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Phase 3RecruitingInterventionalNCT06632444

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

A Randomised, Double-blind, Placebo-controlled, Multicentre, Phase III Trial Evaluating Long-term Efficacy and Safety of Survodutide Weekly Injections in Adult Participants With Noncirrhotic Non-alcoholic Steatohepatitis/Metabolic Dysfunction-associated Steatohepatitis (NASH/MASH) and (F2) - (F3) Stage of Liver Fibrosis

  • Metabolic Dysfunction Associated Steatohepatitis (MASH)
  • Liver Fibrosis
I want to take partRefer a patient15 sites in India · 531 worldwide

At a glance

Phase
Phase 3
Study type
Interventional
Sponsor
Boehringer Ingelheim
Enrolment target
1,800
Started
14 October 2024
Main results due (estimated)
27 December 2031
Study ends (estimated)
27 December 2031
Allocation
Randomized
Design
Parallel
Purpose
Treatment
Masking
Double (participant, investigator)
Sites
531 · 15 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 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
4. Be willing to maintain a stable diet and physical activity levels throughout the entire trial Further inclusion criteria apply

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
8. Model for end-stage liver disease (MELD) score ≥12 due to liver disease. 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 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.

What participants receive

  • Experimental

    Survodutide

    Combination Product: Survodutide

  • Placebo comparator

    Placebo

    Combination Product: Placebo

Interventions

  • SurvodutideCombination product

    Also known as BI 456906

    Subcutaneous injection, prefilled syringe

  • PlaceboCombination product

    Subcutaneous injection, prefilled syringe

What the study measures

Primary outcomes

  1. 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.

  2. Part 1: At least a 1-point improvement in fibrosis stage with no worsening of MASH

    Time frame: Baseline and at Week 52.

  3. 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

    Progression to cirrhosis is defined as histological fibrosis score CRN F4. MELD = Model for End-stage Liver Disease CSPH =clinically significant portal hypertension

    Time frame: Up to 7 years.

Secondary outcomes

  1. Key secondary endpoint part 1: Percentage change from baseline in body weight [kg]

    Time frame: Baseline and at Week 52.

  2. Key secondary endpoint part 1: Absolute change from baseline in glycosylated haemoglobin (HbA1c) [%]

    This endpoint is specified only for the participants with type 2 diabetes mellitus.

    Time frame: Baseline and at Week 52.

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

    Time frame: Baseline and at Week 52.

  4. Key secondary endpoint part 1: Absolute change from baseline in liver stiffness [kPa] assessed by vibration-controlled transient elastography (VCTE)

    Time frame: Baseline and at Week 52.

  5. Key secondary endpoint part 1: Achievement of no progression of fibrosis assessed by central pathology (yes/no)

    Time frame: Baseline and at Week 52.

  6. Key secondary endpoint part 2: Percentage change from baseline in body weight [kg]

    Time frame: At baseline and at Week 114

  7. Key secondary endpoint part 2: Absolute change from baseline in HbA1c [%]

    This endpoint is specified only for the participants with type 2 diabetes mellitus.

    Time frame: At baseline and at Week 114

  8. Key secondary endpoint part 2: Absolute change from baseline in ELF score

    Time frame: At baseline and at Week 114.

  9. Key secondary endpoint part 2: Absolute change from baseline in liver stiffness [kPa] assessed by VCTE

    Time frame: At baseline and at Week 114.

  10. Key secondary endpoint part 2: Achievement of no progression of fibrosis assessed by central pathology (yes/no)

    Time frame: At baseline and at 7 years.

  11. Key secondary endpoint part 2: Occurrence of all-cause hospitalisation (first and recurrent)

    Time frame: Up to 7 years.

  12. Key secondary endpoint part 2: Time to first occurrence of any of the adjudicated components of the composite endpoint 5-point major adverse cardiac event (5P-MACE)5-point major adverse cardiac event (5P-MACE)

    Time frame: Up to 7 years.

  13. Part 1: Improvement of liver fat content (LFC)

    Defined as at least 30% relative reduction in LFC compared with baseline assessed by Magnetic resonance imaging proton density fat fraction (MRI-PDFF). This endpoint will be reported only for a subset of participants in the MRI sub-study.

    Time frame: At baseline and at Week 52.

  14. Part 2: Improvement of LFC

    Defined as at least 30% relative reduction in LFC compared with baseline assessed by MRI-PDFF. This endpoint will be reported only for a subset of participants in the MRI sub-study.

    Time frame: At baseline and at Week 114.

  15. Part 1: Absolute change from baseline in LFC [%] in MRI-PDFF

    This endpoint will be reported only for a subset of participants in the MRI sub-study.

    Time frame: At baseline and at Week 52.

  16. Part 2: Absolute change from baseline in LFC [%] in MRI-PDFF

    This endpoint will be reported only for a subset of participants in the MRI sub-study.

    Time frame: At baseline and at Week 114.

  17. Part 1: Absolute change from baseline in alanine aminotransferase (ALT) [U/L]

    Time frame: At baseline and at Week 52.

  18. Part 2: Absolute change from baseline in alanine aminotransferase (ALT) [U/L]

    Time frame: At baseline and at Week 114.

  19. Part 1: Absolute change from baseline in aspartate aminotransferase (AST) [U/L]

    Time frame: At baseline and at Week 52.

  20. Part 2: Absolute change from baseline in aspartate aminotransferase (AST) [U/L]

    Time frame: At baseline and at Week 114.

  21. Part 1: Absolute change from baseline in systolic blood pressure (SBP) [mmHg]

    Time frame: At baseline and at Week 52.

  22. Part 2: Absolute change from baseline in systolic blood pressure (SBP) [mmHg]

    Time frame: At baseline and at Week 114.

  23. Part 1: Absolute change from baseline in diastolic blood pressure (DBP) [mmHg]

    Time frame: At baseline and at Week 52.

  24. Part 2: Absolute change from baseline in diastolic blood pressure (DBP) [mmHg]

    Time frame: At baseline and at Week 114.

  25. Part 1: Absolute changes from baseline in lipids [mg/dL] (including but not limited to: total cholesterol, LDL cholesterol, very low-density lipoprotein [VLDL] cholesterol, high-density lipoprotein [HDL] cholesterol, triglycerides)

    LDL=low-density lipoprotein

    Time frame: At baseline and at Week 52.

  26. Part 2: Absolute changes from baseline in lipids [mg/dL] (including but not limited to: total cholesterol, LDL cholesterol, very low-density lipoprotein [VLDL] cholesterol, high-density lipoprotein [HDL] cholesterol, triglycerides)

    Time frame: At baseline and at Week 114.

  27. Part 1: Absolute change from baseline in free fatty acids [mg/dL]

    Time frame: At baseline and at Week 52.

  28. Part 2: Absolute change from baseline in free fatty acids [mg/dL]

    Time frame: At baseline and at Week 114.

  29. Part 1: Progression to cirrhosis (defined as histological fibrosis score CRN F4) (yes/no)

    Time frame: At baseline and at Week 52.

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
1404-0044
Other IDs
2024-513739-25-00, U1111-1306-9071

Study sites(531)

Showing 40 of 531 sites, filter to narrow it down. 495 of 531 on this study are recruiting right now, and 15 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 NCT06632444, 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™: A Study to Test Whether Survodutide Helps People With a Liver Disease Called NASH/MASH Who Have Mod | Trialion