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Testing Survodutide for Liver Disease in Patients with Cirrhosis

A Phase III Double-blind, Randomised, Placebo-controlled Trial to Evaluate Liver-related Clinical Outcomes and Safety of Once Weekly Injected Survodutide in Participants With Compensated Non-alcoholic Steatohepatitis/Metabolic Dysfunction Associated Steatohepatitis (NASH/MASH) Cirrhosis

Phase 3 Interventional Boehringer Ingelheim · NCT06632457

This study is testing if a new medication called survodutide can help improve liver function in adults with cirrhosis caused by liver fat buildup.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment1590 (estimated)
Ages18 Years and up
SexAll
SponsorBoehringer Ingelheim Industry-sponsored
Locations443 sites (Peoria, Arizona and 442 other locations)
Trial IDNCT06632457 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the effectiveness of a medication called survodutide in improving liver function in adults diagnosed with non-alcoholic steatohepatitis (NASH) or metabolic-associated steatohepatitis (MASH) who also have cirrhosis. Participants will be randomly assigned to receive either survodutide or a placebo, with both groups receiving weekly injections. The study aims to determine if survodutide can provide significant benefits over the placebo in managing liver disease. Regular counseling will also be provided to participants to support lifestyle changes.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with a BMI of 27 or more (or 25 or more if Asian) and a confirmed diagnosis of NASH or MASH cirrhosis.

Not a fit: Patients with a history of significant alcohol consumption or other chronic liver diseases may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve liver function and overall health for patients with NASH or MASH-related cirrhosis.

How similar studies have performed: While similar studies have explored treatments for liver diseases, the specific use of survodutide in this context is novel and has not been extensively tested.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion criteria:

1. Male or female adults ≥18 years of age at the time of screening, and at least the legal age of consent in countries where it is \>18 years
2. Body mass index (BMI) ≥27 kg/m2(≥25 kg/m2 for Asian trial participants)
3. Compensated metabolic dysfunction-associated steatohepatitis (MASH) cirrhosis.
4. Magnetic resonance imaging proton density fat fraction (MRI-PDFF) fat fraction ≥5% or FibroScan® with controlled attenuation parameter (CAP) ≥288 dB/m, obtained during the screening period or a historic MRI-PDFF ≤12 weeks prior to randomisation (except for patients with 'cryptogenic cirrhosis' where MRI-PDFF \<5% or FibroScan® with CAP \<288 dB/m is allowed). This inclusion criterion does not apply for participants with a recent (≤12 months prior to randomisation) liver biopsy showing steatosis/steatohepatitis.
5. Further inclusion criteria apply.

Exclusion criteria:

1. 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.
2. Model of end-stage liver Disease (MELD) score \>12 due to liver disease
3. History or current (i.e. at screening) hepatic decompensation event of any of the following but not limited to:

   * Portal hypertension-related upper gastrointestinal (GI) bleeding
   * Ascites
   * Hepatic encephalopathy (HE) ≥Grade 1 according to the West Haven criteria
4. Any of the following lab test result at screening

   * Albumin below \<3.5 g/dL (\<35.0 g/L)
   * International normalised ratio (INR) \>1.3 unless due to therapeutic anticoagulants
   * Total bilirubin (TBL) \>1.2x upper limit of normal (ULN) NOTE: Trial participants with Gilbert Syndrome are eligible with a TBL \>1.2x ULN if reticulocyte count is within normal limits, haemoglobin is within normal limits unless due to chronic anaemia and unrelated to haemolysis, and direct bilirubin is \<20% of TBL.
   * Alkaline phosphatase \>1.5x ULN
   * PLT \<100,000/µL (\<100 GI/L)
5. 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
6. Hepatitis B positive (defined as positive hepatitis B surface antigen (HBsAg)) or history of chronic HBV infection
7. Hepatitis C positive (defined as positive hepatitis C virus (HCV) antibody and a positive HCV ribonucleic acid (RNA))
8. Serum aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) \>5x ULN
9. Evidence of alcoholic liver disease, or drug-induced liver disease, as defined on the basis of typical exposure and history
10. History of liver transplantation or listed for liver transplantation
11. History of transjugular intrahepatic portosystemic shunt (TIPS) or other radiological/surgical procedure for portal hypertension treatment
12. Further exclusion criteria apply

Where this trial is running

Peoria, Arizona and 442 other locations

+393 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Metabolic Dysfunction Associated Steatohepatitis
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.