A Phase 3 Study of Efimosfermin Alfa to Assess Safety and Tolerability in Adults with F2‑F3 Stage Metabolic Dysfunction‑Associated Steatohepatitis (MASH)
The study focuses on adults with known or suspected F2 or F3 stage Metabolic Dysfunction-Associated Steatohepatitis, a condition where excess fat and inflammation damage the liver. The investigational medication is efimosfermin alfa, given as a powder that is mixed and injected subcutaneous (under the skin). A matching placebo injection is also used for comparison. The purpose of the study is to evaluate the safety and tolerability of the medication.
Participants will be randomly assigned to receive either the active medication or the placebo for about one year, with regular clinic visits for injections and health checks. Blood samples will be taken to monitor liver enzymes (ALT and AST), a blood test called the ELF score that estimates liver scarring, and other measures such as cholesterol, blood sugar control (HbA1c), and body weight. Imaging tests, including a special ultrasound that measures liver stiffness (VCTE‑LSM), an MRI‑based scan (MRE), and an MRI that quantifies liver fat (MRI‑PDFF), will be performed at the start and at the end of the study to see how the liver is responding. Any side effects or abnormal lab results will be recorded throughout the study period.
1randomization and first injection
after joining the study you will be assigned to one of three groups without knowing which group you are in. this is called a double‑blind design. the assignment is called randomization.
you will receive either efimosfermin alfa or a matching placebo. both are provided as a powder that is mixed for injection and given subcutaneously (under the skin). the labeled dose is 0 mg for the study medication.
2regular injection visits
you will return to the clinic for an injection at regular intervals, typically once each week, for a total period of 52 weeks. each visit includes the administration of the same study medication (either efimosfermin alfa or placebo) in the same dose and route.
the injection schedule continues without interruption unless a safety concern requires a pause or discontinuation.
3routine safety assessments
at scheduled visits (for example at weeks 4, 12, 24, 36 and 52) you will have brief examinations and laboratory tests to check for any adverse events or changes in blood values. these assessments help determine the safety and tolerability of the study medication.
if any severe reaction occurs, the study staff may decide to stop the medication for you.
4final evaluation at week 52
at the end of week 52 you will undergo a comprehensive evaluation that includes the same laboratory tests performed earlier, measurement of liver‑related scores, and assessment of overall health.
the results are used to compare the effects of efimosfermin alfa with the placebo over the one‑year period.
5study completion
after the final evaluation you will be considered to have completed the study. any further follow‑up will be arranged according to the study protocol, but no additional study medication will be given.
Who Can Join the Study?
You can read and sign a written informed consent form (a document that explains the study and your rights) before any study steps begin.
You are at least 18 years old and not older than 75 years when you join the study.
You have had, or currently 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), according to the American Heart Association.
You have been diagnosed with, or your doctor suspects you have, MASH (Metabolic Dysfunction-Associated Steatohepatitis, a type of liver disease linked to metabolic problems).
Who Cannot Join the Study?
ALT or AST levels that are five times higher than the normal range – these are liver enzymes that rise when the liver is injured.
A blood test called phosphatidylethanol (PEth) that is 80 ng/mL or higher – this test shows recent heavy alcohol use.
Any current infection with HIV (human immunodeficiency virus), hepatitis B (detectable surface antigen), or hepatitis C – these are viral infections that affect the liver or immune system.
Other chronic liver diseases, such as alcoholic liver disease, high pressure in the liver’s blood vessels (portal hypertension), any viral hepatitis, a history of cirrhosis, or advanced liver problems like fluid buildup in the abdomen (ascites), bleeding from swollen veins in the esophagus or stomach (gastroesophageal varices), kidney failure caused by liver disease (hepatorenal syndrome), or brain changes from liver failure (hepatic encephalopathy).
Having drunk a lot of alcohol for three or more months within the past year.
Total bilirubin level of 1.3 mg/dL or higher – bilirubin is a waste product the liver normally clears; very high levels may indicate liver trouble (exceptions apply for a condition called Gilbert’s syndrome).
Blood albumin level of 3.5 g/dL or lower – albumin is a protein that shows how well the liver makes proteins.
INR (a clotting test) of 1.3 or higher that is not caused by blood‑thinning medication – a high INR means the blood is taking longer to clot.
Alkaline phosphatase (ALP) level that is twice the normal range – another enzyme that can rise when the liver or bones are affected.
Platelet count below 140,000 per mm³ – platelets help the blood clot; very low numbers can be a sign of liver disease.
Blood creatinine of 1.5 mg/dL or higher, or a kidney‑function estimate (creatinine clearance) of 60 mL/min/1.73 m² or less – these numbers indicate reduced kidney function.
HbA1c (average blood sugar over about three months) of 9.0 % or higher.
A MELD 3.0 score of 12 or higher unless the score is high for reasons unrelated to liver function (for example, Gilbert’s syndrome) – MELD is a score that predicts how severe liver disease is.
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 made from a specially designed protein that is given as an injection under the skin. In this study, it is being tested to see if it can safely help people who have a liver condition called metabolic dysfunction‑associated steatohepatitis (MASH), which can cause liver damage and scarring. The drug works by targeting the liver’s metabolism, aiming to reduce the buildup of fat and inflammation. Researchers are watching participants closely to learn how well the medicine is tolerated and whether it causes any side effects.
Metabolic Dysfunction-Associated Steatohepatitis (MASH) – It is a liver condition characterized by excess fat accumulation together with inflammation and damage to liver cells. The disease typically begins with simple fatty liver and progresses as inflammation worsens, leading to the formation of scar tissue. Over time, the scar tissue can replace healthy liver tissue, reducing the organ’s ability to function properly. The condition often develops slowly and may continue to advance if the underlying metabolic imbalance persists.
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Austria 
Belgium 
Bulgaria 
France 
Germany 
Greece 
Italy 
Poland 
Spain 
The Netherlands