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

Prior treatment

• Treatment with vitamin E (at doses ≥800 IU/day), pioglitazone, obeticholic acid, or resmetirom \<90 days before the first study visit
• Prior bariatric surgery
• Prior endoscopic sleeve gastroplasty
• Patients on corticosteroids, immunosuppressants, or narcotics

Other illness

• Known history of other chronic liver diseases (viral hepatitis, autoimmune hepatitis, drug-induced hepatitis, and genetic)
• History of foregut or gastrointestinal (GI) surgery (except uncomplicated fundoplication, cholecystectomy or appendectomy)
• Any inflammatory disease of the GI tract, including severe (LA Grade C or D) esophagitis, Barrett's esophagus with dysplasia, gastric ulceration, duodenal ulceration, cancer or specific inflammation such as Crohn's disease
• Potential upper gastrointestinal bleeding conditions such as esophageal or gastric varices, congenital or acquired intestinal telangiectasis, or other congenital anomalies of the gastrointestinal tract such as atresias or stenoses
• Severe gastroesophageal reflux disease (GERD)
• Achalasia or any other severe esophageal motility disorder
• Hepatic insufficiency or cirrhosis
• Insulin-dependent diabetes (either type 1 or type 2) or a significant likelihood of requiring insulin treatment in the following 12 months or HgbA1C ≥ 12%
• Patients on an anti-seizure or anti-arrhythmic medication
• History of poorly controlled hypertension, coronary artery disease, congestive heart failure, cardiac arrhythmia
• History of respiratory diseases such as chronic obstructive pulmonary disease (COPD) requiring steroids, pneumonia, or cancer
• History of autoimmune connective tissue disorder such as lupus, scleroderma or immunocompromised disease
• History of active malignancy
• History of genetic or hormonal causes for obesity, such as Prader Willi syndrome
• History of endocrine disorders affecting weight, such as uncontrolled hypothyroidism
• Eating disorders, including night eating syndrome, bulimia, binge eating disorder or compulsive overeating

Lab values

• Patients on an anti-platelet agent, anticoagulant agent or chronic/routine use of NSAIDs

Other

• A structural abnormality in the esophagus or pharynx, such as a stricture or diverticulum, that could impede passage of the endoscope.
• Chronic abdominal pain
• Gastroparesis or intractable constipation
• Severe coagulopathy
• Patients who are pregnant or breastfeeding
• Excessive alcohol consumption (\>20 g per day for women; \>30 g per day for men)
• Active smoking
• Active psychological issues preventing participation in a lifestyle modification program as determined by a psychologist

• 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
• Willingness to NOT start a new anti-obesity medication for the following 12 months
• Residing within a reasonable distance from the investigator's office and able to travel to the investigator to complete routine follow-up visits
• Ability to give informed consent
• Women of childbearing potential (i.e., not post-menopausal, nor surgically sterilized) must agree to use adequate birth control methods