The trial focuses on adults with a liver condition called Metabolic Dysfunction-Associated Steatohepatitis (often shortened to MASH). This disease causes excess fat buildup in the liver, inflammation, and can lead to scarring known as fibrosis. Diagnosis is confirmed by a tiny tissue sample called a biopsy, which is examined under a microscope.
The investigational treatment is an injectable form of efimosfermin alfa, given under the skin (subcutaneous injection). Participants are randomly assigned to receive either the study drug or a placebo, and neither the participants nor the study staff know which one is given (double‑blind). The study lasts about one year, with regular clinic visits for injections and safety checks.
The main goal is to see whether the drug can improve liver health by reducing inflammation and decreasing scarring (fibrosis) compared with the placebo. Researchers will look at changes in the liver tissue, blood tests, and overall health over the treatment period.
1randomization and assignment
after enrollment, the participant is randomly assigned to receive either efimosfermin alfa or a matching placebo in a double‑blind manner.
the assignment determines which subcutaneous injection the participant will receive for the duration of the study.
2baseline assessments
a liver biopsy confirming f2 or f3 stage metabolic dysfunction‑associated steatohepatitis (mash) is performed.
additional baseline measurements such as laboratory tests, imaging, and questionnaires are collected to establish the participant’s initial status.
3initiation of study medication
the participant receives the first subcutaneous injection of the assigned product (efimosfermin alfa or placebo).
the dose and frequency are defined by the study protocol; the specific dose is not disclosed in the provided information.
treatment is planned for a total period of 52 weeks, with the possibility of continuation for up to 48 months for extended evaluation.
4regular treatment visits
the participant returns to the study site at scheduled intervals to receive additional subcutaneous injections according to the protocol.
at each visit safety assessments, including monitoring for treatment‑emergent adverse events, are performed.
efficacy assessments such as laboratory tests, imaging, and questionnaires may be repeated according to the study schedule.
5week 52 evaluation
after 52 weeks of treatment, a liver biopsy is repeated to evaluate histologic resolution of mash and improvement in fibrosis.
the primary objectives are assessed: proportion of participants with at least one‑stage improvement in fibrosis without worsening of steatohepatitis, and proportion with resolution of steatohepatitis without fibrosis worsening.
additional safety and laboratory evaluations are conducted.
6optional continuation to month 48
participants may continue receiving the assigned injection for up to 48 months.
periodic assessments are performed to determine the time to a composite liver‑related clinical outcome and to monitor long‑term safety.
efficacy endpoints such as fibrosis improvement, steatohepatitis resolution, and changes in imaging and laboratory markers are evaluated at month 48.
7study completion and final assessments
at the end of the study period, the participant completes final safety evaluations, laboratory tests, and questionnaires.
all data are compiled for analysis of the primary and secondary endpoints.
the participant is then discharged from the study protocol.
Who Can Join the Study?
You must be able to read, understand, and sign a written informed consent form before any study activities begin; this document explains the study and your rights.
You must be at least 18 years old and not older than 75 years when you join the study.
You need to have at least two of the five health problems that make up metabolic syndrome (such as high blood pressure, high blood sugar, excess belly fat, high triglycerides, or low “good” cholesterol) as defined by the American Heart Association.
A doctor must have taken a small sample of your liver (liver biopsy) that shows you have MASH (Metabolic Dysfunction‑Associated Steatohepatitis) with scar tissue at a level called stage F2 or F3 fibrosis, and the sample must have a NAS score of 4 or higher, confirmed by a specialist pathologist.
Who Cannot Join the Study?
Cannot have a problem that makes a percutaneous liver biopsy (a needle procedure to take a small liver sample) unsafe or impossible.
Blood test showing glycated hemoglobin (a measure of average blood sugar) 9.0% or higher.
Model for End-Stage Liver Disease (MELD) score 12 or higher, unless the high score is due to a condition that does not affect liver function, such as Gilbert’s syndrome.
Blood test showing phosphatidylethanol (PEth) (a marker of recent alcohol use) 80 ng/mL or higher at screening.
Current infection with any of the following: human immunodeficiency virus (HIV), hepatitis B virus (detectable surface antigen), or hepatitis C virus (HCV).
Any other chronic liver disease, including but not limited to alcoholic liver disease, evidence of portal hypertension, viral hepatitis, or any history or evidence of cirrhosis on the screening liver biopsy; or advanced liver problems such as fluid buildup in the abdomen (ascites), bleeding from enlarged veins in the esophagus or stomach (gastroesophageal varices), kidney failure caused by liver disease (hepatorenal syndrome), or brain effects of liver disease (hepatic encephalopathy) before screening or Day 1.
Drinking large amounts of alcohol for three months or more within the 12‑month period before screening.
Liver enzymes ALT or AST that are five times the upper limit of normal (ULN).
Total bilirubin (a substance that colors stool and urine) 1.3 mg/dL or higher, unless the person has documented Gilbert’s syndrome with an isolated increase in total bilirubin of ≥1.3 mg/dL and direct bilirubin ≤20 % of total bilirubin.
Serum albumin 3.5 g/dL or lower.
International Normalized Ratio (INR) 1.3 or higher, unless it is due to therapeutic blood‑thinning medication.
Alkaline phosphatase (ALP) 2 times the upper limit of normal (ULN).
Platelet count less than 140,000 per cubic millimeter (mm³); individuals with a count between 110,000 and 140,000 may be considered after discussion with the study medical monitor.
Serum creatinine 1.5 mg/dL or higher, or creatinine clearance 60 mL/min/1.73 m² or lower (a measure of kidney function).
Want to learn more about this study or check if you can participate? Contact us.
Trial status
Country
Status
Recruitment Start
Austria
Not yet recruiting
06.07.2026
Belgium
Not yet recruiting
06.07.2026
Bulgaria
Not yet recruiting
06.07.2026
France
Not yet recruiting
06.07.2026
Germany
Not yet recruiting
06.07.2026
Greece
Not yet recruiting
06.07.2026
Italy
Not yet recruiting
06.07.2026
Poland
Not yet recruiting
06.07.2026
Spain
Not yet recruiting
06.07.2026
The Netherlands
Not yet recruiting
06.07.2026
Trial locations
EFIMOSFERMIN ALFA is a medication being tested to treat Metabolic Dysfunction‑Associated Steatohepatitis (MASH), a liver disease that can cause scarring and damage. In this study, participants receive the drug as a powder that is mixed with liquid and injected under the skin. The goal is to see if the medicine can improve the liver’s appearance under a microscope, reduce inflammation, and slow or reverse the buildup of scar tissue (fibrosis) over a year of treatment.
Metabolic Dysfunction-Associated Steatohepatitis (MASH) – It is a liver condition where excess fat builds up together with inflammation. Over time the inflammation can cause scarring that becomes thicker and more rigid. The scarring may increase step by step, making the liver less flexible. The amount of fat and inflammation can grow gradually, especially when risk factors such as an unhealthy diet are present. The disease can move from simple fat accumulation to this inflamed state and then to more advanced scarring.
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Austria 
Belgium 
Bulgaria 
France 
Germany 
Greece 
Italy 
Poland 
Spain 
The Netherlands