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New treatment option for Metabolic Dysfunction Associated Steatohepatitis (MASH)
Official title LIVERAGE™: A Study to Test Whether Survodutide Helps People With a Liver Disease Called NASH/MASH Who Have Moderate or Advanced Liver Fibrosis
ClinicalTrials.gov ID: NCT06632444
What this study is testing
What is Survodutide?
Survodutide is an investigational medicine, given as an once-weekly injection under the skin, being studied as a potential treatment for metabolic dysfunction associated steatohepatitis (mash).
Also referred to as BI 456906.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- Time commitment: about 7 years
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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
- Diagnosis of MASH (non-alcoholic fatty liver disease (NAFLD)) activity score [NAS] ≥4
- 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...
- Be willing to maintain a stable diet and physical activity levels throughout the entire trial Further apply
You likely can't join if
- 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)
See the full eligibility 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
- Diagnosis of MASH (non-alcoholic fatty liver disease (NAFLD)) activity score [NAS] ≥4
- 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
- Be willing to maintain a stable diet and physical activity levels throughout the entire trial Further apply
- 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
- Any history or evidence of acute or chronic liver disease other than MASH
- Histologically documented liver cirrhosis (fibrosis stage F4), either at screening or in a historical biopsy
- History of or current diagnosis of hepatocellular carcinoma
- History of or planned liver transplant
- Inability or unwillingness to undergo a liver biopsy at screening (if a suitable historical biopsy is unavailable for central review), or during trial conduct.
- History of portal hypertension or presence of decompensated liver disease
- Model for end-stage liver disease (MELD) score ≥12 due to liver disease. Further exclusion criteria apply
The study team makes the final eligibility decision.
Where it's taking place
- Birmingham, Alabama, United States
- Peoria, Arizona, United States
- Scottsdale, Arizona, United States
- Tucson, Arizona, United States
- Canoga Park, California, United States
- Chula Vista, California, United States
- Coronado, California, United States
- Fountain Valley, California, United States
- Fresno, California, United States
- Gardena, California, United States
- Huntington Park, California, United States
- Inglewood, California, United States
- La Mesa, California, United States
- Lancaster, California, United States
- Long Beach, California, United States
- Los Angeles, California, United States
- Montclair, California, United States
- Orange, California, United States
- Oxnard, California, United States
- Pasadena, California, United States
+ 399 more site(s).
Compensation & support
A stipend or compensation may be offered.
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 7 years per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Birmingham, Alabama, United States; Peoria, Arizona, United States; Scottsdale, Arizona, United States; Tucson, Arizona, United States; Canoga Park, California, United States; Chula Vista, California, United States and 413 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.