Non-alcoholic steatohepatitis (also called MASH) is a liver condition where excess fat builds up in the liver and causes inflammation and scarring. When the scarring, known as fibrosis, reaches stage 2 or 3 it can lead to serious liver problems. The study evaluates a new medication called survodutide, which is given as a small injection under the skin once a week, and compares it with an inactive substance called placebo.
The main goal of the trial is to find out whether survodutide can improve liver health better than the placebo. “Improving liver health” means the disease may disappear without the scar tissue getting worse, and the scar tissue may become less severe. Terms such as MRI refer to a scan that uses magnets to create detailed pictures of the liver, while VCTE is a quick test that measures how stiff the liver is, which helps doctors see how much scarring is present.
Participants will receive the weekly injection for about one year and will attend regular visits where blood samples are taken, weight is measured, and imaging tests such as MRI and VCTE are performed. After the treatment period, they will continue to be followed for several more months to monitor long‑term safety and any changes in liver condition.
1baseline visit
you will attend a first clinic visit after joining the study. during this visit a series of measurements will be taken, including blood tests, imaging of the liver, and assessment of body weight and blood pressure.
you will receive your first subcutaneous injection. the injection will contain either survodutide or a placebo and the amount is listed as 00 mg. the injection is given under the skin using a small needle.
2weekly injections
starting the week after the baseline visit you will receive an injection every week. each injection is given subcutaneously and contains 00 mg of the assigned study product (survodutide or placebo). the schedule continues for at least 52 weeks and may be extended to week 114 depending on the part of the study you are in.
3regular monitoring visits
throughout the study you will return to the clinic at predefined times, for example at weeks 4, 12, 24, 36 and 52. during these visits the staff will check your safety, record any side effects, and repeat some of the tests done at baseline, such as blood work and liver stiffness measurement.
if you continue beyond week 52, additional visits will be scheduled up to week 114 to collect the same type of information.
4primary assessment at week 52
at week 52 a comprehensive evaluation will be performed. this includes an MRI scan to measure liver fat, a liver biopsy or other imaging to assess fibrosis stage, blood tests for liver enzymes, blood sugar (hbA1c), and lipid levels, and measurements of body weight and blood pressure.
the results will be used to determine whether the liver condition has improved without getting worse.
5continued treatment and assessments up to week 114
if you remain in the study after week 52, weekly subcutaneous injections of the same product will continue until week 114.
additional monitoring visits will be held, and the same set of measurements taken at week 52 will be repeated at week 114 to evaluate longer‑term effects.
6final study visit
at the end of the study (week 114 or the final week defined by the protocol) a final set of assessments will be done. these include the same imaging, blood tests, and physical measurements as earlier visits.
the data collected will be used to compare the overall safety and effectiveness of survodutide with the placebo over the whole study period.
Who Can Join the Study?
Be 18 years old or older (or the legal adult age in your country) at the time you sign the consent form.
Have a confirmed diagnosis of Metabolic dysfunction-associated steatohepatitis (MASH), which is a type of liver disease, and a NAFLD activity score (NAS) of 4 or higher; the NAS is a number doctors use to describe how active the disease is.
Have a stable body weight, meaning you have not lost or gained more than 5% of your weight on your own in the three months before screening (or between a past liver biopsy and the start of the study).
Agree to keep your diet and exercise routine about the same for the whole time you are in the study.
Who Cannot Join the Study?
Very high liver enzyme levels (called AST or ALT) that are at least five times the normal upper limit (ULN).
Low platelet count (platelet count less than 140,000 per microliter), meaning fewer blood cells that help with clotting.
Very high alkaline phosphatase (>2 times the normal limit), an enzyme that can signal liver or bone problems.
Poor liver protein production, shown by any one of the following: albumin below 3.5 g/dL, clotting time measured as INR (international normalized ratio) greater than 1.3, or total bilirubin (a waste product) at or above 1.5 times the normal limit.
Any history or evidence of another acute or chronic liver disease besides MASH.
Having liver cirrhosis (fibrosis stage F4) either now or in a past tissue sample.
History of or current diagnosis of liver cancer (hepatocellular carcinoma).
History of or planned liver transplant.
Inability or unwillingness to undergo a liver biopsy (a small tissue sample from the liver) for screening or during the study.
History of portal hypertension (high blood pressure in the veins that bring blood to the liver) or presence of decompensated liver disease (when the liver can no longer perform its normal functions).
A MELD score (a number that predicts severity of liver disease) of 12 or higher due to liver disease.
Survodutide (BI 456906) is an investigational medicine that is given as a liquid that is injected under the skin (subcutaneous injection). In this study, participants receive the injection once a week. The drug is being tested to see if it can help adults with non‑alcoholic steatohepatitis (also called MASH) and moderate to severe liver scarring (fibrosis stage 2 or 3). Researchers hope that Survodutide will improve liver health by reducing the disease activity and preventing the fibrosis from getting worse, while also lowering the risk of serious liver problems or death.
Non-alcoholic steatohepatitis (NASH) – It is a chronic liver condition characterized by the buildup of fat in liver cells together with inflammation and damage. The disease usually develops in people with excess weight or metabolic disorders such as diabetes. Over time, the ongoing inflammation can cause scar tissue (fibrosis) to form in the liver. As fibrosis progresses, the liver becomes stiffer and its ability to function normally declines. The condition can advance from mild changes to more severe scarring without obvious symptoms in early stages.
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