LIVERAGE™: A Study to Test Whether Survodutide Helps People With a Liver Disease Called NASH/MASH Who Have Moderate or Advanced Liver Fibrosis
- Status
- RecruitingResults none
- Why it is watched
- non-weight indication: liver, addiction, mortality
- Who it enrolls
- age 18 Years to no upper limit; no BMI minimum stated; conditions: Metabolic Dysfunction Associated Steatohepatitis (MASH); Liver Fibrosis
- Interventions
- Survodutide; Placebo
- Conditions
- Metabolic Dysfunction Associated Steatohepatitis (MASH); Liver Fibrosis
- Phase and size
- Phase 3 · 1800 participants
- Dates
- Start 2024-10-14
Primary completion 2031-12-27 - Sponsor
- Boehringer Ingelheim (Industry)
- Last checked
- Sep 13, 2026
01Endpoints
What the trial will measure
- 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.
02Eligibility
Who can take part
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
03Change log
Registry changes
No changes recorded since the trial was added.