Study to Evaluate the Safety and Efficacy of Selonsertib,... | NCT03449446 | Trialant
NCT03449446
Sponsor
Gilead Sciences
Status
Completed
Last Update Posted
Dec 3, 2020Actual
Enrollment
395Actual
Phase
Phase 2
Conditions
Nonalcoholic Steatohepatitis
Interventions
SEL
FIR
CILO
Placebo to match FIR
Placebo to match CILO
Placebo to match SEL
Countries
United States
Australia
Canada
Hong Kong
New Zealand
Puerto Rico
Protocol Section
Identification Module
NCT ID
NCT03449446
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
GS-US-454-4378
Secondary IDs
Not provided
Brief Title
Study to Evaluate the Safety and Efficacy of Selonsertib, Firsocostat, Cilofexor, and Combinations in Participants With Bridging Fibrosis or Compensated Cirrhosis Due to Nonalcoholic Steatohepatitis (NASH)
Official Title
A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Selonsertib, GS-0976, GS-9674, and Combinations in Subjects With Bridging (F3) Fibrosis or Compensated Cirrhosis (F4) Due to Nonalcoholic Steatohepatitis (NASH)
Acronym
ATLAS
Organization
Gilead SciencesINDUSTRY
Status Module
Record Verification Date
Dec 2020
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
Mar 21, 2018Actual
Primary Completion Date
Oct 30, 2019Actual
Completion Date
Nov 19, 2019Actual
First Submitted Date
Feb 23, 2018
First Submission Date that Met QC Criteria
Feb 23, 2018
First Posted Date
Feb 28, 2018Actual
Results Waived
Not provided
Results First Submitted Date
Oct 16, 2020
Results First Submitted that Met QC Criteria
Dec 1, 2020
Results First Posted Date
Dec 3, 2020Actual
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
Dec 1, 2020
Last Update Posted Date
Dec 3, 2020Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Gilead SciencesINDUSTRY
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
Yes
FDAAA801 Violation
Not provided
Description Module
Brief Summary
The primary objectives of this study are:
To assess the safety and tolerability of selonsertib (SEL), firsocostat (FIR) and cilofexor (CILO), administered alone or in combination, in participants with bridging fibrosis or compensated cirrhosis due to NASH
To evaluate changes in liver fibrosis, without worsening of NASH
Detailed Description
Not provided
Conditions Module
Conditions
Nonalcoholic Steatohepatitis
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
395Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Selonsertib (SEL)
Experimental
Participants will receive SEL + placebo to match firsocostat 20 mg tablet + placebo to match cilofexor 30 mg tablet orally once daily for 48 weeks.
Drug: SEL
Drug: Placebo to match FIR
Drug: Placebo to match CILO
Firsocostat (FIR)
Experimental
Participants will receive placebo to match SEL 18 mg tablet + FIR + placebo to match CILO 30 mg tablet orally once daily for 48 weeks.
Drug: FIR
Drug: Placebo to match CILO
Drug: Placebo to match SEL
Cilofexor (CILO)
Experimental
Participants will receive placebo to match SEL 18 mg tablet + placebo to match FIR 20 mg tablet + CILO orally once daily for 48 weeks.
Drug: CILO
Drug: Placebo to match FIR
Drug: Placebo to match SEL
Selonsertib (SEL) + Firsocostat (FIR)
Experimental
Participants will receive SEL + FIR + placebo to match CILO 30 mg tablet orally once daily for 48 weeks.
Drug: SEL
Drug: FIR
Drug: Placebo to match CILO
Selonsertib (SEL) + Cilofexor (CILO)
Experimental
Participants will receive SEL + placebo to match FIR 20 mg tablet + CILO orally once daily for 48 weeks.
Interventions
Name
Type
Description
Arm Group Labels
Other Names
SEL
Drug
18 mg tablet administered orally once daily without regard to food
Selonsertib (SEL)
Selonsertib (SEL) + Cilofexor (CILO)
Selonsertib (SEL) + Firsocostat (FIR)
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Percentage of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs)
First dose date up to 48 weeks plus 30 days
Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities
Treatment-emergent laboratory abnormalities were defined as values that increase at least one toxicity grade from baseline. Participants with any laboratory abnormality were reported.
First dose date up to 48 weeks plus 30 days
Percentage of Participants Who Achieved a ≥ 1-Stage Improvement in Fibrosis Without Worsening of NASH at Week 48
Fibrosis improvement was defined as ≥ 1-stage decrease from baseline in fibrosis according to the NASH clinical research network classification (CRN) classification. Worsening of NASH was defined as ≥ 1-point increase from baseline in hepatocellular ballooning or lobular inflammation. The 95% CI was based on the Clopper-Pearson method.
Week 48
Secondary Outcomes
Not provided
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Key Inclusion Criteria:
Liver biopsy consistent with NASH and F3 or F4 in the opinion of the central reader
In participants who have never had a liver biopsy, liver stiffness by FibroScan® ≥ 14.0 kPa and Enhanced Liver Fibrosis (ELF™) Test score ≥ 9.8 at Screening
Screening laboratory parameters, as determined by the central laboratory:
Estimated glomerular filtration rate (eGFR) ≥ 60 mL/min, as calculated by the Cockcroft-Gault equation
Hemoglobin A1c (HbA1c) ≤ 9.5%
Alanine aminotransferase (ALT) < 5 x Upper Limits of Normal (ULN)
Platelet count ≥ 125,000/μL
Key Exclusion Criteria:
Prior history of decompensated liver disease including ascites, hepatic encephalopathy, or variceal bleeding
Child-Pugh (CP) score > 6 at Screening, unless due to an alternative etiology such as Gilbert's syndrome or therapeutic anticoagulation
Model for End-Stage Liver Disease (MELD) score > 12 at Screening, unless due to an alternate etiology such as therapeutic anticoagulation
Other causes of liver disease based on medical history and/or centralized review of liver histology, including but not limited to: alcoholic liver disease, hepatitis B, hepatitis C, autoimmune disorders (eg, primary biliary cholangitis, primary sclerosing cholangitis, autoimmune hepatitis), drug-induced hepatotoxicity, Wilson disease, clinically significant iron overload, or alpha-1-antitrypsin deficiency requiring treatment
History of liver transplantation
Current or prior history of hepatocellular carcinoma
Note: Other protocol defined Inclusion/ Exclusion criteria may apply
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
80 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
Gilead Study Director
Gilead Sciences
Study Director
Locations
Facility
Status
City
State
ZIP
Country
Contacts
The Institute for Liver Health
Chandler
Arizona
85224-5688
United States
Mayo Clinic Arizona, Mayo Clinic Hospital
References Module
Citations
PubMed Identifier
Type
Citation
Retractions
Result
Loomba R, et al. Safety and efficacy of combination therapies including cilofexor/firsocostat in patients with bridging fibrosis and cirrhosis due to NASH: Results of the Phase 2b ATLAS trial [accepted for oral presentation]. European Association for the Study of the Liver (EASL); 2020; Virtual.
Result
Loomba R, Alkhouri N, Strasser S, Wong VWS, Schall RA, McColgan B, et al. Clinical utility and application of non-invasive tests of fibrosis in the selection of patients with advanced fibrosis due to NASH in the Phase 2 ATLAS trial (Poster SAT-315). EASL; 2019; Vienna, Austria.
Result
Loomba R, Alkhouri N, Patel K, Zhang J, McColgan BJ, Djedjos S, et al. Validation of Cutoffs for Controlled Attenuation Parameter with MRI-Proton Density Fat Fraction (PDFF) as a Reference Standard in Subjects with Nonalcoholic Steatohepatitis (NASH) Across Multiple Randomized, Controlled Trials (Poster 1727). American Association for the Study of Liver Diseases (AASLD); 2019; Boston, MA, USA.
Result
Loomba R, Alkhouri N, Noureddin M, Zhang J, McColgan BJ, Djedjos S, et al. Validation of the Diagnostic Accuracy of Magnetic Resonance Elastography (MRE) for the Detection of Advanced Fibrosis Due to Nash Across Multiple Phase 2 and 3 Clinical Trials (Poster 1728). AASLD; 2019; Boston, MA, USA.
Result
Alkhouri N, Strasser SI, Wong VWS, Aguilar R, Chuang J, Huss R, et al. Alcohol use is Underreported in Clinical Trials of NASH: Baseline Alcohol Biomarkers from a Phase 2 Clinical Trial (Poster 1765). AASLD; 2019; Boston, MA, USA.
See Also Links
Not provided
Available IPD Information
Not provided
IPD Sharing Statement Module
Plan to Share IPD
No
Description
Not provided
Types
Not provided
Time Frame
Not provided
Access Criteria
Not provided
URL
Not provided
Results Section
Participant Flow Module
Pre-assignment Details
950 participants were screened.
Recruitment Details
Participants were enrolled at study sites in United States, Australia, Canada, Hong King and New Zealand. The first participant was screened on 21 Mar 2018. The last study visit occurred on 19 Nov 2019.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Selonsertib
Participants received selonsertib (SEL) 18 mg tablet + placebo to match firsocostat (FIR) 20 mg tablet + placebo to match cilofexor (CILO) 30 mg tablet orally once daily for 48 weeks.
FG001
Firsocostat
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Not provided
Uploaded Document Information
Type
Includes Protocol
Includes SAP
Includes ICF
Document Label
Document Date
Document Uploaded Date
Document File Name
Prot
Yes
No
No
Study Protocol
Apr 25, 2019
Sep 21, 2020
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
Estimated Results First Submitted Date
Not provided
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
Double
Masking Description
Not provided
Who Masked
ParticipantInvestigator
Drug: SEL
Drug: CILO
Drug: Placebo to match FIR
Firsocostat (FIR) + Cilofexor (CILO)
Experimental
Participants will receive placebo to match SEL 18 mg tablet + FIR + CILO orally once daily for 48 weeks.
Drug: FIR
Drug: CILO
Drug: Placebo to match SEL
Placebo
Experimental
Participants will receive placebo to match SEL 18 mg + placebo to match FIR 20 mg tablet + placebo to match CILO 30 mg tablet orally once daily for 48 weeks.
Drug: Placebo to match FIR
Drug: Placebo to match CILO
Drug: Placebo to match SEL
FIR
Drug
20 mg tablet administered orally once daily without regard to food
Firsocostat (FIR)
Firsocostat (FIR) + Cilofexor (CILO)
Selonsertib (SEL) + Firsocostat (FIR)
GS-0976
CILO
Drug
30 mg tablet administered orally once daily without regard to food
Cilofexor (CILO)
Firsocostat (FIR) + Cilofexor (CILO)
Selonsertib (SEL) + Cilofexor (CILO)
GS-9674
Placebo to match FIR
Drug
Tablet administered orally once daily without regard to food
Cilofexor (CILO)
Placebo
Selonsertib (SEL)
Selonsertib (SEL) + Cilofexor (CILO)
Placebo to match CILO
Drug
Tablet administered orally once daily without regard to food
Firsocostat (FIR)
Placebo
Selonsertib (SEL)
Selonsertib (SEL) + Firsocostat (FIR)
Placebo to match SEL
Drug
Tablet administered orally once daily without regard to food
Cilofexor (CILO)
Firsocostat (FIR)
Firsocostat (FIR) + Cilofexor (CILO)
Placebo
Phoenix
Arizona
85054
United States
Liver Wellness Center
Little Rock
Arkansas
72204
United States
Arkansas Gastroenterology
North Little Rock
Arkansas
72117
United States
eStudySite
Chula Vista
California
91911-6660
United States
Southern California Liver Center
Coronado
California
92118
United States
Fresno Clinical Research Center
Fresno
California
93720
United States
UCSD NAFLD Clinical Research Center
La Jolla
California
92037
United States
Ruane Clinical Research Group Inc.
Los Angeles
California
90036
United States
Cedars-Sinai Medical Center
Los Angeles
California
99352
United States
California Liver Research Institute
Pasadena
California
91105
United States
Huntington Medical Research Institutes Liver Center
Pasadena
California
91105
United States
Inland Empire Liver Foundation
Rialto
California
92377
United States
University of California, Davis Medical Center (study visits)
Sacramento
California
95817
United States
Medical Associates Research Group
San Diego
California
92123
United States
South Denver Gastroenterology, PC
Englewood
Colorado
80113
United States
Integrity Clinical Research
Doral
Florida
33166
United States
UF Hepatology Research at CTRB
Gainesville
Florida
32610
United States
Schiff Center for Liver Diseases/University of Miami
Miami
Florida
33136
United States
IMIC Inc
Miami
Florida
33157
United States
Genoma Research Group
Miami
Florida
33165
United States
Florida Research Institute
Tampa
Florida
34211
United States
Digestive Healthcare of Georgia
Atlanta
Georgia
30309
United States
Piedmont Hospital
Atlanta
Georgia
30309
United States
Gastrointestinal Diseases Research
Columbus
Georgia
31904
United States
Gastrointestinal Specialists of Georgia
Marietta
Georgia
30060
United States
Northwestern University; Feinberg School of Medicine
Chicago
Illinois
60611
United States
Indianapolis Gastroenterology Research Foundation
Indianapolis
Indiana
46237
United States
Iowa Digestive Disease Center, P.C.
Clive
Iowa
50325
United States
University of Kansas Medical Center
Kansas City
Kansas
66160
United States
Delta Research Partners, LLC
Bastrop
Louisiana
71220
United States
Tulane University
New Orleans
Louisiana
70112
United States
Louisiana Research Center, LLC
Shreveport
Louisiana
71105
United States
Mercy Medical Center
Baltimore
Maryland
21202
United States
Digestive Disease Associates, PA
Catonsville
Maryland
21228
United States
Beth Israel Deaconess Medical Center
Boston
Massachusetts
02215
United States
Henry Ford Health Systems
Detroit
Michigan
48202
United States
Mayo Clinic
Rochester
Minnesota
55905
United States
Southern Therapy and Advanced Research (STAR) LLC
Ridgeland
Mississippi
39157
United States
Saint Luke's Hospital of Kansas City
Kansas City
Missouri
64111
United States
Saint Louis University
St Louis
Missouri
63110
United States
Jubilee Clinical Research, Inc.
Las Vegas
Nevada
89106
United States
Rutgers New Jersey Medical School- Doctors Office Center
Newark
New Jersey
07103
United States
Sandra Atlas Bass Center for Liver Diseases and Transplantation
Manhasset
New York
11030
United States
Icahn School of Medicine at Mount Sinai Beth Israel
New York
New York
10003
United States
Concorde Medical Group, PLLC
New York
New York
10016
United States
NYU Langone Health
New York
New York
10016
United States
Weill Cornell Medical College
New York
New York
10021
United States
Icahn School of Medicine at Mount Sinai
New York
New York
10029
United States
Montefiore Medical Center
The Bronx
New York
10467
United States
Carolinas Healthcare System Center for Liver Disease and Transplant
Charlotte
North Carolina
28204
United States
Duke University Medical Center, Duke South Clinics
Durham
North Carolina
27710
United States
Cumberland Research Associates, LLC
Fayetteville
North Carolina
28304
United States
Consultants for Clinical Research wed
Cincinnati
Ohio
45249
United States
Hospital of the University of Pennsylvania- Perelman Center for Advanced Medicine
Philadelphia
Pennsylvania
19104
United States
Thomas Jefferson University
Philadelphia
Pennsylvania
19107
United States
UPMC - Center for Liver Diseases at the Thomas E. Starlz Institute
Pittsburgh
Pennsylvania
15213
United States
VA Pittsburgh Healthcare System
Pittsburgh
Pennsylvania
15240
United States
University Gastroenterology
Providence
Rhode Island
02905
United States
Medical University of South Carolina (Liver Biopsy)
Charleston
South Carolina
29425
United States
GHS Gastroenterology and Liver Center
Greenville
South Carolina
29605
United States
Gastro One
Germantown
Tennessee
38138
United States
Quality Medical Research, PLLC
Nashville
Tennessee
37211
United States
Texas Clinical Research Institute, LLC
Arlington
Texas
76012
United States
Pinnacle Clinical Research, PLLC
Austin
Texas
78746
United States
Austin Center for Clinical Research
Austin
Texas
78758
United States
The Liver Institute at Methodist Dallas Medical Center
Dallas
Texas
75203
United States
University of Texas Southwestern Medical Center Internal Medicine Digestive and Liver Diseases Clinical Trials
Dallas
Texas
75390
United States
Baylor College of Medicine - Advanced Liver Therapies
Houston
Texas
77030
United States
Houston Methodist Hospital
Houston
Texas
77030
United States
Pinnacle Clinical Research
Live Oak
Texas
78233
United States
American Research Corporation at Texas Liver Institute
San Antonio
Texas
78215
United States
Intermountain Liver Disease and Transplant Center
Murray
Utah
84107
United States
University of Utah Hospital
Salt Lake City
Utah
84132
United States
University of Virginia Medical Center
Charlottesville
Virginia
22908
United States
California Pacific Medical Center - Sutter Pacific Medical Foundation San Francisco Center for Liver Disease Dept. of Transplant
Falls Church
Virginia
22042
United States
Digestive and Liver Disease Specialists
Norfolk
Virginia
23502
United States
Bon Secours Richmond Community Hospital, Inc. d/b/a Bon Secours Liver Institute of Richmond
Richmond
Virginia
23226
United States
McGuire DVAMC
Richmond
Virginia
23249
United States
Virginia Mason Medical Center
Seattle
Washington
98101
United States
Swedish Organ Transplant and Liver Center
Seattle
Washington
98104
United States
Royal Brisbane & Women's Hospital
Herston
Queensland
4029
Australia
Royal Adelaide Hospital
Adelaide
South Australia
5000
Australia
Monash Health, Monash Medical Centre
Clayton
Victoria
3168
Australia
St Vincent's Hospital Melbourne
Fitzroy
Victoria
3065
Australia
Melbourne Health, Royal Melbourne Hospital
Parkville
Victoria
3050
Australia
Sir Charles Gairdner Hospital
Nedlands
Western Australia
6009
Australia
Royal Perth Hospital
Perth
Western Australia
6000
Australia
Royal Prince Alfred Hospital
Camperdown
2050
Australia
St Vincent's Hospital Sydney
Darlinghurst
2010
Australia
Austin Health
Heidelberg
3084
Australia
The Alfred Hospital, Alfred Health
Melbourne
3004
Australia
Westmead Hospital
Westmead
2145
Australia
William Osler Health System-Brampton Civic Hospital
Brampton
L6R 3J7
Canada
University of Calgary Liver Unit (Heritage Medical Research Clinic)
Calgary
T2N 4Z6
Canada
Chronic Viral Illness Service McGill University Health Centre (MUHC)/ Royal Victoria Hospital
Loomba R, Noureddin M, Kowdley KV, Kohli A, Sheikh A, Neff G, Bhandari BR, Gunn N, Caldwell SH, Goodman Z, Wapinski I, Resnick M, Beck AH, Ding D, Jia C, Chuang JC, Huss RS, Chung C, Subramanian GM, Myers RP, Patel K, Borg BB, Ghalib R, Kabler H, Poulos J, Younes Z, Elkhashab M, Hassanein T, Iyer R, Ruane P, Shiffman ML, Strasser S, Wong VW, Alkhouri N; for the ATLAS Investigators. Combination Therapies Including Cilofexor and Firsocostat for Bridging Fibrosis and Cirrhosis Attributable to NASH. Hepatology. 2021 Feb;73(2):625-643. doi: 10.1002/hep.31622.
Participants received placebo to match SEL 18 mg tablet + FIR 20 mg tablet + placebo to match CILO 30 mg tablet orally once daily for 48 weeks.
FG002
Cilofexor
Participants received placebo to match SEL 18 mg + placebo to match FIR 20 mg tablet + CILO 30 mg tablet orally once daily for 48 weeks.
FG003
SEL + FIR
Participants received SEL 18 mg tablet + FIR 20 mg tablet + placebo to match CILO 30 mg tablet orally once daily for 48 weeks.
FG004
SEL + CILO
Participants received SEL 18 mg tablet + placebo to match FIR 20 mg tablet + CILO 30 mg tablet orally once daily for 48 weeks.
FG005
FIR + CILO
Participants received placebo to match SEL 18 mg tablet + FIR 20 mg tablet + CILO 30 mg tablet orally once daily for 48 weeks.
FG006
Placebo
Participants received placebo to match SEL 18 mg tablet + placebo to match FIR 20 mg tablet + placebo to match CILO 30 mg tablet orally once daily for 48 weeks.
FG00039 subjects
FG00140 subjects
FG00241 subjects
FG00380 subjects
FG00478 subjects
FG00578 subjects
FG00639 subjects
COMPLETED
FG0003 subjects
FG00133 subjects
FG00234 subjects
FG00371 subjects
FG00466 subjects
FG00569 subjects
FG00638 subjects
NOT COMPLETED
FG00036 subjects
FG0017 subjects
FG0027 subjects
FG0039 subjects
FG00412 subjects
FG0059 subjects
FG0061 subjects
Type
Comment
Reasons
Randomized but Never Treated
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0031 subjects
FG0041 subjects
FG0050 subjects
FG0060 subjects
Unknown Reason
FG00033 subjects
FG0011 subjects
FG0021 subjects
FG0031 subjects
FG004
Withdrew Consent
FG0001 subjects
FG0013 subjects
FG0021 subjects
FG0034 subjects
FG004
Adverse Event
FG0001 subjects
FG0012 subjects
FG0021 subjects
FG0030 subjects
FG004
Lost to Follow-up
FG0000 subjects
FG0010 subjects
FG0022 subjects
FG0031 subjects
FG004
Investigator's Discretion
FG0000 subjects
FG0011 subjects
FG0021 subjects
FG0032 subjects
FG004
Non Compliance with Study Drug
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Protocol Violation
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Death
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Selonsertib
Participants received SEL 18 mg tablet + placebo to match FIR 20 mg tablet + placebo to match CILO 30 mg tablet orally once daily for 48 weeks.
BG001
Firsocostat
Participants received placebo to match SEL 18 mg tablet + FIR 20 mg tablet + placebo to match CILO 30 mg tablet orally once daily for 48 weeks.
BG002
Cilofexor
Participants received placebo to match SEL 18 mg + placebo to match FIR 20 mg tablet + CILO 30 mg tablet orally once daily for 48 weeks.
BG003
SEL + FIR
Participants received SEL 18 mg tablet + FIR 20 mg tablet + placebo to match CILO 30 mg tablet orally once daily for 48 weeks.
BG004
SEL + CILO
Participants received SEL 18 mg tablet + placebo to match FIR 20 mg tablet + CILO 30 mg tablet orally once daily for 48 weeks.
BG005
FIR + CILO
Participants received placebo to match SEL 18 mg tablet + FIR 20 mg tablet + CILO 30 mg tablet orally once daily for 48 weeks.
BG006
Placebo
Participants received placebo to match SEL 18 mg tablet + placebo to match FIR 20 mg tablet + placebo to match CILO 30 mg tablet orally once daily for 48 weeks.
BG007
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00039
BG00140
BG00240
BG00379
BG00477
BG00578
BG00639
BG007392
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
BG00059± 10.4
BG00160± 10.0
BG00257± 10.2
BG003
Sex: Female, Male
Count of Participants
Participants
No
Title
Denominators
Categories
Title
Measurements
Female
BG00024
BG00125
BG002
Race/Ethnicity, Customized
Not Permitted = local regulators did not allow collection of Race/ Ethnicity information.
Count of Participants
Participants
No
Title
Denominators
Categories
Race
Title
Measurements
American Indian or Alaska Native
BG0001
BG0010
Race/Ethnicity, Customized
Not Permitted = local regulators did not allow collection of Race/ Ethnicity information.
Count of Participants
Participants
No
Title
Denominators
Categories
Ethinicity
Title
Measurements
Hispanic or Latino
BG0008
BG0019
Region of Enrollment
Number
participants
Title
Denominators
Categories
New Zealand
Title
Measurements
BG0001
BG0010
BG002
Diabetes Mellitus Status
Count of Participants
Participants
No
Title
Denominators
Categories
Title
Measurements
Present
BG00026
BG00130
BG002
Cirrhosis Status
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Cirrhotic
BG00021
BG00122
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
Percentage of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
Posted
Number
percentage of participants
First dose date up to 48 weeks plus 30 days
ID
Title
Description
OG000
Selonsertib
Participants received SEL 18 mg tablet + placebo to match FIR 20 mg tablet + placebo to match CILO 30 mg tablet orally once daily for 48 weeks.
OG001
Firsocostat
Participants received placebo to match SEL 18 mg tablet + FIR 20 mg tablet + placebo to match CILO 30 mg tablet orally once daily for 48 weeks.
OG002
Cilofexor
Participants received placebo to match SEL 18 mg + placebo to match FIR 20 mg tablet + CILO 30 mg tablet orally once daily for 48 weeks.
OG003
SEL + FIR
Participants received SEL 18 mg tablet + FIR 20 mg tablet + placebo to match CILO 30 mg tablet orally once daily for 48 weeks.
OG004
SEL + CILO
Participants received SEL 18 mg tablet + placebo to match FIR 20 mg tablet + CILO 30 mg tablet orally once daily for 48 weeks.
OG005
FIR + CILO
Participants received placebo to match SEL 18 mg tablet + FIR 20 mg tablet + CILO 30 mg tablet orally once daily for 48 weeks.
OG006
Placebo
Participants received placebo to match SEL 18 mg tablet + placebo to match FIR 20 mg tablet + placebo to match CILO 30 mg tablet orally once daily for 48 weeks.
Units
Counts
Participants
OG00039
OG00140
OG00240
OG003
Title
Denominators
Categories
Title
Measurements
OG00084.6
OG00185.0
OG00292.5
OG003
Primary
Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities
Treatment-emergent laboratory abnormalities were defined as values that increase at least one toxicity grade from baseline. Participants with any laboratory abnormality were reported.
Participants in the Safety Analysis Set with available data were analyzed.
Posted
Number
percentage of participants
First dose date up to 48 weeks plus 30 days
ID
Title
Description
OG000
Selonsertib
Participants received SEL 18 mg tablet + placebo to match FIR 20 mg tablet + placebo to match CILO 30 mg tablet orally once daily for 48 weeks.
OG001
Firsocostat
Participants received placebo to match SEL 18 mg tablet + FIR 20 mg tablet + placebo to match CILO 30 mg tablet orally once daily for 48 weeks.
OG002
Cilofexor
Participants received placebo to match SEL 18 mg + placebo to match FIR 20 mg tablet + CILO 30 mg tablet orally once daily for 48 weeks.
OG003
SEL + FIR
Primary
Percentage of Participants Who Achieved a ≥ 1-Stage Improvement in Fibrosis Without Worsening of NASH at Week 48
Fibrosis improvement was defined as ≥ 1-stage decrease from baseline in fibrosis according to the NASH clinical research network classification (CRN) classification. Worsening of NASH was defined as ≥ 1-point increase from baseline in hepatocellular ballooning or lobular inflammation. The 95% CI was based on the Clopper-Pearson method.
Participants in the Full Analysis Set (included all participants who took at least 1 dose of study drug and were randomized into the study) with available data were analyzed.
Posted
Number
95% Confidence Interval
percentage of participants
Week 48
ID
Title
Description
OG000
Selonsertib
Participants received SEL 18 mg tablet + placebo to match FIR 20 mg tablet + placebo to match CILO 30 mg tablet orally once daily for 48 weeks.
OG001
Firsocostat
Participants received placebo to match SEL 18 mg tablet + FIR 20 mg tablet + placebo to match CILO 30 mg tablet orally once daily for 48 weeks.
OG002
Cilofexor
Participants received placebo to match SEL 18 mg + placebo to match FIR 20 mg tablet + CILO 30 mg tablet orally once daily for 48 weeks.
Time Frame
First dose date up to 48 weeks plus 30 days
Description
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
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
Selonsertib
Participants received SEL 18 mg tablet + placebo to match FIR 20 mg tablet + placebo to match CILO 30 mg tablet orally once daily for 48 weeks.
0
39
7
39
30
39
EG001
Firsocostat
Participants received placebo to match SEL 18 mg tablet + FIR 20 mg tablet + placebo to match CILO 30 mg tablet orally once daily for 48 weeks.
0
40
3
40
30
40
EG002
Cilofexor
Participants received placebo to match SEL 18 mg + placebo to match FIR 20 mg tablet + CILO 30 mg tablet orally once daily for 48 weeks.
0
40
8
40
34
40
EG003
SEL + FIR
Participants received SEL 18 mg tablet + FIR 20 mg tablet + placebo to match CILO 30 mg tablet orally once daily for 48 weeks.
0
79
7
79
67
79
EG004
SEL + CILO
Participants received SEL 18 mg tablet + placebo to match FIR 20 mg tablet + CILO 30 mg tablet orally once daily for 48 weeks.
1
77
10
77
68
77
EG005
FIR + CILO
Participants received placebo to match SEL 18 mg tablet + FIR 20 mg tablet + CILO 30 mg tablet orally once daily for 48 weeks.
0
78
8
78
66
78
EG006
Placebo
Participants received placebo to match SEL 18 mg tablet + placebo to match FIR 20 mg tablet + placebo to match CILO 30 mg tablet orally once daily for 48 weeks.
0
39
2
39
29
39
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected39 at risk
EG0010 affected40 at risk
EG0021 affected40 at risk
EG0030 affected79 at risk
EG0040 affected77 at risk
EG0050 affected78 at risk
EG0060 affected39 at risk
Immune thrombocytopenic purpura
Blood and lymphatic system disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected39 at risk
EG0011 affected40 at risk
EG0020 affected40 at risk
EG003
Lymphadenitis
Blood and lymphatic system disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected39 at risk
EG0010 affected40 at risk
EG0021 affected40 at risk
EG003
Acute myocardial infarction
Cardiac disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected39 at risk
EG0011 affected40 at risk
EG0020 affected40 at risk
EG003
Cardiac arrest
Cardiac disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected39 at risk
EG0010 affected40 at risk
EG0020 affected40 at risk
EG003
Deafness neurosensory
Ear and labyrinth disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected39 at risk
EG0010 affected40 at risk
EG0021 affected40 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0001 affected39 at risk
EG0010 affected40 at risk
EG0020 affected40 at risk
EG003
Abdominal pain lower
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0001 affected39 at risk
EG0010 affected40 at risk
EG0020 affected40 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected39 at risk
EG0010 affected40 at risk
EG0021 affected40 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0001 affected39 at risk
EG0010 affected40 at risk
EG0020 affected40 at risk
EG003
Dysphagia
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0001 affected39 at risk
EG0010 affected40 at risk
EG0020 affected40 at risk
EG003
Gastric ulcer haemorrhage
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected39 at risk
EG0010 affected40 at risk
EG0020 affected40 at risk
EG003
Gastritis
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected39 at risk
EG0010 affected40 at risk
EG0020 affected40 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected39 at risk
EG0010 affected40 at risk
EG0020 affected40 at risk
EG003
Umbilical hernia
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0001 affected39 at risk
EG0010 affected40 at risk
EG0020 affected40 at risk
EG003
Upper gastrointestinal haemorrhage
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected39 at risk
EG0010 affected40 at risk
EG0020 affected40 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected39 at risk
EG0010 affected40 at risk
EG0020 affected40 at risk
EG003
Pyrexia
General disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected39 at risk
EG0011 affected40 at risk
EG0020 affected40 at risk
EG003
Cellulitis
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 affected39 at risk
EG0010 affected40 at risk
EG0023 affected40 at risk
EG003
Colonic abscess
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0001 affected39 at risk
EG0010 affected40 at risk
EG0020 affected40 at risk
EG003
Influenza
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 affected39 at risk
EG0010 affected40 at risk
EG0020 affected40 at risk
EG003
Kidney infection
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 affected39 at risk
EG0010 affected40 at risk
EG0020 affected40 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 affected39 at risk
EG0010 affected40 at risk
EG0020 affected40 at risk
EG003
Pyelonephritis
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 affected39 at risk
EG0010 affected40 at risk
EG0020 affected40 at risk
EG003
Incision site discharge
Injury, poisoning and procedural complications
MedDRA 22.0
Systematic Assessment
EG0000 affected39 at risk
EG0010 affected40 at risk
EG0020 affected40 at risk
EG003
Meniscus injury
Injury, poisoning and procedural complications
MedDRA 22.0
Systematic Assessment
EG0001 affected39 at risk
EG0010 affected40 at risk
EG0020 affected40 at risk
EG003
Post procedural haematoma
Injury, poisoning and procedural complications
MedDRA 22.0
Systematic Assessment
EG0000 affected39 at risk
EG0010 affected40 at risk
EG0020 affected40 at risk
EG003
Post procedural haemorrhage
Injury, poisoning and procedural complications
MedDRA 22.0
Systematic Assessment
EG0000 affected39 at risk
EG0010 affected40 at risk
EG0020 affected40 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected39 at risk
EG0010 affected40 at risk
EG0020 affected40 at risk
EG003
Diabetic ketoacidosis
Metabolism and nutrition disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected39 at risk
EG0010 affected40 at risk
EG0020 affected40 at risk
EG003
Hypoglycaemia
Metabolism and nutrition disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected39 at risk
EG0010 affected40 at risk
EG0020 affected40 at risk
EG003
Intervertebral disc protrusion
Musculoskeletal and connective tissue disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected39 at risk
EG0010 affected40 at risk
EG0021 affected40 at risk
EG003
Joint swelling
Musculoskeletal and connective tissue disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected39 at risk
EG0010 affected40 at risk
EG0020 affected40 at risk
EG003
Diffuse large B-cell lymphoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 22.0
Systematic Assessment
EG0000 affected39 at risk
EG0010 affected40 at risk
EG0020 affected40 at risk
EG003
Small cell lung cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 22.0
Systematic Assessment
EG0000 affected39 at risk
EG0010 affected40 at risk
EG0020 affected40 at risk
EG003
Ischaemic stroke
Nervous system disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected39 at risk
EG0010 affected40 at risk
EG0020 affected40 at risk
EG003
Optic neuritis
Nervous system disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected39 at risk
EG0010 affected40 at risk
EG0020 affected40 at risk
EG003
Syncope
Nervous system disorders
MedDRA 22.0
Systematic Assessment
EG0001 affected39 at risk
EG0010 affected40 at risk
EG0020 affected40 at risk
EG003
Transient ischaemic attack
Nervous system disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected39 at risk
EG0010 affected40 at risk
EG0020 affected40 at risk
EG003
Depression suicidal
Psychiatric disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected39 at risk
EG0010 affected40 at risk
EG0020 affected40 at risk
EG003
Nephrolithiasis
Renal and urinary disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected39 at risk
EG0010 affected40 at risk
EG0020 affected40 at risk
EG003
Ureterolithiasis
Renal and urinary disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected39 at risk
EG0010 affected40 at risk
EG0020 affected40 at risk
EG003
Urinary tract obstruction
Renal and urinary disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected39 at risk
EG0010 affected40 at risk
EG0020 affected40 at risk
EG003
Dyspnoea exertional
Respiratory, thoracic and mediastinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected39 at risk
EG0010 affected40 at risk
EG0021 affected40 at risk
EG003
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected39 at risk
EG0010 affected40 at risk
EG0020 affected40 at risk
EG003
Angioedema
Skin and subcutaneous tissue disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected39 at risk
EG0010 affected40 at risk
EG0020 affected40 at risk
EG003
Knee arthroplasty
Surgical and medical procedures
MedDRA 22.0
Systematic Assessment
EG0000 affected39 at risk
EG0010 affected40 at risk
EG0020 affected40 at risk
EG003
Hypotension
Vascular disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected39 at risk
EG0010 affected40 at risk
EG0020 affected40 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Vertigo
Ear and labyrinth disorders
MedDRA 22.0
Systematic Assessment
EG0001 affected39 at risk
EG0011 affected40 at risk
EG0020 affected40 at risk
EG0031 affected79 at risk
EG0045 affected77 at risk
EG0050 affected78 at risk
EG0062 affected39 at risk
Vision blurred
Eye disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected39 at risk
EG0011 affected40 at risk
EG0020 affected40 at risk
EG003
Abdominal distension
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0001 affected39 at risk
EG0011 affected40 at risk
EG0021 affected40 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0007 affected39 at risk
EG0012 affected40 at risk
EG0023 affected40 at risk
EG003
Abdominal pain lower
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0002 affected39 at risk
EG0011 affected40 at risk
EG0020 affected40 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0001 affected39 at risk
EG0013 affected40 at risk
EG0021 affected40 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0002 affected39 at risk
EG0010 affected40 at risk
EG0024 affected40 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0002 affected39 at risk
EG0015 affected40 at risk
EG0020 affected40 at risk
EG003
Dry mouth
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected39 at risk
EG0013 affected40 at risk
EG0020 affected40 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected39 at risk
EG0011 affected40 at risk
EG0021 affected40 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0003 affected39 at risk
EG0016 affected40 at risk
EG0023 affected40 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0001 affected39 at risk
EG0010 affected40 at risk
EG0021 affected40 at risk
EG003
Chest pain
General disorders
MedDRA 22.0
Systematic Assessment
EG0001 affected39 at risk
EG0010 affected40 at risk
EG0021 affected40 at risk
EG003
Fatigue
General disorders
MedDRA 22.0
Systematic Assessment
EG0005 affected39 at risk
EG0017 affected40 at risk
EG0023 affected40 at risk
EG003
Malaise
General disorders
MedDRA 22.0
Systematic Assessment
EG0002 affected39 at risk
EG0010 affected40 at risk
EG0020 affected40 at risk
EG003
Oedema peripheral
General disorders
MedDRA 22.0
Systematic Assessment
EG0001 affected39 at risk
EG0012 affected40 at risk
EG0022 affected40 at risk
EG003
Pain
General disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected39 at risk
EG0012 affected40 at risk
EG0020 affected40 at risk
EG003
Peripheral swelling
General disorders
MedDRA 22.0
Systematic Assessment
EG0003 affected39 at risk
EG0010 affected40 at risk
EG0020 affected40 at risk
EG003
Pyrexia
General disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected39 at risk
EG0013 affected40 at risk
EG0021 affected40 at risk
EG003
Seasonal allergy
Immune system disorders
MedDRA 22.0
Systematic Assessment
EG0001 affected39 at risk
EG0010 affected40 at risk
EG0022 affected40 at risk
EG003
Bronchitis
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0001 affected39 at risk
EG0010 affected40 at risk
EG0020 affected40 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0001 affected39 at risk
EG0010 affected40 at risk
EG0020 affected40 at risk
EG003
Helicobacter infection
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 affected39 at risk
EG0012 affected40 at risk
EG0020 affected40 at risk
EG003
Herpes zoster
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 affected39 at risk
EG0011 affected40 at risk
EG0021 affected40 at risk
EG003
Influenza
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 affected39 at risk
EG0013 affected40 at risk
EG0020 affected40 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0002 affected39 at risk
EG0014 affected40 at risk
EG0026 affected40 at risk
EG003
Sinusitis
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0001 affected39 at risk
EG0012 affected40 at risk
EG0023 affected40 at risk
EG003
Tooth abscess
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 affected39 at risk
EG0010 affected40 at risk
EG0021 affected40 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0004 affected39 at risk
EG0017 affected40 at risk
EG0024 affected40 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0006 affected39 at risk
EG0013 affected40 at risk
EG0025 affected40 at risk
EG003
Contusion
Injury, poisoning and procedural complications
MedDRA 22.0
Systematic Assessment
EG0002 affected39 at risk
EG0012 affected40 at risk
EG0021 affected40 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA 22.0
Systematic Assessment
EG0001 affected39 at risk
EG0010 affected40 at risk
EG0022 affected40 at risk
EG003
Procedural pain
Injury, poisoning and procedural complications
MedDRA 22.0
Systematic Assessment
EG0001 affected39 at risk
EG0011 affected40 at risk
EG0023 affected40 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected39 at risk
EG0011 affected40 at risk
EG0022 affected40 at risk
EG003
Diabetes mellitus
Metabolism and nutrition disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected39 at risk
EG0010 affected40 at risk
EG0022 affected40 at risk
EG003
Hypertriglyceridaemia
Metabolism and nutrition disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected39 at risk
EG0010 affected40 at risk
EG0020 affected40 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 22.0
Systematic Assessment
EG0003 affected39 at risk
EG0011 affected40 at risk
EG0023 affected40 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 22.0
Systematic Assessment
EG0002 affected39 at risk
EG0011 affected40 at risk
EG0023 affected40 at risk
EG003
Muscle spasms
Musculoskeletal and connective tissue disorders
MedDRA 22.0
Systematic Assessment
EG0001 affected39 at risk
EG0013 affected40 at risk
EG0021 affected40 at risk
EG003
Musculoskeletal pain
Musculoskeletal and connective tissue disorders
MedDRA 22.0
Systematic Assessment
EG0001 affected39 at risk
EG0011 affected40 at risk
EG0023 affected40 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA 22.0
Systematic Assessment
EG0002 affected39 at risk
EG0010 affected40 at risk
EG0024 affected40 at risk
EG003
Plantar fasciitis
Musculoskeletal and connective tissue disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected39 at risk
EG0010 affected40 at risk
EG0021 affected40 at risk
EG003
Carpal tunnel syndrome
Nervous system disorders
MedDRA 22.0
Systematic Assessment
EG0001 affected39 at risk
EG0012 affected40 at risk
EG0020 affected40 at risk
EG003
Dizziness
Nervous system disorders
MedDRA 22.0
Systematic Assessment
EG0002 affected39 at risk
EG0015 affected40 at risk
EG0022 affected40 at risk
EG003
Headache
Nervous system disorders
MedDRA 22.0
Systematic Assessment
EG0004 affected39 at risk
EG0017 affected40 at risk
EG0024 affected40 at risk
EG003
Hypoaesthesia
Nervous system disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected39 at risk
EG0010 affected40 at risk
EG0022 affected40 at risk
EG003
Depression
Psychiatric disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected39 at risk
EG0010 affected40 at risk
EG0020 affected40 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA 22.0
Systematic Assessment
EG0001 affected39 at risk
EG0011 affected40 at risk
EG0022 affected40 at risk
EG003
Irritability
Psychiatric disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected39 at risk
EG0011 affected40 at risk
EG0022 affected40 at risk
EG003
Nephrolithiasis
Renal and urinary disorders
MedDRA 22.0
Systematic Assessment
EG0001 affected39 at risk
EG0012 affected40 at risk
EG0020 affected40 at risk
EG003
Asthma
Respiratory, thoracic and mediastinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected39 at risk
EG0010 affected40 at risk
EG0022 affected40 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 22.0
Systematic Assessment
EG0003 affected39 at risk
EG0012 affected40 at risk
EG0023 affected40 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 22.0
Systematic Assessment
EG0001 affected39 at risk
EG0010 affected40 at risk
EG0022 affected40 at risk
EG003
Nasal congestion
Respiratory, thoracic and mediastinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected39 at risk
EG0010 affected40 at risk
EG0022 affected40 at risk
EG003
Alopecia
Skin and subcutaneous tissue disorders
MedDRA 22.0
Systematic Assessment
EG0001 affected39 at risk
EG0010 affected40 at risk
EG0022 affected40 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA 22.0
Systematic Assessment
EG0007 affected39 at risk
EG0015 affected40 at risk
EG0028 affected40 at risk
EG003
Pruritus generalised
Skin and subcutaneous tissue disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected39 at risk
EG0013 affected40 at risk
EG0020 affected40 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA 22.0
Systematic Assessment
EG0003 affected39 at risk
EG0012 affected40 at risk
EG0023 affected40 at risk
EG003
Urticaria
Skin and subcutaneous tissue disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected39 at risk
EG0010 affected40 at risk
EG0021 affected40 at risk
EG003
Hypertension
Vascular disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected39 at risk
EG0011 affected40 at risk
EG0021 affected40 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
After conclusion of the study and without prior written approval from Gilead, investigators in this study may communicate, orally present, or publish in scientific journals or other media only after the following conditions have been met:
The results of the study in their entirety have been publicly disclosed by or with the consent of Gilead in an abstract, manuscript, or presentation form; or The study has been completed at all study sites for at least 2 years
Participants received SEL 18 mg tablet + FIR 20 mg tablet + placebo to match CILO 30 mg tablet orally once daily for 48 weeks.
OG004
SEL + CILO
Participants received SEL 18 mg tablet + placebo to match FIR 20 mg tablet + CILO 30 mg tablet orally once daily for 48 weeks.
OG005
FIR + CILO
Participants received placebo to match SEL 18 mg tablet + FIR 20 mg tablet + CILO 30 mg tablet orally once daily for 48 weeks.
OG006
Placebo
Participants received placebo to match SEL 18 mg tablet + placebo to match FIR 20 mg tablet + placebo to match CILO 30 mg tablet orally once daily for 48 weeks.
Units
Counts
Participants
OG00039
OG00140
OG00240
OG00379
OG00477
OG00577
OG00639
Title
Denominators
Categories
Title
Measurements
OG00094.9
OG001100.0
OG00297.5
OG00398.7
OG00496.1
OG005100.0
OG00694.9
OG003
SEL + FIR
Participants received SEL 18 mg tablet + FIR 20 mg tablet + placebo to match CILO 30 mg tablet orally once daily for 48 weeks.
OG004
SEL + CILO
Participants received SEL 18 mg tablet + placebo to match FIR 20 mg tablet + CILO 30 mg tablet orally once daily for 48 weeks.
OG005
FIR + CILO
Participants received placebo to match SEL 18 mg tablet + FIR 20 mg tablet + CILO 30 mg tablet orally once daily for 48 weeks.
OG006
Placebo
Participants received placebo to match SEL 18 mg tablet + placebo to match FIR 20 mg tablet + placebo to match CILO 30 mg tablet orally once daily for 48 weeks.
Units
Counts
Participants
OG0007
OG00133
OG00234
OG00371
OG00468
OG00567
OG00638
Title
Denominators
Categories
Title
Measurements
OG00028.6(3.7 to 71.0)
OG00112.1(3.4 to 28.2)
OG00211.8(3.3 to 27.5)
OG00315.5(8.0 to 26.0)
OG00419.1(10.6 to 30.5)
OG00520.9(11.9 to 32.6)
OG00610.5(2.9 to 24.8)
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
OG001
OG006
Mantel Haenszel
0.9449
The p-value between each pair of treatment groups presented were obtained by the stratum-adjusted Mantel-Haenszel (MH) method, with baseline diabetes mellitus status and baseline cirrhosis status as stratification factors.
Difference in percentages
0.6
2-Sided
95
-17.6
18.8
The percentage difference and 95% C.I. presented were obtained by the stratum-adjusted MH method, with baseline diabetes mellitus status and baseline cirrhosis status as stratification factors.
Superiority
OG002
OG006
Mantel Haenszel
0.9646
The p-value between each pair of treatment groups presented were obtained by the stratum-adjusted MH method, with baseline diabetes mellitus status and baseline cirrhosis status as stratification factors.
Difference in percentages
0.4
2-Sided
95
-17.6
18.4
The percentage difference and 95% C.I. presented were obtained by the stratum-adjusted MH method, with baseline diabetes mellitus status and baseline cirrhosis status as stratification factors.
Superiority
OG003
OG006
Mantel Haenszel
0.6219
The p-value between each pair of treatment groups presented were obtained by the stratum-adjusted MH method, with baseline diabetes mellitus status and baseline cirrhosis status as stratification factors.
Difference in percentages
3.7
2-Sided
95
-10.9
18.3
The percentage difference and 95% C.I. presented were obtained by the stratum-adjusted MH method, with baseline diabetes mellitus status and baseline cirrhosis status as stratification factors.
Superiority
OG004
OG006
Mantel Haenszel
0.2554
The p-value between each pair of treatment groups presented were obtained by the stratum-adjusted MH method, with baseline diabetes mellitus status and baseline cirrhosis status as stratification factors.
Difference in percentages
8.8
2-Sided
95
-6.4
24.1
The percentage difference and 95% C.I. presented were obtained by the stratum-adjusted MH method, with baseline diabetes mellitus status and baseline cirrhosis status as stratification factors.
Superiority
OG005
OG006
Mantel Haenszel
0.1658
The p-value between each pair of treatment groups presented were obtained by the stratum-adjusted MH method, with baseline diabetes mellitus status and baseline cirrhosis status as stratification factors.
Difference in percentages
10.8
2-Sided
95
-4.5
26.1
The percentage difference and 95% C.I. presented were obtained by the stratum-adjusted MH method, with baseline diabetes mellitus status and baseline cirrhosis status as stratification factors.
Superiority
OG001
OG003
Mantel Haenszel
0.6963
The p-value between each pair of treatment groups presented were obtained by the stratum-adjusted MH method, with baseline diabetes mellitus status and baseline cirrhosis status as stratification factors.
Difference in percentages
3.2
2-Sided
95
-12.9
19.4
The percentage difference and 95% C.I. presented were obtained by the stratum-adjusted MH method, with baseline diabetes mellitus status and baseline cirrhosis status as stratification factors.
Superiority
OG001
OG005
Mantel Haenszel
0.2441
The p-value between each pair of treatment groups presented were obtained by the stratum-adjusted MH method, with baseline diabetes mellitus status and baseline cirrhosis status as stratification factors.
Difference in percentages
10.0
2-Sided
95
-6.8
26.8
The percentage difference and 95% C.I. presented were obtained by the stratum-adjusted MH method, with baseline diabetes mellitus status and baseline cirrhosis status as stratification factors.
Superiority
OG002
OG004
Mantel Haenszel
0.5229
The p-value between each pair of treatment groups presented were obtained by the stratum-adjusted MH method, with baseline diabetes mellitus status and baseline cirrhosis status as stratification factors.
Difference in percentages
5.2
2-Sided
95
-10.7
21.0
The percentage difference and 95% C.I. presented were obtained by the stratum-adjusted MH method, with baseline diabetes mellitus status and baseline cirrhosis status as stratification factors.
Superiority
OG002
OG005
Mantel Haenszel
0.2149
The p-value between each pair of treatment groups presented were obtained by the stratum-adjusted MH method, with baseline diabetes mellitus status and baseline cirrhosis status as stratification factors.
Difference in percentages
10.4
2-Sided
95
-6.0
26.9
The percentage difference and 95% C.I. presented were obtained by the stratum-adjusted MH method, with baseline diabetes mellitus status and baseline cirrhosis status as stratification factors.