Status and phase
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About
This study is open to adults who are at least 18 years old and have:
People with a history of other chronic liver diseases or high alcohol intake cannot take part in this study. The purpose of this study is to find out whether a medicine called survodutide helps people with NASH or MASH improve their liver function.
Participants are put into 2 groups randomly, which means by chance. 1 group gets survodutide and 1 group gets placebo. Placebo looks like survodutide but does not contain any medicine. Each participant has twice the chance of getting survodutide. Participants and doctors do not know who is in which group. Participants inject survodutide or placebo under their skin once a week. All participants regularly receive counselling to make changes to their diet and to exercise regularly.
Participants are in the study for up to 4 and a half years. During this time, they visit the study site or have a remote visit by video call every 2, 4 or 6 weeks for about a 1 year and 5 months. After this time participants visit the trial site or have a remote visit every 3 months until the end of the study.
The doctors check participants' health and take note of any unwanted effects. The participants' body weight is regularly measured. At some visits the liver parameters are measured using different imaging methods. The participants also fill in questionnaires about their symptoms. The results are compared between the groups to see whether the treatment works.
Enrollment
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Inclusion criteria
Exclusion criteria
Current or history (<5 years) of significant alcohol consumption, defined as an average of >140 g/week in female patients and >210 g/week in male patients, for a period of >3 consecutive months, or an inability to reliably quantify alcohol consumption based upon judgment of the investigator.
Model of end-stage liver Disease (MELD) score >12 due to liver disease
History or current (i.e. at screening) hepatic decompensation event of any of the following but not limited to:
Any of the following lab test result at screening
History or evidence of other chronic liver diseases, such as primary biliary cholangitis, primary sclerosing cholangitis, autoimmune hepatitis or overlap syndrome, Wilson's disease, alpha-1-antitrypsin deficiency, or genetic haemochromatosis
Hepatitis B positive (defined as positive hepatitis B surface antigen (HBsAg))
Hepatitis C positive (defined as positive hepatitis C virus (HCV) antibody and a positive HCV ribonucleic acid (RNA))
Serum aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) >5x ULN
Evidence of alcoholic liver disease, or drug-induced liver disease, as defined on the basis of typical exposure and history
History of liver transplantation or listed for liver transplantation
History of transjugular intrahepatic portosystemic shunt (TIPS) or other radiological/surgical procedure for portal hypertension treatment
Further exclusion criteria apply
Primary purpose
Allocation
Interventional model
Masking
1,590 participants in 2 patient groups, including a placebo group
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Central trial contact
Boehringer Ingelheim
Data sourced from clinicaltrials.gov
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