A Phase 3 interventional study of Survodutide and Placebo in Metabolic Dysfunction Associated Steatohepatitis (MASH) and Liver Fibrosis, sponsored by Boehringer Ingelheim. Recruiting at 532 sites in 37 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-28.
Sponsored by Boehringer Ingelheim · Phase 3, Interventional, and Treatment
This study is open to adults who are at least 18 years old living with obesity and have:
People with a history of acute or chronic liver diseases other than MASH or chronic 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 MASH and moderate or advanced liver fibrosis improve their liver function.
This study has 2 parts. The purpose of the first part of this study is to find out the effect of survodutide on MASH and liver fibrosis. The purpose of the second part is to find out how safe and effective survodutide is in improving 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. The survodutide doses are slowly increased until the target dose is reached. All participants receive counselling to make changes to their diet and to exercise regularly.
Participants are in the study for up to 7 years. During this time, they regularly visit the study site or have remote visits by video call. For about the first year of the study, participants have these visits every 2 weeks, increasing to every 4 weeks and then every 6 weeks. After being in the study for a little over a year participants will then alternate between visiting the study site or having 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 and effects on the stomach and intestines are regularly measured. At some visits the liver is measured using different imaging methods. At 2 or 3 visits doctors take a small sample of liver tissue (biopsy). The participants also fill in questionnaires about their symptoms and quality of life. The results are compared between the groups to see whether the treatment works.
1,298 studies on the registry are indexed under Liver Cirrhosis; 338 are open to participants now.
This study's planned enrollment of 1,800 is above the median of 78 across 739 interventional studies indexed under Liver Cirrhosis.
Browse Liver Cirrhosis studies →Boehringer Ingelheim is the lead sponsor of 2,304 studies on the registry; 62 are open to participants now.
Of its 167 completed or terminated interventional studies of FDA-regulated products, 123 (74%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion criteria:
Any of the following liver laboratory test abnormalities at screening:
Abnormal synthetic liver function as defined by screening central laboratory evaluation:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
INR, PT and aPTT (clotting tests)
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Combination Product: Survodutide
Combination Product: Placebo
Subcutaneous injection, prefilled syringe
Also known as: BI 456906
Subcutaneous injection, prefilled syringe
Part 1: Resolution of MASH without worsening of liver fibrosis on MASH Clinical Research Network (CRN) fibrosis score
Time frame: Baseline and at Week 52.
Part 1: At least a 1-point improvement in fibrosis stage with no worsening of MASH
Time frame: Baseline and at Week 52.
Part 2: Time to first occurrence of any of components of the composite endpoint consisting of progression to cirrhosis, all-cause mortality, liver transplant, hepatic decompensation event(s), worsening of MELD score to ≥15, progression to CSPH
Progression to cirrhosis is defined as histological fibrosis score CRN F4. MELD = Model for End-stage Liver Disease CSPH =clinically significant portal hypertension
Time frame: Up to 7 years.
Key secondary endpoint part 1: Percentage change from baseline in body weight [kg]
Time frame: Baseline and at Week 52.
Key secondary endpoint part 1: Absolute change from baseline in glycosylated haemoglobin (HbA1c) [%]
This endpoint is specified only for the participants with type 2 diabetes mellitus.
Time frame: Baseline and at Week 52.
Key secondary endpoint part 1: Absolute change from baseline in enhanced liver fibrosis (ELF) score
Time frame: Baseline and at Week 52.
Key secondary endpoint part 1: Absolute change from baseline in liver stiffness [kPa] assessed by vibration-controlled transient elastography (VCTE)
Time frame: Baseline and at Week 52.
Key secondary endpoint part 1: Achievement of no progression of fibrosis assessed by central pathology (yes/no)
Time frame: Baseline and at Week 52.
Key secondary endpoint part 2: Percentage change from baseline in body weight [kg]
Time frame: At baseline and at Week 114
Key secondary endpoint part 2: Absolute change from baseline in HbA1c [%]
This endpoint is specified only for the participants with type 2 diabetes mellitus.
Time frame: At baseline and at Week 114
Key secondary endpoint part 2: Absolute change from baseline in ELF score
Time frame: At baseline and at Week 114.
Key secondary endpoint part 2: Absolute change from baseline in liver stiffness [kPa] assessed by VCTE
Time frame: At baseline and at Week 114.
Key secondary endpoint part 2: Achievement of no progression of fibrosis assessed by central pathology (yes/no)
Time frame: At baseline and at 7 years.
Key secondary endpoint part 2: Occurrence of all-cause hospitalisation (first and recurrent)
Time frame: Up to 7 years.
Key secondary endpoint part 2: Time to first occurrence of any of the adjudicated components of the composite endpoint 5-point major adverse cardiac event (5P-MACE)5-point major adverse cardiac event (5P-MACE)
Time frame: Up to 7 years.
Part 1: Improvement of liver fat content (LFC)
Defined as at least 30% relative reduction in LFC compared with baseline assessed by Magnetic resonance imaging proton density fat fraction (MRI-PDFF). This endpoint will be reported only for a subset of participants in the MRI sub-study.
Time frame: At baseline and at Week 52.
Part 2: Improvement of LFC
Defined as at least 30% relative reduction in LFC compared with baseline assessed by MRI-PDFF. This endpoint will be reported only for a subset of participants in the MRI sub-study.
Time frame: At baseline and at Week 114.
Part 1: Absolute change from baseline in LFC [%] in MRI-PDFF
This endpoint will be reported only for a subset of participants in the MRI sub-study.
Time frame: At baseline and at Week 52.
Part 2: Absolute change from baseline in LFC [%] in MRI-PDFF
This endpoint will be reported only for a subset of participants in the MRI sub-study.
Time frame: At baseline and at Week 114.
Part 1: Absolute change from baseline in alanine aminotransferase (ALT) [U/L]
Time frame: At baseline and at Week 52.
Part 2: Absolute change from baseline in alanine aminotransferase (ALT) [U/L]
Time frame: At baseline and at Week 114.
Part 1: Absolute change from baseline in aspartate aminotransferase (AST) [U/L]
Time frame: At baseline and at Week 52.
Part 2: Absolute change from baseline in aspartate aminotransferase (AST) [U/L]
Time frame: At baseline and at Week 114.
Part 1: Absolute change from baseline in systolic blood pressure (SBP) [mmHg]
Time frame: At baseline and at Week 52.
Part 2: Absolute change from baseline in systolic blood pressure (SBP) [mmHg]
Time frame: At baseline and at Week 114.
Part 1: Absolute change from baseline in diastolic blood pressure (DBP) [mmHg]
Time frame: At baseline and at Week 52.
Part 2: Absolute change from baseline in diastolic blood pressure (DBP) [mmHg]
Time frame: At baseline and at Week 114.
Part 1: Absolute changes from baseline in lipids [mg/dL] (including but not limited to: total cholesterol, LDL cholesterol, very low-density lipoprotein [VLDL] cholesterol, high-density lipoprotein [HDL] cholesterol, triglycerides)
LDL=low-density lipoprotein
Time frame: At baseline and at Week 52.
Part 2: Absolute changes from baseline in lipids [mg/dL] (including but not limited to: total cholesterol, LDL cholesterol, very low-density lipoprotein [VLDL] cholesterol, high-density lipoprotein [HDL] cholesterol, triglycerides)
Time frame: At baseline and at Week 114.
Part 1: Absolute change from baseline in free fatty acids [mg/dL]
Time frame: At baseline and at Week 52.
Part 2: Absolute change from baseline in free fatty acids [mg/dL]
Time frame: At baseline and at Week 114.
Part 1: Progression to cirrhosis (defined as histological fibrosis score CRN F4) (yes/no)
Time frame: At baseline and at Week 52.
Not enrolling at this site — choose another above.
Not enrolling at this site — choose another above.
Showing the first 100 of 532 sites across 37 countries. Choose a country and city above to see the rest.
Plan to share: Yes — Once the criteria in section 'time frame' are fulfilled, researchers can use the following link https:// www.mystudywindow.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement". Furthermore, researchers can request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website.
Supporting information: Study protocol, Statistical analysis plan, Clinical study report
Time frame: One year after the approval has been granted by major Regulatory Authorities and after the primary manuscript has been accepted for publication, or after termination of the development program.
Access criteria: For study documents -upon signing of a 'Document Sharing Agreement '. For study data -1. after the submission and approval of the research proposal (checks will be performed by the sponsor and/or the independent review panel, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a legal agreement.
Data sharing details ↗ · www.clinicalstudies.boehringer-ingelheim.com
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Survodutide