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

NCT06632457 · Recruiting

Last updated 2026-05-28

This clinical trial is testing whether survodutide, a new medication, helps people with cirrhosis caused by a liver disease called NASH/MASH.

Status Recruiting Currently enrolling participants.

Phase Phase 3 Confirms effectiveness in a large group before approval.

Type Interventional (clinical trial)

Design Randomized, double-blind treatment study

Participants 1,590 people Planned (estimated).

Who can join Ages 18+ · all sexes

Timeline Started 2024-11 · est. completion 2029-06

Where 443 sites · Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, China, Czechia, France, Georgia, Germany, Hungary, India, Italy, Japan, Jordan, Kazakhstan, Malaysia, Mexico, Netherlands, New Zealand, Poland, Puerto Rico, Romania, Saudi Arabia, Singapore, South Africa, South Korea, Spain, Switzerland, Taiwan, Turkey (Türkiye), United Kingdom, United States

What this study is testing ClinicalTrials.gov NCT06632457 ↗

Description as written by the study sponsor.

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 MASH improve their liver function. Participants are put into 2 groups randomly, which means by chance. 1 group gets survodutide and 1 group gets placebo. Placebo looks like survodutide but does not contain any medicine. Each participant has twice the chance of getting survodutide. Participants and doctors do not know who is in which group. Participants inject survodutide or placebo under their skin once a week. All participants regularly receive counselling to make changes to their diet and to exercise regularly. Participants are in the study for up to 4 and a half years. During this time, they visit the study site or have a remote visit by video call every 2, 4 or 6 weeks for about a 1 year and 5 months. After this time participants visit the trial site or have a remote visit every 3 months until the end of the study. The doctors check participants' health and take note of any unwanted effects. The participants' body weight is regularly measured. At some visits the liver parameters are measured using different imaging methods. The participants also fill in questionnaires about their symptoms. The results are compared between the groups to see whether the treatment works.

Treatments tested

Survodutide also known as BI 456906 Combination Product

Subcutaneous injection, pre-filled syringe
Placebo matching survodutide Combination Product

Subcutaneous injection, pre-filled syringe

Main thing measured	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
Sponsor	Boehringer Ingelheim
Conditions studied	Metabolic Dysfunction Associated Steatohepatitis
GLP-1 drugs	survodutide

Full protocol, eligibility, and contacts on ClinicalTrials.gov NCT06632457 ↗