Home
Clinical Trials
NCT06632457

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

Last Updated: 2025-11-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

1590 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-11-12

Study Completion Date

2029-06-05

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Metabolic Dysfunction Associated Steatohepatitis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Subcutaneous injection

Intervention Type DRUG

Placebo matching survodutide

Subcutaneous injection

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

BI 456906

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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 \<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.

Exclusion Criteria

1. 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.
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 \<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
* PLT \<100,000/µL (\<100 GI/L)
5. 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
6. Hepatitis B positive (defined as positive hepatitis B surface antigen (HBsAg)) or history of chronic HBV infection
7. Hepatitis C positive (defined as positive hepatitis C virus (HCV) antibody and a positive HCV ribonucleic acid (RNA))
8. Serum aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) \>5x ULN
9. Evidence of alcoholic liver disease, or drug-induced liver disease, as defined on the basis of typical exposure and history
10. History of liver transplantation or listed for liver transplantation
11. History of transjugular intrahepatic portosystemic shunt (TIPS) or other radiological/surgical procedure for portal hypertension treatment

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

York, , United Kingdom

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Identifier Type: REGISTRY

Identifier Source: secondary_id

U1111-1307-0227

Identifier Type: REGISTRY

Identifier Source: secondary_id

1404-0064

Identifier Type: -

Identifier Source: org_study_id

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

Study Results

Basic Information

Brief Summary

Detailed Description

Conditions

Study Design

Study Groups

Survodutide

Survodutide

Placebo

Placebo matching survodutide

Interventions

Survodutide

Placebo matching survodutide

Other Intervention Names

Eligibility Criteria

Inclusion Criteria

Exclusion Criteria

Sponsors

Boehringer Ingelheim

Responsible Party

Locations

The Institute for Liver Health II DBA Arizona Clinical Trials

Scottsdale Clinical Trials

Del Sol Research Management, LLC

Hope Clinical Research

Velocity Clinical Research-Chula Vista

Southern California Research Center

ARK Clinical Research

Velocity Clinical Research-Huntington Park

310 Clinical Research

Velocity Clinical Research, San Diego

Om Research, LLC

Catalina Research Institute, LLC-Montclair-69754

Clinnova Research Solutions

Fomat Medical Research

Cadena Care Institute, Llc

Ficramed Research Institute

Inland Empire Clinical Trials, LLC

Metro Clinical Trials

Acclaim Clinical Research

Future Innovative Treatments

South Denver Gastroenterology PC

Connecticut Gastroenterology Clinical Research Foundation

Synergy Healthcare

Access research Institute

Hi Tech and Global Research, LLC

Top Medical Research, Inc

Covenant Metabolic Specialists, LLC - Fort Myers

Floridian Clinical Research-Hialeah-66084

Neoclinical Research

Evolution Clinical Trials

Global Research Associates

Lake Center for Clinical Research

Research Associates of South Florida, LLC

Optimus U Corporation-Miami-69452

Schiff Center Liver Diseases

BioMed Research & Medical Center

MplusM - Century Research

ECIR Miami Holdings LLC dba IMIC

Entrust Clinical Research

Advanced Research Institute

Charter Research

Omega Research Orlando, LLC

Endoscopic Research, Inc

Innovation Medical Research Center

MplusM - Best Choice Medical and Research Service

Covenant Metabolic Specialists, LLC-Sarasota-68343

Global Clinical Professionals

Synergy Healthcare

International Center for Research

Charter Research

Conquest Research

Florida Medical Clinic, P.A.

Piedmont Hospital

Gastroenterology Associates of Central Georgia

EmVenio Research-Atlanta-69582

ASHA Clinical Research - Munster, LLC

Digestive Research Alliance of Michiana