Endoscopic sleeve gastroplasty for people with obesity and MASH
Effect of Endoscopic Sleeve Gastroplasty on Patients With Obesity and Concomitant Metabolic Dysfunction-Associated Steatohepatitis (MASH): A Multicenter, Open-label, Randomized Controlled Trial
This study will test whether endoscopic sleeve gastroplasty plus lifestyle changes helps adults with obesity and MASH lose weight and improve liver health compared with lifestyle changes alone.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 132 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Brigham and Women's Hospital Academic / other |
| Locations | 2 sites (Boston, Massachusetts and 1 other locations) |
| Trial ID | NCT06138821 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults age 18 or older with obesity (BMI ≥30) and MASH who have had stable weight recently, can attend follow-up visits, and agree not to start new anti-obesity medications are the ideal candidates.
Not a fit: People with other chronic liver diseases, those taking excluded liver medications, those unwilling to follow the protocol or travel for visits, or those who start new anti-obesity drugs may not gain benefit from this trial.
Why it matters
Potential benefit: If successful, ESG could provide a less-invasive option to produce sustained weight loss and improve liver inflammation and fibrosis in patients with MASH.
How similar studies have performed: Prior studies show ESG produces substantial weight loss (about 18% total weight loss at one year with durable results), and bariatric surgery has improved MASH, but the direct effects of ESG on MASH and fibrosis are less well established and are being tested here.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Age ≥ 18 (male or female) 2. BMI ≥30 kg/m2 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 ≥ 10% 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 this trial is running
Boston, Massachusetts and 1 other locations
- 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: Michele Research Manager, MS
- Email: mryan@bwh.harvard.edu
- Phone: 6175258266
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.