Condition: Metabolic Dysfunction-associated Steatotic Liver Disease (MASLD) · Non-Alcoholic Fatty Liver Disease · Metabolic Dysfunction-Associated Steatohepatitis (MASH) · Sponsor: Ali Aminian
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.
This description comes directly from the study's public registry record.
Awwab F Hammad, MD · +1 216 444 5022 · hammada4@ccf.org
Chytaine Hall · 216-445-3983 · hallc1@ccf.org
Always discuss trial participation with your own doctor first.
| Banner Health Center | Phoenix, Arizona, United States | Not Yet Recruiting |
| Indiana University | Indianapolis, Indiana, United States | Not Yet Recruiting |
| Mayo Clinic | Rochester, Minnesota, United States | Not Yet Recruiting |
| Cleveland Clinic | Cleveland, Ohio, United States | Recruiting |
| Hospital Alemão Oswaldo Cruz | São Paulo, Brazil | Recruiting |
| McGill University | Montreal, Canada | Not Yet Recruiting |
| Turku University Hospital | Turku, Finland | Not Yet Recruiting |
| Sri Aurobindo Institute of Medical Sciences | Indore, India | Not Yet Recruiting |
| The Digestive Health Institute | Mumbai, India | Not Yet Recruiting |
| University College Dublin | Dublin, Ireland | Not Yet Recruiting |
| Università Cattolica del Sacro Cuore | Milan, Italy | Not Yet Recruiting |
| Sapienza Università di Roma | Roma, Italy | Not Yet Recruiting |
+ 10 more locations — full list on the registry record.
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Source record: clinicaltrials.gov/study/NCT06374875