Study of Semaglutide, and Cilofexor/Firsocostat, Alone and in Combination, in Adults With Cirrhosis Due to Nonalcoholic Steatohepatitis (NASH) (WAYFIND)

November 12, 2025 updated by: Gilead Sciences

A Phase 2, Randomized, Double-Blind, Double-Dummy, Placebo-Controlled Study Evaluating the Safety and Efficacy of Semaglutide, and the Fixed-Dose Combination of Cilofexor and Firsocostat, Alone and in Combination, in Subjects With Compensated Cirrhosis (F4) Due to Nonalcoholic Steatohepatitis (NASH)

The goal of this clinical study is to understand whether the study drugs, semaglutide (SEMA) with the fixed-dose combination (FDC) of cilofexor/firsocostat (CILO/FIR), cause fibrosis improvement and Nonalcoholic Steatohepatitis (NASH) resolution in participants with cirrhosis due to NASH.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

457

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Liverpool, New South Wales, Australia, 2170
        • Liverpool Hospital
      • Westmead, New South Wales, Australia, 2145
        • Westmead Hospital
    • Queensland
      • Herston, Queensland, Australia, 4029
        • Royal Brisbane and Women's Hospital
    • South Australia
      • Adelaide, South Australia, Australia, 5042
        • Flinders Medical Centre
    • Victoria
      • Box Hill, Victoria, Australia, 3128
        • Eastern Health, Box Hill Hospital
      • Clayton, Victoria, Australia, 3168
        • Monash Health, Monash Medical Centre (Clayton)
    • Western Australia
      • Perth, Western Australia, Australia, 6000
        • Royal Perth Hospital
  • Canada
      • Brampton, Canada, L6R 3J7
        • Wlliam Osler Health System - Brampton Civic Hospital
      • Calgary, Canada, T2N 4Z6
        • University of Calgary Liver Unit - Heritage Medical Research Clinic
      • Hamilton, Canada, L8N 3Z5
        • McMaster University Medical Center
      • London, Canada, N6A 5A5
        • London Health Sciences Centre - University Hospital
      • Montreal, Canada, H2X 0A9
        • Centre de Recherche du Centre Hospitalier de I'Universite de Montreal (CRCHUM)
      • Montreal, Canada, H4A 3J1
        • Chronic Viral Illness Service, Royal Victoria Hospital, McGill University Health Centre (MUHC)
      • Toronto, Canada, M6H 3M1
        • Toronto Liver Centre
      • Toronto, Canada, M5G 2C4
        • Toronto General Hospital - University Health Network
      • Vancouver, Canada, V5Z 1M9
        • Gordon and Leslie Diamond Health Care Centre, Vancouver General Hospital, UBC Division of Gastroenterology
      • Vancouver, Canada, V6Z 2K5
        • (G.I.R.I.) Gastrointestinal Research Institute
      • Vanghan, Canada, L4L 4Y7
        • Toronto Digestive Disease Associates Specialty Research
  • France
      • Amiens, France, 80054
        • CHU Amiens Picardie
      • Angers, France, 49033
        • Centre Hosptitalier Universitaire d'Angers
      • Chambray-lès-Tours, France, 37170
        • Centre Hospitalier Regional Universitaire de Tours - Hopital Trousseau
      • Créteil, France, 94010
        • Hôpital Henri Mondor
      • Grenoble, France, 38043
        • CHU de Grenoble
      • Lille, France, 59 037
        • Hopital Claude Huriez
      • Limoges, France, 87042
        • Centre Hospitalier Universitaire Limoges
      • Lyon, France, 69004
        • Hôpital de la Croix-Rousse
      • Marseille, France, 13008
        • Hopital Saint Joseph
      • Montpellier, France, 34295
        • Centre Hospitalier Universitarie de Montpellier - Hospital Saint-Eloi
      • Nice, France, 06202
        • Centre Hospitalier Universitaire de Nice - Hôpital l'Archet
      • Paris, France, 75013
        • Hôpital Universitaire Pitié Salpêtrière
      • Paris, France, 75014
        • Hopitaux de Paris - Hopital Cochin
      • Pessac, France, 33604
        • Hopital Haut Leveque
      • Pessac, France, 33600
        • Hopital Beaujon
      • Rennes, France, 35000
        • Chu Rennes Pontchaillou
      • Toulouse, France, 31300
        • Hopital Rangueil
      • Vandœuvre-lès-Nancy, France, 54500
        • Hôpital Brabois Adultes - CHU de Nancy
  • Japan
      • Fukui, Japan, 918-8503
        • Fukui-ken Saiseikai Hospital
      • Izunokuni, Japan, 410-2295
        • Juntendo University Shizouka Hospital
      • Kyoto, Japan, 602-8566
        • University Hospital, Kyoto Prefectural University of Medicine
      • Musashino, Japan, 1808610
        • Japanese Red Cross Masashino Hospital
      • Osaka, Japan, 5458586
        • Osaka City University Hospital
      • Saga, Japan, 849-0937
        • Saga University Hospital
      • Sapporo, Japan, 060-0033
        • Sapporo-Kosei General Hospital
      • Suita, Japan, 564-0013
        • Saiseikai Suita Hospital
      • Tokyo, Japan, 105-8470
        • Federation of National Public Service Personnel Mutual Aid Associations Toranomon Hospital
      • Toon-Shi, Japan, 791-0295
        • Ehime University Hospital
      • Yamagata, Japan, 9909585
        • Yamagata University Hospital
      • Yokohama, Japan, 2360004
        • Yokohama City University Hospital
  • Puerto Rico
      • San Juan, Puerto Rico, 00909
        • Latin Clinical Trial Center
      • San Juan, Puerto Rico, 00927
        • FDI Clinical Research
      • San Juan, Puerto Rico, 00921
        • VA Caribbean Healthcare System
  • Spain
      • Almería, Spain, 04009
        • Hospital Universitario Torrecárdenas
      • Barcelona, Spain, 08003
        • Hospital Del Mar
      • Barcelona, Spain, 08035
        • Hospital Universitari Vall d'Hebron
      • Barcelona, Spain, 8036
        • Hospital Clinic de Barcelona
      • Madrid, Spain, 28034
        • Hospital Universitario Ramon y Cajal
      • Madrid, Spain, 28007
        • Hospital General Universiatrio Gregorio Maranon
      • Madrid, Spain, 28046
        • Hospital Universitario La Paz Edificio de Malemidad
      • Majadahonda, Spain, 28222
        • Hospital Universitario Puerta de Hierro-Majadahonda
      • Pontevedra, Spain, 36071
        • Complejo Hospitalario de Pontevedra
      • Santander, Spain, 39008
        • Hospital Universitario Marqués de Valdecilla
      • Santiago de Compostela, Spain, 15706
        • Hospital Clinico Universitario de Santiago
      • Seville, Spain, 41013
        • Hospital Universitario Virgin del Rocio
      • Valencia, Spain, 46014
        • Consorcio Hospital General Universitario de Valencia
      • Valencia, Spain, 46026
        • Hospital Universitario y Politecnlo la Fe
      • Valladolid, Spain, 47010
        • Hospital Clínico Universitario de Valladolid
    • Barcelona
      • Badalona, Barcelona, Spain, 08916
        • Hospital Germans Trias i Pujol
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35233
        • University of Alabama At Birmingham Hospital
      • Dothan, Alabama, United States, 36305
        • Digestive Health Specialists
      • Madison, Alabama, United States, 35758
        • North Alabama Health Research, LLC
    • Arizona
      • Chandler, Arizona, United States, 85225
        • Arizona Health Research
      • Chandler, Arizona, United States, 85224
        • The Institution For Liver Health dba Arizona Liver Health
      • Peoria, Arizona, United States, 85381
        • The Institute for Liver Health DBA Arizona Liver Health
      • Sun City, Arizona, United States, 85351
        • Gastrointestinal Alliance - Sun City
      • Tucson, Arizona, United States, 85712
        • Adobe Clinical Research, LLC
      • Tucson, Arizona, United States, 85712
        • The Institution For Liver Health dba Arizona Liver Health
    • Arkansas
      • Little Rock, Arkansas, United States, 72204
        • Arkansas Diagnostic Center
      • Little Rock, Arkansas, United States, 72205
        • ARcare Center for Clinical Research
      • North Little Rock, Arkansas, United States, 72117
        • Arkansas Gastroenterology
    • California
      • Coronado, California, United States, 92118
        • Southern California Research Center
      • Fresno, California, United States, 93701
        • University of California, San Francisco - Fresno
      • La Jolla, California, United States, 92037
        • University of California, San Diego - Altman Clinical and Translational Research Institute
      • Lancaster, California, United States, 93534
        • Gastro Care Institute (Fibroscan)
      • Long Beach, California, United States, 90808
        • Digestive Health Research of Southern California
      • Los Angeles, California, United States, 90027
        • Kaiser Permanente Los Angeles Medical Center
      • Los Angeles, California, United States, 90033
        • Keck Medical Center of USC Healthcare Consultation II
      • Los Angeles, California, United States, 90035
        • Biopharma Informatic, LLC
      • Murrieta, California, United States, 92563
        • United Medical Doctors
      • Orange, California, United States, 92868
        • Knowledge Research Center
      • Palm Springs, California, United States, 92262
        • Palmtree Clinical Research, Inc.
      • Pasadena, California, United States, 91105
        • California Liver Research Institute
      • Poway, California, United States, 92064
        • Cadena Care Institute, LLC
      • Redwood City, California, United States, 94063
        • Stanford Medicine Outpatient Center
      • Rialto, California, United States, 92377
        • Inland Empire Clinical Trials
      • Sacramento, California, United States, 95817
        • University of California, Davis Medical Center
      • San Diego, California, United States, 92123
        • Medical Associates Research Group
      • San Diego, California, United States, 92114
        • Precision Research Institute
      • San Diego, California, United States, 92108
        • TriWest Research Associates, LLC
      • San Diego, California, United States, 92105
        • Research and Education Inc.
      • San Francisco, California, United States, 94115
        • Quest Clinical Research
      • San Francisco, California, United States, 94143
        • University of California, San Francisco - Liver Clinic
      • San Jose, California, United States, 95128
        • San Jose Gastroenterology at One Health
    • Colorado
      • Aurora, Colorado, United States, 80045
        • University of Colorado Anschutz Medical Campus
      • Englewood, Colorado, United States, 80113
        • South Denver Gastroenterology
    • Connecticut
      • New Haven, Connecticut, United States, 06519
        • Yale Center for Clinical Investigation, Church Street Research Unit
    • Florida
      • Boca Raton, Florida, United States, 33434
        • Excel Medical Clinical Trials, LLC
      • Bradenton, Florida, United States, 34208
        • Synergy Healthcare
      • Fort Myers, Florida, United States, 33907
        • Southwest General Healthcare Center
      • Gainesville, Florida, United States, 32610
        • University of Florida Hepatology Research at the Clinical and Translational Research Building
      • Hallandale, Florida, United States, 33009
        • Velocity Clinical Research, Hallandale Beach
      • Hialeah, Florida, United States, 33012
        • Indago Research and Health Center, Inc.
      • Hialeah, Florida, United States, 33016
        • New Generation of Medical Research
      • Hialeah, Florida, United States, 33016
        • Maya Research Center
      • Hialeah Gardens, Florida, United States, 33016
        • Evolution Clinical Research, INC
      • Homestead, Florida, United States, 33032
        • Sunbright Health Medical Center
      • Inverness, Florida, United States, 34452
        • Nature Coast Clinical Research
      • Jacksonville, Florida, United States, 32256
        • Encore Borland-Groover Clinical Research
      • Jacksonville, Florida, United States, 32224
        • UF Health Jacksonville-Gastroenterology Emerson
      • Lakewood Rch, Florida, United States, 34211
        • Florida Research Institute
      • Miami, Florida, United States, 33147
        • Advanced Pharma CR, LLC
      • Miami, Florida, United States, 33136
        • Schiff Center for Liver Diseases/ University of Miami
      • Miami, Florida, United States, 33126
        • G+C Research Group
      • Miami, Florida, United States, 33173
        • Century Research, LLC
      • Miami, Florida, United States, 33175
        • ProLive Medical Research, Corp
      • Miami, Florida, United States, 33176
        • International Medical Investigational Centers, Inc.
      • Miami Springs, Florida, United States, 33166
        • Ocean Blue Medical Research Center, Inc
      • Naples, Florida, United States, 34102
        • Gastroenterology Group Of Naples
      • New Port Richey, Florida, United States, 34653
        • Advanced Research Institute, Inc.
      • Ocala, Florida, United States, 34471
        • Ocala GI Research
      • Port Orange, Florida, United States, 32127
        • Progressive Medical Research
      • Port Orange, Florida, United States, 32127
        • Advanced Medical Research Center
      • Sarasota, Florida, United States, 34240
        • Covenant Metabolic Specialists, LLC
      • Winter Park, Florida, United States, 32792
        • Charter Research
      • Zephyrhills, Florida, United States, 33542
        • Florida Medical Clinic, LLC
    • Georgia
      • Dalton, Georgia, United States, 30720
        • Southeast Clinical Research LLC
      • Marietta, Georgia, United States, 30060
        • Gastrointestinal (GI) Specialists of Georgia
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Rush University Medical Group - Department of Hepatology
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Indiana University Health Enterprise Clinical Research Operations
      • New Albany, Indiana, United States, 47150
        • Gastroenterology Health Partners, PLLC
      • South Bend, Indiana, United States, 44635
        • Digestive Research Alliance of Michigan
    • Iowa
      • Clive, Iowa, United States, 50325
        • Iowa Digestive Disease Center, PC
      • Iowa City, Iowa, United States, 52242
        • University of Iowa Hospitals and Clinics
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • University Of Kansas Medical Center
      • Topeka, Kansas, United States, 66606
        • Kansas Medical Clinic PA
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70809
        • GI Alliance
      • Lafayette, Louisiana, United States, 70503
        • Combined Gastro Research, LLC
      • Marrero, Louisiana, United States, 70072
        • Tandem Clinical Research GI, LLC
      • Monroe, Louisiana, United States, 71201
        • Delta Research Partners
      • New Orleans, Louisiana, United States, 70112
        • Tulane University Health Sciences Center
      • New Orleans, Louisiana, United States, 70121
        • Oschner Clinic Foundation
      • Shreveport, Louisiana, United States, 71105
        • Louisiana Research Center, LLC
    • Maryland
      • Baltimore, Maryland, United States, 21202
        • Mercy Medical Center
      • Bethesda, Maryland, United States, 20889
        • Walter Reed National Military Medical Center
      • Glen Burnie, Maryland, United States, 21061
        • Woodholme Gastroenterology Associates
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Beth Israel Deaconess Medical Center
      • Framingham, Massachusetts, United States, 01702
        • Greater Boston Gastroenterology
      • South Dartmouth, Massachusetts, United States, 02747
        • Hawthorn Medical Associates
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • Michigan Medicine - University of Michigan
      • Chesterfield, Michigan, United States, 48047
        • Clinical Research Institute of Michigan, LLC
      • Detroit, Michigan, United States, 48202
        • Henry Ford Health System
      • Wyoming, Michigan, United States, 49519
        • Gastroenterology Associates of Western Michigan, PLC d.b.a. West Michigan Clinical Research Center
      • Ypsilanti, Michigan, United States, 48197
        • Huron Gastroenterology Associates
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic
    • Mississippi
      • Flowood, Mississippi, United States, 39232
        • GI Alliance
      • Jackson, Mississippi, United States, 39216
        • Southern Therapy and Advanced Research
    • Missouri
      • Chesterfield, Missouri, United States, 63005
        • Clinical Research Professionals
      • Columbia, Missouri, United States, 65201
        • GI Associates Research
      • Kansas City, Missouri, United States, 64131
        • Kansas City Research Institute
    • Nevada
      • Las Vegas, Nevada, United States, 89106
        • Sierra Clinical Research
    • New Jersey
      • Florham Park, New Jersey, United States, 07932
        • Digestive Disease Research
      • Freehold, New Jersey, United States, 07728
        • Allied Health Clinical Research Organization, LLC
      • Newark, New Jersey, United States, 07103
        • Rutgers New Jersey Medical School
    • New Mexico
      • Albuquerque, New Mexico, United States, 87109
        • Center for Research at Southwest Gastroenterology Associates, PC
    • New York
      • Manhasset, New York, United States, 11030
        • Northwell Health Center for Liver Diseases
      • New York, New York, United States, 10029
        • Mount Sinai Medical Center
      • New York, New York, United States, 10016
        • New York University Langone Health
      • New York, New York, United States, 10032
        • Liver Clinic (study visits, Fibroscan): Columbia University Irving Medical Center / NewYork Presbyterian Hospital
      • New York, New York, United States, 10065
        • The New York - Presbyterian Hospital
      • Rochester, New York, United States, 14642
        • University of Rochester Medical Center
    • North Carolina
      • Asheville, North Carolina, United States, 28801
        • Asheville Gastroenterology, a Division of Digestive Health Partners, PA
      • Charlotte, North Carolina, United States, 28207
        • Charlotte Gastroenterology & Hepatology, PLLC
      • Charlotte, North Carolina, United States, 28204
        • Atrium Health Transplant and Center for Liver Disease
      • Concord, North Carolina, United States, 28027
        • Northeast GI Research Division
      • Fayetteville, North Carolina, United States, 28304
        • Coastal Research Institute
      • Morehead City, North Carolina, United States, 28557
        • Lucas Research, Inc.
      • Raleigh, North Carolina, United States, 27607
        • Carolina's GI Research, LLC
    • Ohio
      • Columbus, Ohio, United States, 43235
        • Optimed Research
      • Springboro, Ohio, United States, 45066
        • DSI Research
      • Westlake, Ohio, United States, 44145
        • Clinical Research Institute of Ohio, LLC
    • Oklahoma
      • Tulsa, Oklahoma, United States, 74104
        • Options Health Research, LLC
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
        • University of Pittsburgh Medical Center
    • Rhode Island
      • East Greenwich, Rhode Island, United States, 02818
        • Velocity Clinical Research - Providence
      • Providence, Rhode Island, United States, 02905
        • University Gastroenterology
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Medical University of South Carolina
      • Columbia, South Carolina, United States, 29204
        • Columbia Digestive Health Research
      • Greenwood, South Carolina, United States, 29646
        • Digestive Disease Research Center
      • Spartanburg, South Carolina, United States, 29303
        • Velocity Clinical Research, Spartanburg
    • Tennessee
      • Chattanooga, Tennessee, United States, 37421
        • Wake Research - ClinsSearch, LLC
      • Johnson City, Tennessee, United States, 37604
        • Gastrointestinal Associates of Northeast Tennessee
      • Nashville, Tennessee, United States, 37211
        • Quality Medical Research, PLLC
    • Texas
      • Arlington, Texas, United States, 76012
        • Texas Clinical Research Institute
      • Austin, Texas, United States, 78757
        • Pinnacle Clinical Research
      • Brownsville, Texas, United States, 78520
        • South Texas Research Institute
      • Cedar Park, Texas, United States, 78613
        • GI Alliance
      • Dallas, Texas, United States, 75203
        • The Liver Institute at Methodist Dallas Medical Center
      • Dallas, Texas, United States, 75246
        • GI Alliance
      • Dallas, Texas, United States, 75390
        • Internal Medicine Digestive and Liver Diseases Clinical Trials
      • Denison, Texas, United States, 75020
        • Soma Clinical Trials, LLC
      • Edinburg, Texas, United States, 78539
        • South Texas Research Institute
      • Edinburg, Texas, United States, 78539
        • DHR Health Institute for Research and Development Cancer Research Center
      • Fort Worth, Texas, United States, 76104
        • GI Alliance
      • Garland, Texas, United States, 75044
        • GI Alliance
      • Georgetown, Texas, United States, 78626
        • Pinnacle Clinical Research
      • Harlingen, Texas, United States, 78550
        • Texas Digestive Specialists
      • Houston, Texas, United States, 77030
        • Houston Methodist Hospital
      • Houston, Texas, United States, 77043
        • Biopharma Informatic, LLC
      • Houston, Texas, United States, 77084
        • Biopharma Informatic, LLC
      • Houston, Texas, United States, 77030
        • Liver Associates of Texas, P.A.
      • Houston, Texas, United States, 77030
        • Liver Specialists of Texas
      • Houston, Texas, United States, 77079
        • Houston Research Institute
      • Katy, Texas, United States, 77494
        • BioStar Clinical Research Group Inc.
      • Lubbock, Texas, United States, 79410
        • GI Alliance
      • McAllen, Texas, United States, 78503
        • Biopharma Informatic, LLC
      • Pasadena, Texas, United States, 77505
        • Digestive System Healthcare
      • San Antonio, Texas, United States, 78215
        • American Research Corporation at The Texas Liver Institute
      • San Antonio, Texas, United States, 78229
        • Diabetes and Glandular Disease Clinic, P.A.
      • San Antonio, Texas, United States, 78229
        • Pinnacle Clinical Research, LLC
      • San Marcos, Texas, United States, 78666
        • GI Alliance (Patients Seen, IP Shipment & Fibroscan)
      • Waco, Texas, United States, 76710
        • Impact Research Institute
      • Webster, Texas, United States, 77598
        • GI Alliance
      • Wichita Falls, Texas, United States, 07960
        • Digestive Health Research of North Texas
    • Utah
      • Murray, Utah, United States, 84107
        • Intermountain Medical Center
      • Salt Lake City, Utah, United States, 84132
        • University of Utah Hospital
      • West Jordan, Utah, United States, 84088
        • Velocity Clinical Research, Salt Lake City
    • Vermont
      • Burlington, Vermont, United States, 05401
        • The University of Vermont Medical Center
    • Virginia
      • Charlottesville, Virginia, United States, 22908
        • University of Virginia Medical Center
      • Manassas, Virginia, United States, 20110
        • Manassas Clinical Research Center
      • Norfolk, Virginia, United States, 23502
        • Digestive and Liver Disease Specialists
      • Richmond, Virginia, United States, 23226
        • Bon Secours Richmond Community Hospital, Inc. d/b/a Bon Secours Liver Institute of Richmond
      • Richmond, Virginia, United States, 23298
        • Virginia Commonwealth University Health Clinical Research Services Unit
    • Washington
      • Seattle, Washington, United States, 98105
        • Liver Institute Northwest
      • Seattle, Washington, United States, 98101
        • Virginia Mason

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Key Inclusion Criteria:

  • Liver biopsy consistent with cirrhosis (F4) due to nonalcoholic steatohepatitis (NASH) in the opinion of the central reader. In individuals who have never had a liver biopsy, a screening liver biopsy may be performed.

  • Screening laboratory parameters as determined by the study central laboratory:

    • Estimated glomerular filtration rate (eGFR) ≥ 30 mL/min/1.73 m^2, as calculated by the Modification of Diet in Renal Disease (MDRD) equation.
    • Hemoglobin A1c (HbA1c) ≤ 10%
    • International normalized ratio (INR) ≤ 1.4, unless due to therapeutic anticoagulation
    • Platelet count ≥ 125,000/µL
    • Alanine aminotransferase (ALT) < 5 x upper limit of normal (ULN)
    • Serum albumin ≥ 3.5 g/dL
    • Serum alkaline phosphatase (ALP) ≤ 2 x ULN
  • Body mass index (BMI) ≥ 23 kg/m^2 at screening.

Key Exclusion Criteria:

  • Prior history of decompensated liver disease, including ascites, hepatic encephalopathy (HE), 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 alternative etiology such as therapeutic anticoagulation.
  • Other causes of liver disease based on medical history and/or central reader review of liver histology, including but not limited to: alcoholic liver disease, 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.
  • Chronic hepatitis B virus (HBV) infection (HBsAg positive), or Chronic hepatitis C virus (HCV) infection (HCV antibody and HCV ribonucleic acid (RNA) positive). Individuals cured of HCV infection less than 2 years prior to the screening visit are not eligible.
  • History of liver transplantation.
  • Current or prior history of hepatocellular carcinoma (HCC).

  • Men who habitually drink greater than 21 units/week of alcohol or women who habitually drink greater than 14 units/week of alcohol (1 unit is equivalent to 12 ounce (oz)/360 mL of beer, a 4 oz/120 mL glass of wine, or 1 oz/30 mL of hard liquor).

    • For individuals on vitamin E regimen ≥ 800 IU/day, or pioglitazone, dose must be stable, in the opinion of the investigator for at least 180 days prior to the historical or screening liver biopsy.
    • For individuals on medications for diabetes, dose must be stable, in the opinion of the investigator, for at least 90 days prior to the historical or screening liver biopsy.
  • History of type 1 diabetes.
  • Treatment with a glucagon-like peptide-1 receptor agonist (GLP-1 RA) in the period from 90 days prior to the screening visit and for individuals with a qualifying historical liver biopsy, for 90 days prior to the date of the historical liver biopsy.
  • For individuals who have not completed a series of an authorized coronavirus disease 2019 (COVID-19) vaccination regimen prior to screening, a positive result for COVID-19 on severe acute respiratory syndrome (SARS)-coronavirus 2 (CoV-2) reverse transcriptase-polymerase chain reaction (RT-PCR) test.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: SEMA + CILO/FIR FDC
Participants will receive semaglutide (SEMA) 3.0 mg/mL, once weekly and cilofexor and firsocostat (CILO/FIR) 30 mg/20 mg fixed-dose combination (FDC) tablet, once daily up to 72 weeks.
Drug: Semaglutide (SEMA)
Administered as subcutaneous (SC) injection
Drug: Cilofexor (CILO)/Firsocostat (FIR)
Tablets administered orally
Other Names:
  • GS-9674/GS-0976
Experimental: SEMA + PTM CILO/FIR
Participants will receive SEMA 3.0 mg/mL, once weekly and Placebo-To-Match (PTM) CILO/FIR FDC tablet, once daily up to 72 weeks.
Drug: Semaglutide (SEMA)
Administered as subcutaneous (SC) injection
Drug: PTM CILO/FIR
Tablets administered orally
Experimental: PTM SEMA + CILO/FIR FDC
Participants will receive PTM SEMA, once weekly and CILO/FIR 30 mg/20 mg FDC tablet, once daily up to 72 weeks.
Drug: Cilofexor (CILO)/Firsocostat (FIR)
Tablets administered orally
Other Names:
  • GS-9674/GS-0976
Drug: PTM SEMA
Administered as SC injection
Placebo Comparator: PTM SEMA + PTM CILO/FIR
Participants will receive PTM SEMA, once weekly and PTM CILO/FIR FDC tablet, once daily up to 72 weeks.
Drug: PTM CILO/FIR
Tablets administered orally
Drug: PTM SEMA
Administered as SC injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants Who Achieved ≥ 1-Stage Improvement in Fibrosis Without Worsening of Nonalcoholic Steatohepatitis (NASH) at Week 72 in Semaglutide (SEMA) + Cilofexor/Firsocostat (CILO/FIR) Fixed Dose Combination (FDC) Versus Placebo Groups
Time Frame: Week 72

Fibrosis improvement was defined as ≥ 1-stage decrease from baseline in fibrosis according to the NASH clinical research network (CRN) classification. Worsening of NASH was defined as ≥ 1-point increase from baseline in hepatocellular ballooning or lobular inflammation.

Clopper-Pearson method was used in outcome measure analysis in each arm. Percentages were rounded-off.
Week 72

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants Who Achieved ≥1-Stage Improvement in Fibrosis Without Worsening of NASH at Week 72 in SEMA + CILO/FIR FDC Versus SEMA Alone
Time Frame: Week 72

Fibrosis improvement was defined as ≥ 1-stage decrease from baseline in fibrosis according to the NASH CRN classification. Worsening of NASH was defined as ≥ 1-point increase from baseline in hepatocellular ballooning or lobular inflammation.

Clopper-Pearson method was used in outcome measure analysis in each arm. Percentages were rounded-off.
Week 72
Percentage of Participants With NASH Resolution Without Worsening in Fibrosis at Week 72 in SEMA + CILO/FIR FDC Versus Placebo Groups
Time Frame: Week 72

NASH resolution is defined as lobular inflammation of 0 or 1 and hepatocellular ballooning of 0. Worsening in fibrosis was defined as a change in fibrosis worsening stage as per NASH CRN criteria.

Clopper-Pearson method was used in outcome measure analysis in each arm. Percentages were rounded-off.
Week 72
Percentage of Participants With NASH Resolution Without Worsening in Fibrosis In Participants Treated With SEMA + CILO/FIR FDC Versus CILO/FIR Alone Groups
Time Frame: Week 72

NASH resolution is defined as lobular inflammation of 0 or 1 and hepatocellular ballooning of 0. Worsening in fibrosis was defined as a change in fibrosis worsening stage as per NASH CRN criteria.

Clopper-Pearson method was used in outcome measure analysis in each arm. Percentages were rounded-off.
Week 72

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gilead Sciences

Collaborators

Novo Nordisk A/S

Investigators

  • Study Director: Gilead Study Director, Gilead Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 9, 2021

Primary Completion (Actual)

November 12, 2024

Study Completion (Actual)

December 9, 2024

Study Registration Dates

First Submitted

July 20, 2021

First Submitted That Met QC Criteria

July 20, 2021

First Posted (Actual)

July 21, 2021

Study Record Updates

Last Update Posted (Actual)

November 26, 2025

Last Update Submitted That Met QC Criteria

November 12, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GS-US-454-6075
  • 2021-001445-12 (EudraCT Number)
  • jRCT2071210112 (Registry Identifier: Japan Registry of Clinical Trials)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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