Endoscopic sleeve gastroplasty for people with obesity and MASH

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized controlled trial will compare endoscopic sleeve gastroplasty (ESG) combined with lifestyle modification to lifestyle modification alone in adults with obesity and metabolic dysfunction-associated steatohepatitis (MASH). ESG uses an FDA-authorized endoscopic suturing device to reduce gastric volume and promote weight loss, performed by trained endoscopists at participating centers. Participants must have BMI ≥30, stable recent weight, agree not to start new anti-obesity medications for 12 months, and complete follow-up visits and counseling. Outcomes will include weight loss and measures of liver fat, inflammation, and fibrosis over the study period at sites in Boston and West Virginia.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Age ≥ 18 (male or female)
2. BMI ≥30 kg/m2 or ≥27 kg/m2 with at least one obesity-related comorbidity
3. Self-reported stable weight (no weight change \>5%) for 6 months prior to the first study visit
4. Willingness to follow protocol requirements, including signed informed consent, routine follow-up schedule, completing laboratory/imaging/additional tests, and completing diet counseling
5. Willingness to NOT start a new anti-obesity medication for the following 12 months
6. Residing within a reasonable distance from the investigator's office and able to travel to the investigator to complete routine follow-up visits
7. Ability to give informed consent
8. Women of childbearing potential (i.e., not post-menopausal, nor surgically sterilized) must agree to use adequate birth control methods

Exclusion Criteria:

1. Known history of other chronic liver diseases (viral hepatitis, autoimmune hepatitis, drug-induced hepatitis, and genetic)
2. Treatment with vitamin E (at doses ≥800 IU/day), pioglitazone, obeticholic acid, or resmetirom \<90 days before the first study visit
3. History of foregut or gastrointestinal (GI) surgery (except uncomplicated fundoplication, cholecystectomy or appendectomy)
4. Prior bariatric surgery
5. Prior endoscopic sleeve gastroplasty
6. 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
7. 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
8. Severe gastroesophageal reflux disease (GERD)
9. A structural abnormality in the esophagus or pharynx, such as a stricture or diverticulum, that could impede passage of the endoscope.
10. Achalasia or any other severe esophageal motility disorder
11. Chronic abdominal pain
12. Gastroparesis or intractable constipation
13. Hepatic insufficiency or cirrhosis
14. Severe coagulopathy
15. 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%
16. Patients on an anti-platelet agent, anticoagulant agent or chronic/routine use of NSAIDs
17. Patients on corticosteroids, immunosuppressants, or narcotics
18. Patients on an anti-seizure or anti-arrhythmic medication
19. Patients who are pregnant or breastfeeding
20. Excessive alcohol consumption (\>20 g per day for women; \>30 g per day for men)
21. Active smoking
22. History of poorly controlled hypertension, coronary artery disease, congestive heart failure, cardiac arrhythmia
23. History of respiratory diseases such as chronic obstructive pulmonary disease (COPD) requiring steroids, pneumonia, or cancer
24. History of autoimmune connective tissue disorder such as lupus, scleroderma or immunocompromised disease
25. History of active malignancy
26. History of genetic or hormonal causes for obesity, such as Prader Willi syndrome
27. History of endocrine disorders affecting weight, such as uncontrolled hypothyroidism
28. Eating disorders, including night eating syndrome, bulimia, binge eating disorder or compulsive overeating
29. Active psychological issues preventing participation in a lifestyle modification program as determined by a psychologist

Where it's running

• Brigham and Women's Hospital
  Boston, Massachusetts, United States Recruiting
• West Virginia University
  Morgantown, West Virginia, United States Recruiting

Study contacts

• Principal investigator: Pichamol Jirapinyo, MD, MPH — Brigham and Women's Hospital
• Study coordinator: Delaney Clinical Research Coordinator
• Email: dmanahan@bwh.harvard.edu
• Phone: 617-732-5174

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.