Status:
RECRUITING
LIVERAGE™ - Cirrhosis: A Study to Test Whether Survodutide Helps People With a Liver Disease Called NASH/MASH Who Have Cirrhosis
Lead Sponsor:
Boehringer Ingelheim
Conditions:
Metabolic Dysfunction Associated Steatohepatitis
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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...
Eligibility Criteria
Inclusion criteria:
- 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
- Body mass index (BMI) ≥27 kg/m2(≥25 kg/m2 for Asian trial participants)
- Compensated metabolic dysfunction-associated steatohepatitis (MASH) cirrhosis.
- 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.
- Further inclusion criteria apply.
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:
- Portal hypertension-related upper gastrointestinal (GI) bleeding
- Ascites
- Hepatic encephalopathy (HE) ≥Grade 1 according to the West Haven criteria
-
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)
-
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)) or history of chronic HBV infection
-
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
Key Trial Info
Start Date :
November 7 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 5 2029
Estimated Enrollment :
1590 Patients enrolled
Trial Details
Trial ID
NCT06632457
Start Date
November 7 2024
End Date
June 5 2029
Last Update
April 16 2026
Active Locations (438)
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1
The Institute for Liver Health II DBA Arizona Clinical Trials
Peoria, Arizona, United States, 85381
2
Scottsdale Medical Specialists, Ltd
Scottsdale, Arizona, United States, 85258
3
Adobe Clinical Research, LLC
Tucson, Arizona, United States, 85712
4
Arizona Liver Health - Tucson
Tucson, Arizona, United States, 85712