Last updated 7 days ago
LIVERAGE™ - Cirrhosis: A Study to Test Whether Survodutide Helps People With a Liver Disease Called NASH/MASH Who Have Cirrhosis
1590 patients around the world
Available in Chile, Brazil, Argentina, Mexico
Boehringer Ingelheim
15Research sites
1590Patients around the world
This study is for people with
Steatohepatitis
Metabolic dysfunction-associated steatohepatitis - MASH
Cirrhosis
Requirements for the patient
From 18 Years
All Gender
Medical requirements
- 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 diagnosed according to modified Liver Forum criteria (Noureddin et al, Gastroenterology 2020;159:422-427).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 or FibroScan® with CAP ≤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.
- 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:History of 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.Platelet count <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)).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.
Sites
Centro de Investigaciones Metabólicas (CINME) S.A. - CABA, Buenos Aires
CEDIMBA - DIM Clínica Privada - Buenos Aires
Hospital El Cruce - Nestor Kirchner
Hospital Universitario Austral - Pilar
Centro Médico Saavedra
Recruiting
Buenos Aires Mácula S.A.
Associação Hospitalar Moinhos de Vento
Universidade Federal do Pará
HOSPITAL DAS CLÍNICAS FMUSP
Hospital De Base de São José do Rio Preto - CIP São José
SponsorBoehringer Ingelheim
Study typeInterventional
Conditions
Metabolic dysfunction-associated steatohepatitis - MASHCirrhosis
Requirements
From 18 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT06632457
