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New treatment option for Metabolic Dysfunction Associated Steatohepatitis
Official title LIVERAGE™ - Cirrhosis: A Study to Test Whether Survodutide Helps People With a Liver Disease Called NASH/MASH Who Have Cirrhosis
ClinicalTrials.gov ID: NCT06632457
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.
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 and have: A confirmed liver disease called non-alcoholic steatohepatitis (NASH) or A confirmed liver disease called metabolic-associated steatohepatitis (MASH) BMI of 27 kg/m2 or more or 25 kg/m2 or more if the participant is Asian. People with a history of other chronic liver diseases or high alcohol intake cannot take part in this study.
- Phase 3: a large, late-stage study
- 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 adults ≥18 years of age at the time of screening, and at least the legal age of consent in countries where it is \>18 years
- Body mass index (BMI) ≥27 kg/m2(≥25 kg/m2 for Asian trial participants)
- Compensated metabolic dysfunction-associated steatohepatitis (MASH) cirrhosis.
- Magnetic resonance imaging proton density fat fraction (MRI-PDFF) fat fraction ≥5% or FibroScan® with controlled attenuation parameter (CAP) ≥288...
- Further apply.
You likely can't join if
- Current or history (\ 140 g/week in female patients and \>210 g/week in male patients, for a period of \>3 consecutive months, or an inability to...
- Model of end-stage liver Disease (MELD) score \>12 due to liver disease
- History or current (i.e. at screening) hepatic decompensation event of any of the following but not limited to:
- Portal hypertension-related upper gastrointestinal (GI) bleeding
- Ascites
- Hepatic encephalopathy (HE) ≥Grade 1 according to the West Haven criteria
See the full eligibility criteria
- Male or female adults ≥18 years of age at the time of screening, and at least the legal age of consent in countries where it is \>18 years
- Body mass index (BMI) ≥27 kg/m2(≥25 kg/m2 for Asian trial participants)
- Compensated metabolic dysfunction-associated steatohepatitis (MASH) cirrhosis.
- Magnetic resonance imaging proton density fat fraction (MRI-PDFF) fat fraction ≥5% or FibroScan® with controlled attenuation parameter (CAP) ≥288 dB/m, obtained during the screening period or a historic MRI-PDFF ≤12...
- Further apply.
- Current or history (\ 140 g/week in female patients and \>210 g/week in male patients, for a period of \>3 consecutive months, or an inability to reliably quantify alcohol consumption based upon judgment of the...
- Model of end-stage liver Disease (MELD) score \>12 due to liver disease
- History or current (i.e. at screening) hepatic decompensation event of any of the following but not limited to:
- Portal hypertension-related upper gastrointestinal (GI) bleeding
- Ascites
- Hepatic encephalopathy (HE) ≥Grade 1 according to the West Haven criteria
- Any of the following lab test result at screening
- Albumin below \<3.5 g/dL (\<35.0 g/L)
- International normalised ratio (INR) \>1.3 unless due to therapeutic anticoagulants
- Total bilirubin (TBL) \>1.2x upper limit of normal (ULN) NOTE: Trial participants with Gilbert Syndrome are eligible with a TBL \>1.2x ULN if reticulocyte count is within normal limits, haemoglobin is within normal...
- Alkaline phosphatase \>1.5x ULN
- PLT \<100,000/µL (\<100 GI/L)
- History or evidence of other chronic liver diseases, such as primary biliary cholangitis, primary sclerosing cholangitis, autoimmune hepatitis or overlap syndrome, Wilson's disease, alpha-1-antitrypsin deficiency, or...
- Hepatitis B positive (defined as positive hepatitis B surface antigen (HBsAg)) or history of chronic HBV infection
- Hepatitis C positive (defined as positive hepatitis C virus (HCV) antibody and a positive HCV ribonucleic acid (RNA))
- Serum aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) \>5x ULN
- Evidence of alcoholic liver disease, or drug-induced liver disease, as defined on the basis of typical exposure and history
- History of liver transplantation or listed for liver transplantation
- History of transjugular intrahepatic portosystemic shunt (TIPS) or other radiological/surgical procedure for portal hypertension treatment
- Further exclusion criteria apply
The study team makes the final eligibility decision.
Where it's taking place
- 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
- Huntington Park, California, United States
- Inglewood, California, United States
- La Mesa, California, United States
- Lancaster, California, United States
- Los Angeles, California, United States
- Montclair, California, United States
- Orange, California, United States
- Oxnard, California, United States
- Poway, California, United States
- Rialto, California, United States
- San Bernardino, California, United States
- San Diego, California, United States
- Colorado Springs, Colorado, United States
+ 334 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 listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to 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 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 and 348 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.