STATUS Study Complete

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

Gilead Clinical Study Information Center:
Monday – Friday, 5am – 6pm PT
Email: [email protected]

STATUS

Study Complete

GILEAD STUDY ID

GS-US-454-6075

Gilead Clinical Study Information Center:
Monday – Friday, 5am – 6pm PT
Email: [email protected]

LAST UPDATED

November 26, 2025

Clinicaltrials.gov ID

NCT04971785

EudraCT ID

2021-001445-12

STUDY DOCUMENTS

View study documents

OVERVIEW

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) (WAYFIND)

PROTOCOL 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.

Participation requirements

Age

18 years - 80 years

Sex

All

Healthy Volunteers

Study details

Medical Condition

Nonalcoholic Steatohepatitis

Gender

N/A

Date

August 2021 - November 2024

Study Type

Interventional

Study Phase

Phase 2

Product

Semaglutide (SEMA), Cilofexor (CILO)/Firsocostat (FIR), PTM SEMA, PTM CILO/FIR

Eligibility information

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.

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.

Locations

Locations (242)

University of Alabama at Birmingham Hospital

Birmingham, Alabama, United States, 35233

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

For more information, please contact the

For more information, please contact the

OVERVIEW

PROTOCOL SUMMARY

Participation requirements

Study details

Eligibility information

Inclusion criteria

Exclusion criteria

Locations

Locations (242)

University of Alabama at Birmingham Hospital

Digestive Health Specialists

North Alabama Health Research, LLC

The Institution For Liver Health dba Arizona Liver Health

Arizona Health Research

The Institute for Liver Health DBA Arizona Liver Health

Gastrointestinal Alliance - Sun City

Adobe Clinical Research, LLC

The Institution For Liver Health dba Arizona Liver Health

Arkansas Diagnostic Center

ARCare Center for Clinical Research

Arkansas Gastroenterology

Southern California Research Center

University of California, San Francisco - Fresno

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

Gastro Care Institute (Fibroscan)

Digestive Health Research of Southern California

Kaiser Permanente Los Angeles Medical Center

Keck Medical Center of USC Healthcare Consultation II

Biopharma Informatic, LLC

United Medical Doctors

Knowledge Research Center

Palmtree Clinical Research, Inc.

California Liver Research Institute

Cadena Care Institute, LLC

Stanford Medicine Outpatient Center

Inland Empire Clinical Trials

University of California, Davis Medical Center

Research and Education Inc.

TriWest Research Associates, LLC

Precision Research Institute

Medical Associates Research Group

Quest Clinical Research

University of California, San Francisco - Liver Clinic

San Jose Gastroenterology at One Health

University of Colorado Anschutz Medical Campus

South Denver Gastroenterology

Yale Center for Clinical Investigation, Church Street Research Unit

Excel Medical Clinical Trials, LLC

Synergy Healthcare

Southwest General Healthcare Center

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

Velocity Clinical Research, Hallandale Beach

Indago Research and Health Center, Inc.

Maya Research Center

New Generation of Medical Research

Evolution Clinical Research, INC

Sunbright Health Medical Center

Nature Coast Clinical Research

UF Health Jacksonville-Gastroenterology Emerson

Encore Borland-Groover Clinical Research

Florida Research Institute

G+C Research Group

Schiff Center for Liver Diseases/ University of Miami

Advanced Pharma CR, LLC

Century Research, LLC

ProLive Medical Research, Corp

International Medical Investigational Centers, Inc.

Ocean Blue Medical Research Center, Inc

Gastroenterology Group of Naples

Advanced Research Institute, Inc.

Ocala GI Research

Advanced Medical Research Center

Progressive Medical Research

Covenant Metabolic Specialists, LLC

Charter Research

Florida Medical Clinic, LLC

Southeast Clinical Research LLC