Testing Survodutide for Liver Disease in Patients with Cirrhosis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• The Institute for Liver Health II DBA Arizona Clinical Trials
  Peoria, Arizona, United States Recruiting
• Scottsdale Medical Specialists, Ltd
  Scottsdale, Arizona, United States Recruiting
• Adobe Clinical Research, LLC
  Tucson, Arizona, United States Recruiting
• Arizona Liver Health - Tucson
  Tucson, Arizona, United States Recruiting
• Del Sol Research Management, LLC
  Tucson, Arizona, United States Recruiting
• Hope Clinical Research
  Canoga Park, California, United States Recruiting

+397 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Boehringer Ingelheim
• Email: clintriage.rdg@boehringer-ingelheim.com
• Phone: 1-800-243-0127

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.