CompletedNCT03449446ATLASUpdated Dec 3, 2020Results posted

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)

A Phase 2 interventional study of SEL and FIR in Nonalcoholic Steatohepatitis, sponsored by Gilead Sciences. Completed at 101 sites in 6 countries. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2020-12-03.

Sponsored by Gilead Sciences · Phase 2, Interventional, and Treatment

Phase: Phase 2
Study type: Interventional
Enrollment: 395
Allocation: Randomized
Ages: 18 Years to 80 Years
Sex: All

Study 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

Conditions studied

Nonalcoholic Steatohepatitis

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Who can participate

Ages eligible: 18 Years to 80 Years
Sexes eligible: All
Accepts healthy volunteers: No

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

Study design

Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Double (Participant, Investigator)
Enrollment: 395 participants (actual)

Study arms

Experimental
Selonsertib (SEL)
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
Experimental
Firsocostat (FIR)
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
Experimental
Cilofexor (CILO)
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
Experimental
Selonsertib (SEL) + Firsocostat (FIR)
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
Experimental
Selonsertib (SEL) + Cilofexor (CILO)
Participants will receive SEL + placebo to match FIR 20 mg tablet + CILO orally once daily for 48 weeks.
Drug: SEL · Drug: CILO · Drug: Placebo to match FIR
Experimental
Firsocostat (FIR) + Cilofexor (CILO)
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
Experimental
Placebo
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

Interventions

DrugSEL
18 mg tablet administered orally once daily without regard to food
DrugFIR
20 mg tablet administered orally once daily without regard to food
Also known as: GS-0976
DrugCILO
30 mg tablet administered orally once daily without regard to food
Also known as: GS-9674
DrugPlacebo to match FIR
Tablet administered orally once daily without regard to food
DrugPlacebo to match CILO
Tablet administered orally once daily without regard to food
DrugPlacebo to match SEL
Tablet administered orally once daily without regard to food

What researchers measure

Primary outcomes

Percentage of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs)
Time frame: 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.
Time frame: 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.
Time frame: Week 48

Results

Posted Dec 3, 2020

Participant flow

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.

Participant flow — Overall Study
Milestone	Selonsertib	Firsocostat	Cilofexor	SEL + FIR	SEL + CILO	FIR + CILO	Placebo
Started	39	40	41	80	78	78	39
Completed	3	33	34	71	66	69	38
Not completed	36	7	7	9	12	9	1
Withdrew: Randomized but never treated	0	0	1	1	1	0	0
Withdrew: Unknown reason	33	1	1	1	2	2	0
Withdrew: Withdrew consent	1	3	1	4	4	4	1
Withdrew: Adverse event	1	2	1	0	0	2	0
Withdrew: Lost to follow-up	0	0	2	1	3	0	0
Withdrew: Investigator's discretion	0	1	1	2	0	0	0
Withdrew: Non compliance with study drug	1	0	0	0	0	0	0
Withdrew: Protocol violation	0	0	0	0	1	1	0
Withdrew: Death	0	0	0	0	1	0	0

Outcome measures

PrimaryPercentage of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs)

Time frame:: First dose date up to 48 weeks plus 30 days
Reported as:: Number · percentage of participants

Percentage of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs)
percentage of participants	Selonsertib	Firsocostat	Cilofexor	SEL + FIR	SEL + CILO	FIR + CILO	Placebo
Percentage of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs)	84.6	85.0	92.5	88.6	96.1	91.0	79.5

PrimaryPercentage 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.

Time frame:: First dose date up to 48 weeks plus 30 days
Reported as:: Number · percentage of participants

Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities
percentage of participants	Selonsertib	Firsocostat	Cilofexor	SEL + FIR	SEL + CILO	FIR + CILO	Placebo
Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities	94.9	100.0	97.5	98.7	96.1	100.0	94.9

PrimaryPercentage 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.

Time frame:: Week 48
Reported as:: Number · percentage of participants

Percentage of Participants Who Achieved a ≥ 1-Stage Improvement in Fibrosis Without Worsening of NASH at Week 48
percentage of participants	Selonsertib	Firsocostat	Cilofexor	SEL + FIR	SEL + CILO	FIR + CILO	Placebo
Percentage of Participants Who Achieved a ≥ 1-Stage Improvement in Fibrosis Without Worsening of NASH at Week 48	28.6 (3.7 to 71.0)	12.1 (3.4 to 28.2)	11.8 (3.3 to 27.5)	15.5 (8.0 to 26.0)	19.1 (10.6 to 30.5)	20.9 (11.9 to 32.6)	10.5 (2.9 to 24.8)

Statistical analysis

Firsocostat vs Placebo · Mantel Haenszel · p = 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 · 95% CI -17.6 to 18.8The 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.
Cilofexor vs Placebo · Mantel Haenszel · p = 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 · 95% CI -17.6 to 18.4The 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.
SEL + FIR vs Placebo · Mantel Haenszel · p = 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 · 95% CI -10.9 to 18.3The 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.
SEL + CILO vs Placebo · Mantel Haenszel · p = 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 · 95% CI -6.4 to 24.1The 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.
FIR + CILO vs Placebo · Mantel Haenszel · p = 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 · 95% CI -4.5 to 26.1The 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.
Firsocostat vs SEL + FIR · Mantel Haenszel · p = 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 · 95% CI -12.9 to 19.4The 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.
Firsocostat vs FIR + CILO · Mantel Haenszel · p = 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 · 95% CI -6.8 to 26.8The 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.
Cilofexor vs SEL + CILO · Mantel Haenszel · p = 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 · 95% CI -10.7 to 21.0The 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.
Cilofexor vs FIR + CILO · Mantel Haenszel · p = 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 · 95% CI -6.0 to 26.9The 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.

Adverse events

Collected over First dose date up to 48 weeks plus 30 days. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Selonsertib	0/39 (0%)	7/39 (17.9%)	30/39 (76.9%)
Firsocostat	0/40 (0%)	3/40 (7.5%)	30/40 (75%)
Cilofexor	0/40 (0%)	8/40 (20%)	34/40 (85%)
SEL + FIR	0/79 (0%)	7/79 (8.9%)	67/79 (84.8%)
SEL + CILO	1/77 (1.3%)	10/77 (13%)	68/77 (88.3%)
FIR + CILO	0/78 (0%)	8/78 (10.3%)	66/78 (84.6%)
Placebo	0/39 (0%)	2/39 (5.1%)	29/39 (74.4%)

Most frequent serious events

Showing 10 of 48

Most frequent serious events
Event	Selonsertib	Firsocostat	Cilofexor	SEL + FIR	SEL + CILO	FIR + CILO	Placebo
CellulitisInfections and infestations	0/39	0/40	3/40	1/79	0/77	0/78	0/39
Abdominal painGastrointestinal disorders	1/39	0/40	0/40	0/79	0/77	0/78	0/39
Abdominal pain lowerGastrointestinal disorders	1/39	0/40	0/40	0/79	0/77	0/78	0/39
ConstipationGastrointestinal disorders	1/39	0/40	0/40	0/79	0/77	0/78	0/39
DysphagiaGastrointestinal disorders	1/39	0/40	0/40	0/79	0/77	0/78	0/39
Gastric ulcer haemorrhageGastrointestinal disorders	0/39	0/40	0/40	0/79	0/77	0/78	1/39
Umbilical herniaGastrointestinal disorders	1/39	0/40	0/40	0/79	0/77	0/78	0/39
Colonic abscessInfections and infestations	1/39	0/40	0/40	0/79	0/77	0/78	0/39
Kidney infectionInfections and infestations	0/39	0/40	0/40	0/79	0/77	0/78	1/39
Meniscus injuryInjury, poisoning and procedural complications	1/39	0/40	0/40	0/79	0/77	0/78	0/39

Most frequent other events

Showing 10 of 60

Most frequent other events
Event	Selonsertib	Firsocostat	Cilofexor	SEL + FIR	SEL + CILO	FIR + CILO	Placebo
PruritusSkin and subcutaneous tissue disorders	7/39	5/40	8/40	12/79	20/77	19/78	5/39
NauseaGastrointestinal disorders	3/39	6/40	3/40	20/79	10/77	10/78	1/39
Upper respiratory tract infectionInfections and infestations	4/39	7/40	4/40	14/79	12/77	8/78	9/39
HeadacheNervous system disorders	4/39	7/40	4/40	11/79	6/77	15/78	3/39
Abdominal painGastrointestinal disorders	7/39	2/40	3/40	6/79	6/77	7/78	2/39
FatigueGeneral disorders	5/39	7/40	3/40	14/79	9/77	8/78	3/39
DiarrhoeaGastrointestinal disorders	2/39	5/40	0/40	11/79	7/77	13/78	2/39
Urinary tract infectionInfections and infestations	6/39	3/40	5/40	9/79	9/77	6/78	2/39
NasopharyngitisInfections and infestations	2/39	4/40	6/40	3/79	3/77	9/78	5/39
ConstipationGastrointestinal disorders	2/39	0/40	4/40	8/79	11/77	6/78	3/39

Baseline characteristics

The Safety Analysis Set included all participants who took at least 1 dose of study drug.

Age, Continuous
Age, Continuous(years)	Selonsertib	Firsocostat	Cilofexor	SEL + FIR	SEL + CILO	FIR + CILO	Placebo	Total
Mean	59 ± 10.4	60 ± 10.0	57 ± 10.2	59 ± 8.3	60 ± 9.0	61 ± 8.4	61 ± 8.2	60 ± 9.0

Sex: Female, Male
Sex: Female, Male(Participants)	Selonsertib	Firsocostat	Cilofexor	SEL + FIR	SEL + CILO	FIR + CILO	Placebo	Total
Female	24	25	29	49	51	48	27	253
Male	15	15	11	30	26	30	12	139

Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)	Selonsertib	Firsocostat	Cilofexor	SEL + FIR	SEL + CILO	FIR + CILO	Placebo	Total
Race — American Indian or Alaska Native	1	0	0	1	1	1	0	4
Race — Asian	7	3	0	3	4	5	3	25
Race — Black	0	1	0	1	2	2	1	7
Race — Native Hawaiian or Pacific Islander	0	1	0	0	0	0	0	1
Race — White	30	35	40	73	68	68	35	349
Race — Not Permitted	1	0	0	0	0	0	0	1
Race — Other	0	0	0	1	2	2	0	5

Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)	Selonsertib	Firsocostat	Cilofexor	SEL + FIR	SEL + CILO	FIR + CILO	Placebo	Total
Ethinicity — Hispanic or Latino	8	9	14	18	25	17	14	105
Ethinicity — Not Hispanic or Latino	31	31	26	60	52	60	25	285
Ethinicity — Not Permitted	0	0	0	1	0	1	0	2

Region of Enrollment
Region of Enrollment(participants)	Selonsertib	Firsocostat	Cilofexor	SEL + FIR	SEL + CILO	FIR + CILO	Placebo	Total
New Zealand	1	0	0	0	0	0	0	1
Canada	3	2	2	5	4	3	3	22
Hong Kong	2	0	0	3	2	2	1	10
United States	30	35	37	67	66	66	35	336
Australia	3	3	1	4	5	7	0	23

Diabetes Mellitus Status
Diabetes Mellitus Status(Participants)	Selonsertib	Firsocostat	Cilofexor	SEL + FIR	SEL + CILO	FIR + CILO	Placebo	Total
Present	26	30	27	57	58	57	27	282
Absent	13	10	13	22	19	21	12	110

Cirrhosis Status
Cirrhosis Status(Participants)	Selonsertib	Firsocostat	Cilofexor	SEL + FIR	SEL + CILO	FIR + CILO	Placebo	Total
Cirrhotic	21	22	22	46	46	42	22	221
Non-Cirrhotic	18	18	18	33	31	36	17	171

Study locations

101 sites

The Institute for Liver Health
Chandler, Arizona 85224-5688, United States
Mayo Clinic Arizona, Mayo Clinic Hospital
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
Saint 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
Montefiore Medical Center
Bronx, New York 10467, 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
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
Montreal, H4A 3J1, Canada
Toronto General Hospital
Toronto, M5G 2C4, Canada
Toronto Liver Centre
Toronto, M6H 3M1, Canada
Prince of Wales Hospital
Shatin, Hong Kong
Auckland City Hospital
Auckland, 1023, New Zealand

Showing the first 100 of 101 sites across 6 countries.

References and documents

Publications

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.
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.
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.
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.
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.
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. PubMed 33169409 ↗

Study documents

Study protocol · Apr 25, 2019
Statistical analysis plan · May 22, 2019

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

Registry details

Key details

Study ID: NCT03449446
Lead sponsor: Gilead Sciences
Responsible party: Sponsor
First posted: Feb 28, 2018
Start date: Mar 21, 2018
Primary completion: Oct 30, 2019
Completion: Nov 19, 2019
Results posted: Dec 3, 2020
Last update: Dec 3, 2020

Study contacts

Gilead Study Director

study director · Gilead Sciences

Oversight

Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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