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

What Was Tested

This registered phase 3 trial tested Survodutide.

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.

It had two arms (groups): Survodutide (experimental) and Placebo (placebo comparator).

The registry classes the interventions as combination product.

Who Took Part

Enrollment: 1590 planned participants were the target.

It was open to people of any sex aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: 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. Further inclusion criteria apply.

The full record lists 5 inclusion and 20 exclusion criteria; among the exclusions: 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.

How the Study Was Run

Design: randomized, parallel-group and double-blind.

Random assignment meant chance, not the researchers, decided who got Survodutide and who got the comparison, which limits bias.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Neither the participants nor the staff measuring them knew who was on Survodutide, so expectations could not easily colour the readings.

Those kept unaware of assignments: participant and investigator.

It started in 2024-11-12 with completion listed for 2029-06-05.

It ran at 447 sites in United States (126), Japan (55), China (50), United Kingdom (21), Germany (15) and France (14).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Time to first occurrence of any component of the composite clinical endpoint (at EoS) consisting of: all-cause mortality, liver transplant, hepatic decompensation events, worsening of MELD score to ≥15 and progression to CSPH (time frame: up to 4.5 years).

It also tracked 13 secondary outcomes, for example Key secondary endpoint: Absolute change from baseline in enhanced liver fibrosis (ELF) score, Key secondary endpoint: Percentage change from baseline in body weight, Percentage change from baseline in liver stiffness in FibroScan® VCTE, Time to first occurrence of progression to CSPH, Occurrence of all-cause hospitalisation (first and recurrent) and Time to first occurrence of any of the adjudicated components of the composite endpoint 5-point major adverse cardiac event (5P-MACE).

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Survodutide in 1590 people.

With 1590 participants it is a large trial for this field.

It is still recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Survodutide compound page, all human trials.