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FXR Agonist
Semaglutide + Cilofexor/Firsocostat for NASH with Cirrhosis (WAYFIND Trial)
Phase 2
Waitlist Available
Research Sponsored by Gilead Sciences
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Liver biopsy consistent with cirrhosis (F4) due to NASH in the opinion of the central reader. In participants who have never had a liver biopsy, a screening liver biopsy may be performed
Estimated glomerular filtration rate (eGFR) ≥ 30 mL/min/1.73m^2, as calculated by the Modification of Diet in Renal Disease (MDRD) equation
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 72
Awards & highlights
WAYFIND Trial Summary
This trial is testing if a combination of two drugs can help improve NASH and fibrosis in people with compensated cirrhosis.
Who is the study for?
This trial is for adults with cirrhosis due to Nonalcoholic Steatohepatitis (NASH). Participants must have a certain level of kidney function, blood sugar control, liver enzymes, and blood clotting ability. They need a body mass index (BMI) over 23 at screening and may require a liver biopsy if they haven't had one before.Check my eligibility
What is being tested?
The study tests Semaglutide alone or combined with Cilofexor/Firsocostat in treating NASH-related cirrhosis. It aims to see if these drugs can improve liver fibrosis and resolve NASH symptoms.See study design
What are the potential side effects?
Potential side effects include digestive issues like nausea or diarrhea, possible changes in blood sugar levels, allergic reactions, fatigue, and possibly an impact on liver enzyme levels.
WAYFIND Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My liver biopsy shows I have severe cirrhosis due to NASH.
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My kidney function, measured by eGFR, is at least 30 mL/min/1.73m^2.
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Your blood's ability to clot is normal, unless you are taking medication to prevent blood clots.
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You have a body mass index (BMI) of 23 or higher at the time of screening.
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I know my height in inches.
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I weigh... pounds.
WAYFIND Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ week 72
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 72
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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
Percentage of Participants With NASH Resolution in Participants Treated with SEMA+CILO/FIR Versus Placebo
Secondary outcome measures
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
Percentage of Participants With NASH Resolution In Participants Treated With SEMA+CILO/FIR Versus CILO/FIR Alone
WAYFIND Trial Design
4Treatment groups
Experimental Treatment
Placebo Group
Group I: SEMA + Placebo-To-Match (PTM) CILO/FIRExperimental Treatment2 Interventions
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
Group II: SEMA + CILO/FIR FDCExperimental Treatment2 Interventions
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
Group III: PTM SEMA + CILO/FIR FDCExperimental Treatment2 Interventions
PTM Semaglutide once weekly and CILO/FIR 30 mg/20 mg FDC administered once daily for 72 weeks
Group IV: PTM SEMA + PTM CILO/FIRPlacebo Group2 Interventions
PTM Semaglutide once weekly and PTM CILO/FIR once daily for 72 weeks
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Semaglutide, a GLP-1 receptor agonist, enhances insulin sensitivity and promotes weight loss, which helps reduce liver fat and inflammation in NAFLD patients. Cilofexor, an FXR agonist, regulates bile acid synthesis and lipid metabolism, reducing liver fat accumulation and fibrosis.
Firsocostat, an ACC inhibitor, decreases de novo lipogenesis, thereby lowering liver fat content. These mechanisms are crucial for NAFLD patients as they target the underlying metabolic dysfunctions, potentially reversing liver damage and improving overall liver health.
Safety and efficacy of combination therapy with semaglutide, cilofexor and firsocostat in patients with non-alcoholic steatohepatitis: A randomised, open-label phase II trial.
Safety and efficacy of combination therapy with semaglutide, cilofexor and firsocostat in patients with non-alcoholic steatohepatitis: A randomised, open-label phase II trial.
Find a Location
Who is running the clinical trial?
Gilead SciencesLead Sponsor
1,085 Previous Clinical Trials
847,688 Total Patients Enrolled
14 Trials studying Non-alcoholic Fatty Liver Disease
3,801 Patients Enrolled for Non-alcoholic Fatty Liver Disease
Novo Nordisk A/SIndustry Sponsor
1,520 Previous Clinical Trials
2,415,908 Total Patients Enrolled
17 Trials studying Non-alcoholic Fatty Liver Disease
3,888 Patients Enrolled for Non-alcoholic Fatty Liver Disease
Gilead Study DirectorStudy DirectorGilead Sciences
343 Previous Clinical Trials
186,118 Total Patients Enrolled
12 Trials studying Non-alcoholic Fatty Liver Disease
3,227 Patients Enrolled for Non-alcoholic Fatty Liver Disease
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I know my height in inches.I weigh... pounds.Your blood's ability to clot is normal, unless you are taking medication to prevent blood clots.My liver biopsy shows I have severe cirrhosis due to NASH.You have a body mass index (BMI) of 23 or higher at the time of screening.My kidney function, measured by eGFR, is at least 30 mL/min/1.73m^2.
Research Study Groups:
This trial has the following groups:- Group 1: PTM SEMA + PTM CILO/FIR
- Group 2: SEMA + Placebo-To-Match (PTM) CILO/FIR
- Group 3: SEMA + CILO/FIR FDC
- Group 4: PTM SEMA + CILO/FIR FDC
Awards:
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