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)
Who is this study for? Patients with compensated cirrhosis due to nonalcoholic steatohepatitis
Status: Completed
Location: See all (242) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:
• 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.
Locations
United States
Alabama
University of Alabama at Birmingham Hospital
Birmingham
Digestive Health Specialists
Dothan
North Alabama Health Research, LLC
Madison
Arkansas
ARCare Center for Clinical Research
Little Rock
Arkansas Diagnostic Center
Little Rock
Arkansas Gastroenterology
North Little Rock
Arizona
Arizona Health Research
Chandler
The Institution For Liver Health dba Arizona Liver Health
Chandler
The Institute for Liver Health DBA Arizona Liver Health
Peoria
Gastrointestinal Alliance - Sun City
Sun City
Adobe Clinical Research, LLC
Tucson
The Institution For Liver Health dba Arizona Liver Health
Tucson
California
Southern California Research Center
Coronado
University of California, San Francisco - Fresno
Fresno
University of California, San Diego - Altman Clinical and Translational Research Institute
La Jolla
Gastro Care Institute (Fibroscan)
Lancaster
Digestive Health Research of Southern California
Long Beach
Biopharma Informatic, LLC
Los Angeles
Kaiser Permanente Los Angeles Medical Center
Los Angeles
Keck Medical Center of USC Healthcare Consultation II
Los Angeles
United Medical Doctors
Murrieta
Knowledge Research Center
Orange
Palmtree Clinical Research, Inc.
Palm Springs
California Liver Research Institute
Pasadena
Cadena Care Institute, LLC
Poway
Stanford Medicine Outpatient Center
Redwood City
Inland Empire Clinical Trials
Rialto
University of California, Davis Medical Center
Sacramento
Medical Associates Research Group
San Diego
Precision Research Institute
San Diego
Research and Education Inc.
San Diego
TriWest Research Associates, LLC
San Diego
Quest Clinical Research
San Francisco
University of California, San Francisco - Liver Clinic
San Francisco
San Jose Gastroenterology at One Health
San Jose
Colorado
University of Colorado Anschutz Medical Campus
Aurora
South Denver Gastroenterology
Englewood
Connecticut
Yale Center for Clinical Investigation, Church Street Research Unit
New Haven
Florida
Excel Medical Clinical Trials, LLC
Boca Raton
Synergy Healthcare
Bradenton
Southwest General Healthcare Center
Fort Myers
University of Florida Hepatology Research at the Clinical and Translational Research Building
Gainesville
Velocity Clinical Research, Hallandale Beach
Hallandale
Indago Research and Health Center, Inc.
Hialeah
Maya Research Center
Hialeah
New Generation of Medical Research
Hialeah
Evolution Clinical Research, INC
Hialeah Gardens
Sunbright Health Medical Center
Homestead
Nature Coast Clinical Research
Inverness
Encore Borland-Groover Clinical Research
Jacksonville
UF Health Jacksonville-Gastroenterology Emerson
Jacksonville
Florida Research Institute
Lakewood Rch
Advanced Pharma CR, LLC
Miami
Century Research, LLC
Miami
G+C Research Group
Miami
International Medical Investigational Centers, Inc.
Miami
ProLive Medical Research, Corp
Miami
Schiff Center for Liver Diseases/ University of Miami
Miami
Ocean Blue Medical Research Center, Inc
Miami Springs
Gastroenterology Group of Naples
Naples
Advanced Research Institute, Inc.
New Port Richey
Ocala GI Research
Ocala
Advanced Medical Research Center
Port Orange
Progressive Medical Research
Port Orange
Covenant Metabolic Specialists, LLC
Sarasota
Charter Research
Winter Park
Florida Medical Clinic, LLC
Zephyrhills
Georgia
Southeast Clinical Research LLC
Dalton
Gastrointestinal (GI) Specialists of Georgia
Marietta
Iowa
Iowa Digestive Disease Center, PC
Clive
University of Iowa Hospitals and Clinics
Iowa City
Illinois
Rush University Medical Group - Department of Hepatology
Chicago
Indiana
Indiana University Health Enterprise Clinical Research Operations
Indianapolis
Gastroenterology Health Partners, PLLC
New Albany
Digestive Research Alliance of Michigan
South Bend
Kansas
University of Kansas Medical Center
Kansas City
Kansas Medical Clinic PA
Topeka
Louisiana
GI Alliance
Baton Rouge
Combined Gastro Research, LLC
Lafayette
Tandem Clinical Research GI, LLC
Marrero
Delta Research Partners
Monroe
Oschner Clinic Foundation
New Orleans
Tulane University Health Sciences Center
New Orleans
Louisiana Research Center, LLC
Shreveport
Massachusetts
Beth Israel Deaconess Medical Center
Boston
Greater Boston Gastroenterology
Framingham
Hawthorn Medical Associates
South Dartmouth
Maryland
Mercy Medical Center
Baltimore
Walter Reed National Military Medical Center
Bethesda
Woodholme Gastroenterology Associates
Glen Burnie
Michigan
Michigan Medicine - University of Michigan
Ann Arbor
Clinical Research Institute of Michigan, LLC
Chesterfield
Henry Ford Health System
Detroit
Gastroenterology Associates of Western Michigan, PLC d.b.a. West Michigan Clinical Research Center
Wyoming
Huron Gastroenterology Associates
Ypsilanti
Minnesota
Mayo Clinic
Rochester
Missouri
Clinical Research Professionals
Chesterfield
GI Associates Research
Columbia
Kansas City Research Institute
Kansas City
Mississippi
GI Alliance
Flowood
Southern Therapy and Advanced Research
Jackson
North Carolina
Asheville Gastroenterology, a Division of Digestive Health Partners, PA
Asheville
Atrium Health Transplant and Center for Liver Disease
Charlotte
Charlotte Gastroenterology & Hepatology, PLLC
Charlotte
Northeast GI Research Division
Concord
Coastal Research Institute
Fayetteville
Lucas Research, Inc.
Morehead City
Carolina's GI Research, LLC
Raleigh
New Jersey
Digestive Disease Research
Florham Park
Allied Health Clinical Research Organization, LLC
Freehold
Rutgers New Jersey Medical School
Newark
New Mexico
Center for Research at Southwest Gastroenterology Associates, PC
Albuquerque
Nevada
Sierra Clinical Research
Las Vegas
New York
Northwell Health Center for Liver Diseases
Manhasset
Liver Clinic (study visits, Fibroscan): Columbia University Irving Medical Center / NewYork Presbyterian Hospital
New York
Mount Sinai Medical Center
New York
New York University Langone Health
New York
The New York - Presbyterian Hospital
New York
University of Rochester Medical Center
Rochester
Ohio
Optimed Research
Columbus
DSI Research
Springboro
Clinical Research Institute of Ohio, LLC
Westlake
Oklahoma
Options Health Research, LLC
Tulsa
Pennsylvania
University of Pittsburgh Medical Center
Pittsburgh
Rhode Island
Velocity Clinical Research - Providence
East Greenwich
University Gastroenterology
Providence
South Carolina
Medical University of South Carolina
Charleston
Columbia Digestive Health Research
Columbia
Digestive Disease Research Center
Greenwood
Velocity Clinical Research, Spartanburg
Spartanburg
Tennessee
Wake Research - ClinsSearch, LLC
Chattanooga
Gastrointestinal Associates of Northeast Tennessee
Johnson City
Quality Medical Research, PLLC
Nashville
Texas
Texas Clinical Research Institute
Arlington
Pinnacle Clinical Research
Austin
South Texas Research Institute
Brownsville
GI Alliance
Cedar Park
GI Alliance
Dallas
Internal Medicine Digestive and Liver Diseases Clinical Trials
Dallas
The Liver Institute at Methodist Dallas Medical Center
Dallas
Soma Clinical Trials, LLC
Denison
DHR Health Institute for Research and Development Cancer Research Center
Edinburg
South Texas Research Institute
Edinburg
GI Alliance
Fort Worth
GI Alliance
Garland
Pinnacle Clinical Research
Georgetown
Texas Digestive Specialists
Harlingen
Biopharma Informatic, LLC
Houston
Biopharma Informatic, LLC
Houston
Houston Methodist Hospital
Houston
Houston Research Institute
Houston
Liver Associates of Texas, P.A.
Houston
Liver Specialists of Texas
Houston
BioStar Clinical Research Group Inc.
Katy
GI Alliance
Lubbock
Biopharma Informatic, LLC
Mcallen
Digestive System Healthcare
Pasadena
American Research Corporation at the Texas Liver Institute
San Antonio
Diabetes and Glandular Disease Clinic, P.A.
San Antonio
Pinnacle Clinical Research, LLC
San Antonio
GI Alliance (Patients Seen, IP Shipment & Fibroscan)
San Marcos
Impact Research Institute
Waco
GI Alliance
Webster
Digestive Health Research of North Texas
Wichita Falls
Utah
Intermountain Medical Center
Murray
University of Utah Hospital
Salt Lake City
Velocity Clinical Research, Salt Lake City
West Jordan
Virginia
University of Virginia Medical Center
Charlottesville
Manassas Clinical Research Center
Manassas
Digestive and Liver Disease Specialists
Norfolk
Bon Secours Richmond Community Hospital, Inc. d/b/a Bon Secours Liver Institute of Richmond
Richmond
Virginia Commonwealth University Health Clinical Research Services Unit
Richmond
Vermont
The University Of Vermont Medical Center
Burlington
Washington
Liver Institute Northwest
Seattle
Virginia Mason
Seattle
Other Locations
Australia
Flinders Medical Centre
Adelaide
Eastern Health, Box Hill Hospital
Box Hill
Monash Health, Monash Medical Centre (Clayton)
Clayton
Royal Brisbane and Women's Hospital
Herston
Liverpool Hospital
Liverpool
Royal Perth Hospital
Perth
Westmead Hospital
Westmead
Canada
Wlliam Osler Health System - Brampton Civic Hospital
Brampton
University of Calgary Liver Unit - Heritage Medical Research Clinic
Calgary
McMaster University Medical Center
Hamilton
London Health Sciences Centre - University Hospital
London
Centre de Recherche du Centre Hospitalier de I'Universite de Montreal (CRCHUM)
Montreal
Chronic Viral Illness Service, Royal Victoria Hospital, McGill University Health Centre (MUHC)
Montreal
Toronto General Hospital - University Health Network
Toronto
Toronto Liver Centre
Toronto
(G.I.R.I.) Gastrointestinal Research Institute
Vancouver
Gordon and Leslie Diamond Health Care Centre, Vancouver General Hospital, UBC Division of Gastroenterology
Vancouver
Toronto Digestive Disease Associates Specialty Research
Vanghan
France
CHU Amiens Picardie
Amiens
Centre Hosptitalier Universitaire d'Angers
Angers
Centre Hospitalier Regional Universitaire de Tours - Hopital Trousseau
Chambray-lès-tours
Hopital Henri Mondor
Créteil
CHU de Grenoble
Grenoble
Hopital Claude Huriez
Lille
Centre Hospitalier Universitaire Limoges
Limoges
Hopital de la Croix-Rousse
Lyon
Hopital Saint Joseph
Marseille
Centre Hospitalier Universitarie de Montpellier - Hospital Saint-Eloi
Montpellier
Centre Hospitalier Universitaire de Nice - Hopital L'archet
Nice
Hopital Universitaire Pitie Salpetriere
Paris
Hopitaux de Paris - Hopital Cochin
Paris
Hopital Beaujon
Pessac
Hopital Haut Leveque
Pessac
CHU Rennes Pontchaillou
Rennes
Hopital Rangueil
Toulouse
Hopital Brabois Adultes - CHU de Nancy
Vandœuvre-lès-nancy
Japan
Fukui-ken Saiseikai Hospital
Fukui
Juntendo University Shizouka Hospital
Izunokuni
University Hospital, Kyoto Prefectural University of Medicine
Kyoto
Japanese Red Cross Masashino Hospital
Musashino
Osaka City University Hospital
Osaka
Saga University Hospital
Saga
Sapporo-Kosei General Hospital
Sapporo
Saiseikai Suita Hospital
Suita
Federation of National Public Service Personnel Mutual Aid Associations Toranomon Hospital
Tokyo
Ehime University Hospital
Toon-shi
Yamagata University Hospital
Yamagata
Yokohama City University Hospital
Yokohama
Puerto Rico
FDI Clinical Research
San Juan
Latin Clinical Trial Center
San Juan
VA Caribbean Healthcare System
San Juan
Spain
Hospital Universitario Torrecardenas
Almería
Hospital Germans Trias i Pujol
Badalona
Hospital Clinic De Barcelona
Barcelona
Hospital del Mar
Barcelona
Hospital Universitari Vall d'Hebron
Barcelona
Hospital General Universiatrio Gregorio Maranon
Madrid
Hospital Universitario La Paz Edificio de Malemidad
Madrid
Hospital Universitario Ramon y Cajal
Madrid
Hospital Universitario Puerta de Hierro-Majadahonda
Majadahonda
Complejo Hospitalario de Pontevedra
Pontevedra
Hospital Universitario Marques de Valdecilla
Santander
Hospital Clinico Universitario de Santiago
Santiago De Compostela
Hospital Universitario Virgin del Rocio
Seville
Consorcio Hospital General Universitario de Valencia
Valencia
Hospital Universitario y Politecnlo la Fe
Valencia
Hospital Clinico Universitario de Valladolid
Valladolid
Time Frame
Start Date: 2021-08-09
Completion Date: 2024-12-09
Participants
Target number of participants: 457
Treatments
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.
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.
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.
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.
Related Therapeutic Areas
Sponsors
Collaborators: Novo Nordisk A/S
Leads: Gilead Sciences