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LIVERAGE™: A Study of Survodutide for MASH and Liver Fibrosis

This study, called LIVERAGE™, is testing whether a medicine called survodutide can help adults with a liver disease called MASH (Metabolic Dysfunction Associated Steatohepatitis) and moderate or advanced liver scarring (fibrosis). You might be able to join if you are at least 18 years old, have MASH, and moderate or advanced liver fibrosis. People with other liver diseases or who drink a lot of alcohol cannot participate. The study aims to see if survodutide can resolve MASH without worsening fibrosis, or improve fibrosis without worsening MASH. It also looks at long-term liver health outcomes. The study is currently recruiting about 1800 participants.

Study design
This is an interventional study comparing survodutide to a placebo (an inactive substance). It is planned to enroll 1800 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants in Part 1 will be followed for 52 weeks. Participants in Part 2 will be followed for up to 7 years.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06632444

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

Recruiting
PHASE3Ages 18+InterventionalTreatment
Boehringer Ingelheim
~1,800 participants
Updated 2026-08-21 on ClinicalTrials.gov
What's tested:SurvodutidePlacebo

At a glance

Recruiting sites
487 of 528 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Part 1: Resolution of MASH without worsening of liver fibrosis on MASH Clinical Research Network (CRN) fibrosis score
Measured over Baseline and at Week 52.
+2 more outcomes measured

Conditions

Metabolic Dysfunction Associated Steatohepatitis (MASH)
Liver Fibrosis

Explore related trials

Liver FibrosisMetabolic Dysfunction Associated Steatohepatitis

Where it's being run

528 sites across 74 states
China58
Japan57
Texas38
Florida37
California25
United Kingdom23
Germany17
India15

Who to contact

Boehringer Ingelheim
[email protected]
1-800-243-0127
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Exclusion

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

What this trial measures

  • Part 1: Resolution of MASH without worsening of liver fibrosis on MASH Clinical Research Network (CRN) fibrosis scoreBaseline and at Week 52.
  • Part 1: At least a 1-point improvement in fibrosis stage with no worsening of MASHBaseline and at Week 52.
  • 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 CSPHUp to 7 years.

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