NCT06632444 · Boehringer Ingelheim
LIVERAGE™: A Study to Test Whether Survodutide Helps People With a Liver Disease Called NASH/MASH Who Have Moderate or Advanced Liver Fibrosis
What this study is about
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.
View original scientific description
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.
Interventions
COMBINATION_PRODUCT
Survodutide
Subcutaneous injection, prefilled syringe
COMBINATION_PRODUCT
Placebo
Subcutaneous injection, prefilled syringe
Primary outcome measures
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.
Part 1: At least a 1-point improvement in fibrosis stage with no worsening of MASH
Time frame: Baseline 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 CSPH
Time frame: Up 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
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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
- 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: *
Where
- Birmingham, Alabama
- Peoria, Arizona
- Scottsdale, Arizona
- Tucson, Arizona
- Canoga Park, California
- Chula Vista, California
- Coronado, California
- Fountain Valley, California
- Fresno, California
- Gardena, California
- Huntington Park, California
- Inglewood, California
And 121 more locations — see the full list below.
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 9, 2026 · Source of record for eligibility and locations