A Pivotal Clinical Study to Investigate Efimosfermin Alfa in Participants With Biopsy-confirmed F2- or F3-stage MASH
Recruiting · 40 sites across 9 states
Always free
Study care at no cost to you
For your time and travel
Many studies pay you back
Most need no insurance or papers
Legal status usually isn't required; we'll tell you each study's requirements
Interpreters available
Ask for your language
Your choice
Voluntary — you can stop anytime
What is this study?
The purpose of this study is to assess the safety and efficacy of efimosfermin alfa in the resolution of steatohepatitis and improvement of liver-related clinical outcome compared to placebo in individuals with MASH and biopsy-confirmed F2- or F3-stage fibrosis.
It is , overseen by an independent and licensed medical staff.
Read the full clinical description
The purpose of this study is to assess the safety and efficacy of efimosfermin alfa in the resolution of steatohepatitis and improvement of liver-related clinical outcome compared to placebo in individuals with MASH and biopsy-confirmed F2- or F3-stage fibrosis.
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…
- •Age 18 to 75 years old
- •Have MASH on a liver biopsy showing F2 or F3 fibrosis (also needs a NAS score of 4 or higher confirmed by a central pathologist)
- •Have a history or current presence of 2 or more of the 5 components of metabolic syndrome (per the American Heart Association definition)
- •Can understand and sign a written informed consent form before study procedures
🚫 You may not be able to join if…
- •Cannot safely have a percutaneous (through-the-skin) liver biopsy
- •High liver blood tests (ALT or AST at least 5 times the upper limit of normal)
- •High bilirubin (total bilirubin at least 1.3 mg/dL), except certain people with Gilbert’s syndrome may be allowed under specific conditions
- •Severely abnormal blood counts or other lab problems (example: low platelets under 140,000/mm³, or low albumin at or below 3.5 g/dL)
- •Serious infections or other major liver causes, including HIV, hepatitis B (detectable HBsAg), hepatitis C, alcohol-related liver disease, portal hypertension, or cirrhosis/decompensated liver disease on screening
Are you a good fit?
Simplified highlights. The study team always confirms the full details with you.
- ✓Adults roughly 18–75
- ✓Have Fatty liver disease (NASH/MASH)
- !Some conditions may not be a fit: High blood pressure, Kidney disease
What to expect, step by step
- 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
If 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.
Has this treatment been tested before?
Yes. This treatment has already been through earlier human studies for safety before reaching this stage.
What you need to know before you apply
What is this study testing?+
The purpose of this study is to assess the safety and efficacy of efimosfermin alfa in the resolution of steatohepatitis and improvement of liver-related clinical outcome compared to placebo in individuals with MASH and biopsy-confirmed F2- or F3-stage fibrosis.
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.
Some requirements (like specific lab values or timing) are confirmed directly by the study team, not by us.
Source: ClinicalTrials.gov · NCT07221227 · Locations: California · Florida · Kansas · Missouri · New York · North Carolina · Ohio · Tennessee · Texas