ClinicaliQ Trial Snapshot
- LIVERAGE™ – Cirrhosis: A Study to Test Whether Survodutide Helps People With a Liver Disease Called NASH/MASH Who Have Cirrhosis — Recruiting • Phase III • Cardiology / Cardiovascular • NCT06632457.
- 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….
- Sponsor: Boehringer Ingelheim.
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What This Trial Is Studying
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…
Eligibility Snapshot
- : 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 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 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…
Use the source registry for the full inclusion and exclusion criteria before discussing referral or enrolment.