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

PHASE2CompletedINTERVENTIONAL
Enrollment

457

Participants

Timeline

Start Date

August 9, 2021

Primary Completion Date

November 12, 2024

Study Completion Date

December 9, 2024

Conditions
Nonalcoholic Steatohepatitis
Interventions
DRUG

Semaglutide (SEMA)

Administered as subcutaneous (SC) injection

DRUG

Cilofexor (CILO)/Firsocostat (FIR)

Tablets administered orally

DRUG

PTM SEMA

Administered as SC injection

DRUG

PTM CILO/FIR

Tablets administered orally

Trial Locations (242)

2145

Westmead Hospital, Westmead

2170

Liverpool Hospital, Liverpool

3128

Eastern Health, Box Hill Hospital, Box Hill

3168

Monash Health, Monash Medical Centre (Clayton), Clayton

4029

Royal Brisbane and Women's Hospital, Herston

5042

Flinders Medical Centre, Adelaide

6000

Royal Perth Hospital, Perth

8036

Hospital Clinic De Barcelona, Barcelona

10016

New York University Langone Health, New York

10029

Mount Sinai Medical Center, New York

10032

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

10065

The New York - Presbyterian Hospital, New York

11030

Northwell Health Center for Liver Diseases, Manhasset

13008

Hopital Saint Joseph, Marseille

14642

University of Rochester Medical Center, Rochester

15213

University of Pittsburgh Medical Center, Pittsburgh

15706

Hospital Clinico Universitario de Santiago, Santiago de Compostela

20110

Manassas Clinical Research Center, Manassas

20889

Walter Reed National Military Medical Center, Bethesda

21061

Woodholme Gastroenterology Associates, Glen Burnie

21202

Mercy Medical Center, Baltimore

22908

University of Virginia Medical Center, Charlottesville

23226

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

23298

Virginia Commonwealth University Health Clinical Research Services Unit, Richmond

23502

Digestive and Liver Disease Specialists, Norfolk

27607

Carolina's GI Research, LLC, Raleigh

28007

Hospital General Universiatrio Gregorio Maranon, Madrid

28027

Northeast GI Research Division, Concord

28034

Hospital Universitario Ramon y Cajal, Madrid

28046

Hospital Universitario La Paz Edificio de Malemidad, Madrid

28204

Atrium Health Transplant and Center for Liver Disease, Charlotte

28207

Charlotte Gastroenterology & Hepatology, PLLC, Charlotte

28222

Hospital Universitario Puerta de Hierro-Majadahonda, Majadahonda

28304

Coastal Research Institute, Fayetteville

28557

Lucas Research, Inc., Morehead City

28801

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

29204

Columbia Digestive Health Research, Columbia

29303

Velocity Clinical Research, Spartanburg, Spartanburg

29425

Medical University of South Carolina, Charleston

29646

Digestive Disease Research Center, Greenwood

30060

Gastrointestinal (GI) Specialists of Georgia, Marietta

30720

Southeast Clinical Research LLC, Dalton

31300

Hopital Rangueil, Toulouse

32127

Advanced Medical Research Center, Port Orange

Progressive Medical Research, Port Orange

32224

UF Health Jacksonville-Gastroenterology Emerson, Jacksonville

32256

Encore Borland-Groover Clinical Research, Jacksonville

32610

University of Florida Hepatology Research at the Clinical and Translational Research Building, Gainesville

32792

Charter Research, Winter Park

33009

Velocity Clinical Research, Hallandale Beach, Hallandale

33012

Indago Research and Health Center, Inc., Hialeah

33016

Maya Research Center, Hialeah

New Generation of Medical Research, Hialeah

Evolution Clinical Research, INC, Hialeah Gardens

33032

Sunbright Health Medical Center, Homestead

33126

G+C Research Group, Miami

33136

Schiff Center for Liver Diseases/ University of Miami, Miami

33147

Advanced Pharma CR, LLC, Miami

33166

Ocean Blue Medical Research Center, Inc, Miami Springs

33173

Century Research, LLC, Miami

33175

ProLive Medical Research, Corp, Miami

33176

International Medical Investigational Centers, Inc., Miami

33434

Excel Medical Clinical Trials, LLC, Boca Raton

33542

Florida Medical Clinic, LLC, Zephyrhills

33600

Hopital Beaujon, Pessac

33604

Hopital Haut Leveque, Pessac

33907

Southwest General Healthcare Center, Fort Myers

34102

Gastroenterology Group of Naples, Naples

34208

Synergy Healthcare, Bradenton

34211

Florida Research Institute, Lakewood Rch

34240

Covenant Metabolic Specialists, LLC, Sarasota

34295

Centre Hospitalier Universitarie de Montpellier - Hospital Saint-Eloi, Montpellier

34452

Nature Coast Clinical Research, Inverness

34471

Ocala GI Research, Ocala

34653

Advanced Research Institute, Inc., New Port Richey

35000

CHU Rennes Pontchaillou, Rennes

35233

University of Alabama at Birmingham Hospital, Birmingham

35758

North Alabama Health Research, LLC, Madison

36071

Complejo Hospitalario de Pontevedra, Pontevedra

36305

Digestive Health Specialists, Dothan

37170

Centre Hospitalier Regional Universitaire de Tours - Hopital Trousseau, Chambray-lès-Tours

37211

Quality Medical Research, PLLC, Nashville

37421

Wake Research - ClinsSearch, LLC, Chattanooga

37604

Gastrointestinal Associates of Northeast Tennessee, Johnson City

38043

CHU de Grenoble, Grenoble

39008

Hospital Universitario Marques de Valdecilla, Santander

39216

Southern Therapy and Advanced Research, Jackson

39232

GI Alliance, Flowood

41013

Hospital Universitario Virgin del Rocio, Seville

43235

Optimed Research, Columbus

44145

Clinical Research Institute of Ohio, LLC, Westlake

44635

Digestive Research Alliance of Michigan, South Bend

45066

DSI Research, Springboro

46014

Consorcio Hospital General Universitario de Valencia, Valencia

46026

Hospital Universitario y Politecnlo la Fe, Valencia

46202

Indiana University Health Enterprise Clinical Research Operations, Indianapolis

47010

Hospital Clinico Universitario de Valladolid, Valladolid

47150

Gastroenterology Health Partners, PLLC, New Albany

48047

Clinical Research Institute of Michigan, LLC, Chesterfield

48109

Michigan Medicine - University of Michigan, Ann Arbor

48197

Huron Gastroenterology Associates, Ypsilanti

48202

Henry Ford Health System, Detroit

49033

Centre Hosptitalier Universitaire d'Angers, Angers

49519

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

50325

Iowa Digestive Disease Center, PC, Clive

52242

University of Iowa Hospitals and Clinics, Iowa City

54500

Hopital Brabois Adultes - CHU de Nancy, Vandœuvre-lès-Nancy

55905

Mayo Clinic, Rochester

60612

Rush University Medical Group - Department of Hepatology, Chicago

63005

Clinical Research Professionals, Chesterfield

64131

Kansas City Research Institute, Kansas City

65201

GI Associates Research, Columbia

66160

University of Kansas Medical Center, Kansas City

66606

Kansas Medical Clinic PA, Topeka

69004

Hopital de la Croix-Rousse, Lyon

70072

Tandem Clinical Research GI, LLC, Marrero

70112

Tulane University Health Sciences Center, New Orleans

70121

Oschner Clinic Foundation, New Orleans

70503

Combined Gastro Research, LLC, Lafayette

70809

GI Alliance, Baton Rouge

71105

Louisiana Research Center, LLC, Shreveport

71201

Delta Research Partners, Monroe

72117

Arkansas Gastroenterology, North Little Rock

72204

Arkansas Diagnostic Center, Little Rock

72205

ARCare Center for Clinical Research, Little Rock

74104

Options Health Research, LLC, Tulsa

75013

Hopital Universitaire Pitie Salpetriere, Paris

75014

Hopitaux de Paris - Hopital Cochin, Paris

75020

Soma Clinical Trials, LLC, Denison

75044

GI Alliance, Garland

75203

The Liver Institute at Methodist Dallas Medical Center, Dallas

75246

GI Alliance, Dallas

75390

Internal Medicine Digestive and Liver Diseases Clinical Trials, Dallas

76012

Texas Clinical Research Institute, Arlington

76104

GI Alliance, Fort Worth

76710

Impact Research Institute, Waco

77030

Houston Methodist Hospital, Houston

Liver Associates of Texas, P.A., Houston

Liver Specialists of Texas, Houston

77043

Biopharma Informatic, LLC, Houston

77079

Houston Research Institute, Houston

77084

Biopharma Informatic, LLC, Houston

77494

BioStar Clinical Research Group Inc., Katy

77505

Digestive System Healthcare, Pasadena

77598

GI Alliance, Webster

78215

American Research Corporation at the Texas Liver Institute, San Antonio

78229

Diabetes and Glandular Disease Clinic, P.A., San Antonio

Pinnacle Clinical Research, LLC, San Antonio

78503

Biopharma Informatic, LLC, McAllen

78520

South Texas Research Institute, Brownsville

78539

DHR Health Institute for Research and Development Cancer Research Center, Edinburg

South Texas Research Institute, Edinburg

78550

Texas Digestive Specialists, Harlingen

78613

GI Alliance, Cedar Park

78626

Pinnacle Clinical Research, Georgetown

78666

GI Alliance (Patients Seen, IP Shipment & Fibroscan), San Marcos

78757

Pinnacle Clinical Research, Austin

79410

GI Alliance, Lubbock

80045

University of Colorado Anschutz Medical Campus, Aurora

80054

CHU Amiens Picardie, Amiens

80113

South Denver Gastroenterology, Englewood

84088

Velocity Clinical Research, Salt Lake City, West Jordan

84107

Intermountain Medical Center, Murray

84132

University of Utah Hospital, Salt Lake City

85224

The Institution For Liver Health dba Arizona Liver Health, Chandler

85225

Arizona Health Research, Chandler

85351

Gastrointestinal Alliance - Sun City, Sun City

85381

The Institute for Liver Health DBA Arizona Liver Health, Peoria

85712

Adobe Clinical Research, LLC, Tucson

The Institution For Liver Health dba Arizona Liver Health, Tucson

87042

Centre Hospitalier Universitaire Limoges, Limoges

87109

Center for Research at Southwest Gastroenterology Associates, PC, Albuquerque

89106

Sierra Clinical Research, Las Vegas

90027

Kaiser Permanente Los Angeles Medical Center, Los Angeles

90033

Keck Medical Center of USC Healthcare Consultation II, Los Angeles

90035

Biopharma Informatic, LLC, Los Angeles

90808

Digestive Health Research of Southern California, Long Beach

91105

California Liver Research Institute, Pasadena

92037

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

92064

Cadena Care Institute, LLC, Poway

92105

Research and Education Inc., San Diego

92108

TriWest Research Associates, LLC, San Diego

92114

Precision Research Institute, San Diego

92118

Southern California Research Center, Coronado

92123

Medical Associates Research Group, San Diego

92262

Palmtree Clinical Research, Inc., Palm Springs

92377

Inland Empire Clinical Trials, Rialto

92563

United Medical Doctors, Murrieta

92868

Knowledge Research Center, Orange

93534

Gastro Care Institute (Fibroscan), Lancaster

93701

University of California, San Francisco - Fresno, Fresno

94010

Hopital Henri Mondor, Créteil

94063

Stanford Medicine Outpatient Center, Redwood City

94115

Quest Clinical Research, San Francisco

94143

University of California, San Francisco - Liver Clinic, San Francisco

95128

San Jose Gastroenterology at One Health, San Jose

95817

University of California, Davis Medical Center, Sacramento

98101

Virginia Mason, Seattle

98105

Liver Institute Northwest, Seattle

1808610

Japanese Red Cross Masashino Hospital, Musashino

2360004

Yokohama City University Hospital, Yokohama

5458586

Osaka City University Hospital, Osaka

9909585

Yamagata University Hospital, Yamagata

06519

Yale Center for Clinical Investigation, Church Street Research Unit, New Haven

02215

Beth Israel Deaconess Medical Center, Boston

01702

Greater Boston Gastroenterology, Framingham

02747

Hawthorn Medical Associates, South Dartmouth

07932

Digestive Disease Research, Florham Park

07728

Allied Health Clinical Research Organization, LLC, Freehold

07103

Rutgers New Jersey Medical School, Newark

02818

Velocity Clinical Research - Providence, East Greenwich

02905

University Gastroenterology, Providence

07960

Digestive Health Research of North Texas, Wichita Falls

05401

The University Of Vermont Medical Center, Burlington

L6R 3J7

Wlliam Osler Health System - Brampton Civic Hospital, Brampton

T2N 4Z6

University of Calgary Liver Unit - Heritage Medical Research Clinic, Calgary

L8N 3Z5

McMaster University Medical Center, Hamilton

N6A 5A5

London Health Sciences Centre - University Hospital, London

H2X 0A9

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

H4A 3J1

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

M5G 2C4

Toronto General Hospital - University Health Network, Toronto

M6H 3M1

Toronto Liver Centre, Toronto

V5Z 1M9

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

V6Z 2K5

(G.I.R.I.) Gastrointestinal Research Institute, Vancouver

L4L 4Y7

Toronto Digestive Disease Associates Specialty Research, Vanghan

59 037

Hopital Claude Huriez, Lille

06202

Centre Hospitalier Universitaire de Nice - Hopital L'archet, Nice

918-8503

Fukui-ken Saiseikai Hospital, Fukui

410-2295

Juntendo University Shizouka Hospital, Izunokuni

602-8566

University Hospital, Kyoto Prefectural University of Medicine, Kyoto

849-0937

Saga University Hospital, Saga

060-0033

Sapporo-Kosei General Hospital, Sapporo

564-0013

Saiseikai Suita Hospital, Suita

105-8470

Federation of National Public Service Personnel Mutual Aid Associations Toranomon Hospital, Tokyo

791-0295

Ehime University Hospital, Toon-Shi

00909

Latin Clinical Trial Center, San Juan

00921

VA Caribbean Healthcare System, San Juan

00927

FDI Clinical Research, San Juan

08916

Hospital Germans Trias i Pujol, Badalona

04009

Hospital Universitario Torrecardenas, Almería

08003

Hospital del Mar, Barcelona

08035

Hospital Universitari Vall d'Hebron, Barcelona

Sponsors

Lead Sponsor

Collaborators (1)

All Listed Sponsors
collaborator

Novo Nordisk A/S

INDUSTRY

lead

Gilead Sciences

INDUSTRY