The study focuses on adults who have Metabolic Dysfunction-Associated Steatohepatitis (MASH), a condition in which excess fat builds up in the liver and causes inflammation and scarring. Participants receive an injection of the investigational drug efimosfermin alfa under the skin, while other participants receive a matching placebo for comparison.
The purpose of the study is to assess the safety and tolerability of efimosfermin alfa. Over approximately one year, participants are randomly assigned to receive either the active drug, a lower dose of the drug, or the placebo, with regular clinic visits to monitor health. Safety checks include reports of any unwanted effects and blood tests, while effectiveness assessments involve simple blood tests called the ELF score that estimate liver scarring, an ultrasound‑based measurement known as VCTE-LSM that gauges liver stiffness, a special MRI technique called MRE that also measures stiffness, and an MRI method termed MRI-PDFF that quantifies liver fat. These procedures help researchers understand how the treatment affects the liver without requiring complex technical explanations.
1randomization and start of treatment
after you are enrolled, you will be assigned by the study to receive either efimosfermin alfa or a placebo without knowing which one you get.
the assignment is done by a computer system to keep the study unbiased.
2receiving subcutaneous injection
you will receive a subcutaneous injection, which means the medication is placed under the skin.
the injection will contain either efimosfermin alfa or the placebo according to your randomization.
the exact amount of medication and the schedule for the injections are defined by the study protocol and will continue for up to week 52.
3regular study visits
you will attend scheduled visits at the study site where the injections are given and where health professionals will check your condition.
during each visit you will be asked about any symptoms or problems you have experienced since the previous visit.
4laboratory tests and safety monitoring
blood samples will be taken to perform laboratory tests that look at your liver enzymes, blood sugar, cholesterol and other safety markers.
the tests are done at baseline and at various times throughout the study, including at week 52.
any serious problems found in the tests will be recorded as adverse events.
5assessment of treatment effects
the study will measure changes in specific scores and imaging results that reflect the health of your liver.
these measurements are taken at the start of the study and again at week 52 to see whether there has been improvement.
6completion of the 52‑week treatment period
after the final injection and final assessments at week 52, your participation in the treatment phase ends.
you will receive a summary of the safety findings and any instructions for follow‑up care.
Who Can Join the Study?
Be able and willing to read, understand, and sign a written informed consent form (ICF), which is a document that explains the study and confirms your agreement to take part before any procedures begin.
Be between 18 and 75 years old at the time you join the study.
Have a history or current presence of at least two of the five health factors that make up metabolic syndrome (such as high blood pressure, high blood sugar, extra belly fat, high triglycerides, or low “good” cholesterol) as defined by the American Heart Association.
Have a known or suspected diagnosis of Metabolic Dysfunction-Associated Steatohepatitis (MASH), a liver condition where fat builds up and causes inflammation.
Who Cannot Join the Study?
Having liver enzymes ALT or AST that are five times higher than the normal upper limit.
Blood test shows Phosphatidylethanol (PEth) ≥ 80 ng/mL, which indicates recent heavy alcohol use.
Current infection with Human immunodeficiency virus (HIV), hepatitis B virus (detectable surface antigen), or hepatitis C virus.
Having another chronic liver disease such as alcoholic liver disease, portal hypertension (high pressure in the liver’s blood vessels), any viral hepatitis, cirrhosis (scarring of the liver), or advanced liver problems like fluid buildup in the abdomen (ascites), bleeding veins in the esophagus or stomach (gastroesophageal varices), kidney problems caused by liver disease (hepatorenal syndrome), or brain problems caused by liver disease (hepatic encephalopathy).
Drinking a lot of alcohol or having a history of heavy drinking for three or more months within the past year.
Having a total bilirubin level ≥ 1.3 mg/dL, unless you have Gilbert’s syndrome with a specific pattern of bilirubin increase.
Having a blood protein level of albumin ≤ 3.5 g/dL.
Having a clotting test result (INR) ≥ 1.3 that is not caused by prescribed blood‑thinning medication.
Having an alkaline phosphatase level that is two times higher than the normal upper limit.
Having a platelet count (cells that help blood clot) lower than 140,000 per mm³ (counts between 110,000 and 140,000 may need special review).
Having kidney function tests showing serum creatinine ≥ 1.5 mg/dL or creatinine clearance ≤ 60 mL/min/1.73 m².
Having an HbA1c (average blood sugar over three months) ≥ 9.0%.
Having a MELD score (a score that predicts liver disease severity) ≥ 12, unless the high score is due to a condition that does not affect liver 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
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 an experimental medication being tested in a clinical study. It is given as a powder that is mixed with liquid and injected under the skin (subcutaneous injection). The drug is being studied to see if it is safe and well‑tolerated in people who have known or suspected metabolic dysfunction‑associated steatohepatitis (MASH), a type of liver disease. Researchers are watching participants closely to understand any side effects and how the body reacts to the medication.
Metabolic Dysfunction-Associated Steatohepatitis (MASH) – It is a liver condition in which excess fat builds up and causes inflammation. Over time the fat accumulation can damage liver cells and trigger a healing response that leads to scar tissue. The disease often appears in people with obesity, diabetes, or other metabolic problems. As the condition progresses, the liver becomes increasingly stiff and its ability to process substances declines. The condition may evolve from simple fat accumulation to inflammation and then to fibrosis.
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Austria 
Belgium 
France 
Germany 
Greece 
Italy 
Poland 
Spain 
The Netherlands