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

NCT04971785 | Completed Phase 2 Results DMC FDA Drug

• 3 other identifiers: GS-US-454-60752021-001445-12jRCT2071210112
• Study Type: interventional
• Target: 457
• Locations: 7 countries
• Sites: 242

Brief 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.

Conditions

Nonalcoholic Steatohepatitis

Outcome Measures

Primary Outcomes (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.

  Week 72

Secondary Outcomes (3)

• 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

  Week 72

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

  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

  Week 72

Study Arms (4)

SEMA + CILO/FIR FDC

EXPERIMENTAL

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); Drug: Cilofexor (CILO)/Firsocostat (FIR)

SEMA + PTM CILO/FIR

EXPERIMENTAL

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); Drug: PTM CILO/FIR

PTM SEMA + CILO/FIR FDC

EXPERIMENTAL

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); Drug: PTM SEMA

PTM SEMA + PTM CILO/FIR

PLACEBO COMPARATOR

Participants will receive PTM SEMA, once weekly and PTM CILO/FIR FDC tablet, once daily up to 72 weeks.

Drug: PTM SEMA; Drug: PTM CILO/FIR

Interventions

Semaglutide (SEMA) DRUG

Administered as subcutaneous (SC) injection

SEMA + CILO/FIR FDC; SEMA + PTM CILO/FIR

Cilofexor (CILO)/Firsocostat (FIR) DRUG

Tablets administered orally

Also known as: GS-9674/GS-0976

PTM SEMA + CILO/FIR FDC; SEMA + CILO/FIR FDC

PTM SEMA DRUG

Administered as SC injection

PTM SEMA + CILO/FIR FDC; PTM SEMA + PTM CILO/FIR

PTM CILO/FIR DRUG

Tablets administered orally

PTM SEMA + PTM CILO/FIR; SEMA + PTM CILO/FIR

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Gilead Sciences: lead
• Novo Nordisk A/S: collaborator

Study Sites (242)

University of Alabama at Birmingham Hospital

Birmingham, Alabama, 35233, United States

Location

Digestive Health Specialists

Dothan, Alabama, 36305, United States

Location

North Alabama Health Research, LLC

Madison, Alabama, 35758, United States

Location

The Institution For Liver Health dba Arizona Liver Health

Chandler, Arizona, 85224, United States

Location

Arizona Health Research

Chandler, Arizona, 85225, United States

Location

The Institute for Liver Health DBA Arizona Liver Health

Peoria, Arizona, 85381, United States

Location

Gastrointestinal Alliance - Sun City

Sun City, Arizona, 85351, United States

Location

Adobe Clinical Research, LLC

Tucson, Arizona, 85712, United States

Location

The Institution For Liver Health dba Arizona Liver Health

Tucson, Arizona, 85712, United States

Location

Arkansas Diagnostic Center

Little Rock, Arkansas, 72204, United States

Location

ARCare Center for Clinical Research

Little Rock, Arkansas, 72205, United States

Location

Arkansas Gastroenterology

North Little Rock, Arkansas, 72117, United States

Location

Southern California Research Center

Coronado, California, 92118, United States

Location

University of California, San Francisco - Fresno

Fresno, California, 93701, United States

Location

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

La Jolla, California, 92037, United States

Location

Gastro Care Institute (Fibroscan)

Lancaster, California, 93534, United States

Location

Digestive Health Research of Southern California

Long Beach, California, 90808, United States

Location

Kaiser Permanente Los Angeles Medical Center

Los Angeles, California, 90027, United States

Location

Keck Medical Center of USC Healthcare Consultation II

Los Angeles, California, 90033, United States

Location

Biopharma Informatic, LLC

Los Angeles, California, 90035, United States

Location

United Medical Doctors

Murrieta, California, 92563, United States

Location

Knowledge Research Center

Orange, California, 92868, United States

Location

Palmtree Clinical Research, Inc.

Palm Springs, California, 92262, United States

Location

California Liver Research Institute

Pasadena, California, 91105, United States

Location

Cadena Care Institute, LLC

Poway, California, 92064, United States

Location

Stanford Medicine Outpatient Center

Redwood City, California, 94063, United States

Location

Inland Empire Clinical Trials

Rialto, California, 92377, United States

Location

University of California, Davis Medical Center

Sacramento, California, 95817, United States

Location

Research and Education Inc.

San Diego, California, 92105, United States

Location

TriWest Research Associates, LLC

San Diego, California, 92108, United States

Location

Precision Research Institute

San Diego, California, 92114, United States

Location

Medical Associates Research Group

San Diego, California, 92123, United States

Location

Quest Clinical Research

San Francisco, California, 94115, United States

Location

University of California, San Francisco - Liver Clinic

San Francisco, California, 94143, United States

Location

San Jose Gastroenterology at One Health

San Jose, California, 95128, United States

Location

University of Colorado Anschutz Medical Campus

Aurora, Colorado, 80045, United States

Location

South Denver Gastroenterology

Englewood, Colorado, 80113, United States

Location

Yale Center for Clinical Investigation, Church Street Research Unit

New Haven, Connecticut, 06519, United States

Location

Excel Medical Clinical Trials, LLC

Boca Raton, Florida, 33434, United States

Location

Synergy Healthcare

Bradenton, Florida, 34208, United States

Location

Southwest General Healthcare Center

Fort Myers, Florida, 33907, United States

Location

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

Gainesville, Florida, 32610, United States

Location

Velocity Clinical Research, Hallandale Beach

Hallandale, Florida, 33009, United States

Location

Indago Research and Health Center, Inc.

Hialeah, Florida, 33012, United States

Location

Maya Research Center

Hialeah, Florida, 33016, United States

Location

New Generation of Medical Research

Hialeah, Florida, 33016, United States

Location

Evolution Clinical Research, INC

Hialeah Gardens, Florida, 33016, United States

Location

Sunbright Health Medical Center

Homestead, Florida, 33032, United States

Location

Nature Coast Clinical Research

Inverness, Florida, 34452, United States

Location

UF Health Jacksonville-Gastroenterology Emerson

Jacksonville, Florida, 32224, United States

Location

Encore Borland-Groover Clinical Research

Jacksonville, Florida, 32256, United States

Location

Florida Research Institute

Lakewood Rch, Florida, 34211, United States

Location

G+C Research Group

Miami, Florida, 33126, United States

Location

Schiff Center for Liver Diseases/ University of Miami

Miami, Florida, 33136, United States

Location

Advanced Pharma CR, LLC

Miami, Florida, 33147, United States

Location

Century Research, LLC

Miami, Florida, 33173, United States

Location

ProLive Medical Research, Corp

Miami, Florida, 33175, United States

Location

International Medical Investigational Centers, Inc.

Miami, Florida, 33176, United States

Location

Ocean Blue Medical Research Center, Inc

Miami Springs, Florida, 33166, United States

Location

Gastroenterology Group of Naples

Naples, Florida, 34102, United States

Location

Advanced Research Institute, Inc.

New Port Richey, Florida, 34653, United States

Location

Ocala GI Research

Ocala, Florida, 34471, United States

Location

Advanced Medical Research Center

Port Orange, Florida, 32127, United States

Location

Progressive Medical Research

Port Orange, Florida, 32127, United States

Location

Covenant Metabolic Specialists, LLC

Sarasota, Florida, 34240, United States

Location

Charter Research

Winter Park, Florida, 32792, United States

Location

Florida Medical Clinic, LLC

Zephyrhills, Florida, 33542, United States

Location

Southeast Clinical Research LLC

Dalton, Georgia, 30720, United States

Location

Gastrointestinal (GI) Specialists of Georgia

Marietta, Georgia, 30060, United States

Location

Rush University Medical Group - Department of Hepatology

Chicago, Illinois, 60612, United States

Location

Indiana University Health Enterprise Clinical Research Operations

Indianapolis, Indiana, 46202, United States

Location

Gastroenterology Health Partners, PLLC

New Albany, Indiana, 47150, United States

Location

Digestive Research Alliance of Michigan

South Bend, Indiana, 44635, United States

Location

Iowa Digestive Disease Center, PC

Clive, Iowa, 50325, United States

Location

University of Iowa Hospitals and Clinics

Iowa City, Iowa, 52242, United States

Location

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

Kansas Medical Clinic PA

Topeka, Kansas, 66606, United States

Location

GI Alliance

Baton Rouge, Louisiana, 70809, United States

Location

Combined Gastro Research, LLC

Lafayette, Louisiana, 70503, United States

Location

Tandem Clinical Research GI, LLC

Marrero, Louisiana, 70072, United States

Location

Delta Research Partners

Monroe, Louisiana, 71201, United States

Location

Tulane University Health Sciences Center

New Orleans, Louisiana, 70112, United States

Location

Oschner Clinic Foundation

New Orleans, Louisiana, 70121, United States

Location

Louisiana Research Center, LLC

Shreveport, Louisiana, 71105, United States

Location

Mercy Medical Center

Baltimore, Maryland, 21202, United States

Location

Walter Reed National Military Medical Center

Bethesda, Maryland, 20889, United States

Location

Woodholme Gastroenterology Associates

Glen Burnie, Maryland, 21061, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Greater Boston Gastroenterology

Framingham, Massachusetts, 01702, United States

Location

Hawthorn Medical Associates

South Dartmouth, Massachusetts, 02747, United States

Location

Michigan Medicine - University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Clinical Research Institute of Michigan, LLC

Chesterfield, Michigan, 48047, United States

Location

Henry Ford Health System

Detroit, Michigan, 48202, United States

Location

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

Wyoming, Michigan, 49519, United States

Location

Huron Gastroenterology Associates

Ypsilanti, Michigan, 48197, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

GI Alliance

Flowood, Mississippi, 39232, United States

Location

Southern Therapy and Advanced Research

Jackson, Mississippi, 39216, United States

Location

Clinical Research Professionals

Chesterfield, Missouri, 63005, United States

Location

GI Associates Research

Columbia, Missouri, 65201, United States

Location

Kansas City Research Institute

Kansas City, Missouri, 64131, United States

Location

Sierra Clinical Research

Las Vegas, Nevada, 89106, United States

Location

Digestive Disease Research

Florham Park, New Jersey, 07932, United States

Location

Allied Health Clinical Research Organization, LLC

Freehold, New Jersey, 07728, United States

Location

Rutgers New Jersey Medical School

Newark, New Jersey, 07103, United States

Location

Center for Research at Southwest Gastroenterology Associates, PC

Albuquerque, New Mexico, 87109, United States

Location

Northwell Health Center for Liver Diseases

Manhasset, New York, 11030, United States

Location

New York University Langone Health

New York, New York, 10016, United States

Location

Mount Sinai Medical Center

New York, New York, 10029, United States

Location

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

New York, New York, 10032, United States

Location

The New York - Presbyterian Hospital

New York, New York, 10065, United States

Location

University of Rochester Medical Center

Rochester, New York, 14642, United States

Location

Asheville Gastroenterology, a Division of Digestive Health Partners, PA

Asheville, North Carolina, 28801, United States

Location

Atrium Health Transplant and Center for Liver Disease

Charlotte, North Carolina, 28204, United States

Location

Charlotte Gastroenterology & Hepatology, PLLC

Charlotte, North Carolina, 28207, United States

Location

Northeast GI Research Division

Concord, North Carolina, 28027, United States

Location

Coastal Research Institute

Fayetteville, North Carolina, 28304, United States

Location

Lucas Research, Inc.

Morehead City, North Carolina, 28557, United States

Location

Carolina's GI Research, LLC

Raleigh, North Carolina, 27607, United States

Location

Optimed Research

Columbus, Ohio, 43235, United States

Location

DSI Research

Springboro, Ohio, 45066, United States

Location

Clinical Research Institute of Ohio, LLC

Westlake, Ohio, 44145, United States

Location

Options Health Research, LLC

Tulsa, Oklahoma, 74104, United States

Location

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States

Location

Velocity Clinical Research - Providence

East Greenwich, Rhode Island, 02818, United States

Location

University Gastroenterology

Providence, Rhode Island, 02905, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Columbia Digestive Health Research

Columbia, South Carolina, 29204, United States

Location

Digestive Disease Research Center

Greenwood, South Carolina, 29646, United States

Location

Velocity Clinical Research, Spartanburg

Spartanburg, South Carolina, 29303, United States

Location

Wake Research - ClinsSearch, LLC

Chattanooga, Tennessee, 37421, United States

Location

Gastrointestinal Associates of Northeast Tennessee

Johnson City, Tennessee, 37604, United States

Location

Quality Medical Research, PLLC

Nashville, Tennessee, 37211, United States

Location

Texas Clinical Research Institute

Arlington, Texas, 76012, United States

Location

Pinnacle Clinical Research

Austin, Texas, 78757, United States

Location

South Texas Research Institute

Brownsville, Texas, 78520, United States

Location

GI Alliance

Cedar Park, Texas, 78613, United States

Location

The Liver Institute at Methodist Dallas Medical Center

Dallas, Texas, 75203, United States

Location

GI Alliance

Dallas, Texas, 75246, United States

Location

Internal Medicine Digestive and Liver Diseases Clinical Trials

Dallas, Texas, 75390, United States

Location

Soma Clinical Trials, LLC

Denison, Texas, 75020, United States

Location

DHR Health Institute for Research and Development Cancer Research Center

Edinburg, Texas, 78539, United States

Location

South Texas Research Institute

Edinburg, Texas, 78539, United States

Location

GI Alliance

Fort Worth, Texas, 76104, United States

Location

GI Alliance

Garland, Texas, 75044, United States

Location

Pinnacle Clinical Research

Georgetown, Texas, 78626, United States

Location

Texas Digestive Specialists

Harlingen, Texas, 78550, United States

Location

Houston Methodist Hospital

Houston, Texas, 77030, United States

Location

Liver Associates of Texas, P.A.

Houston, Texas, 77030, United States

Location

Liver Specialists of Texas

Houston, Texas, 77030, United States

Location

Biopharma Informatic, LLC

Houston, Texas, 77043, United States

Location

Houston Research Institute

Houston, Texas, 77079, United States

Location

Biopharma Informatic, LLC

Houston, Texas, 77084, United States

Location

BioStar Clinical Research Group Inc.

Katy, Texas, 77494, United States

Location

GI Alliance

Lubbock, Texas, 79410, United States

Location

Biopharma Informatic, LLC

McAllen, Texas, 78503, United States

Location

Digestive System Healthcare

Pasadena, Texas, 77505, United States

Location

American Research Corporation at the Texas Liver Institute

San Antonio, Texas, 78215, United States

Location

Diabetes and Glandular Disease Clinic, P.A.

San Antonio, Texas, 78229, United States

Location

Pinnacle Clinical Research, LLC

San Antonio, Texas, 78229, United States

Location

GI Alliance (Patients Seen, IP Shipment & Fibroscan)

San Marcos, Texas, 78666, United States

Location

Impact Research Institute

Waco, Texas, 76710, United States

Location

GI Alliance

Webster, Texas, 77598, United States

Location

Digestive Health Research of North Texas

Wichita Falls, Texas, 07960, United States

Location

Intermountain Medical Center

Murray, Utah, 84107, United States

Location

University of Utah Hospital

Salt Lake City, Utah, 84132, United States

Location

Velocity Clinical Research, Salt Lake City

West Jordan, Utah, 84088, United States

Location

The University Of Vermont Medical Center

Burlington, Vermont, 05401, United States

Location

University of Virginia Medical Center

Charlottesville, Virginia, 22908, United States

Location

Manassas Clinical Research Center

Manassas, Virginia, 20110, United States

Location

Digestive and Liver Disease Specialists

Norfolk, Virginia, 23502, United States

Location

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

Richmond, Virginia, 23226, United States

Location

Virginia Commonwealth University Health Clinical Research Services Unit

Richmond, Virginia, 23298, United States

Location

Virginia Mason

Seattle, Washington, 98101, United States

Location

Liver Institute Northwest

Seattle, Washington, 98105, United States

Location

Liverpool Hospital

Liverpool, New South Wales, 2170, Australia

Location

Westmead Hospital

Westmead, New South Wales, 2145, Australia

Location

Royal Brisbane and Women's Hospital

Herston, Queensland, 4029, Australia

Location

Flinders Medical Centre

Adelaide, South Australia, 5042, Australia

Location

Eastern Health, Box Hill Hospital

Box Hill, Victoria, 3128, Australia

Location

Monash Health, Monash Medical Centre (Clayton)

Clayton, Victoria, 3168, Australia

Location

Royal Perth Hospital

Perth, Western Australia, 6000, Australia

Location

Wlliam Osler Health System - Brampton Civic Hospital

Brampton, L6R 3J7, Canada

Location

University of Calgary Liver Unit - Heritage Medical Research Clinic

Calgary, T2N 4Z6, Canada

Location

McMaster University Medical Center

Hamilton, L8N 3Z5, Canada

Location

London Health Sciences Centre - University Hospital

London, N6A 5A5, Canada

Location

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

Montreal, H2X 0A9, Canada

Location

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

Montreal, H4A 3J1, Canada

Location

Toronto General Hospital - University Health Network

Toronto, M5G 2C4, Canada

Location

Toronto Liver Centre

Toronto, M6H 3M1, Canada

Location

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

Vancouver, V5Z 1M9, Canada

Location

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

Vancouver, V6Z 2K5, Canada

Location

Toronto Digestive Disease Associates Specialty Research

Vanghan, L4L 4Y7, Canada

Location

CHU Amiens Picardie

Amiens, 80054, France

Location

Centre Hosptitalier Universitaire d'Angers

Angers, 49033, France

Location

Centre Hospitalier Regional Universitaire de Tours - Hopital Trousseau

Chambray-lès-Tours, 37170, France

Location

Hopital Henri Mondor

Créteil, 94010, France

Location

CHU de Grenoble

Grenoble, 38043, France

Location

Hopital Claude Huriez

Lille, 59 037, France

Location

Centre Hospitalier Universitaire Limoges

Limoges, 87042, France

Location

Hopital de la Croix-Rousse

Lyon, 69004, France

Location

Hopital Saint Joseph

Marseille, 13008, France

Location

Centre Hospitalier Universitarie de Montpellier - Hospital Saint-Eloi

Montpellier, 34295, France

Location

Centre Hospitalier Universitaire de Nice - Hopital L'archet

Nice, 06202, France

Location

Hopital Universitaire Pitie Salpetriere

Paris, 75013, France

Location

Hopitaux de Paris - Hopital Cochin

Paris, 75014, France

Location

Hopital Beaujon

Pessac, 33600, France

Location

Hopital Haut Leveque

Pessac, 33604, France

Location

CHU Rennes Pontchaillou

Rennes, 35000, France

Location

Hopital Rangueil

Toulouse, 31300, France

Location

Hopital Brabois Adultes - CHU de Nancy

Vandœuvre-lès-Nancy, 54500, France

Location

Fukui-ken Saiseikai Hospital

Fukui, 918-8503, Japan

Location

Juntendo University Shizouka Hospital

Izunokuni, 410-2295, Japan

Location

University Hospital, Kyoto Prefectural University of Medicine

Kyoto, 602-8566, Japan

Location

Japanese Red Cross Masashino Hospital

Musashino, 1808610, Japan

Location

Osaka City University Hospital

Osaka, 5458586, Japan

Location

Saga University Hospital

Saga, 849-0937, Japan

Location

Sapporo-Kosei General Hospital

Sapporo, 060-0033, Japan

Location

Saiseikai Suita Hospital

Suita, 564-0013, Japan

Location

Federation of National Public Service Personnel Mutual Aid Associations Toranomon Hospital

Tokyo, 105-8470, Japan

Location

Ehime University Hospital

Toon-Shi, 791-0295, Japan

Location

Yamagata University Hospital

Yamagata, 9909585, Japan

Location

Yokohama City University Hospital

Yokohama, 2360004, Japan

Location

Latin Clinical Trial Center

San Juan, 00909, Puerto Rico

Location

VA Caribbean Healthcare System

San Juan, 00921, Puerto Rico

Location

FDI Clinical Research

San Juan, 00927, Puerto Rico

Location

Hospital Germans Trias i Pujol

Badalona, Barcelona, 08916, Spain

Location

Hospital Universitario Torrecardenas

Almería, 04009, Spain

Location

Hospital del Mar

Barcelona, 08003, Spain

Location

Hospital Universitari Vall d'Hebron

Barcelona, 08035, Spain

Location

Hospital Clinic De Barcelona

Barcelona, 8036, Spain

Location

Hospital General Universiatrio Gregorio Maranon

Madrid, 28007, Spain

Location

Hospital Universitario Ramon y Cajal

Madrid, 28034, Spain

Location

Hospital Universitario La Paz Edificio de Malemidad

Madrid, 28046, Spain

Location

Hospital Universitario Puerta de Hierro-Majadahonda

Majadahonda, 28222, Spain

Location

Complejo Hospitalario de Pontevedra

Pontevedra, 36071, Spain

Location

Hospital Universitario Marques de Valdecilla

Santander, 39008, Spain

Location

Hospital Clinico Universitario de Santiago

Santiago de Compostela, 15706, Spain

Location

Hospital Universitario Virgin del Rocio

Seville, 41013, Spain

Location

Consorcio Hospital General Universitario de Valencia

Valencia, 46014, Spain

Location

Hospital Universitario y Politecnlo la Fe

Valencia, 46026, Spain

Location

Hospital Clinico Universitario de Valladolid

Valladolid, 47010, Spain

Location

Related Links

• Gilead Clinical Trials Website

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Interventions

semaglutide; cilofexor

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases

Results Point of Contact

• Title: Gilead Clinical Study Information Center
• Organization: Gilead Sciences

GileadClinicalTrials@gilead.com

1-833-445-3230 (GILEAD-0)

Study Officials

• Gilead Study Director

  Gilead Sciences

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 20, 2021
• First Posted: July 21, 2021
• Study Start: August 9, 2021
• Primary Completion: November 12, 2024
• Study Completion: December 9, 2024
• Last Updated: November 26, 2025
• Results First Posted: November 26, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

CA (11); JP (12); PR (3); AU (7); ES (16); FR (18); US (175)