The study focuses on a liver condition called NASH/MASH, where excess fat builds up in the liver and can cause inflammation and scarring. When the scarring becomes extensive, it leads to cirrhosis, a stage in which the liver’s ability to function is reduced. The investigational medication, survodutide, is given as a once‑weekly injection under the skin and is being compared with a placebo, which looks the same but does not contain the active drug.
The purpose of the trial is to determine whether survodutide can lower the risk of serious liver‑related events and death in people with compensated cirrhosis due to NASH/MASH. Participants will receive the study injection each week for about a year and will attend regular clinic visits for safety checks, blood tests, and imaging. The main outcome looks at the time until the first occurrence of any major event such as liver transplant, death, hepatic decompensation (a worsening of liver function), a rise in the MELD score (a number that reflects how well the liver works) to 15 or higher, or the development of CSPH (high blood pressure in the vessels of the liver). Additional measurements include changes in the ELF score (a blood test that indicates liver scarring), body weight, blood sugar levels, and liver stiffness assessed by FibroScan (an ultrasound that measures how firm the liver is) and MRE (a type of MRI scan for the same purpose). Blood tests will also track liver enzymes AST and ALT, which rise when liver cells are damaged.
1randomisation
after joining the study you are assigned by chance to receive either survodutide or a placebo. the assignment is concealed, so neither you nor the clinic staff knows which product you will receive.
2baseline assessments
before the first injection you undergo a series of evaluations that may include a physical exam, blood tests, liver imaging, and measurement of body weight. these results establish your starting point for later comparisons.
3start of weekly injections
you begin receiving a subcutaneous injection (injection under the skin) once a week. the dose listed for the study drug is 00 mg, and the same schedule applies if you are assigned to the placebo. the injections continue for a total of 76 weeks.
4ongoing clinic visits and safety monitoring
each week you receive the scheduled injection at the clinic or a designated location. in addition, you attend regular visits that may occur every few weeks to allow the study team to check your health, perform blood tests, record any side effects, and measure weight and liver-related parameters.
5mid‑study evaluations
around the middle of the treatment period you undergo repeat assessments similar to the baseline visit. these help determine how your liver health and other measurements are changing over time.
6final assessments at week 76
at the end of the 76‑week injection period you complete a comprehensive set of evaluations. these include the ELF score (a blood test that reflects liver health), body weight, HbA1c (blood sugar level) for participants with diabetes, liver stiffness measured by FibroScan® and magnetic resonance elastography, and standard liver enzyme tests (AST and ALT). the results are used to compare the effect of survodutide with the placebo.
7study completion
after the final assessments you attend a closing visit where the study staff discuss the overall findings and advise on any further medical follow‑up that may be needed.
Who Can Join the Study?
Be an adult who is at least 18 years old (or older if the legal consent age in your country is higher).
Have a body mass index (BMI) of 27 kg/m² or higher (for Asian participants the limit is 25 kg/m²). BMI is a number that compares your weight to your height.
Have compensated MASH cirrhosis. This means you have scarring of the liver from MASH, but the liver is still able to work well enough for daily life.
Show enough liver fat on a test: either a MRI‑PDFF scan that reports a fat fraction of 5% or more, or a FibroScan® with a CAP reading of 288 decibels per meter (dB/m) or higher. MRI‑PDFF is an MRI scan that measures the amount of fat in the liver, and FibroScan® is a quick, painless device that uses sound waves to assess liver fat (CAP). If you have “cryptogenic cirrhosis,” lower values are allowed, and if you had a liver biopsy in the last 12 months that already showed fat, this test is not required.
Meet any additional requirements that the study may have (these are referred to as “further inclusion criteria”).
Who Cannot Join the Study?
You have recently (within the past 5 years) drunk a large amount of alcohol – more than about 140 g per week for women or 210 g per week for men – for at least three months in a row, or you cannot accurately tell how much you drink.
You test positive for hepatitis C, a viral infection that affects the liver.
Your blood test shows liver enzymes called AST or ALT that are more than five times higher than the normal range (ULN), indicating significant liver injury.
You have liver damage caused by alcohol or by certain medicines (known as alcoholic or drug‑induced liver disease).
You have previously had a liver transplant or are on a waiting list for a liver transplant.
You have had a procedure called transjugular intrahepatic portosystemic shunt (TIPS) or any other surgery/radiology to treat portal hypertension (high pressure in the veins that go to the liver).
Other unspecified reasons may also prevent participation.
Your MELD score (a number that predicts how severe liver disease is) is higher than 12.
You have a history or current sign of liver failure such as bleeding in the upper digestive tract caused by portal hypertension, fluid buildup in the abdomen (ascites), or mild brain changes from liver disease (hepatic encephalopathy grade 1 according to the West Haven criteria).
Lab results show any of the following: blood protein albumin lower than 3.5 g/dL, clotting test INR higher than 1.3 (unless you are taking blood‑thinning medication), or total bilirubin more than 1.2 times the normal limit (except if you have Gilbert Syndrome with normal red blood cell count, normal hemoglobin, and direct bilirubin less than 20 % of total).
You have another chronic liver disease such as primary biliary cholangitis, primary sclerosing cholangitis, autoimmune hepatitis, Wilson’s disease, alpha‑1‑antitrypsin deficiency, or genetic hemochromatosis.
You test positive for hepatitis B (presence of hepatitis B surface antigen), a viral infection that affects the liver.
survodutide is an experimental medicine that is given as a solution for injection under the skin once a week. In this study it is being tested to see if it can lower the risk of serious liver problems and death in people who have early-stage liver scarring caused by fatty liver disease (NASH/MASH). Researchers hope that the drug will improve liver health and prevent the disease from getting worse.
BI 456906 is the code name used for the same investigational drug in the trial. It is also administered as a subcutaneous injection in a liquid form. The study is looking at how this medication works to protect the liver and improve outcomes for participants with compensated cirrhosis due to NASH/MASH.
Metabolic dysfunction-associated steatohepatitis (MASH) – It is a chronic liver disease characterized by the accumulation of fat in liver cells together with inflammation and damage. The condition is not caused by alcohol consumption and is linked to metabolic risk factors such as obesity and insulin resistance. Over time, repeated injury can cause the liver tissue to become scarred (fibrosis). As fibrosis advances, the liver may develop cirrhosis, which reflects extensive scarring and altered liver architecture. Some patients may also experience worsening of liver function tests as the disease progresses.
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