A Study Evaluating Efruxifermin in Subjects With Compensated Cirrhosis Due to NASH/MASH
Recruiting · 40 sites across 8 states
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Study care at no cost to you
For your time and travel
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Legal status usually isn't required; we'll tell you each study's requirements
Interpreters available
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Your choice
Voluntary — you can stop anytime
What is this study?
This is a multi-center evaluation of efruxifermin (EFX) in a randomized, double-blind, placebo-controlled study in subjects with compensated cirrhosis due to NASH/MASH.
It is , overseen by an independent and licensed medical staff.
Read the full clinical description
This is a multi-center evaluation of efruxifermin (EFX) in a randomized, double-blind, placebo-controlled study in subjects with compensated cirrhosis due to NASH/MASH.
Who this study is looking for
In plain language, from the study's own rules. The study team confirms the full details with you — this isn't a final yes or no.
✅ You may be able to join if…
- •Have compensated cirrhosis with fibrosis stage 4
- •Cirrhosis is due to NASH/MASH
- •For Cohort 1: biopsy proven, with NAS score of at least 3 (at least 1 in each category) or evidence of steatosis plus 2 metabolic comorbidities
- •For Cohort 2: biopsy proven or diagnosed with non-invasive methods
🚫 You may not be able to join if…
- •Have other causes of liver disease based on medical history and/or liver biopsy/histology and/or central lab results
- •Have Type 1 diabetes or unstable Type 2 diabetes
- •Have any current or past history of decompensated liver disease
Are you a good fit?
Simplified highlights. The study team always confirms the full details with you.
- ✓People with compensated cirrhosis caused by NASH/MASH (fibrosis stage 4).
- ✓May be eligible if diagnosed by biopsy or (for some cohorts) non-invasive methods.
- ✓Typically require NASH/MASH evidence and specific liver biopsy scoring for one cohort.
- ✓Not eligible if cirrhosis is from another cause or if liver disease has been decompensated.
- !Some conditions may not be a fit: Type 2 diabetes
How this study is designed
The real details, in plain words. Tap the underlined words to learn what they mean.
- •Some participants receive a . The study team tells you your chances of getting the active treatment before you decide.
- •You'd be placed into a group by chance, like a coin flip — this keeps the study fair.
- •This study is , so results can't be swayed by expectations. Your medical team always knows what you're getting.
- •There are 2 groups in this study.
What to expect, step by step
· This study lasts about 260 weeks (~60 months)- 1
Usually a few weeks
The study team checks whether the study is a good fit for you, with a visit and sometimes lab tests. You can ask any questions before deciding.
- 2
Treatment
About 260 weeksIf you join and choose to continue, you receive the study treatment and are watched closely by medical staff.
- 3
Follow-up
After treatment, the team checks on your health and confirms the visit schedule with you. You can leave the study at any point.
What's being tested
- Drug: Efruxifermin
- Drug: Placebo
Has this treatment been tested before?
Yes. This treatment has already been through earlier human studies for safety before reaching this stage.
Who's running this study?
Sponsor
Akero Therapeutics, Inc
Every study is also reviewed by an independent that protects participants.
What you need to know before you apply
What is this study testing?+
This is a multi-center evaluation of efruxifermin (EFX) in a randomized, double-blind, placebo-controlled study in subjects with compensated cirrhosis due to NASH/MASH.
Is it safe? Who makes sure of that?+
This is a late-stage study (Phase 3), testing how well the treatment works in more people. Every study is reviewed and monitored by an independent ethics board (called an IRB) whose job is to protect participants, and care is overseen by licensed medical staff. You'll be told the known risks before you agree to anything, and you can stop at any time.
Will I get a placebo instead of the real treatment?+
Some studies compare a treatment against a placebo (an inactive version), and some don't. If this one does, the study team will explain your chances of receiving the active treatment before you decide. Nothing is hidden from you.
Do I have to stop taking my current medications?+
It depends on the study. Some let you stay on your current medications and some ask you to adjust them. Never stop a medication on your own — the study team will review everything with you first.
Does it cost anything? Will I be paid?+
The study treatment and study-related visits are provided at no cost to you. This study may also compensate you for your time and travel — the team will tell you the amount before you join. You should never be asked to pay to take part.
Do I need insurance? Will anyone ask about my immigration status?+
No. You do not need health insurance to take part in a research study, and you will not be asked about your immigration status to join. Taking part is about whether you're a medical fit for the study.
What if English isn't my first language?+
You have the right to understand everything before you agree. Study sites can often provide materials or an interpreter in your language — you can ask the coordinator for one.
Is my information private?+
Yes. Your health information is only shared with the study sites you choose to be contacted by, and only to help match and enroll you. It is never sold, and you can ask us to delete it at any time.
Source: ClinicalTrials.gov · NCT06528314 · Locations: Alabama · Arizona · Arkansas · California · Colorado · Connecticut · District of Columbia · Florida