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Phase 3RecruitingInterventionalNCT06632457

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

A Phase III Double-blind, Randomised, Placebo-controlled Trial to Evaluate Liver-related Clinical Outcomes and Safety of Once Weekly Injected Survodutide in Participants With Compensated Non-alcoholic Steatohepatitis/Metabolic Dysfunction Associated Steatohepatitis (NASH/MASH) Cirrhosis

  • Metabolic Dysfunction Associated Steatohepatitis
I want to take partRefer a patient12 sites in India · 446 worldwide

At a glance

Phase
Phase 3
Study type
Interventional
Sponsor
Boehringer Ingelheim
Enrolment target
1,590
Started
12 November 2024
Main results due (estimated)
5 June 2029
Study ends (estimated)
5 June 2029
Allocation
Randomized
Design
Parallel
Purpose
Treatment
Masking
Double (participant, investigator)
Sites
446 · 12 in India
First posted
9 October 2024
Registry updated
1 October 2026

Can you take part?

  • Aged 18 years and over.
  • Open to any sex.
  • You need the condition being studied. Healthy volunteers are not accepted.

Age groups: adult, older adult.

These are the headline rules. Every study has a longer list, and whether you are eligible is decided by the research team at the site, never by this page.

Read the full eligibility criteria
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.
5. Further inclusion criteria apply.

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
12. Further exclusion criteria apply

What this study is about

In the sponsor’s own words, from the registry.

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.

What participants receive

  • Experimental

    Survodutide

    Combination Product: Survodutide

  • Placebo comparator

    Placebo

    Combination Product: Placebo matching survodutide

Interventions

  • SurvodutideCombination product

    Also known as BI 456906

    Subcutaneous injection, pre-filled syringe

  • Placebo matching survodutideCombination product

    Subcutaneous injection, pre-filled syringe

What the study measures

Primary outcomes

  1. 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

    MELD = model of end-stage liver disease CSPH = Clinically significant portal hypertension

    Time frame: up to 4.5 years.

Secondary outcomes

  1. Key secondary endpoint: Absolute change from baseline in enhanced liver fibrosis (ELF) score

    Time frame: At baseline and at Week 76.

  2. Key secondary endpoint: Percentage change from baseline in body weight

    Time frame: At baseline and at Week 76.

  3. Key secondary endpoint: Absolute change from baseline in glycosylated haemoglobin A1c (HbA1c) (%) in participants with type 2 diabetes mellitus (T2DM) at baseline

    Time frame: At baseline and at Week 76.

  4. Key secondary endpoint: Absolute change from baseline in liver stiffness (kPa) in FibroScan® vibration-controlled transient elastography (VCTE)

    Time frame: At baseline and at Week 76.

  5. Percentage change from baseline in liver stiffness in FibroScan® VCTE

    Time frame: At baseline and at Week 76.

  6. Time to first occurrence of progression to CSPH

    Time frame: up to 4.5 years.

  7. Time to first occurrence of any of the hepatic decompensation events (ascites, HE, or portal hypertension-related upper GI bleeding), or worsening of MELD score to ≥15

    Time frame: up to 4.5 years.

  8. Occurrence of all-cause hospitalisation (first and recurrent)

    Time frame: up to 4.5 years.

  9. Time to first occurrence of any of the adjudicated components of the composite endpoint 5-point major adverse cardiac event (5P-MACE)

    Time frame: up to 4.5 years.

  10. Absolute changes from baseline in lipids (mg/dL)

    Time frame: At baseline and at Week 76.

  11. Absolute change from baseline in aspartate aminotransferase (AST) (U/L)

    Time frame: At baseline and at Week 76.

  12. Absolute change from baseline in alanine aminotransferase (ALT) (U/L)

    Time frame: At baseline and at Week 76.

  13. Absolute change from baseline in liver stiffness (kPa) assessed by magnetic resonance elastography (MRE)

    Time frame: At baseline and at Week 76.

Who is running it

Lead sponsor
Boehringer Ingelheim
Sponsor type
Industry
Responsible party
The sponsor
Organisation
Boehringer Ingelheim
Data monitoring committee
Yes
US FDA-regulated drug
Yes
US FDA-regulated device
No
Sponsor's study ID
1404-0064
Other IDs
2024-513741-36-00, U1111-1307-0227

Study sites(446)

Showing 40 of 446 sites, filter to narrow it down. 427 of 446 on this study are recruiting right now, and 12 are in India. A site can stop enrolling while the study as a whole is still open.

References and data sharing

Participant data shared
Yes
What is shared
Study protocol, Sap, Csr
When
One year after the approval has been granted by major Regulatory Authorities and after the primary manuscript has been accepted for publication, or after termination of the development program.
Access
For study documents -upon signing of a 'Document Sharing Agreement'. For study data -1. after the submission and approval of the research proposal (checks will be performed by the sponsor and/or the independent review panel, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a legal agreement.

Once the criteria in section 'time frame' are fulfilled, researchers can use the following link https:// www.mystudywindow.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement". Furthermore, researchers can request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website.

Source: ClinicalTrials.gov record NCT06632457, status verified September 2026. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.

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