LIVERAGE™: A Study to Test Whether Survodutide Helps People With a Liver Disease Called NASH/MASH Who Have Moderate or Advanced Liver Fibrosis

What Was Tested

This registered phase 3 trial tested Survodutide.

This study is open to adults who are at least 18 years old living with obesity and have: * a confirmed liver disease called non-alcoholic steatohepatitis (NASH)/metabolic associated steatohepatitis (MASH) and * moderate or advanced liver fibrosis People with a history of acute or chronic liver diseases other than MASH or chronic alcohol intake cannot take part in this study.

This study has 2 parts.

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

The registry classes the interventions as combination product.

Who Took Part

Enrollment: 1800 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 participants ≥18 years (or who are of legal age in countries where that is greater than 18 years) of age at time of consent. Diagnosis of MASH (non-alcoholic fatty liver disease (NAFLD)) activity score \[NAS\] ≥4. Be willing to maintain a stable diet and physical activity levels throughout the entire trial Further inclusion criteria apply.

The full record lists 4 inclusion and 15 exclusion criteria; among the exclusions: any of the following liver laboratory test abnormalities at screening:; serum ast and/or alanine aminotransferase (alt) elevation ≥5x upper limit of normal (uln); platelet count \<140 000/mm\^3 (\<140 gi/l).

How the Study Was Run

The set-up was 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.

The Survodutide group and the comparison group ran side by side rather than switching.

As a double-blind Survodutide study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant and investigator.

It started in 2024-10-14 with completion listed for 2031-12-27.

It ran at 532 sites in United States (165), China (58), Japan (57), United Kingdom (24), Germany (18) and India (15).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Part 1: Resolution of MASH without worsening of liver fibrosis on MASH Clinical Research Network (CRN) fibrosis score (time frame: Baseline and at Week 52). Part 2: Time to first occurrence of any of components of the composite endpoint consisting of progression to cirrhosis, all-cause mortality, liver transplant, hepatic decompensation event(s), worsening of MELD score to ≥15, progression to CSPH (time frame: Up to 7 years).

It also tracked 29 secondary outcomes, for example Key secondary endpoint part 1: Percentage change from baseline in body weight [kg], Key secondary endpoint part 1: Absolute change from baseline in glycosylated haemoglobin (HbA1c) [%], Key secondary endpoint part 1: Absolute change from baseline in enhanced liver fibrosis (ELF) score, Key secondary endpoint part 1: Achievement of no progression of fibrosis assessed by central pathology (yes/no), Key secondary endpoint part 2: Percentage change from baseline in body weight [kg] and Key secondary endpoint part 2: Absolute change from baseline in HbA1c [%].

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Survodutide in 1800 people.

With 1800 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.