Last updated 4 days ago
LIVERAGE™: A Study to Test Whether Survodutide Helps People With a Liver Disease Called NASH/MASH Who Have Moderate or Advanced Liver Fibrosis
1800 patients around the world
Available in Argentina
Boehringer Ingelheim
14Research sites
1800Patients around the world
This study is for people with
Steatohepatitis
Metabolic dysfunction-associated steatohepatitis - MASH
Requirements for the patient
From 18 Years
All Gender
Medical requirements
- 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, with at least 1 point in inflammation and ballooning each) and fibrosis stage F2-F3 proven by a biopsy conducted during the screening period or by a historical biopsy conducted within the last 6 months prior to randomisation.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.
- 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 (unless participant is on anticoagulants).OR total serum bilirubin concentration ≥1.5x ULN (participants with a documented history of Gilbert's syndrome can be enrolled if the direct bilirubin is within normal reference range).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 (including hepatic encephalopathy, variceal bleeding, ascites, and spontaneous bacterial peritonitis).Model for end-stage liver disease (MELD) score ≥12 due to liver disease.Treatment with any medication for the indication obesity within 3 months before screening biopsy or historical biopsy time point.History of either chronic or acute pancreatitis or elevation of serum lipase or amylase >2x ULN as measured by the central laboratory at screening.Major surgery (in the opinion of the investigator) performed within 3 months prior to screening or planned during the trial.
Sites
CIPREC Centro de Investigación y Prevención Cardiovascular - CABA
Recruiting
CEDIMBA - DIM Clínica Privada - Buenos Aires
Recruiting
Centro Médico Saavedra
Recruiting
Centro de Investigaciones Metabólicas (CINME) S.A. - CABA, Buenos Aires
Recruiting
IDIM - Sede Centro - CABA
Recruiting
Buenos Aires Mácula S.A.
Recruiting
Hospital El Cruce - Nestor Kirchner
Recruiting
Hospital Universitario Austral - Pilar
Recruiting
Hospital General de Agudos J. M. Ramos Mejía - Buenos Aires, CABA
Recruiting
Hospital Moinhos de Vento - Porto Alegre
Recruiting
StudyLIVERAGE
SponsorBoehringer Ingelheim
Study typeInterventional
Conditions
Metabolic dysfunction-associated steatohepatitis - MASH
Requirements
From 18 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT06632444
