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LIVERAGE™ - Cirrhosis: A Study to Test Whether Survodutide Helps People With a Liver Disease Called NASH/MASH Who Have Cirrhosis

RecruitingPhase 3Ages 18 Years - anyAllBoehringer Ingelheim
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In plain words

What the trial is, and whether it could suit you

This study is open to adults who are at least 18 years old and have: * A confirmed liver disease called non-alcoholic steatohepatitis (NASH) or * A confirmed liver disease called metabolic-associated steatohepatitis (MASH) * BMI of 27 kg/m2 or more or * 25 kg/m2 or more if the participant is Asian. 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 placeb

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
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
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What it tests

  • Survodutide
  • Placebo matching survodutide
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Where

446 sites
The Institute for Liver Health II DBA Arizona Clinical Trials
Peoria, United States
Scottsdale Medical Specialists, Ltd
Scottsdale, United States
Adobe Clinical Research, LLC
Tucson, United States
Arizona Liver Health - Tucson
Tucson, United States
Del Sol Research Management, LLC
Tucson, United States
Hope Clinical Research
Canoga Park, United States
Velocity Clinical Research-Chula Vista
Chula Vista, United States
Southern California Research Center
Coronado, United States

…and 438 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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