AzTrials
AzTrials

Nonalcoholic SteatohepatitisPhase 2WAYFINDNCT04971785

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

A Phase 2 study testing Semaglutide (SEMA), Cilofexor (CILO)/Firsocostat (FIR) and PTM SEMA in people with Nonalcoholic Steatohepatitis, run by Gilead Sciences at 242 sites in 7 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Nonalcoholic Steatohepatitis
What is being tested?
Semaglutide (SEMA), Cilofexor (CILO)/Firsocostat (FIR) and PTM SEMA
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
457 participants
Where
242 sitesin 7 countries
Study dates
9 Aug 2021to 9 Dec 2024
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 10Show fewer
  • 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.

Who cannot join

  • 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.
Show all 14Show fewer
  • 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.

Trial locations and contacts

242 sites in 7 countries.

242 sites in 7 countries

United States175 sites

  • Center for Research at Southwest Gastroenterology Associates, PC

    Albuquerque, New Mexico, 87109

  • Michigan Medicine - University of Michigan

    Ann Arbor, Michigan, 48109

  • Texas Clinical Research Institute

    Arlington, Texas, 76012

  • Asheville Gastroenterology, a Division of Digestive Health Partners, PA

    Asheville, North Carolina, 28801

  • University of Colorado Anschutz Medical Campus

    Aurora, Colorado, 80045

  • Pinnacle Clinical Research

    Austin, Texas, 78757

  • Mercy Medical Center

    Baltimore, Maryland, 21202

  • GI Alliance

    Baton Rouge, Louisiana, 70809

  • Walter Reed National Military Medical Center

    Bethesda, Maryland, 20889

  • University of Alabama at Birmingham Hospital

    Birmingham, Alabama, 35233

  • Excel Medical Clinical Trials, LLC

    Boca Raton, Florida, 33434

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215

  • Synergy Healthcare

    Bradenton, Florida, 34208

  • South Texas Research Institute

    Brownsville, Texas, 78520

  • The University Of Vermont Medical Center

    Burlington, Vermont, 05401

  • GI Alliance

    Cedar Park, Texas, 78613

  • The Institution For Liver Health dba Arizona Liver Health

    Chandler, Arizona, 85224

  • Arizona Health Research

    Chandler, Arizona, 85225

  • Medical University of South Carolina

    Charleston, South Carolina, 29425

  • Atrium Health Transplant and Center for Liver Disease

    Charlotte, North Carolina, 28204

  • Charlotte Gastroenterology & Hepatology, PLLC

    Charlotte, North Carolina, 28207

  • University of Virginia Medical Center

    Charlottesville, Virginia, 22908

  • Wake Research - ClinsSearch, LLC

    Chattanooga, Tennessee, 37421

  • Clinical Research Institute of Michigan, LLC

    Chesterfield, Michigan, 48047

  • Clinical Research Professionals

    Chesterfield, Missouri, 63005

  • Rush University Medical Group - Department of Hepatology

    Chicago, Illinois, 60612

  • Iowa Digestive Disease Center, PC

    Clive, Iowa, 50325

  • GI Associates Research

    Columbia, Missouri, 65201

  • Columbia Digestive Health Research

    Columbia, South Carolina, 29204

  • Optimed Research

    Columbus, Ohio, 43235

  • Northeast GI Research Division

    Concord, North Carolina, 28027

  • Southern California Research Center

    Coronado, California, 92118

  • The Liver Institute at Methodist Dallas Medical Center

    Dallas, Texas, 75203

  • GI Alliance

    Dallas, Texas, 75246

  • Internal Medicine Digestive and Liver Diseases Clinical Trials

    Dallas, Texas, 75390

  • Southeast Clinical Research LLC

    Dalton, Georgia, 30720

  • Soma Clinical Trials, LLC

    Denison, Texas, 75020

  • Henry Ford Health System

    Detroit, Michigan, 48202

  • Digestive Health Specialists

    Dothan, Alabama, 36305

  • Velocity Clinical Research - Providence

    East Greenwich, Rhode Island, 02818

  • DHR Health Institute for Research and Development Cancer Research Center

    Edinburg, Texas, 78539

  • South Texas Research Institute

    Edinburg, Texas, 78539

  • South Denver Gastroenterology

    Englewood, Colorado, 80113

  • Coastal Research Institute

    Fayetteville, North Carolina, 28304

  • Digestive Disease Research

    Florham Park, New Jersey, 07932

  • GI Alliance

    Flowood, Mississippi, 39232

  • Southwest General Healthcare Center

    Fort Myers, Florida, 33907

  • GI Alliance

    Fort Worth, Texas, 76104

  • Greater Boston Gastroenterology

    Framingham, Massachusetts, 01702

  • Allied Health Clinical Research Organization, LLC

    Freehold, New Jersey, 07728

  • University of California, San Francisco - Fresno

    Fresno, California, 93701

  • University of Florida Hepatology Research at the Clinical and Translational Research Building

    Gainesville, Florida, 32610

  • GI Alliance

    Garland, Texas, 75044

  • Pinnacle Clinical Research

    Georgetown, Texas, 78626

  • Woodholme Gastroenterology Associates

    Glen Burnie, Maryland, 21061

  • Digestive Disease Research Center

    Greenwood, South Carolina, 29646

  • Velocity Clinical Research, Hallandale Beach

    Hallandale, Florida, 33009

  • Texas Digestive Specialists

    Harlingen, Texas, 78550

  • Indago Research and Health Center, Inc.

    Hialeah, Florida, 33012

  • Maya Research Center

    Hialeah, Florida, 33016

  • New Generation of Medical Research

    Hialeah, Florida, 33016

  • Evolution Clinical Research, INC

    Hialeah Gardens, Florida, 33016

  • Sunbright Health Medical Center

    Homestead, Florida, 33032

  • Houston Methodist Hospital

    Houston, Texas, 77030

  • Liver Associates of Texas, P.A.

    Houston, Texas, 77030

  • Liver Specialists of Texas

    Houston, Texas, 77030

  • Biopharma Informatic, LLC

    Houston, Texas, 77043

  • Houston Research Institute

    Houston, Texas, 77079

  • Biopharma Informatic, LLC

    Houston, Texas, 77084

  • Indiana University Health Enterprise Clinical Research Operations

    Indianapolis, Indiana, 46202

  • Nature Coast Clinical Research

    Inverness, Florida, 34452

  • University of Iowa Hospitals and Clinics

    Iowa City, Iowa, 52242

  • Southern Therapy and Advanced Research

    Jackson, Mississippi, 39216

  • UF Health Jacksonville-Gastroenterology Emerson

    Jacksonville, Florida, 32224

  • Encore Borland-Groover Clinical Research

    Jacksonville, Florida, 32256

  • Gastrointestinal Associates of Northeast Tennessee

    Johnson City, Tennessee, 37604

  • University of Kansas Medical Center

    Kansas City, Kansas, 66160

  • Kansas City Research Institute

    Kansas City, Missouri, 64131

  • BioStar Clinical Research Group Inc.

    Katy, Texas, 77494

  • University of California, San Diego - Altman Clinical and Translational Research Institute

    La Jolla, California, 92037

  • Combined Gastro Research, LLC

    Lafayette, Louisiana, 70503

  • Florida Research Institute

    Lakewood Rch, Florida, 34211

  • Gastro Care Institute (Fibroscan)

    Lancaster, California, 93534

  • Sierra Clinical Research

    Las Vegas, Nevada, 89106

  • Arkansas Diagnostic Center

    Little Rock, Arkansas, 72204

  • ARCare Center for Clinical Research

    Little Rock, Arkansas, 72205

  • Digestive Health Research of Southern California

    Long Beach, California, 90808

  • Kaiser Permanente Los Angeles Medical Center

    Los Angeles, California, 90027

  • Keck Medical Center of USC Healthcare Consultation II

    Los Angeles, California, 90033

  • Biopharma Informatic, LLC

    Los Angeles, California, 90035

  • GI Alliance

    Lubbock, Texas, 79410

  • North Alabama Health Research, LLC

    Madison, Alabama, 35758

  • Manassas Clinical Research Center

    Manassas, Virginia, 20110

  • Northwell Health Center for Liver Diseases

    Manhasset, New York, 11030

  • Gastrointestinal (GI) Specialists of Georgia

    Marietta, Georgia, 30060

  • Tandem Clinical Research GI, LLC

    Marrero, Louisiana, 70072

  • Biopharma Informatic, LLC

    McAllen, Texas, 78503

  • G+C Research Group

    Miami, Florida, 33126

  • Schiff Center for Liver Diseases/ University of Miami

    Miami, Florida, 33136

  • Advanced Pharma CR, LLC

    Miami, Florida, 33147

  • Century Research, LLC

    Miami, Florida, 33173

  • ProLive Medical Research, Corp

    Miami, Florida, 33175

  • International Medical Investigational Centers, Inc.

    Miami, Florida, 33176

  • Ocean Blue Medical Research Center, Inc

    Miami Springs, Florida, 33166

  • Delta Research Partners

    Monroe, Louisiana, 71201

  • Lucas Research, Inc.

    Morehead City, North Carolina, 28557

  • Intermountain Medical Center

    Murray, Utah, 84107

  • United Medical Doctors

    Murrieta, California, 92563

  • Gastroenterology Group of Naples

    Naples, Florida, 34102

  • Quality Medical Research, PLLC

    Nashville, Tennessee, 37211

  • Gastroenterology Health Partners, PLLC

    New Albany, Indiana, 47150

  • Yale Center for Clinical Investigation, Church Street Research Unit

    New Haven, Connecticut, 06519

  • Tulane University Health Sciences Center

    New Orleans, Louisiana, 70112

  • Oschner Clinic Foundation

    New Orleans, Louisiana, 70121

  • Advanced Research Institute, Inc.

    New Port Richey, Florida, 34653

  • New York University Langone Health

    New York, New York, 10016

  • Mount Sinai Medical Center

    New York, New York, 10029

  • Liver Clinic (study visits, Fibroscan): Columbia University Irving Medical Center / NewYork Presbyterian Hospital

    New York, New York, 10032

  • The New York - Presbyterian Hospital

    New York, New York, 10065

  • Rutgers New Jersey Medical School

    Newark, New Jersey, 07103

  • Digestive and Liver Disease Specialists

    Norfolk, Virginia, 23502

  • Arkansas Gastroenterology

    North Little Rock, Arkansas, 72117

  • Ocala GI Research

    Ocala, Florida, 34471

  • Knowledge Research Center

    Orange, California, 92868

  • Palmtree Clinical Research, Inc.

    Palm Springs, California, 92262

  • California Liver Research Institute

    Pasadena, California, 91105

  • Digestive System Healthcare

    Pasadena, Texas, 77505

  • The Institute for Liver Health DBA Arizona Liver Health

    Peoria, Arizona, 85381

  • University of Pittsburgh Medical Center

    Pittsburgh, Pennsylvania, 15213

  • Advanced Medical Research Center

    Port Orange, Florida, 32127

  • Progressive Medical Research

    Port Orange, Florida, 32127

  • Cadena Care Institute, LLC

    Poway, California, 92064

  • University Gastroenterology

    Providence, Rhode Island, 02905

  • Carolina's GI Research, LLC

    Raleigh, North Carolina, 27607

  • Stanford Medicine Outpatient Center

    Redwood City, California, 94063

  • Inland Empire Clinical Trials

    Rialto, California, 92377

  • Bon Secours Richmond Community Hospital, Inc. d/b/a Bon Secours Liver Institute of Richmond

    Richmond, Virginia, 23226

  • Virginia Commonwealth University Health Clinical Research Services Unit

    Richmond, Virginia, 23298

  • Mayo Clinic

    Rochester, Minnesota, 55905

  • University of Rochester Medical Center

    Rochester, New York, 14642

  • University of California, Davis Medical Center

    Sacramento, California, 95817

  • University of Utah Hospital

    Salt Lake City, Utah, 84132

  • American Research Corporation at the Texas Liver Institute

    San Antonio, Texas, 78215

  • Diabetes and Glandular Disease Clinic, P.A.

    San Antonio, Texas, 78229

  • Pinnacle Clinical Research, LLC

    San Antonio, Texas, 78229

  • Research and Education Inc.

    San Diego, California, 92105

  • TriWest Research Associates, LLC

    San Diego, California, 92108

  • Precision Research Institute

    San Diego, California, 92114

  • Medical Associates Research Group

    San Diego, California, 92123

  • Quest Clinical Research

    San Francisco, California, 94115

  • University of California, San Francisco - Liver Clinic

    San Francisco, California, 94143

  • San Jose Gastroenterology at One Health

    San Jose, California, 95128

  • GI Alliance (Patients Seen, IP Shipment & Fibroscan)

    San Marcos, Texas, 78666

  • Covenant Metabolic Specialists, LLC

    Sarasota, Florida, 34240

  • Virginia Mason

    Seattle, Washington, 98101

  • Liver Institute Northwest

    Seattle, Washington, 98105

  • Louisiana Research Center, LLC

    Shreveport, Louisiana, 71105

  • Digestive Research Alliance of Michigan

    South Bend, Indiana, 44635

  • Hawthorn Medical Associates

    South Dartmouth, Massachusetts, 02747

  • Velocity Clinical Research, Spartanburg

    Spartanburg, South Carolina, 29303

  • DSI Research

    Springboro, Ohio, 45066

  • Gastrointestinal Alliance - Sun City

    Sun City, Arizona, 85351

  • Kansas Medical Clinic PA

    Topeka, Kansas, 66606

  • Adobe Clinical Research, LLC

    Tucson, Arizona, 85712

  • The Institution For Liver Health dba Arizona Liver Health

    Tucson, Arizona, 85712

  • Options Health Research, LLC

    Tulsa, Oklahoma, 74104

  • Impact Research Institute

    Waco, Texas, 76710

  • GI Alliance

    Webster, Texas, 77598

  • Velocity Clinical Research, Salt Lake City

    West Jordan, Utah, 84088

  • Clinical Research Institute of Ohio, LLC

    Westlake, Ohio, 44145

  • Digestive Health Research of North Texas

    Wichita Falls, Texas, 07960

  • Charter Research

    Winter Park, Florida, 32792

  • Gastroenterology Associates of Western Michigan, PLC d.b.a. West Michigan Clinical Research Center

    Wyoming, Michigan, 49519

  • Huron Gastroenterology Associates

    Ypsilanti, Michigan, 48197

  • Florida Medical Clinic, LLC

    Zephyrhills, Florida, 33542

Other trials in United States

France18 sites

  • CHU Amiens Picardie

    Amiens, 80054

  • Centre Hosptitalier Universitaire d'Angers

    Angers, 49033

  • Centre Hospitalier Regional Universitaire de Tours - Hopital Trousseau

    Chambray-lès-Tours, 37170

  • Hopital Henri Mondor

    Créteil, 94010

  • CHU de Grenoble

    Grenoble, 38043

  • Hopital Claude Huriez

    Lille, 59 037

  • Centre Hospitalier Universitaire Limoges

    Limoges, 87042

  • Hopital de la Croix-Rousse

    Lyon, 69004

  • Hopital Saint Joseph

    Marseille, 13008

  • Centre Hospitalier Universitarie de Montpellier - Hospital Saint-Eloi

    Montpellier, 34295

  • Centre Hospitalier Universitaire de Nice - Hopital L'archet

    Nice, 06202

  • Hopital Universitaire Pitie Salpetriere

    Paris, 75013

  • Hopitaux de Paris - Hopital Cochin

    Paris, 75014

  • Hopital Beaujon

    Pessac, 33600

  • Hopital Haut Leveque

    Pessac, 33604

  • CHU Rennes Pontchaillou

    Rennes, 35000

  • Hopital Rangueil

    Toulouse, 31300

  • Hopital Brabois Adultes - CHU de Nancy

    Vandœuvre-lès-Nancy, 54500

Other trials in France

Spain16 sites

  • Hospital Universitario Torrecardenas

    Almería, 04009

  • Hospital Germans Trias i Pujol

    Badalona, Barcelona, 08916

  • Hospital del Mar

    Barcelona, 08003

  • Hospital Universitari Vall d'Hebron

    Barcelona, 08035

  • Hospital Clinic De Barcelona

    Barcelona, 8036

  • Hospital General Universiatrio Gregorio Maranon

    Madrid, 28007

  • Hospital Universitario Ramon y Cajal

    Madrid, 28034

  • Hospital Universitario La Paz Edificio de Malemidad

    Madrid, 28046

  • Hospital Universitario Puerta de Hierro-Majadahonda

    Majadahonda, 28222

  • Complejo Hospitalario de Pontevedra

    Pontevedra, 36071

  • Hospital Universitario Marques de Valdecilla

    Santander, 39008

  • Hospital Clinico Universitario de Santiago

    Santiago de Compostela, 15706

  • Hospital Universitario Virgin del Rocio

    Seville, 41013

  • Consorcio Hospital General Universitario de Valencia

    Valencia, 46014

  • Hospital Universitario y Politecnlo la Fe

    Valencia, 46026

  • Hospital Clinico Universitario de Valladolid

    Valladolid, 47010

Other trials in Spain

Japan12 sites

  • Fukui-ken Saiseikai Hospital

    Fukui, 918-8503

  • Juntendo University Shizouka Hospital

    Izunokuni, 410-2295

  • University Hospital, Kyoto Prefectural University of Medicine

    Kyoto, 602-8566

  • Japanese Red Cross Masashino Hospital

    Musashino, 1808610

  • Osaka City University Hospital

    Osaka, 5458586

  • Saga University Hospital

    Saga, 849-0937

  • Sapporo-Kosei General Hospital

    Sapporo, 060-0033

  • Saiseikai Suita Hospital

    Suita, 564-0013

  • Federation of National Public Service Personnel Mutual Aid Associations Toranomon Hospital

    Tokyo, 105-8470

  • Ehime University Hospital

    Toon-Shi, 791-0295

  • Yamagata University Hospital

    Yamagata, 9909585

  • Yokohama City University Hospital

    Yokohama, 2360004

Other trials in Japan

Canada11 sites

  • Wlliam Osler Health System - Brampton Civic Hospital

    Brampton, L6R 3J7

  • University of Calgary Liver Unit - Heritage Medical Research Clinic

    Calgary, T2N 4Z6

  • McMaster University Medical Center

    Hamilton, L8N 3Z5

  • London Health Sciences Centre - University Hospital

    London, N6A 5A5

  • Centre de Recherche du Centre Hospitalier de I'Universite de Montreal (CRCHUM)

    Montreal, H2X 0A9

  • Chronic Viral Illness Service, Royal Victoria Hospital, McGill University Health Centre (MUHC)

    Montreal, H4A 3J1

  • Toronto General Hospital - University Health Network

    Toronto, M5G 2C4

  • Toronto Liver Centre

    Toronto, M6H 3M1

  • Gordon and Leslie Diamond Health Care Centre, Vancouver General Hospital, UBC Division of Gastroenterology

    Vancouver, V5Z 1M9

  • (G.I.R.I.) Gastrointestinal Research Institute

    Vancouver, V6Z 2K5

  • Toronto Digestive Disease Associates Specialty Research

    Vanghan, L4L 4Y7

Other trials in Canada

Australia7 sites

  • Flinders Medical Centre

    Adelaide, South Australia, 5042

  • Eastern Health, Box Hill Hospital

    Box Hill, Victoria, 3128

  • Monash Health, Monash Medical Centre (Clayton)

    Clayton, Victoria, 3168

  • Royal Brisbane and Women's Hospital

    Herston, Queensland, 4029

  • Liverpool Hospital

    Liverpool, New South Wales, 2170

  • Royal Perth Hospital

    Perth, Western Australia, 6000

  • Westmead Hospital

    Westmead, New South Wales, 2145

Other trials in Australia

Puerto Rico3 sites

  • Latin Clinical Trial Center

    San Juan, 00909

  • VA Caribbean Healthcare System

    San Juan, 00921

  • FDI Clinical Research

    San Juan, 00927

Other trials in Puerto Rico

About this study

Official title: 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.

Being tested
Semaglutide (SEMA), Cilofexor (CILO)/Firsocostat (FIR), PTM SEMA, PTM CILO/FIR
Medical subject headings
Non-alcoholic Fatty Liver Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Semaglutide (SEMA)Drug

    Administered as subcutaneous (SC) injection

  • Cilofexor (CILO)/Firsocostat (FIR)Drug

    Also called GS-9674/GS-0976

    Tablets administered orally

  • PTM SEMADrug

    Administered as SC injection

  • PTM CILO/FIRDrug

    Tablets administered orally

Study groups in NCT04971785
Study groupRoleWhat they receive
SEMA + CILO/FIR FDCExperimentalParticipants 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.
Receives: Drug: Semaglutide (SEMA); Drug: Cilofexor (CILO)/Firsocostat (FIR)
SEMA + PTM CILO/FIRExperimentalParticipants will receive SEMA 3.0 mg/mL, once weekly and Placebo-To-Match (PTM) CILO/FIR FDC tablet, once daily up to 72 weeks.
Receives: Drug: Semaglutide (SEMA); Drug: PTM CILO/FIR
PTM SEMA + CILO/FIR FDCExperimentalParticipants will receive PTM SEMA, once weekly and CILO/FIR 30 mg/20 mg FDC tablet, once daily up to 72 weeks.
Receives: Drug: Cilofexor (CILO)/Firsocostat (FIR); Drug: PTM SEMA
PTM SEMA + PTM CILO/FIRPlacebo comparatorParticipants will receive PTM SEMA, once weekly and PTM CILO/FIR FDC tablet, once daily up to 72 weeks.
Receives: Drug: PTM SEMA; Drug: PTM CILO/FIR

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    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.

    Measured: Week 72

Secondary outcomes (3)

  1. 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

    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.

    Measured: Week 72

  2. Percentage of Participants With NASH Resolution Without Worsening in Fibrosis at Week 72 in SEMA + CILO/FIR FDC Versus Placebo Groups

    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.

    Measured: Week 72

  3. Percentage of Participants With NASH Resolution Without Worsening in Fibrosis In Participants Treated With SEMA + CILO/FIR FDC Versus CILO/FIR Alone Groups

    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.

    Measured: Week 72

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Jul 2021
  2. Study start9 Aug 2021
  3. Primary completion12 Nov 2024
  4. Study completion9 Dec 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
457 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04971785
Sponsor's protocol ID
GS-US-454-6075
Other IDs
2021-001445-12, jRCT2071210112
Acronym
WAYFIND
Status last verified
Nov 2025
First submitted
20 Jul 2021
Last updated
26 Nov 2025
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Semaglutide (SEMA), Cilofexor (CILO)/Firsocostat (FIR) and PTM SEMA in people with Nonalcoholic Steatohepatitis, run by Gilead Sciences at 242 sites in 7 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 242 sites in United States, France, Spain, Japan, Canada and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 26 Nov 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04971785.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Nov 2025; AzTrials last refreshed its copy on 26 Oct 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in