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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 below
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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 weeks
Treatment ~ Varies
Follow Up ~week 72
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 72 for reporting.

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

Find a Location

Who is running the clinical trial?

Gilead SciencesLead Sponsor
1,082 Previous Clinical Trials
842,384 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
1,513 Previous Clinical Trials
2,414,572 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
186,378 Total Patients Enrolled
12 Trials studying Non-alcoholic Fatty Liver Disease
3,227 Patients Enrolled for Non-alcoholic Fatty Liver Disease

Media Library

Cilofexor/Firsocostat (FXR Agonist) Clinical Trial Eligibility Overview. Trial Name: NCT04971785 — Phase 2
Non-alcoholic Fatty Liver Disease Research Study Groups: PTM SEMA + PTM CILO/FIR, SEMA + Placebo-To-Match (PTM) CILO/FIR, SEMA + CILO/FIR FDC, PTM SEMA + CILO/FIR FDC
Non-alcoholic Fatty Liver Disease Clinical Trial 2023: Cilofexor/Firsocostat Highlights & Side Effects. Trial Name: NCT04971785 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the FDA issued approval for Cilofexor/Firsocostat?

"The combination therapy of CILO and FIR has been rated a 2, since there are some safety data available but no efficacy evidence yet."

Answered by AI

Is this endeavor a pioneering effort in its field?

"At the present time, 58 trials are ongoing for Cilofexor (CILO)/Firsocostat (FIR) in 55 countries and 772 cities. The inaugural trial began back in 2018 with Novo Nordisk A/S sponsoring it and 1387 participants included. Subsequently, 133 studies have been executed to date following its Phase 4 drug authorization stage."

Answered by AI

May I be included in the experiment?

"For this clinical trial, 440 individuals aged 18-80 with nonalcoholic steatohepatitis are sought. Essential criteria include: Height (in inches), Weight (in lbs.), BMI ≥ 23 kg/m^2 at screening and INR ≤ 1.4 unless on anticoagulant therapy."

Answered by AI

What is the common purpose of utilizing Cilofexor (CILO)/Firsocostat (FIR) therapeutically?

"Cilofexor (CILO)/Firsocostat (FIR) is a therapy designed to tackle obesity and other weight-related issues. It can be used in combination with reduced calorie intake, physical activity, and management of at least one comorbid condition."

Answered by AI

Are there any additional investigations into the effects of Cilofexor/Firsocostat?

"CILO and FIR were first evaluated in 2018 at Novo Nordisk Investigational Site. To date, there have been 133 completed clinical trials with 58 active studies being conducted mostly out of Lubbock, Texas."

Answered by AI

Are there many healthcare facilities executing this medical research in our state?

"Currently, this trial is recruiting from 100 distinct medical centres. Locations of interest include Lubbock, Hialeah and Seattle as well as dozens of other sites. To reduce travel commitment, it's essential to select the closest participating location when signing up for the study."

Answered by AI

What is the projected enrollment size for this clinical trial?

"Correct. The clinicaltrials.gov page for this trial indicates that recruitment is ongoing since the initial posting on August 9th 2021, with the most recent edit taking place November 30th 2022. 440 individuals are needed to fulfill enrolment across 100 sites worldwide."

Answered by AI

Is enrollment for this medical experiment still open?

"According to clinicaltrials.gov, this research endeavor is currently seeking participants whose profiles meet the criteria stated in the trial's original posting on August 9th 2021 and its most recent amendment on November 30th 2022."

Answered by AI

Are adults of any age allowed to join this experiment?

"The age range for prospective participants of this medical trial is between 18 to 80 years old. For those under the age of consent, there are 29 trials available and 241 options for elderly patients over 65 years old."

Answered by AI

Who else is applying?

What state do they live in?
California
Texas
Florida
Other
How old are they?
65+
18 - 65
What site did they apply to?
Clinical Research Professionals
Southern California Research Center
Sierra Clinical Research
Other
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
1
0

Why did patients apply to this trial?

Looking for a cure. Want to get control of health issues. I would like to contribute to the research.
PatientReceived no prior treatments
Retired. Overweight. Interested in helping. I was hoping there are more options for treatment.
PatientReceived 2+ prior treatments

What questions have other patients asked about this trial?

I live in Spokane, WA. How much travel will be involved? How long do the screening visit take and will you cover travel costs?
PatientReceived 1 prior treatment
Could I learn more about the study? How long is the screening process?
PatientReceived no prior treatments

How responsive is this trial?

Most responsive sites:
  1. Texas Clinical Research Institute: < 48 hours
Average response time
  • < 2 Days
Typically responds via
Email
Recent research and studies
clinicaltrials.govStudy
Study of Semaglutide, and the Fixed-Dose Combination of Cilofexor and Firsocostat, Alone and in Combination, in Adults With Cirrhosis Due to Nonalcoholic Steatohepatitis (NASH)
2021. "Study of Semaglutide, and the Fixed-Dose Combination of Cilofexor and Firsocostat, Alone and in Combination, in Adults With Cirrhosis Due to Nonalcoholic Steatohepatitis (NASH)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04971785.
All > Autoimmune Hepatitis > Cirrhosis
~72 spots leftby Nov 2024
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