Comparing Metabolic Surgery and Incretin-Based Medical Therapies for Advanced Metabolic Dysfunction-Associated Steatohepatitis and Liver Fibrosis in Adults with Obesity

What this Trial Is About

Metabolic dysfunction-associated steatotic liver disease MASLD, previously called non-alcoholic fatty liver disease NAFLD, is a common chronic liver condition linked to obesity, diabetes, and dyslipidemia. This condition ranges from simple fat buildup in the liver to more severe forms like metabolic dysfunction-associated steatohepatitis MASH, which can cause liver injury, advanced fibrosis, cirrhosis, or liver cancer. Patients with MASH also face risks of cardiovascular disease and death. Currently, there is no universally approved medication for MASH, and weight loss remains the main treatment approach. This study is a randomized controlled trial comparing two treatments for adults with obesity and biopsy-confirmed MASH and liver fibrosis. Participants will be randomly assigned to receive either metabolic surgery including Roux-en-Y Gastric Bypass or Sleeve Gastrectomy or medical treatment using incretin-based therapies such as liraglutide, semaglutide, or tirzepatide. The study will follow participants for two years, after which a repeat liver biopsy will assess changes in liver fibrosis and MASH. Participants will undergo a baseline liver biopsy if none is available, followed by treatment with either surgery or medication. Throughout the two-year study, they will be monitored regularly, with assessments including liver biopsies to measure fibrosis improvement or progression, resolution of MASH, weight changes, and quality of life. Safety and treatment adherence will also be tracked to understand the impact of these interventions on liver health and overall well-being.

Fibrosis Lessens After Metabolic Surgery