Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT04971785
Registration number
NCT04971785
Ethics application status
Date submitted
20/07/2021
Date registered
21/07/2021
Date last updated
28/02/2024
Titles & IDs
Public title
Study of Semaglutide, and Cilofexor/Firsocostat, Alone and in Combination, in Adults With Cirrhosis Due to Nonalcoholic Steatohepatitis (NASH)
Query!
Scientific 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)
Query!
Secondary ID [1]
0
0
2021-001445-12
Query!
Secondary ID [2]
0
0
GS-US-454-6075
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
WAYFIND
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Nonalcoholic Steatohepatitis
0
0
Query!
Condition category
Condition code
Oral and Gastrointestinal
0
0
0
0
Query!
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Query!
Metabolic and Endocrine
0
0
0
0
Query!
Metabolic disorders
Query!
Diet and Nutrition
0
0
0
0
Query!
Obesity
Query!
Intervention/exposure
Study type
Interventional
Query!
Description of intervention(s) / exposure
Treatment: Drugs - Semaglutide (SEMA)
Treatment: Drugs - Cilofexor (CILO)/Firsocostat (FIR)
Treatment: Drugs - PTM SEMA
Treatment: Drugs - PTM CILO/FIR
Experimental: SEMA + CILO/FIR FDC - Participants will receive semaglutide (SEMA) 0.24-2.4 mg once weekly (dose escalation every 4 weeks) and fixed-dose combination (FDC) of cilofexor and firsocostat (CILO/FIR 30 mg/20 mg) once daily for 72 weeks
Experimental: SEMA + Placebo-To-Match (PTM) CILO/FIR - Participants will receive SEMA 0.24-2.4 mg once weekly (dose escalation every 4 weeks) and PTM CILO/FIR administered once daily for 72 weeks
Experimental: PTM SEMA + CILO/FIR FDC - PTM Semaglutide once weekly and CILO/FIR 30 mg/20 mg FDC administered once daily for 72 weeks
Placebo Comparator: PTM SEMA + PTM CILO/FIR - PTM Semaglutide once weekly and PTM CILO/FIR once daily for 72 weeks
Treatment: Drugs: Semaglutide (SEMA)
Administered as subcutaneous (SC) injection
Treatment: Drugs: Cilofexor (CILO)/Firsocostat (FIR)
Tablets administered orally
Treatment: Drugs: PTM SEMA
Administered as SC injection
Treatment: Drugs: PTM CILO/FIR
Tablets administered orally
Query!
Intervention code [1]
0
0
Treatment: Drugs
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Percentage of Participants Who Achieve = 1-Stage Improvement in Fibrosis According to the NASH Clinical Research Network (CRN) Classification Without Worsening of NASH in Participants Treated With SEMA + CILO/FIR Versus Placebo
Query!
Assessment method [1]
0
0
Worsening of NASH is defined as a = 1-point increase in hepatocellular ballooning or lobular inflammation.
Query!
Timepoint [1]
0
0
Week 72
Query!
Secondary outcome [1]
0
0
Percentage of Participants Who Achieve =1-Stage Improvement in Fibrosis (According to the NASH CRN Classification) Without Worsening of NASH in Participants Treated With SEMA+CILO/FIR Versus SEMA Alone
Query!
Assessment method [1]
0
0
Worsening of NASH is defined as a = 1-point increase in hepatocellular ballooning or lobular inflammation.
Query!
Timepoint [1]
0
0
Week 72
Query!
Secondary outcome [2]
0
0
Percentage of Participants With NASH Resolution in Participants Treated with SEMA+CILO/FIR Versus Placebo
Query!
Assessment method [2]
0
0
NASH resolution is defined as lobular inflammation of 0 or 1 and hepatocellular ballooning of 0.
Query!
Timepoint [2]
0
0
Week 72
Query!
Secondary outcome [3]
0
0
Percentage of Participants With NASH Resolution In Participants Treated With SEMA+CILO/FIR Versus CILO/FIR Alone
Query!
Assessment method [3]
0
0
Query!
Timepoint [3]
0
0
Week 72
Query!
Eligibility
Key inclusion criteria
Key
- 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/1.73m^2, as calculated by
the Modification of Diet in Renal Disease (MDRD) equation.
- HbA1c = 10%
- International normalized ratio (INR) = 1.4, unless due to therapeutic
anticoagulation
- Platelet count = 125,000/uL
- Alanine aminotransferase (ALT) < 5 x ULN
- Serum albumin = 3.5 g/dL
- Serum alkaline phosphatase (ALP) = 2 x ULN
- Body mass index (BMI) = 23 kg/m^2 at screening.
Key
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
80
Years
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key 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 coronavirus 2 (SARS-CoV-2) reverse
transcriptase-polymerase chain reaction (RT-PCR) test.
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Blinded (masking used)
Query!
Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Phase 2
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Active, not recruiting
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
9/08/2021
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
1/12/2024
Query!
Actual
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
457
Query!
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
Query!
Recruitment hospital [1]
0
0
Liverpool Hospital - Liverpool
Query!
Recruitment hospital [2]
0
0
Westmead Hospital - Westmead
Query!
Recruitment hospital [3]
0
0
Royal Brisbane and Women's Hospital - Herston
Query!
Recruitment hospital [4]
0
0
Flinders Medical Centre - Adelaide
Query!
Recruitment hospital [5]
0
0
Eastern Health, Box Hill Hospital - Box Hill
Query!
Recruitment hospital [6]
0
0
Monash Health, Monash Medical Centre (Clayton) - Clayton
Query!
Recruitment hospital [7]
0
0
Royal Perth Hospital - Perth
Query!
Recruitment postcode(s) [1]
0
0
2170 - Liverpool
Query!
Recruitment postcode(s) [2]
0
0
2145 - Westmead
Query!
Recruitment postcode(s) [3]
0
0
4029 - Herston
Query!
Recruitment postcode(s) [4]
0
0
5042 - Adelaide
Query!
Recruitment postcode(s) [5]
0
0
3128 - Box Hill
Query!
Recruitment postcode(s) [6]
0
0
3168 - Clayton
Query!
Recruitment postcode(s) [7]
0
0
6000 - Perth
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
Alabama
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
Arizona
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
Arkansas
Query!
Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
California
Query!
Country [5]
0
0
United States of America
Query!
State/province [5]
0
0
Colorado
Query!
Country [6]
0
0
United States of America
Query!
State/province [6]
0
0
Connecticut
Query!
Country [7]
0
0
United States of America
Query!
State/province [7]
0
0
Florida
Query!
Country [8]
0
0
United States of America
Query!
State/province [8]
0
0
Georgia
Query!
Country [9]
0
0
United States of America
Query!
State/province [9]
0
0
Illinois
Query!
Country [10]
0
0
United States of America
Query!
State/province [10]
0
0
Indiana
Query!
Country [11]
0
0
United States of America
Query!
State/province [11]
0
0
Iowa
Query!
Country [12]
0
0
United States of America
Query!
State/province [12]
0
0
Kansas
Query!
Country [13]
0
0
United States of America
Query!
State/province [13]
0
0
Louisiana
Query!
Country [14]
0
0
United States of America
Query!
State/province [14]
0
0
Maryland
Query!
Country [15]
0
0
United States of America
Query!
State/province [15]
0
0
Massachusetts
Query!
Country [16]
0
0
United States of America
Query!
State/province [16]
0
0
Michigan
Query!
Country [17]
0
0
United States of America
Query!
State/province [17]
0
0
Minnesota
Query!
Country [18]
0
0
United States of America
Query!
State/province [18]
0
0
Mississippi
Query!
Country [19]
0
0
United States of America
Query!
State/province [19]
0
0
Missouri
Query!
Country [20]
0
0
United States of America
Query!
State/province [20]
0
0
Nevada
Query!
Country [21]
0
0
United States of America
Query!
State/province [21]
0
0
New Jersey
Query!
Country [22]
0
0
United States of America
Query!
State/province [22]
0
0
New Mexico
Query!
Country [23]
0
0
United States of America
Query!
State/province [23]
0
0
New York
Query!
Country [24]
0
0
United States of America
Query!
State/province [24]
0
0
North Carolina
Query!
Country [25]
0
0
United States of America
Query!
State/province [25]
0
0
Ohio
Query!
Country [26]
0
0
United States of America
Query!
State/province [26]
0
0
Oklahoma
Query!
Country [27]
0
0
United States of America
Query!
State/province [27]
0
0
Pennsylvania
Query!
Country [28]
0
0
United States of America
Query!
State/province [28]
0
0
Rhode Island
Query!
Country [29]
0
0
United States of America
Query!
State/province [29]
0
0
South Carolina
Query!
Country [30]
0
0
United States of America
Query!
State/province [30]
0
0
Tennessee
Query!
Country [31]
0
0
United States of America
Query!
State/province [31]
0
0
Texas
Query!
Country [32]
0
0
United States of America
Query!
State/province [32]
0
0
Utah
Query!
Country [33]
0
0
United States of America
Query!
State/province [33]
0
0
Vermont
Query!
Country [34]
0
0
United States of America
Query!
State/province [34]
0
0
Virginia
Query!
Country [35]
0
0
United States of America
Query!
State/province [35]
0
0
Washington
Query!
Country [36]
0
0
Canada
Query!
State/province [36]
0
0
Brampton
Query!
Country [37]
0
0
Canada
Query!
State/province [37]
0
0
Calgary
Query!
Country [38]
0
0
Canada
Query!
State/province [38]
0
0
Hamilton
Query!
Country [39]
0
0
Canada
Query!
State/province [39]
0
0
London
Query!
Country [40]
0
0
Canada
Query!
State/province [40]
0
0
Montreal
Query!
Country [41]
0
0
Canada
Query!
State/province [41]
0
0
Toronto
Query!
Country [42]
0
0
Canada
Query!
State/province [42]
0
0
Vancouver
Query!
Country [43]
0
0
Canada
Query!
State/province [43]
0
0
Vanghan
Query!
Country [44]
0
0
France
Query!
State/province [44]
0
0
Amiens
Query!
Country [45]
0
0
France
Query!
State/province [45]
0
0
Angers
Query!
Country [46]
0
0
France
Query!
State/province [46]
0
0
Chambray-les-Tours
Query!
Country [47]
0
0
France
Query!
State/province [47]
0
0
Creteil
Query!
Country [48]
0
0
France
Query!
State/province [48]
0
0
Grenoble Cedex 9
Query!
Country [49]
0
0
France
Query!
State/province [49]
0
0
Lille Cedex
Query!
Country [50]
0
0
France
Query!
State/province [50]
0
0
Limoges
Query!
Country [51]
0
0
France
Query!
State/province [51]
0
0
Lyon
Query!
Country [52]
0
0
France
Query!
State/province [52]
0
0
Marseille
Query!
Country [53]
0
0
France
Query!
State/province [53]
0
0
Montpellier
Query!
Country [54]
0
0
France
Query!
State/province [54]
0
0
Nice
Query!
Country [55]
0
0
France
Query!
State/province [55]
0
0
Paris
Query!
Country [56]
0
0
France
Query!
State/province [56]
0
0
Pessac Cedex
Query!
Country [57]
0
0
France
Query!
State/province [57]
0
0
Pessac
Query!
Country [58]
0
0
France
Query!
State/province [58]
0
0
Rennes
Query!
Country [59]
0
0
France
Query!
State/province [59]
0
0
Toulouse
Query!
Country [60]
0
0
France
Query!
State/province [60]
0
0
Vandoeuvre les Nancy
Query!
Country [61]
0
0
Japan
Query!
State/province [61]
0
0
Fukui
Query!
Country [62]
0
0
Japan
Query!
State/province [62]
0
0
Izunokuni
Query!
Country [63]
0
0
Japan
Query!
State/province [63]
0
0
Kyoto
Query!
Country [64]
0
0
Japan
Query!
State/province [64]
0
0
Musashino-city
Query!
Country [65]
0
0
Japan
Query!
State/province [65]
0
0
Osaka
Query!
Country [66]
0
0
Japan
Query!
State/province [66]
0
0
Saga-shi
Query!
Country [67]
0
0
Japan
Query!
State/province [67]
0
0
Sapporo-shi
Query!
Country [68]
0
0
Japan
Query!
State/province [68]
0
0
Suita
Query!
Country [69]
0
0
Japan
Query!
State/province [69]
0
0
Tokyo
Query!
Country [70]
0
0
Japan
Query!
State/province [70]
0
0
Toon-Shi
Query!
Country [71]
0
0
Japan
Query!
State/province [71]
0
0
Yamagata
Query!
Country [72]
0
0
Japan
Query!
State/province [72]
0
0
Yokohama-shi
Query!
Country [73]
0
0
Puerto Rico
Query!
State/province [73]
0
0
San Juan
Query!
Country [74]
0
0
Spain
Query!
State/province [74]
0
0
Barcelona
Query!
Country [75]
0
0
Spain
Query!
State/province [75]
0
0
Almeria
Query!
Country [76]
0
0
Spain
Query!
State/province [76]
0
0
Madrid
Query!
Country [77]
0
0
Spain
Query!
State/province [77]
0
0
Majadahonda
Query!
Country [78]
0
0
Spain
Query!
State/province [78]
0
0
Pontevedra
Query!
Country [79]
0
0
Spain
Query!
State/province [79]
0
0
Santander
Query!
Country [80]
0
0
Spain
Query!
State/province [80]
0
0
Santiago De Compostella
Query!
Country [81]
0
0
Spain
Query!
State/province [81]
0
0
Sevilla
Query!
Country [82]
0
0
Spain
Query!
State/province [82]
0
0
Valencia
Query!
Country [83]
0
0
Spain
Query!
State/province [83]
0
0
Valladolid
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Query!
Name
Gilead Sciences
Query!
Address
Query!
Country
Query!
Other collaborator category [1]
0
0
Commercial sector/Industry
Query!
Name [1]
0
0
Novo Nordisk A/S
Query!
Address [1]
0
0
Query!
Country [1]
0
0
Query!
Ethics approval
Ethics application status
Query!
Summary
Brief summary
The goals of this clinical study are to learn more about the study drugs, semaglutide (SEMA)
with the fixed-dose combination (FDC) of cilofexor/firsocostat (CILO/FIR), and understand
whether they cause fibrosis improvement and Nonalcoholic Steatohepatitis (NASH) resolution in
participants with cirrhosis due to NASH.
Query!
Trial website
https://clinicaltrials.gov/ct2/show/NCT04971785
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Gilead Study Director
Query!
Address
0
0
Gilead Sciences
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT04971785
Download to PDF