Study of Endoscopic Sleeve Gastroplasty Plus Lifestyle Changes Versus Lifestyle Changes Alone in Adults With Obesity and Metabolic Dysfunction-Associated Steatohepatitis

What this Trial Is About

Metabolic dysfunction-associated steatotic liver disease MASLD is a common chronic liver condition linked with obesity and related complications. This research evaluates the effect of adding endoscopic sleeve gastroplasty ESG, a minimally invasive weight loss procedure, to lifestyle modification compared with lifestyle modification alone in patients with obesity and metabolic dysfunction-associated steatohepatitis MASH. The study aims to understand whether ESG improves liver disease outcomes beyond weight loss alone. Participants will be randomly assigned to one of two groups one receiving ESG plus a lifestyle modification program and the other receiving lifestyle modification alone for 12 months. ESG involves using an FDA-approved endoscopic suturing device to reduce stomach size by 70%, aiming to promote sustained weight loss. Both groups will follow diet and exercise therapy during the study period. During the 12-month study, participants will undergo assessments including liver biopsies, imaging, blood tests, and questionnaires to measure liver health, weight loss, insulin resistance, quality of life, and safety parameters. Researchers will monitor changes in liver fibrosis and fat content, metabolic markers, and physical function. The primary outcome is MASH resolution without worsening liver fibrosis at 12 months, with ongoing safety and efficacy evaluations throughout the study.

Effect of Endoscopic Sleeve Gastroplasty in Patients With Obesity and MASH: A Randomized Controlled Trial