About this trial
Metabolic dysfunction-associated steatotic liver disease (MASLD) is the most common chronic liver disease globally. While weight loss through lifestyle modification is the standard treatment, most patients regain weight limiting ultimate improvement in liver disease. On the other end of the spectrum, bariatric surgery has shown promise in the treatment of MASLD/metabolic dysfunction-associated steatohepatitis (MASH) due to its efficacy in inducing weight loss. Nevertheless, its adoption has been hindered by the perceived invasiveness of surgery.
Over the past decade, endoscopic sleeve gastroplasty (ESG) has gained recognition as a promising minimally-invasive approach to weight loss. The procedure involves utilizing a Food and Drug Administration (FDA)-authorized endoscopic suturing device to reduce the gastric volume by 70%. Studies reveal that ESG is associated with approximately 18.2% weight loss at one year after the procedure, with sustained results for at least 10 years. Nevertheless, the effect of ESG on MASH remains unknown.
In this study, the investigators will compare ESG + lifestyle modification versus lifestyle modification alone in treating histologic MASH. The study will randomize patients to one of two different treatment options: ESG + lifestyle modification or lifestyle modification alone.
Eligibility criteria
Qualifiers
Age ≥ 18 (male or female)
BMI ≥30 kg/m2 or ≥27 kg/m2 with at least one obesity-related comorbidity
Self-reported stable weight (no weight change >5%) for 6 months prior to the first study visit
Willingness to follow protocol requirements, including signed informed consent, routine follow-up schedule, completing laboratory/imaging/additional tests, and completing diet counseling
Disqualifiers
Known history of other chronic liver diseases (viral hepatitis, autoimmune hepatitis, drug-induced hepatitis, and genetic)
Treatment with vitamin E (at doses ≥800 IU/day), pioglitazone, obeticholic acid, or resmetirom <90 days before the first study visit
History of foregut or gastrointestinal (GI) surgery (except uncomplicated fundoplication, cholecystectomy or appendectomy)
Prior bariatric surgery
Trial design
Treatments tested in this trial
- ESG + lifestyle modification
- Lifestyle modification
Treatment groups
Sponsors and collaborators
Pichamol Jirapinyo, MD, MPH
Lead sponsor
Brigham and Women's Hospital
Sponsor institution
Boston Scientific Corporation
Collaborator
Cook Group Incorporated
Collaborator