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NCT06632444

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

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

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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

1800 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-10-14

Study Completion Date

2031-12-27

Brief Summary

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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. The purpose of this study is to find out whether a medicine called survodutide helps people with MASH and moderate or advanced liver fibrosis improve their liver function.

This study has 2 parts. The purpose of the first part of this study is to find out the effect of survodutide on MASH and liver fibrosis. The purpose of the second part is to find out how safe and effective survodutide is in improving 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. The survodutide doses are slowly increased until the target dose is reached. All participants receive counselling to make changes to their diet and to exercise regularly.

Participants are in the study for up to 7 years. During this time, they regularly visit the study site or have remote visits by video call. For about the first year of the study, participants have these visits every 2 weeks, increasing to every 4 weeks and then every 6 weeks. After being in the study for a little over a year participants will then alternate between visiting the study site or having 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 and effects on the stomach and intestines are regularly measured. At some visits the liver is measured using different imaging methods. At 2 or 3 visits doctors take a small sample of liver tissue (biopsy). The participants also fill in questionnaires about their symptoms and quality of life. The results are compared between the groups to see whether the treatment works.

Detailed Description

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Conditions

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Metabolic Dysfunction Associated Steatohepatitis (MASH) Liver Fibrosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Subcutaneous injection

Intervention Type DRUG

Placebo

Subcutaneous injection

Intervention Type DRUG

Other Intervention Names

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BI 456906

Eligibility Criteria

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Inclusion Criteria

1. 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
2. Diagnosis of MASH (non-alcoholic fatty liver disease (NAFLD)) activity score \[NAS\] ≥4
3. Stable body weight defined as less than 5% self-reported change in body weight 3 months prior to the screening or during the period between the historical biopsy and randomisation, if a historical biopsy is used

Exclusion Criteria

1. 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)
* Alkaline phosphatase \>2x upper limit of normal (ULN)
* Abnormal synthetic liver function as defined by screening central laboratory evaluation:

* Albumin below \<3.5 g/dL (35.0 g/L)
* OR International normalised ratio (INR) of prothrombin time \>1.3
* OR total serum bilirubin concentration ≥1.5x ULN
2. Any history or evidence of acute or chronic liver disease other than MASH
3. Histologically documented liver cirrhosis (fibrosis stage F4), either at screening or in a historical biopsy
4. History of or current diagnosis of hepatocellular carcinoma
5. History of or planned liver transplant
6. Inability or unwillingness to undergo a liver biopsy at screening (if a suitable historical biopsy is unavailable for central review), or during trial conduct.
7. History of portal hypertension or presence of decompensated liver disease

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

Identifier Type: REGISTRY

Identifier Source: secondary_id

U1111-1306-9071

Identifier Type: REGISTRY

Identifier Source: secondary_id

1404-0044

Identifier Type: -

Identifier Source: org_study_id

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

Study Results

Basic Information

Brief Summary

Detailed Description

Conditions

Study Design

Study Groups

Survodutide

Survodutide

Placebo

Placebo

Interventions

Survodutide

Placebo

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

Adobe Clinical Research, LLC

Arizona Liver Health - Tucson

Del Sol Research Management, LLC

Hope Clinical Research

Velocity Clinical Research-Chula Vista

Southern California Research Center

Velocity Clinical Research-Gardena-69773

Velocity Clinical Research-Huntington Park

310 Clinical Research

Velocity Clinical Research, San Diego

Om Research, LLC

ARK Clinical Research

Velocity Clinical Research, Westlake

Catalina Research Institute, LLC-Montclair-69754

Velocity Clinical Research - Boise

Clinnova Research Solutions

Fomat Medical Research

California Liver Research Institute

Cadena Care Institute, Llc

Ficramed Research Institute

Inland Empire Clinical Trials, LLC

Metro Clinical Trials

Velocity Clinical Research - San Bernardino

Acclaim Clinical Research

Om Research, LLC

Future Innovative Treatments

South Denver Gastroenterology PC

Connecticut Gastroenterology Clinical Research Foundation

Yale University School of Medicine

Synergy Healthcare

Access research Institute

Tampa Bay Medical Research

K2 Medical Research

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

K2 Medical Research

Research Associates of South Florida, LLC

Optimus U Corporation-Miami-69452

Schiff Center Liver Diseases

BioMed Research & Medical Center

ECIR Miami Holdings LLC dba IMIC

Entrust Clinical Research

GI Pros Research

Charter Research

K2 Medical Research

Omega Research Orlando, LLC

Endoscopic Research, Inc

Innovation Medical Research Center

Progressive Medical Research