet of DGAT2i 25 mg, 1 tablet of DGAT2i 50 mg and 1 tablet of ACCi matching placebo BID for 48 weeks by oral administration. Participants were followed up to 52 weeks.
Secondary
Mean Proportion of Participants Achieving Resolution of NASH, Without Worsening of Fibrosis Based on Assessment by Sponsor-Identified Central Pathologist(s) at Week 48: Bayesian Dose Response Model
Resolution of NASH: disappearance of ballooning (NAS ballooning score= 0; where 0= no ballooning, 1= few balloon cells, 2= many cells with prominent ballooning; higher scores= more disease activity), residual or no lobular inflammation (NAS lobular inflammation score 0 or 1, where 0= no foci, 1= <2 foci, 2= 2-4 foci, 3= >4 foci; higher scores= more disease activity), NAS steatosis score 0, 1, 2 or 3, where 0= <5% HI, 1= 5-33% HI, 2= 34-66% HI, 3= >66% HI; higher scores= more disease activity. No worsening of fibrosis: no change or decrease of at least 1 stage in BKS compared to baseline. BKS: scaling for fibrosis (0= none, 1= perisinusoidal/ periportal, 2= perisinusoidal, portal/ periportal, 3= bridging, 4= cirrhosis; higher scores= more disease activity). BDRM utilized to characterize dose response across BID treatment groups, estimate posterior mean proportion (& 90% credible interval [CI], indicated as 'confidence interval' below) for placebo and each BID dose studied.
FAS included all randomized participants who took at least 1 dose of investigational product who had provided baseline data for primary endpoint. This outcome measure was not planned to be analyzed in combination arms (DGAT2i/PF-06865571 150 mg BID + ACCi/PF-05221304 5 mg BID and DGAT2i/PF-06865571 300 mg BID + ACCi/PF-05221304 10 mg BID).
Posted
Mean
90% Confidence Interval
Proportion of participants
Week 48
ID
Title
Description
OG000
Placebo
Participants were randomized to receive 2 tablets of diacylglycerol acyltransferase 2 inhibitor (PF-06865571/DGAT2i) matching placebo and 1 tablet of acetyl-CoA carboxylase inhibitor (PF-05221304/ACCi) matching placebo twice a day (BID) for 48 weeks by oral administration. Participants were followed up to 52 weeks.
Secondary
Number of Participants Achieving Resolution of NASH, Without Worsening of Fibrosis Based on Assessment by Sponsor-Identified Central Pathologist(s) at Week 48: Pairwise Comparisons With Logistic Regression Model
Resolution of NASH: disappearance of ballooning (NAS ballooning score= 0; where 0= no ballooning, 1= few balloon cells, 2= many cells with prominent ballooning; higher scores= more disease activity), residual or no lobular inflammation (NAS lobular inflammation score 0 or 1, where 0= no foci, 1= <2 foci, 2= 2-4 foci, 3= >4 foci; higher scores= more disease activity), NAS steatosis score 0, 1, 2 or 3, where 0= <5% hepatocytes involved, 1= 5-33% hepatocytes involved, 2= 34-66% hepatocytes involved, 3= >66% hepatocytes involved; higher scores= more disease activity. No worsening of fibrosis: no change or decrease of at least 1 stage in Brunt-Kleiner scale compared to baseline. Brunt-Kleiner scale included scaling for fibrosis (0= none, 1= perisinusoidal/ periportal, 2= perisinusoidal, portal/ periportal, 3= bridging, 4= cirrhosis; higher scores = more disease activity). Logistic Regression model included treatment and baseline fibrosis stage (F2/F3) as factors.
Full analysis set included all randomized participants who took at least 1 dose of investigational product who had provided baseline data for primary endpoint.
Posted
Count of Participants
Participants
Week 48
ID
Title
Description
OG000
Placebo
Participants were randomized to receive 2 tablets of diacylglycerol acyltransferase 2 inhibitor (PF-06865571/DGAT2i) matching placebo and 1 tablet of acetyl-CoA carboxylase inhibitor (PF-05221304/ACCi) matching placebo twice a day (BID) for 48 weeks by oral administration. Participants were followed up to 52 weeks.
Secondary
Mean Proportion of Participants Achieving Improvement in Fibrosis by >=1 Stage, Without Worsening of NASH Based on Assessment by Sponsor-Identified Central Pathologist(s) at Week 48: Bayesian Dose Response Model
Improvement in fibrosis by >=1 stage: decrease of at least 1 stage in Brunt-Kleiner scale compared to baseline. No worsening of fibrosis: no change or decrease of at least 1 stage in Brunt-Kleiner scale compared to baseline. Brunt-Kleiner scale included scaling for fibrosis (0= none, 1= perisinusoidal/ periportal, 2= perisinusoidal, portal/ periportal, 3= bridging, 4= cirrhosis; higher scores = more disease activity). BDRM utilized to characterize dose response across BID treatment groups, estimate posterior mean proportion (& 90% credible interval [CI], indicated as 'confidence interval' below) for placebo and each BID dose studied.
Full analysis set included all randomized participants who took at least 1 dose of investigational product who had provided baseline data for primary endpoint. This outcome measure was not planned to be analyzed in combination arms (DGAT2i/PF-06865571 150 mg BID + ACCi/PF-05221304 5 mg BID and DGAT2i/PF-06865571 300 mg BID + ACCi/PF-05221304 10 mg BID).
Posted
Mean
90% Confidence Interval
Proportion of participants
Week 48
ID
Title
Description
OG000
Placebo
Participants were randomized to receive 2 tablets of diacylglycerol acyltransferase 2 inhibitor (PF-06865571/DGAT2i) matching placebo and 1 tablet of acetyl-CoA carboxylase inhibitor (PF-05221304/ACCi) matching placebo twice a day (BID) for 48 weeks by oral administration. Participants were followed up to 52 weeks.
Secondary
Number of Participants Achieving Improvement in Fibrosis by >=1 Stage, Without Worsening of NASH Based on Assessment by Sponsor-Identified Central Pathologist(s) at Week 48: Pairwise Comparisons With Logistic Regression Model
Improvement in fibrosis by >=1 stage: decrease of at least 1 stage in Brunt-Kleiner scale compared to baseline. No worsening of fibrosis: no change/decrease of at least 1 stage in Brunt-Kleiner scale compared to baseline. Brunt-Kleiner scale included scaling for fibrosis (0= none, 1= perisinusoidal/ periportal, 2= perisinusoidal, portal/ periportal, 3= bridging, 4= cirrhosis; higher scores = more DA). Logistic Regression model included treatment and baseline fibrosis stage (F2/F3) as factors.
Full analysis set included all randomized participants who took at least 1 dose of investigational product who had provided baseline data for primary endpoint.
Posted
Count of Participants
Participants
Week 48
ID
Title
Description
OG000
Placebo
Participants were randomized to receive 2 tablets of diacylglycerol acyltransferase 2 inhibitor (PF-06865571/DGAT2i) matching placebo and 1 tablet of acetyl-CoA carboxylase inhibitor (PF-05221304/ACCi) matching placebo twice a day (BID) for 48 weeks by oral administration. Participants were followed up to 52 weeks.
OG001
DGAT2i/PF-06865571 25 mg BID
Participants were randomized to receive 1 tablet of DGAT2i 25 milligrams (mg) along with 1 tablet of DGAT2i and ACCi matching placebo BID for 48 weeks by oral administration. Participants were followed up to 52 weeks.
Secondary
Mean Proportion of Participants Achieving Improvement in Fibrosis by >=2 Stage, Without Worsening of NASH Based on Assessment by Sponsor-Identified Central Pathologist(s) at Week 48: Bayesian Dose Response Model
Improvement in fibrosis by >=2 stage: decrease of at least 2 points in total NAS compared to baseline, without progression of fibrosis. No worsening of NASH: no change or no increase in NAS for ballooning (NAS ballooning score= 0; where 0= no ballooning, 1= few balloon cells, 2= many cells with prominent ballooning; higher scores= more disease activity), inflammation (NAS lobular inflammation score 0 or 1, where 0= no foci, 1= <2 foci, 2= 2-4 foci, 3= >4 foci; higher scores= more disease activity), steatosis (NAS steatosis score 0, 1, 2, or 3, where 0= <5% hepatocytes involved, 1= 5-33% hepatocytes involved, 2= 34-66% hepatocytes involved, 3= >66% hepatocytes involved; higher scores=more disease activity) compared to baseline. BDRM utilized to characterize dose response across BID treatment groups, estimate posterior mean proportion (& 90% credible interval [CI], indicated as 'confidence interval' below) for placebo and each BID dose studied.
Full analysis set included all randomized participants who took at least 1 dose of investigational product who had provided baseline data for primary endpoint. This outcome measure was not planned to be analyzed in combination arms (DGAT2i/PF-06865571 150 mg BID + ACCi/PF-05221304 5 mg BID and DGAT2i/PF-06865571 300 mg BID + ACCi/PF-05221304 10 mg BID).
Posted
Mean
90% Confidence Interval
Proportion of participants
Week 48
ID
Title
Description
OG000
Placebo
Participants were randomized to receive 2 tablets of diacylglycerol acyltransferase 2 inhibitor (PF-06865571/DGAT2i) matching placebo and 1 tablet of acetyl-CoA carboxylase inhibitor (PF-05221304/ACCi) matching placebo twice a day (BID) for 48 weeks by oral administration. Participants were followed up to 52 weeks.
Secondary
Number of Participants Achieving Improvement in Fibrosis by >=2 Stage, Without Worsening of NASH Based on Assessment by Sponsor-Identified Central Pathologist(s) at Week 48: Pairwise Comparisons With Logistic Regression Model
Improvement in fibrosis by >=2 stage: decrease of at least 2 points in total NAS compared to baseline, without progression of fibrosis. No worsening of NASH: no change or no increase in NAS for ballooning (NAS ballooning score= 0; where 0= no ballooning, 1= few balloon cells, 2= many cells with prominent ballooning; higher scores= more disease activity), inflammation (NAS lobular inflammation score 0 or 1, where 0= no foci, 1= <2 foci, 2= 2-4 foci, 3= >4 foci; higher scores= more disease activity), steatosis (NAS steatosis score 0, 1, 2 or 3, where 0= <5% hepatocytes involved, 1= 5-33% hepatocytes involved, 2= 34-66% hepatocytes involved, 3= >66% hepatocytes involved; higher scores= more disease activity) compared to baseline. Logistic Regression model included treatment and baseline fibrosis stage (F2/F3) as factors.
Full analysis set included all randomized participants who took at least 1 dose of investigational product who had provided baseline data for primary endpoint.
Posted
Count of Participants
Participants
Week 48
ID
Title
Description
OG000
Placebo
Participants were randomized to receive 2 tablets of diacylglycerol acyltransferase 2 inhibitor (PF-06865571/DGAT2i) matching placebo and 1 tablet of acetyl-CoA carboxylase inhibitor (PF-05221304/ACCi) matching placebo twice a day (BID) for 48 weeks by oral administration. Participants were followed up to 52 weeks.
Secondary
Mean Proportion of Participants Achieving Improvement of >=2 Points in Total NAS, Without Progression of Fibrosis Based on Assessment by Sponsor-Identified Central Pathologist(s) at Week 48: Bayesian Dose Response Model
Improvement of >=2 points in Total NAS: decrease of at least 2 points in Total NAS compared to baseline, without progression of fibrosis. Total NAS ranged 0 to 8, higher scores= more disease activity and calculated as sum of scores of steatosis (0= <5% hepatocytes involved, 1=5-33% hepatocytes involved, 2=34-66% hepatocytes involved, 3= >66% hepatocytes involved; higher scores= more disease activity), lobular inflammation (0= no foci, 1= <2 foci, 2= 2-4 foci, 3= >4 foci; higher scores= more disease activity), ballooning (0= no ballooning, 1= few balloon cells, 2= many cells with prominent ballooning; higher scores= more disease activity). If sub-scale scores non evaluable or missing, total score was derived as missing. BDRM utilized to characterize dose response across BID treatment groups, estimate posterior mean proportion (& 90% credible interval [CI], indicated as 'confidence interval' below) for placebo and each BID dose studied.
Full analysis set included all randomized participants who took at least 1 dose of investigational product who had provided baseline data for primary endpoint. This outcome measure was not planned to be analyzed in combination arms (DGAT2i/PF-06865571 150 mg BID + ACCi/PF-05221304 5 mg BID and DGAT2i/PF-06865571 300 mg BID + ACCi/PF-05221304 10 mg BID).
Posted
Mean
90% Confidence Interval
Proportion of participants
Week 48
ID
Title
Description
OG000
Placebo
Participants were randomized to receive 2 tablets of diacylglycerol acyltransferase 2 inhibitor (PF-06865571/DGAT2i) matching placebo and 1 tablet of acetyl-CoA carboxylase inhibitor (PF-05221304/ACCi) matching placebo twice a day (BID) for 48 weeks by oral administration. Participants were followed up to 52 weeks.
Secondary
Number of Participants Achieving Improvement of >=2 Points in Total NAS Without Progression of Fibrosis Based on Assessment by Sponsor-Identified Central Pathologist(s) at Week 48: Pairwise Comparisons With Logistic Regression Model
Improvement of >=2 points in Total NAS: decrease of at least 2 points in Total NAS compared to baseline, without progression of fibrosis. Total NAS ranged from 0 to 8, higher scores= more DA and calculated as sum of scores of steatosis (0= <5% hepatocytes involved, 1= 5-33% hepatocytes involved, 2= 34-66% hepatocytes involved, 3= >66% hepatocytes involved; higher scores= more DA), lobular inflammation (0= no foci, 1= <2 foci, 2= 2-4 foci, 3= >4 foci; higher scores= more DA), ballooning (0= no ballooning, 1= few balloon cells, 2= many cells with prominent ballooning; higher scores= more DA). If any of the sub-scale scores were non evaluable/missing, then the total score was derived as missing. Logistic Regression model included treatment and baseline fibrosis stage (F2/F3) as factors.
Full analysis set included all randomized participants who took at least 1 dose of investigational product who had provided baseline data for primary endpoint.
Posted
Count of Participants
Participants
Week 48
ID
Title
Description
OG000
Placebo
Participants were randomized to receive 2 tablets of diacylglycerol acyltransferase 2 inhibitor (PF-06865571/DGAT2i) matching placebo and 1 tablet of acetyl-CoA carboxylase inhibitor (PF-05221304/ACCi) matching placebo twice a day (BID) for 48 weeks by oral administration. Participants were followed up to 52 weeks.
OG001
Secondary
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
An adverse event (AE) was any untoward medical occurrence in a participant/ clinical investigational participant administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Serious adverse events (SAE) was any untoward medical occurrence at any dose that: resulted in death, was life threatening (risk of death), required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions), resulted in congenital anomaly/birth defect. AEs included both serious and all non-serious AEs. TEAEs were defined as newly occurring or worsening AE after the first dose of study drug.
Safety population included all participants who took at least 1 dose of investigational product.
Posted
Count of Participants
Participants
From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
ID
Title
Description
OG000
Placebo
Participants were randomized to receive 2 tablets of diacylglycerol acyltransferase 2 inhibitor (PF-06865571/DGAT2i) matching placebo and 1 tablet of acetyl-CoA carboxylase inhibitor (PF-05221304/ACCi) matching placebo twice a day (BID) for 48 weeks by oral administration. Participants were followed up to 52 weeks.
OG001
DGAT2i/PF-06865571 25 mg BID
Secondary
Number of Participants With Laboratory Test Abnormalities
Safety population included all participants who took at least 1 dose of investigational product. Here, ''Number of Participants Analyzed'' signifies participants evaluable for this outcome measure.
Posted
Count of Participants
Participants
From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
ID
Title
Description
OG000
Placebo
Participants were randomized to receive 2 tablets of diacylglycerol acyltransferase 2 inhibitor (PF-06865571/DGAT2i) matching placebo and 1 tablet of acetyl-CoA carboxylase inhibitor (PF-05221304/ACCi) matching placebo twice a day (BID) for 48 weeks by oral administration. Participants were followed up to 52 weeks.
Secondary
Number of Participants With Clinically Significant Abnormalities in Vital Signs
Number of participants with clinically significant vital signs were reported in this outcome measure. Vital signs included blood pressure, and heart rate. Clinical significance in vital signs abnormalities was judged by investigator.
Safety population included all participants who took at least 1 dose of investigational product. Here, ''Number of Participants Analyzed'' signifies participants evaluable for this outcome measure.
Posted
Count of Participants
Participants
From first dose of study drug (Day 1) upto Week 48 (maximum up to approximately 50 weeks)
ID
Title
Description
OG000
Placebo
Participants were randomized to receive 2 tablets of diacylglycerol acyltransferase 2 inhibitor (PF-06865571/DGAT2i) matching placebo and 1 tablet of acetyl-CoA carboxylase inhibitor (PF-05221304/ACCi) matching placebo twice a day (BID) for 48 weeks by oral administration. Participants were followed up to 52 weeks.
OG001
DGAT2i/PF-06865571 25 mg BID
Participants were randomized to receive 1 tablet of DGAT2i 25 milligrams (mg) along with 1 tablet of DGAT2i and ACCi matching placebo BID for 48 weeks by oral administration. Participants were followed up to 52 weeks.
OG002
DGAT2i/PF-06865571 75 mg BID
Secondary
Number of Participants With Clinically Significant Abnormalities in Electrocardiograms (ECG) Parameters
Number of participants with clinically significant ECG abnormalities were reported in this outcome measure. ECG parameters included heart rate, PR interval, QRS interval and QTcF interval.
Safety population included all participants who took at least 1 dose of investigational product. Here, ''Number of Participants Analyzed'' signifies participants evaluable for this outcome measure.
Posted
Count of Participants
Participants
From first dose of study drug (Day 1) upto Week 48 (maximum up to approximately 50 weeks)
ID
Title
Description
OG000
Placebo
Participants were randomized to receive 2 tablets of diacylglycerol acyltransferase 2 inhibitor (PF-06865571/DGAT2i) matching placebo and 1 tablet of acetyl-CoA carboxylase inhibitor (PF-05221304/ACCi) matching placebo twice a day (BID) for 48 weeks by oral administration. Participants were followed up to 52 weeks.
OG001
DGAT2i/PF-06865571 25 mg BID
Participants were randomized to receive 1 tablet of DGAT2i 25 milligrams (mg) along with 1 tablet of DGAT2i and ACCi matching placebo BID for 48 weeks by oral administration. Participants were followed up to 52 weeks.
OG002
DGAT2i/PF-06865571 75 mg BID
Time Frame
From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Description
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Placebo
Participants were randomized to receive 2 tablets of diacylglycerol acyltransferase 2 inhibitor (PF-06865571/DGAT2i) matching placebo and 1 tablet of acetyl-CoA carboxylase inhibitor (PF-05221304/ACCi) matching placebo twice a day (BID) for 48 weeks by oral administration. Participants were followed up to 52 weeks.
0
34
1
34
21
34
EG001
DGAT2i/PF-06865571 25 mg BID
Participants were randomized to receive 1 tablet of DGAT2i 25 milligrams (mg) along with 1 tablet of DGAT2i and ACCi matching placebo BID for 48 weeks by oral administration. Participants were followed up to 52 weeks.
0
35
1
35
21
35
EG002
DGAT2i/PF-06865571 75 mg BID
Participants were randomized to receive 1 tablet of DGAT2i 25 mg, 1 tablet of DGAT2i 50 mg and 1 tablet of ACCi matching placebo BID for 48 weeks by oral administration. Participants were followed up to 52 weeks.
0
48
5
48
28
48
EG003
DGAT2i/PF-06865571 150 mg BID
Participants were randomized to receive 1 tablet of DGAT2i matching placebo, 1 tablet of DGAT2i 150 mg and 1 tablet of ACCi matching placebo BID for 48 weeks by oral administration. Participants were followed up to 52 weeks.
Participants were randomized to receive 1 tablet of DGAT2i matching placebo, 1 tablet of DGAT2i 150 mg and 1 tablet of ACCi 5 mg BID for 48 weeks by oral administration. Participants were followed up to 52 weeks.
0
35
5
35
19
35
EG005
DGAT2i/PF-06865571 300 mg BID
Participants were randomized to receive 2 tablets of DGAT2i 150 mg and 1 tablet of ACCi matching placebo BID for 48 weeks by oral administration. Participants were followed up to 52 weeks.
Participants were randomized to receive 2 tablets of DGAT2i 150 mg and 1 tablet of ACCi 10 mg BID for 48 weeks by oral administration. Participants were followed up to 52 weeks.
0
30
2
30
15
30
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Coronary artery stenosis
Cardiac disorders
MedDRA v27.0
Non-systematic Assessment
EG0000 affected34 at risk
EG0010 affected35 at risk
EG0020 affected48 at risk
EG0030 affected42 at risk
EG0040 affected35 at risk
EG0050 affected31 at risk
EG0061 affected30 at risk
Myocardial infarction
Cardiac disorders
MedDRA v27.0
Non-systematic Assessment
EG0000 affected34 at risk
EG0010 affected35 at risk
EG0020 affected48 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA v27.0
Non-systematic Assessment
EG0000 affected34 at risk
EG0010 affected35 at risk
EG0020 affected48 at risk
EG003
Obstructive pancreatitis
Gastrointestinal disorders
MedDRA v27.0
Non-systematic Assessment
EG0000 affected34 at risk
EG0010 affected35 at risk
EG0020 affected48 at risk
EG003
Pyrexia
General disorders
MedDRA v27.0
Non-systematic Assessment
EG0000 affected34 at risk
EG0010 affected35 at risk
EG0021 affected48 at risk
EG003
Cholecystitis acute
Hepatobiliary disorders
MedDRA v27.0
Non-systematic Assessment
EG0000 affected34 at risk
EG0010 affected35 at risk
EG0021 affected48 at risk
EG003
Drug-induced liver injury
Hepatobiliary disorders
MedDRA v27.0
Non-systematic Assessment
EG0000 affected34 at risk
EG0010 affected35 at risk
EG0020 affected48 at risk
EG003
Hepatic haemorrhage
Hepatobiliary disorders
MedDRA v27.0
Non-systematic Assessment
EG0000 affected34 at risk
EG0010 affected35 at risk
EG0020 affected48 at risk
EG003
Subcapsular hepatic hematoma
Hepatobiliary disorders
MedDRA v27.0
Non-systematic Assessment
EG0000 affected34 at risk
EG0010 affected35 at risk
EG0021 affected48 at risk
EG003
Appendicitis
Infections and infestations
MedDRA v27.0
Non-systematic Assessment
EG0001 affected34 at risk
EG0010 affected35 at risk
EG0020 affected48 at risk
EG003
COVID-19
Infections and infestations
MedDRA v27.0
Non-systematic Assessment
EG0000 affected34 at risk
EG0011 affected35 at risk
EG0020 affected48 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA v27.0
Non-systematic Assessment
EG0000 affected34 at risk
EG0010 affected35 at risk
EG0020 affected48 at risk
EG003
Osteoarthritis
Musculoskeletal and connective tissue disorders
MedDRA v27.0
Non-systematic Assessment
EG0000 affected34 at risk
EG0010 affected35 at risk
EG0020 affected48 at risk
EG003
Breast cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA v27.0
Non-systematic Assessment
EG0000 affected34 at risk
EG0010 affected35 at risk
EG0021 affected48 at risk
EG003
Mucoepidermoid carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA v27.0
Non-systematic Assessment
EG0000 affected34 at risk
EG0010 affected35 at risk
EG0020 affected48 at risk
EG003
Acute kidney injury
Renal and urinary disorders
MedDRA v27.0
Non-systematic Assessment
EG0000 affected34 at risk
EG0010 affected35 at risk
EG0020 affected48 at risk
EG003
Benign prostatic hyperplasia
Reproductive system and breast disorders
MedDRA v27.0
Non-systematic Assessment
EG0000 affected34 at risk
EG0010 affected35 at risk
EG0020 affected48 at risk
EG003
Asthma
Respiratory, thoracic and mediastinal disorders
MedDRA v27.0
Non-systematic Assessment
EG0000 affected34 at risk
EG0010 affected35 at risk
EG0021 affected48 at risk
EG003
Chronic obstructive pulmonary disease
Respiratory, thoracic and mediastinal disorders
MedDRA v27.0
Non-systematic Assessment
EG0000 affected34 at risk
EG0010 affected35 at risk
EG0021 affected48 at risk
EG003
Venous thrombosis
Vascular disorders
MedDRA v27.0
Non-systematic Assessment
EG0000 affected34 at risk
EG0010 affected35 at risk
EG0021 affected48 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Abdominal pain
Gastrointestinal disorders
MedDRA v27.0
Non-systematic Assessment
EG0001 affected34 at risk
EG0014 affected35 at risk
EG0023 affected48 at risk
EG0032 affected42 at risk
EG0041 affected35 at risk
EG0052 affected31 at risk
EG0060 affected30 at risk
Abdominal pain upper
Gastrointestinal disorders
MedDRA v27.0
Non-systematic Assessment
EG0003 affected34 at risk
EG0010 affected35 at risk
EG0020 affected48 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA v27.0
Non-systematic Assessment
EG0000 affected34 at risk
EG0012 affected35 at risk
EG0021 affected48 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA v27.0
Non-systematic Assessment
EG0001 affected34 at risk
EG0013 affected35 at risk
EG0025 affected48 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA v27.0
Non-systematic Assessment
EG0002 affected34 at risk
EG0011 affected35 at risk
EG0025 affected48 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA v27.0
Non-systematic Assessment
EG0000 affected34 at risk
EG0011 affected35 at risk
EG0024 affected48 at risk
EG003
Fatigue
General disorders
MedDRA v27.0
Non-systematic Assessment
EG0000 affected34 at risk
EG0010 affected35 at risk
EG0024 affected48 at risk
EG003
Puncture site pain
General disorders
MedDRA v27.0
Non-systematic Assessment
EG0000 affected34 at risk
EG0012 affected35 at risk
EG0021 affected48 at risk
EG003
Pyrexia
General disorders
MedDRA v27.0
Non-systematic Assessment
EG0002 affected34 at risk
EG0011 affected35 at risk
EG0023 affected48 at risk
EG003
COVID-19
Infections and infestations
MedDRA v27.0
Non-systematic Assessment
EG0002 affected34 at risk
EG0012 affected35 at risk
EG0024 affected48 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA v27.0
Non-systematic Assessment
EG0001 affected34 at risk
EG0010 affected35 at risk
EG0020 affected48 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA v27.0
Non-systematic Assessment
EG0004 affected34 at risk
EG0011 affected35 at risk
EG0024 affected48 at risk
EG003
Sinusitis
Infections and infestations
MedDRA v27.0
Non-systematic Assessment
EG0000 affected34 at risk
EG0012 affected35 at risk
EG0021 affected48 at risk
EG003
Tooth abscess
Infections and infestations
MedDRA v27.0
Non-systematic Assessment
EG0000 affected34 at risk
EG0011 affected35 at risk
EG0020 affected48 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA v27.0
Non-systematic Assessment
EG0001 affected34 at risk
EG0011 affected35 at risk
EG0022 affected48 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA v27.0
Non-systematic Assessment
EG0001 affected34 at risk
EG0011 affected35 at risk
EG0020 affected48 at risk
EG003
Arthropod bite
Injury, poisoning and procedural complications
MedDRA v27.0
Non-systematic Assessment
EG0000 affected34 at risk
EG0011 affected35 at risk
EG0020 affected48 at risk
EG003
Procedural pain
Injury, poisoning and procedural complications
MedDRA v27.0
Non-systematic Assessment
EG0000 affected34 at risk
EG0010 affected35 at risk
EG0020 affected48 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA v27.0
Non-systematic Assessment
EG0002 affected34 at risk
EG0010 affected35 at risk
EG0020 affected48 at risk
EG003
SARS-CoV-2 test positive
Investigations
MedDRA v27.0
Non-systematic Assessment
EG0000 affected34 at risk
EG0011 affected35 at risk
EG0021 affected48 at risk
EG003
Diabetes mellitus inadequate control
Metabolism and nutrition disorders
MedDRA v27.0
Non-systematic Assessment
EG0004 affected34 at risk
EG0016 affected35 at risk
EG0025 affected48 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA v27.0
Non-systematic Assessment
EG0002 affected34 at risk
EG0010 affected35 at risk
EG0022 affected48 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA v27.0
Non-systematic Assessment
EG0000 affected34 at risk
EG0010 affected35 at risk
EG0023 affected48 at risk
EG003
Muscle spasms
Musculoskeletal and connective tissue disorders
MedDRA v27.0
Non-systematic Assessment
EG0000 affected34 at risk
EG0010 affected35 at risk
EG0021 affected48 at risk
EG003
Osteoarthritis
Musculoskeletal and connective tissue disorders
MedDRA v27.0
Non-systematic Assessment
EG0001 affected34 at risk
EG0012 affected35 at risk
EG0020 affected48 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA v27.0
Non-systematic Assessment
EG0001 affected34 at risk
EG0010 affected35 at risk
EG0022 affected48 at risk
EG003
Dizziness
Nervous system disorders
MedDRA v27.0
Non-systematic Assessment
EG0000 affected34 at risk
EG0010 affected35 at risk
EG0022 affected48 at risk
EG003
Headache
Nervous system disorders
MedDRA v27.0
Non-systematic Assessment
EG0004 affected34 at risk
EG0012 affected35 at risk
EG0025 affected48 at risk
EG003
Hypoaesthesia
Nervous system disorders
MedDRA v27.0
Non-systematic Assessment
EG0002 affected34 at risk
EG0011 affected35 at risk
EG0020 affected48 at risk
EG003
Postmenopausal haemorrhage
Reproductive system and breast disorders
MedDRA v27.0
Non-systematic Assessment
EG0001 affected34 at risk
EG0010 affected35 at risk
EG0020 affected48 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA v27.0
Non-systematic Assessment
EG0002 affected34 at risk
EG0011 affected35 at risk
EG0023 affected48 at risk
EG003
Nasal congestion
Respiratory, thoracic and mediastinal disorders
MedDRA v27.0
Non-systematic Assessment
EG0000 affected34 at risk
EG0010 affected35 at risk
EG0020 affected48 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA v27.0
Non-systematic Assessment
EG0000 affected34 at risk
EG0011 affected35 at risk
EG0020 affected48 at risk
EG003
Asteatosis
Skin and subcutaneous tissue disorders
MedDRA v27.0
Non-systematic Assessment
EG0000 affected34 at risk
EG0010 affected35 at risk
EG0020 affected48 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
The model was applied to the raw number of responders and non-responders utilizing a Bayesian methodology approach with non-informative priors as described in the SAP.
Risk Difference (RD)
0.10
2-Sided
90
-0.03
0.24
Reported values reflect a 90% Credible Interval rather than a 90% Confidence Interval.
Superiority
OG000
OG003
The model was applied to the raw number of responders and non-responders utilizing a Bayesian methodology approach with non-informative priors as described in the SAP.
Risk Difference (RD)
0.12
2-Sided
90
-0.03
0.26
Reported values reflect a 90% Credible Interval rather than a 90% Confidence Interval.
Superiority
OG000
OG004
The model was applied to the raw number of responders and non-responders utilizing a Bayesian methodology approach with non-informative priors as described in the SAP.
Risk Difference (RD)
0.13
2-Sided
90
-0.04
0.28
Reported values reflect a 90% Credible Interval rather than a 90% Confidence Interval.
Superiority
OG001
DGAT2i/PF-06865571 25 mg BID
Participants were randomized to receive 1 tablet of DGAT2i 25 milligrams (mg) along with 1 tablet of DGAT2i and ACCi matching placebo BID for 48 weeks by oral administration. Participants were followed up to 52 weeks.
OG002
DGAT2i/PF-06865571 75 mg BID
Participants were randomized to receive 1 tablet of DGAT2i 25 mg, 1 tablet of DGAT2i 50 mg and 1 tablet of ACCi matching placebo BID for 48 weeks by oral administration. Participants were followed up to 52 weeks.
OG003
DGAT2i/PF-06865571 150 mg BID
Participants were randomized to receive 1 tablet of DGAT2i matching placebo, 1 tablet of DGAT2i 150 mg and 1 tablet of ACCi matching placebo BID for 48 weeks by oral administration. Participants were followed up to 52 weeks.
Participants were randomized to receive 1 tablet of DGAT2i matching placebo, 1 tablet of DGAT2i 150 mg and 1 tablet of ACCi 5 mg BID for 48 weeks by oral administration. Participants were followed up to 52 weeks.
OG005
DGAT2i/PF-06865571 300 mg BID
Participants were randomized to receive 2 tablets of DGAT2i 150 mg and 1 tablet of ACCi matching placebo BID for 48 weeks by oral administration. Participants were followed up to 52 weeks.
Participants were randomized to receive 2 tablets of DGAT2i 150 mg and 1 tablet of ACCi 10 mg BID for 48 weeks by oral administration. Participants were followed up to 52 weeks.
Units
Counts
Participants
OG00034
OG00135
OG00248
OG00342
OG00435
OG00531
OG00630
Title
Denominators
Categories
Title
Measurements
OG00013(NA to NA)
OG00116(0.61 to 3.05)
OG00225(0.83 to 3.72)
OG00321(0.74 to 3.48)
OG00423(1.35 to 7.04)
OG00514(0.58 to 3.08)
OG00619(1.19 to 6.56)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG002
Risk difference and 2-sided 90% confidence interval for risk difference were calculated by using the observed placebo/corresponding BID rate and estimated odds ratio from the logistic regression model.
Risk Difference (RD)
0.14
2-Sided
90
-0.04
0.32
Superiority
OG000
OG001
Risk difference and 2-sided 90% confidence interval for risk difference were calculated by using the observed placebo/corresponding BID rate and estimated odds ratio from the logistic regression model.
Risk Difference (RD)
0.08
2-Sided
90
-0.11
0.27
Superiority
OG000
OG003
Risk difference and 2-sided 90% confidence interval for risk difference were calculated by using the observed placebo/corresponding BID rate and estimated odds ratio from the logistic regression model.
Risk Difference (RD)
0.12
2-Sided
90
-0.07
0.30
Superiority
OG000
OG004
Risk difference and 2-sided 90% confidence interval for risk difference were calculated by using the observed placebo/corresponding BID rate and estimated odds ratio from the logistic regression model.
Risk Difference (RD)
0.27
2-Sided
90
0.07
0.43
Superiority
OG000
OG005
Risk difference and 2-sided 90% confidence interval for risk difference were calculated by using the observed placebo/corresponding BID rate and estimated odds ratio from the logistic regression model.
Risk Difference (RD)
0.07
2-Sided
90
-0.12
0.27
Superiority
OG000
OG006
Risk difference and 2-sided 90% confidence interval for risk difference were calculated by using the observed placebo/corresponding BID rate and estimated odds ratio from the logistic regression model.
Risk Difference (RD)
0.25
2-Sided
90
0.04
0.42
Superiority
OG003
OG004
Risk difference and 2-sided 50% confidence interval for risk difference were calculated by using the observed placebo/corresponding BID rate and estimated odds ratio from the logistic regression model.
Risk Difference (RD)
0.16
2-Sided
50
0.08
0.23
Superiority
OG003
OG004
Risk difference and 2-sided 90% confidence interval for risk difference were calculated by using the observed placebo/corresponding BID rate and estimated odds ratio from the logistic regression model.
Risk Difference (RD)
0.16
2-Sided
90
-0.03
0.31
Superiority
OG005
OG006
Risk difference and 2-sided 50% confidence interval for risk difference were calculated by using the observed placebo/corresponding BID rate and estimated odds ratio from the logistic regression model.
Risk Difference (RD)
0.18
2-Sided
50
0.09
0.26
Superiority
OG005
OG006
Risk difference and 2-sided 90% confidence interval for risk difference were calculated by using the observed placebo/corresponding BID rate and estimated odds ratio from the logistic regression model.
Risk Difference (RD)
0.18
2-Sided
90
-0.03
0.35
Superiority
OG002
DGAT2i/PF-06865571 75 mg BID
Participants were randomized to receive 1 tablet of DGAT2i 25 mg, 1 tablet of DGAT2i 50 mg and 1 tablet of ACCi matching placebo BID for 48 weeks by oral administration. Participants were followed up to 52 weeks.
OG003
DGAT2i/PF-06865571 150 mg BID
Participants were randomized to receive 1 tablet of DGAT2i matching placebo, 1 tablet of DGAT2i 150 mg and 1 tablet of ACCi matching placebo BID for 48 weeks by oral administration. Participants were followed up to 52 weeks.
OG004
DGAT2i/PF-06865571 300 mg BID
Participants were randomized to receive 2 tablets of DGAT2i 150 mg and 1 tablet of ACCi matching placebo BID for 48 weeks by oral administration. Participants were followed up to 52 weeks.
Units
Counts
Participants
OG00015
OG00114
OG00221
OG00318
OG00411
Title
Denominators
Categories
Title
Measurements
OG000-10.79(-38.30 to 18.99)
OG001-36.76(-52.57 to -20.15)
OG002-46.20(-59.64 to -32.82)
OG003-51.33(-66.78 to -36.59)
OG004-55.53(-77.23 to -37.64)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Least Square (LS) Mean
-25.98
2-Sided
90
-58.42
-2.57
Superiority
OG000
OG002
LS Mean
-35.41
2-Sided
90
-69.41
-5.42
Superiority
OG000
OG003
LS Mean
-40.54
2-Sided
90
-75.55
-7.32
Superiority
OG000
OG004
LS Mean
-44.74
2-Sided
90
-81.72
-8.42
Superiority
OG003
DGAT2i/PF-06865571 150 mg BID
Participants were randomized to receive 1 tablet of DGAT2i matching placebo, 1 tablet of DGAT2i 150 mg and 1 tablet of ACCi matching placebo BID for 48 weeks by oral administration. Participants were followed up to 52 weeks.
Participants were randomized to receive 1 tablet of DGAT2i matching placebo, 1 tablet of DGAT2i 150 mg and 1 tablet of ACCi 5 mg BID for 48 weeks by oral administration. Participants were followed up to 52 weeks.
OG005
DGAT2i/PF-06865571 300 mg BID
Participants were randomized to receive 2 tablets of DGAT2i 150 mg and 1 tablet of ACCi matching placebo BID for 48 weeks by oral administration. Participants were followed up to 52 weeks.
Participants were randomized to receive 2 tablets of DGAT2i 150 mg and 1 tablet of ACCi 10 mg BID for 48 weeks by oral administration. Participants were followed up to 52 weeks.
Units
Counts
Participants
OG0009
OG00112
OG00218
OG00312
OG00411
OG0058
OG0068
Title
Denominators
Categories
Title
Measurements
OG0001.41± 22.11
OG001-41.00± 18.89
OG002-42.53± 15.66
OG003-58.77± 19.44
OG004-67.76± 19.93
OG005-49.76± 23.70
OG006-68.83± 23.72
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Log-transformed relative changes from baseline are modelled using an ANCOVA model with treatment and baseline fibrosis stage (F2/F3) as factors, and log-transformed baseline liver fat as a covariate.
LS Mean
-41.82
2-Sided
90
-62.57
-9.57
Superiority
OG000
OG002
Log-transformed relative changes from baseline are modelled using an ANCOVA model with treatment and baseline fibrosis stage (F2/F3) as factors, and log-transformed baseline liver fat as a covariate.
LS Mean
-43.33
2-Sided
90
-62.37
-14.64
Superiority
OG000
OG003
Log-transformed relative changes from baseline are modelled using an ANCOVA model with treatment and baseline fibrosis stage (F2/F3) as factors, and log-transformed baseline liver fat as a covariate.
LS Mean
-59.35
2-Sided
90
-73.95
-36.55
Superiority
OG000
OG004
Log-transformed relative changes from baseline are modelled using an ANCOVA model with treatment and baseline fibrosis stage (F2/F3) as factors, and log-transformed baseline liver fat as a covariate.
LS Mean
-68.21
2-Sided
90
-79.72
-50.15
Superiority
OG000
OG005
Log-transformed relative changes from baseline are modelled using an ANCOVA model with treatment and baseline fibrosis stage (F2/F3) as factors, and log-transformed baseline liver fat as a covariate.
LS Mean
-50.46
2-Sided
90
-69.53
-19.44
Superiority
OG000
OG006
Log-transformed relative changes from baseline are modelled using an ANCOVA model with treatment and baseline fibrosis stage (F2/F3) as factors, and log-transformed baseline liver fat as a covariate.
LS Mean
-69.27
2-Sided
90
-81.08
-50.07
Superiority
OG003
OG004
Log-transformed relative changes from baseline are modelled using an ANCOVA model with treatment and baseline fibrosis stage (F2/F3) as factors, and log-transformed baseline liver fat as a covariate.
LS Mean
-21.80
2-Sided
50
-34.02
-7.32
Superiority
OG003
OG004
Log-transformed relative changes from baseline are modelled using an ANCOVA model with treatment and baseline fibrosis stage (F2/F3) as factors, and log-transformed baseline liver fat as a covariate.
LS Mean
-21.80
2-Sided
90
-48.51
18.76
Superiority
OG005
OG006
Log-transformed relative changes from baseline are modelled using an ANCOVA model with treatment and baseline fibrosis stage (F2/F3) as factors, and log-transformed baseline liver fat as a covariate.
LS Mean
-37.97
2-Sided
50
-49.40
-23.95
Superiority
OG005
OG006
Log-transformed relative changes from baseline are modelled using an ANCOVA model with treatment and baseline fibrosis stage (F2/F3) as factors, and log-transformed baseline liver fat as a covariate.
LS Mean
-37.97
2-Sided
90
-62.41
2.37
Superiority
OG001
DGAT2i/PF-06865571 25 mg BID
Participants were randomized to receive 1 tablet of DGAT2i 25 milligrams (mg) along with 1 tablet of DGAT2i and ACCi matching placebo BID for 48 weeks by oral administration. Participants were followed up to 52 weeks.
OG002
DGAT2i/PF-06865571 75 mg BID
Participants were randomized to receive 1 tablet of DGAT2i 25 mg, 1 tablet of DGAT2i 50 mg and 1 tablet of ACCi matching placebo BID for 48 weeks by oral administration. Participants were followed up to 52 weeks.
OG003
DGAT2i/PF-06865571 150 mg BID
Participants were randomized to receive 1 tablet of DGAT2i matching placebo, 1 tablet of DGAT2i 150 mg and 1 tablet of ACCi matching placebo BID for 48 weeks by oral administration. Participants were followed up to 52 weeks.
OG004
DGAT2i/PF-06865571 300 mg BID
Participants were randomized to receive 2 tablets of DGAT2i 150 mg and 1 tablet of ACCi matching placebo BID for 48 weeks by oral administration. Participants were followed up to 52 weeks.
Units
Counts
Participants
OG00034
OG00135
OG00248
OG00342
OG00431
Title
Denominators
Categories
Title
Measurements
OG0000.11(0.04 to 0.20)
OG0010.32(0.23 to 0.40)
OG0020.37(0.31 to 0.44)
OG0030.40(0.33 to 0.47)
OG0040.41(0.34 to 0.50)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
The model was applied to the raw number of responders and non-responders utilizing a Bayesian methodology approach with non-informative priors as described in the SAP.
Risk Difference (RD)
0.21
2-Sided
90
0.09
0.32
Reported values reflect a 90% Credible Interval rather than a 90% Confidence Interval.
Superiority
OG000
OG002
The model was applied to the raw number of responders and non-responders utilizing a Bayesian methodology approach with non-informative priors as described in the SAP.
Risk Difference (RD)
0.27
2-Sided
90
0.15
0.37
Reported values reflect a 90% Credible Interval rather than a 90% Confidence Interval.
Superiority
OG000
OG003
The model was applied to the raw number of responders and non-responders utilizing a Bayesian methodology approach with non-informative priors as described in the SAP.
Risk Difference (RD)
0.29
2-Sided
90
0.18
0.39
Reported values reflect a 90% Credible Interval rather than a 90% Confidence Interval.
Superiority
OG000
OG004
The model was applied to the raw number of responders and non-responders utilizing a Bayesian methodology approach with non-informative priors as described in the SAP.
Risk Difference (RD)
0.31
2-Sided
90
0.19
0.42
Reported values reflect a 90% Credible Interval rather than a 90% Confidence Interval.
Superiority
OG001
DGAT2i/PF-06865571 25 mg BID
Participants were randomized to receive 1 tablet of DGAT2i 25 milligrams (mg) along with 1 tablet of DGAT2i and ACCi matching placebo BID for 48 weeks by oral administration. Participants were followed up to 52 weeks.
OG002
DGAT2i/PF-06865571 75 mg BID
Participants were randomized to receive 1 tablet of DGAT2i 25 mg, 1 tablet of DGAT2i 50 mg and 1 tablet of ACCi matching placebo BID for 48 weeks by oral administration. Participants were followed up to 52 weeks.
OG003
DGAT2i/PF-06865571 150 mg BID
Participants were randomized to receive 1 tablet of DGAT2i matching placebo, 1 tablet of DGAT2i 150 mg and 1 tablet of ACCi matching placebo BID for 48 weeks by oral administration. Participants were followed up to 52 weeks.
Participants were randomized to receive 1 tablet of DGAT2i matching placebo, 1 tablet of DGAT2i 150 mg and 1 tablet of ACCi 5 mg BID for 48 weeks by oral administration. Participants were followed up to 52 weeks.
OG005
DGAT2i/PF-06865571 300 mg BID
Participants were randomized to receive 2 tablets of DGAT2i 150 mg and 1 tablet of ACCi matching placebo BID for 48 weeks by oral administration. Participants were followed up to 52 weeks.
Participants were randomized to receive 2 tablets of DGAT2i 150 mg and 1 tablet of ACCi 10 mg BID for 48 weeks by oral administration. Participants were followed up to 52 weeks.
Units
Counts
Participants
OG00034
OG00135
OG00248
OG00342
OG00435
OG00531
OG00630
Title
Denominators
Categories
Title
Measurements
OG0003
OG00111
OG00222
OG00313
OG00422
OG00513
OG00617
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Risk difference and 2-sided 90% confidence interval for risk difference were calculated by using the observed placebo/corresponding BID rate and estimated odds ratio from the logistic regression model.
Risk Difference (RD)
0.23
2-Sided
90
0.04
0.51
Superiority
OG000
OG002
Risk difference and 2-sided 90% confidence interval for risk difference were calculated by using the observed placebo/corresponding BID rate and estimated odds ratio from the logistic regression model.
Risk Difference (RD)
0.37
2-Sided
90
0.13
0.63
Superiority
OG000
OG003
Risk difference and 2-sided 90% confidence interval for risk difference were calculated by using the observed placebo/corresponding BID rate and estimated odds ratio from the logistic regression model.
Risk Difference (RD)
0.22
2-Sided
90
0.04
0.49
Superiority
OG000
OG004
Risk difference and 2-sided 90% confidence interval for risk difference were calculated by using the observed placebo/corresponding BID rate and estimated odds ratio from the logistic regression model.
Risk Difference (RD)
0.54
2-Sided
90
0.26
0.75
Superiority
OG000
OG005
Risk difference and 2-sided 90% confidence interval for risk difference were calculated by using the observed placebo/corresponding BID rate and estimated odds ratio from the logistic regression model.
Risk Difference (RD)
0.34
2-Sided
90
0.10
0.61
Superiority
OG000
OG006
Risk difference and 2-sided 90% confidence interval for risk difference were calculated by using the observed placebo/corresponding BID rate and estimated odds ratio from the logistic regression model.
Risk Difference (RD)
0.48
2-Sided
90
0.20
0.72
Superiority
OG003
OG004
Risk difference and 2-sided 50% confidence interval for risk difference were calculated by using the observed placebo/corresponding BID rate and estimated odds ratio from the logistic regression model.
Risk Difference (RD)
0.32
2-Sided
50
0.24
0.39
Superiority
OG003
OG004
Risk difference and 2-sided 90% confidence interval for risk difference were calculated by using the observed placebo/corresponding BID rate and estimated odds ratio from the logistic regression model.
Risk Difference (RD)
0.32
2-Sided
90
0.12
0.48
Superiority
OG005
OG006
Risk difference and 2-sided 50% confidence interval for risk difference were calculated by using the observed placebo/corresponding BID rate and estimated odds ratio from the logistic regression model.
Risk Difference (RD)
0.14
2-Sided
50
0.06
0.23
Superiority
OG005
OG006
Risk difference and 2-sided 90% confidence interval for risk difference were calculated by using the observed placebo/corresponding BID rate and estimated odds ratio from the logistic regression model.
Risk Difference (RD)
0.14
2-Sided
90
-0.06
0.33
Superiority
OG001
DGAT2i/PF-06865571 25 mg BID
Participants were randomized to receive 1 tablet of DGAT2i 25 milligrams (mg) along with 1 tablet of DGAT2i and ACCi matching placebo BID for 48 weeks by oral administration. Participants were followed up to 52 weeks.
OG002
DGAT2i/PF-06865571 75 mg BID
Participants were randomized to receive 1 tablet of DGAT2i 25 mg, 1 tablet of DGAT2i 50 mg and 1 tablet of ACCi matching placebo BID for 48 weeks by oral administration. Participants were followed up to 52 weeks.
OG003
DGAT2i/PF-06865571 150 mg BID
Participants were randomized to receive 1 tablet of DGAT2i matching placebo, 1 tablet of DGAT2i 150 mg and 1 tablet of ACCi matching placebo BID for 48 weeks by oral administration. Participants were followed up to 52 weeks.
OG004
DGAT2i/PF-06865571 300 mg BID
Participants were randomized to receive 2 tablets of DGAT2i 150 mg and 1 tablet of ACCi matching placebo BID for 48 weeks by oral administration. Participants were followed up to 52 weeks.
Units
Counts
Participants
OG00034
OG00135
OG00248
OG00342
OG00431
Title
Denominators
Categories
Title
Measurements
OG0000.33(0.22 to 0.45)
OG0010.28(0.21 to 0.35)
OG0020.25(0.20 to 0.31)
OG0030.24(0.18 to 0.30)
OG0040.22(0.14 to 0.30)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
The model was applied to the raw number of responders and non-responders utilizing a Bayesian methodology approach with non-informative priors as described in the SAP.
Risk Difference (RD)
-0.05
2-Sided
90
-0.16
0.02
Reported values reflect a 90% Credible Interval rather than a 90% Confidence Interval.
Superiority
OG000
OG002
The model was applied to the raw number of responders and non-responders utilizing a Bayesian methodology approach with non-informative priors as described in the SAP.
Risk Difference (RD)
-0.07
2-Sided
90
-0.20
0.03
Reported values reflect a 90% Credible Interval rather than a 90% Confidence Interval.
Superiority
OG000
OG003
The model was applied to the raw number of responders and non-responders utilizing a Bayesian methodology approach with non-informative priors as described in the SAP.
Risk Difference (RD)
-0.09
2-Sided
90
-0.23
0.04
Reported values reflect a 90% Credible Interval rather than a 90% Confidence Interval.
Superiority
OG000
OG004
The model was applied to the raw number of responders and non-responders utilizing a Bayesian methodology approach with non-informative priors as described in the SAP.
Risk Difference (RD)
-0.10
2-Sided
90
-0.26
0.05
Reported values reflect a 90% Credible Interval rather than a 90% Confidence Interval.
Superiority
OG002
DGAT2i/PF-06865571 75 mg BID
Participants were randomized to receive 1 tablet of DGAT2i 25 mg, 1 tablet of DGAT2i 50 mg and 1 tablet of ACCi matching placebo BID for 48 weeks by oral administration. Participants were followed up to 52 weeks.
OG003
DGAT2i/PF-06865571 150 mg BID
Participants were randomized to receive 1 tablet of DGAT2i matching placebo, 1 tablet of DGAT2i 150 mg and 1 tablet of ACCi matching placebo BID for 48 weeks by oral administration. Participants were followed up to 52 weeks.
Participants were randomized to receive 1 tablet of DGAT2i matching placebo, 1 tablet of DGAT2i 150 mg and 1 tablet of ACCi 5 mg BID for 48 weeks by oral administration. Participants were followed up up to 52 weeks.
OG005
DGAT2i/PF-06865571 300 mg BID
Participants were randomized to receive 2 tablets of DGAT2i 150 mg and 1 tablet of ACCi matching placebo BID for 48 weeks by oral administration. Participants were followed up to 52 weeks.
Participants were randomized to receive 2 tablets of DGAT2i 150 mg and 1 tablet of ACCi 10 mg BID for 48 weeks by oral administration. Participants were followed up to 52 weeks.
Units
Counts
Participants
OG00034
OG00135
OG00248
OG00342
OG00435
OG00531
OG00630
Title
Denominators
Categories
Title
Measurements
OG00012
OG00110
OG00210
OG00314
OG00413
OG0054
OG00612
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Risk difference and 2-sided 90% confidence interval for risk difference were calculated by using the observed placebo/corresponding BID rate and estimated odds ratio from the logistic regression model.
Risk Difference (RD)
-0.07
2-Sided
90
-0.21
0.13
Superiority
OG000
OG002
Risk difference and 2-sided 90% confidence interval for risk difference were calculated by using the observed placebo/corresponding BID rate and estimated odds ratio from the logistic regression model.
Risk Difference (RD)
-0.14
2-Sided
90
-0.25
0.02
Superiority
OG000
OG003
Risk difference and 2-sided 90% confidence interval for risk difference were calculated by using the observed placebo/corresponding BID rate and estimated odds ratio from the logistic regression model.
Risk Difference (RD)
-0.02
2-Sided
90
-0.17
0.17
Superiority
OG000
OG004
Risk difference and 2-sided 90% confidence interval for risk difference were calculated by using the observed placebo/corresponding BID rate and estimated odds ratio from the logistic regression model.
Risk Difference (RD)
0.02
2-Sided
90
-0.15
0.22
Superiority
OG000
OG005
Risk difference and 2-sided 90% confidence interval for risk difference were calculated by using the observed placebo/corresponding BID rate and estimated odds ratio from the logistic regression model.
Risk Difference (RD)
-0.22
2-Sided
90
-0.30
-0.05
Superiority
OG000
OG006
Risk difference and 2-sided 90% confidence interval for risk difference were calculated by using the observed placebo/corresponding BID rate and estimated odds ratio from the logistic regression model.
Risk Difference (RD)
0.05
2-Sided
90
-0.13
0.26
Superiority
OG003
OG004
Risk difference and 2-sided 50% confidence interval for risk difference were calculated by using the observed placebo/corresponding BID rate and estimated odds ratio from the logistic regression model.
Risk Difference (RD)
0.04
2-Sided
50
-0.03
0.12
Superiority
OG003
OG004
Risk difference and 2-sided 90% confidence interval for risk difference were calculated by using the observed placebo/corresponding BID rate and estimated odds ratio from the logistic regression model.
Risk Difference (RD)
0.04
2-Sided
90
-0.12
0.23
Superiority
OG005
OG006
Risk difference and 2-sided 50% confidence interval for risk difference were calculated by using the observed placebo/corresponding BID rate and estimated odds ratio from the logistic regression model.
Risk Difference (RD)
0.27
2-Sided
50
0.17
0.38
Superiority
OG005
OG006
Risk difference and 2-sided 90% confidence interval for risk difference were calculated by using the observed placebo/corresponding BID rate and estimated odds ratio from the logistic regression model.
Risk Difference (RD)
0.27
2-Sided
90
0.06
0.53
Superiority
OG001
DGAT2i/PF-06865571 25 mg BID
Participants were randomized to receive 1 tablet of DGAT2i 25 milligrams (mg) along with 1 tablet of DGAT2i and ACCi matching placebo BID for 48 weeks by oral administration. Participants were followed up to 52 weeks.
OG002
DGAT2i/PF-06865571 75 mg BID
Participants were randomized to receive 1 tablet of DGAT2i 25 mg, 1 tablet of DGAT2i 50 mg and 1 tablet of ACCi matching placebo BID for 48 weeks by oral administration. Participants were followed up to 52 weeks.
OG003
DGAT2i/PF-06865571 150 mg BID
Participants were randomized to receive 1 tablet of DGAT2i matching placebo, 1 tablet of DGAT2i 150 mg and 1 tablet of ACCi matching placebo BID for 48 weeks by oral administration. Participants were followed up to 52 weeks.
OG004
DGAT2i/PF-06865571 300 mg BID
Participants were randomized to receive 2 tablets of DGAT2i 150 mg and 1 tablet of ACCi matching placebo BID for 48 weeks by oral administration. Participants were followed up to 52 weeks.
Units
Counts
Participants
OG00034
OG00135
OG00248
OG00342
OG00431
Title
Denominators
Categories
Title
Measurements
OG0000.05(0.01 to 0.10)
OG0010.08(0.04 to 0.11)
OG0020.09(0.05 to 0.12)
OG0030.09(0.06 to 0.14)
OG0040.10(0.06 to 0.16)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
The model was applied to the raw number of responders and non-responders utilizing a Bayesian methodology approach with non-informative priors as described in the SAP.
Risk Difference (RD)
0.03
2-Sided
90
-0.01
0.08
Reported values reflect a 90% Credible Interval rather than a 90% Confidence Interval.
Superiority
OG000
OG002
The model was applied to the raw number of responders and non-responders utilizing a Bayesian methodology approach with non-informative priors as described in the SAP.
Risk Difference (RD)
0.04
2-Sided
90
-0.02
0.09
Reported values reflect a 90% Credible Interval rather than a 90% Confidence Interval.
Superiority
OG000
OG003
The model was applied to the raw number of responders and non-responders utilizing a Bayesian methodology approach with non-informative priors as described in the SAP.
Risk Difference (RD)
0.05
2-Sided
90
-0.02
0.11
Reported values reflect a 90% Credible Interval rather than a 90% Confidence Interval.
Superiority
OG000
OG004
The model was applied to the raw number of responders and non-responders utilizing a Bayesian methodology approach with non-informative priors as described in the SAP.
Risk Difference (RD)
0.05
2-Sided
90
-0.02
0.12
Reported values reflect a 90% Credible Interval rather than a 90% Confidence Interval.
Superiority
OG001
DGAT2i/PF-06865571 25 mg BID
Participants were randomized to receive 1 tablet of DGAT2i 25 milligrams (mg) along with 1 tablet of DGAT2i and ACCi matching placebo BID for 48 weeks by oral administration. Participants were followed up to 52 weeks.
OG002
DGAT2i/PF-06865571 75 mg BID
Participants were randomized to receive 1 tablet of DGAT2i 25 mg, 1 tablet of DGAT2i 50 mg and 1 tablet of ACCi matching placebo BID for 48 weeks by oral administration. Participants were followed up to 52 weeks.
OG003
DGAT2i/PF-06865571 150 mg BID
Participants were randomized to receive 1 tablet of DGAT2i matching placebo, 1 tablet of DGAT2i 150 mg and 1 tablet of ACCi matching placebo BID for 48 weeks by oral administration. Participants were followed up to 52 weeks.
Participants were randomized to receive 1 tablet of DGAT2i matching placebo, 1 tablet of DGAT2i 150 mg and 1 tablet of ACCi 5 mg BID for 48 weeks by oral administration. Participants were followed up to 52 weeks.
OG005
DGAT2i/PF-06865571 300 mg BID
Participants were randomized to receive 2 tablets of DGAT2i 150 mg and 1 tablet of ACCi matching placebo BID for 48 weeks by oral administration. Participants were followed up to 52 weeks.
Participants were randomized to receive 2 tablets of DGAT2i 150 mg and 1 tablet of ACCi 10 mg BID for 48 weeks by oral administration. Participants were followed up to 52 weeks.
Units
Counts
Participants
OG00034
OG00135
OG00248
OG00342
OG00435
OG00531
OG00630
Title
Denominators
Categories
Title
Measurements
OG0001
OG0014
OG0023
OG0035
OG0047
OG0052
OG0066
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Risk difference and 2-sided 90% confidence interval for risk difference were calculated by using the observed placebo/corresponding BID rate and estimated odds ratio from the logistic regression model.
Risk Difference (RD)
0.09
2-Sided
90
-0.01
0.43
Superiority
OG000
OG002
Risk difference and 2-sided 90% confidence interval for risk difference were calculated by using the observed placebo/corresponding BID rate and estimated odds ratio from the logistic regression model.
Risk Difference (RD)
0.03
2-Sided
90
-0.02
0.29
Superiority
OG000
OG003
Risk difference and 2-sided 90% confidence interval for risk difference were calculated by using the observed placebo/corresponding BID rate and estimated odds ratio from the logistic regression model.
Risk Difference (RD)
0.09
2-Sided
90
-0.01
0.43
Superiority
OG000
OG004
Risk difference and 2-sided 90% confidence interval for risk difference were calculated by using the observed placebo/corresponding BID rate and estimated odds ratio from the logistic regression model.
Risk Difference (RD)
0.17
2-Sided
90
0.01
0.57
Superiority
OG000
OG005
Risk difference and 2-sided 90% confidence interval for risk difference were calculated by using the observed placebo/corresponding BID rate and estimated odds ratio from the logistic regression model.
Risk Difference (RD)
0.04
2-Sided
90
-0.02
0.33
Superiority
OG000
OG006
Risk difference and 2-sided 90% confidence interval for risk difference were calculated by using the observed placebo/corresponding BID rate and estimated odds ratio from the logistic regression model.
Risk Difference (RD)
0.17
2-Sided
90
0.01
0.58
Superiority
OG003
OG004
Risk difference and 2-sided 50% confidence interval for risk difference were calculated by using the observed placebo/corresponding BID rate and estimated odds ratio from the logistic regression model.
Risk Difference (RD)
0.08
2-Sided
50
0.02
0.16
Superiority
OG003
OG004
Risk difference and 2-sided 90% confidence interval for risk difference were calculated by using the observed placebo/corresponding BID rate and estimated odds ratio from the logistic regression model.
Risk Difference (RD)
0.08
2-Sided
90
-0.04
0.30
Superiority
OG005
OG006
Risk difference and 2-sided 50% confidence interval for risk difference were calculated by using the observed placebo/corresponding BID rate and estimated odds ratio from the logistic regression model.
Risk Difference (RD)
0.13
2-Sided
50
0.06
0.24
Superiority
OG005
OG006
Risk difference and 2-sided 90% confidence interval for risk difference were calculated by using the observed placebo/corresponding BID rate and estimated odds ratio from the logistic regression model.
Risk Difference (RD)
0.13
2-Sided
90
-0.01
0.44
Superiority
OG001
DGAT2i/PF-06865571 25 mg BID
Participants were randomized to receive 1 tablet of DGAT2i 25 milligrams (mg) along with 1 tablet of DGAT2i and ACCi matching placebo BID for 48 weeks by oral administration. Participants were followed up to 52 weeks.
OG002
DGAT2i/PF-06865571 75 mg BID
Participants were randomized to receive 1 tablet of DGAT2i 25 mg, 1 tablet of DGAT2i 50 mg and 1 tablet of ACCi matching placebo BID for 48 weeks by oral administration. Participants were followed up to 52 weeks.
OG003
DGAT2i/PF-06865571 150 mg BID
Participants were randomized to receive 1 tablet of DGAT2i matching placebo, 1 tablet of DGAT2i 150 mg and 1 tablet of ACCi matching placebo BID for 48 weeks by oral administration. Participants were followed up to 52 weeks.
OG004
DGAT2i/PF-06865571 300 mg BID
Participants were randomized to receive 2 tablets of DGAT2i 150 mg and 1 tablet of ACCi matching placebo BID for 48 weeks by oral administration. Participants were followed up to 52 weeks.
Units
Counts
Participants
OG00034
OG00135
OG00248
OG00342
OG00431
Title
Denominators
Categories
Title
Measurements
OG0000.24(0.13 to 0.37)
OG0010.42(0.33 to 0.50)
OG0020.47(0.40 to 0.54)
OG0030.49(0.42 to 0.57)
OG0040.51(0.43 to 0.59)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
The model was applied to the raw number of responders and non-responders utilizing a Bayesian methodology approach with non-informative priors as described in the SAP.
Risk Difference (RD)
0.18
2-Sided
90
0.05
0.31
Reported values reflect a 90% Credible Interval rather than a 90% Confidence Interval.
Superiority
OG000
OG002
The model was applied to the raw number of responders and non-responders utilizing a Bayesian methodology approach with non-informative priors as described in the SAP.
Risk Difference (RD)
0.23
2-Sided
90
0.09
0.36
Reported values reflect a 90% Credible Interval rather than a 90% Confidence Interval.
Superiority
OG000
OG003
The model was applied to the raw number of responders and non-responders utilizing a Bayesian methodology approach with non-informative priors as described in the SAP.
Risk Difference (RD)
0.25
2-Sided
90
0.10
0.38
Reported values reflect a 90% Credible Interval rather than a 90% Confidence Interval.
Superiority
OG000
OG004
The model was applied to the raw number of responders and non-responders utilizing a Bayesian methodology approach with non-informative priors as described in the SAP.
Risk Difference (RD)
0.27
2-Sided
90
0.11
0.40
Reported values reflect a 90% Credible Interval rather than a 90% Confidence Interval.
Superiority
DGAT2i/PF-06865571 25 mg BID
Participants were randomized to receive 1 tablet of DGAT2i 25 milligrams (mg) along with 1 tablet of DGAT2i and ACCi matching placebo BID for 48 weeks by oral administration. Participants were followed up to 52 weeks.
OG002
DGAT2i/PF-06865571 75 mg BID
Participants were randomized to receive 1 tablet of DGAT2i 25 mg, 1 tablet of DGAT2i 50 mg and 1 tablet of ACCi matching placebo BID for 48 weeks by oral administration. Participants were followed up to 52 weeks.
OG003
DGAT2i/PF-06865571 150 mg BID
Participants were randomized to receive 1 tablet of DGAT2i matching placebo, 1 tablet of DGAT2i 150 mg and 1 tablet of ACCi matching placebo BID for 48 weeks by oral administration. Participants were followed up to 52 weeks.
Participants were randomized to receive 1 tablet of DGAT2i matching placebo, 1 tablet of DGAT2i 150 mg and 1 tablet of ACCi 5 mg BID for 48 weeks by oral administration. Participants were followed up to 52 weeks.
OG005
DGAT2i/PF-06865571 300 mg BID
Participants were randomized to receive 2 tablets of DGAT2i 150 mg and 1 tablet of ACCi matching placebo BID for 48 weeks by oral administration. Participants were followed up to 52 weeks.
Participants were randomized to receive 2 tablets of DGAT2i 150 mg and 1 tablet of ACCi 10 mg BID for 48 weeks by oral administration. Participants were followed up to 52 weeks.
Units
Counts
Participants
OG00034
OG00135
OG00248
OG00342
OG00435
OG00531
OG00630
Title
Denominators
Categories
Title
Measurements
OG0008
OG00113
OG00228
OG00321
OG00425
OG00512
OG00619
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Risk difference and 2-sided 90% confidence interval for risk difference were calculated by using the observed placebo/corresponding BID rate and estimated odds ratio from the logistic regression model.
Risk Difference (RD)
0.14
2-Sided
90
-0.04
0.36
Superiority
OG000
OG002
Risk difference and 2-sided 90% confidence interval for risk difference were calculated by using the observed placebo/corresponding BID rate and estimated odds ratio from the logistic regression model.
Risk Difference (RD)
0.35
2-Sided
90
0.15
0.53
Superiority
OG000
OG003
Risk difference and 2-sided 90% confidence interval for risk difference were calculated by using the observed placebo/corresponding BID rate and estimated odds ratio from the logistic regression model.
Risk Difference (RD)
0.26
2-Sided
90
0.06
0.46
Superiority
OG000
OG004
Risk difference and 2-sided 90% confidence interval for risk difference were calculated by using the observed placebo/corresponding BID rate and estimated odds ratio from the logistic regression model.
Risk Difference (RD)
0.48
2-Sided
90
0.27
0.63
Superiority
OG000
OG005
Risk difference and 2-sided 90% confidence interval for risk difference were calculated by using the observed placebo/corresponding BID rate and estimated odds ratio from the logistic regression model.
Risk Difference (RD)
0.16
2-Sided
90
-0.03
0.38
Superiority
OG000
OG006
Risk difference and 2-sided 90% confidence interval for risk difference were calculated by using the observed placebo/corresponding BID rate and estimated odds ratio from the logistic regression model.
Risk Difference (RD)
0.40
2-Sided
90
0.18
0.58
Superiority
OG003
OG004
Risk difference and 2-sided 50% confidence interval for risk difference were calculated by using the observed placebo/corresponding BID rate and estimated odds ratio from the logistic regression model.
Risk Difference (RD)
0.22
2-Sided
50
0.15
0.28
Superiority
OG003
OG004
Risk difference and 2-sided 90% confidence interval for risk difference were calculated by using the observed placebo/corresponding BID rate and estimated odds ratio from the logistic regression model.
Risk Difference (RD)
0.22
2-Sided
90
0.03
0.35
Superiority
OG005
OG006
Risk difference and 2-sided 50% confidence interval for risk difference were calculated by using the observed placebo/corresponding BID rate and estimated odds ratio from the logistic regression model.
Risk Difference (RD)
0.24
2-Sided
50
0.16
0.32
Superiority
OG005
OG006
Risk difference and 2-sided 90% confidence interval for risk difference were calculated by using the observed placebo/corresponding BID rate and estimated odds ratio from the logistic regression model.
Risk Difference (RD)
0.24
2-Sided
90
0.03
0.42
Superiority
Participants were randomized to receive 1 tablet of DGAT2i 25 milligrams (mg) along with 1 tablet of DGAT2i and ACCi matching placebo BID for 48 weeks by oral administration. Participants were followed up to 52 weeks.
OG002
DGAT2i/PF-06865571 75 mg BID
Participants were randomized to receive 1 tablet of DGAT2i 25 mg, 1 tablet of DGAT2i 50 mg and 1 tablet of ACCi matching placebo BID for 48 weeks by oral administration. Participants were followed up to 52 weeks.
OG003
DGAT2i/PF-06865571 150 mg BID
Participants were randomized to receive 1 tablet of DGAT2i matching placebo, 1 tablet of DGAT2i 150 mg and 1 tablet of ACCi matching placebo BID for 48 weeks by oral administration. Participants were followed up to 52 weeks.
Participants were randomized to receive 1 tablet of DGAT2i matching placebo, 1 tablet of DGAT2i 150 mg and 1 tablet of ACCi 5 mg BID for 48 weeks by oral administration. Participants were followed up up to 52 weeks.
OG005
DGAT2i/PF-06865571 300 mg BID
Participants were randomized to receive 2 tablets of DGAT2i 150 mg and 1 tablet of ACCi matching placebo BID for 48 weeks by oral administration. Participants were followed up to 52 weeks.
Participants were randomized to receive 2 tablets of DGAT2i 150 mg and 1 tablet of ACCi 10 mg BID for 48 weeks by oral administration. Participants were followed up to 52 weeks.
Units
Counts
Participants
OG00034
OG00135
OG00248
OG00342
OG00435
OG00531
OG00630
Title
Denominators
Categories
Title
Measurements
OG00026
OG00125
OG00238
OG00330
OG00425
OG00526
OG00623
OG001
DGAT2i/PF-06865571 25 mg BID
Participants were randomized to receive 1 tablet of DGAT2i 25 milligrams (mg) along with 1 tablet of DGAT2i and ACCi matching placebo BID for 48 weeks by oral administration. Participants were followed up to 52 weeks.
OG002
DGAT2i/PF-06865571 75 mg BID
Participants were randomized to receive 1 tablet of DGAT2i 25 mg, 1 tablet of DGAT2i 50 mg and 1 tablet of ACCi matching placebo BID for 48 weeks by oral administration. Participants were followed up to 52 weeks.
OG003
DGAT2i/PF-06865571 150 mg BID
Participants were randomized to receive 1 tablet of DGAT2i matching placebo, 1 tablet of DGAT2i 150 mg and 1 tablet of ACCi matching placebo BID for 48 weeks by oral administration. Participants were followed up to 52 weeks.
Participants were randomized to receive 1 tablet of DGAT2i matching placebo, 1 tablet of DGAT2i 150 mg and 1 tablet of ACCi 5 mg BID for 48 weeks by oral administration. Participants were followed up to 52 weeks.
OG005
DGAT2i/PF-06865571 300 mg BID
Participants were randomized to receive 2 tablets of DGAT2i 150 mg and 1 tablet of ACCi matching placebo BID for 48 weeks by oral administration. Participants were followed up to 52 weeks.
Participants were randomized to receive 2 tablets of DGAT2i 150 mg and 1 tablet of ACCi 10 mg BID for 48 weeks by oral administration. Participants were followed up to 52 weeks.
Units
Counts
Participants
OG00034
OG00134
OG00248
OG00342
OG00435
OG00531
OG00630
Title
Denominators
Categories
Title
Measurements
OG00031
OG00132
OG00246
OG00339
OG00434
OG00527
OG00630
Participants were randomized to receive 1 tablet of DGAT2i 25 mg, 1 tablet of DGAT2i 50 mg and 1 tablet of ACCi matching placebo BID for 48 weeks by oral administration. Participants were followed up to 52 weeks.
OG003
DGAT2i/PF-06865571 150 mg BID
Participants were randomized to receive 1 tablet of DGAT2i matching placebo, 1 tablet of DGAT2i 150 mg and 1 tablet of ACCi matching placebo BID for 48 weeks by oral administration. Participants were followed up to 52 weeks.
Participants were randomized to receive 1 tablet of DGAT2i matching placebo, 1 tablet of DGAT2i 150 mg and 1 tablet of ACCi 5 mg BID for 48 weeks by oral administration. Participants were followed up to 52 weeks.
OG005
DGAT2i/PF-06865571 300 mg BID
Participants were randomized to receive 2 tablets of DGAT2i 150 mg and 1 tablet of ACCi matching placebo BID for 48 weeks by oral administration. Participants were followed up to 52 weeks.
Participants were randomized to receive 2 tablets of DGAT2i 150 mg and 1 tablet of ACCi 10 mg BID for 48 weeks by oral administration. Participants were followed up to 52 weeks.
Units
Counts
Participants
OG00034
OG00134
OG00248
OG00342
OG00435
OG00531
OG00630
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
Participants were randomized to receive 1 tablet of DGAT2i 25 mg, 1 tablet of DGAT2i 50 mg and 1 tablet of ACCi matching placebo BID for 48 weeks by oral administration. Participants were followed up to 52 weeks.
OG003
DGAT2i/PF-06865571 150 mg BID
Participants were randomized to receive 1 tablet of DGAT2i matching placebo, 1 tablet of DGAT2i 150 mg and 1 tablet of ACCi matching placebo BID for 48 weeks by oral administration. Participants were followed up to 52 weeks.
Participants were randomized to receive 1 tablet of DGAT2i matching placebo, 1 tablet of DGAT2i 150 mg and 1 tablet of ACCi 5 mg BID for 48 weeks by oral administration. Participants were followed up to 52 weeks.
OG005
DGAT2i/PF-06865571 300 mg BID
Participants were randomized to receive 2 tablets of DGAT2i 150 mg and 1 tablet of ACCi matching placebo BID for 48 weeks by oral administration. Participants were followed up to 52 weeks.
Participants were randomized to receive 2 tablets of DGAT2i 150 mg and 1 tablet of ACCi 10 mg BID for 48 weeks by oral administration. Participants were followed up to 52 weeks.