About this trial
Metabolic dysfunction-associated steatotic liver disease (MASLD), formerly known as non-alcoholic fatty liver disease (NAFLD), a major global public health concern, is commonly associated with obesity, diabetes, and dyslipidemia. MASLD is currently the most common cause of chronic liver disease affecting about 80% of people with obesity, ranging from simple fat deposits in the liver to Metabolic Dysfunction-Associated Steatohepatitis (MASH), cellular injury, advanced fibrosis, cirrhosis, or hepatocellular carcinoma. Patients with MASH are also at risk for cardiovascular disease and mortality. There is no universally approved medication for MASH. Weight loss remains the cornerstone of MASH treatment.
Patients meeting the inclusion and exclusion criteria and who give informed consent will be enrolled in the trial and undergo the baseline liver biopsy (if none available). Approximately 120 patients with MASH and liver fibrosis (F1-F4 in baseline liver biopsy) will be randomized in a 1:1 ratio to metabolic surgery or medical treatment (incretin-based therapies ± other medical therapies for MASH) and followed for 2 years at which time a repeat liver biopsy will be performed for the assessment of the primary end point.
Eligibility criteria
Qualifiers
Is a candidate for general anesthesia
Is eligible for metabolic surgery (RYGB or SG) based on the ASMBS/IFSO 2022 guidelines
Has insurance coverage for metabolic surgery (the requirements may vary in each country)
Is ≥18 and ≤75 years old at the time of signing the informed consent
Disqualifiers
Hepatitis B as detected by presence of hepatitis B surface antigen (HBsAg)
Hepatitis C as detected by presence of hepatitis C virus (HCV) RNA (in case the screening test for hepatitis C is positive, the confirmative test is decisive)
Autoimmune liver disease as diagnosed by antibodies or compatible liver histology
Primary biliary cirrhosis as defined by the presence of at least 2 criteria (elevated alkaline phosphatase, presence of anti-mitochondrial antibody, and histologic evidence of nonsuppurative destructive cholangitis and destruction of interlobular bile ducts)
Trial design
Treatments tested in this trial
- Metabolic surgery
- Incretin-Based Therapy
Treatment groups
Locations
22Sponsors and collaborators
Ali Aminian
Lead sponsor
The Cleveland Clinic
Sponsor institution
Sobia Laique, MD
Collaborator