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

Launched by PICHAMOL JIRAPINYO, MD, MPH · Nov 14, 2023

Keywords

ClinConnect Summary

This clinical trial is studying the effects of a procedure called endoscopic sleeve gastroplasty (ESG) in patients with obesity and a liver condition known as metabolic dysfunction-associated steatotic liver disease (MASH). MASH is a common chronic liver disease that can worsen with obesity, and while losing weight is important for improving liver health, many people struggle to maintain their weight loss. The trial aims to compare the combination of ESG and lifestyle changes, like diet and exercise, to lifestyle changes alone to see which approach better helps improve liver health and promotes weight loss.

To participate in this study, you need to be at least 18 years old and have obesity (with a body mass index between 30 and 50) along with a diagnosis of MASH that isn’t too severe. Participants will be randomly assigned to either receive ESG plus lifestyle support or just lifestyle support. It’s important to note that this trial is not yet recruiting participants, and there are specific eligibility requirements, such as not having severe liver damage (cirrhosis) or certain other health conditions. If you qualify and choose to participate, you can expect regular check-ins to monitor your progress and health throughout the study.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. 18 years or older
• • 2. Obesity with a body mass index of 30-50 kg/m2
• • 3. A diagnosis of MASH with stage 1 (F1), 2 (F2), or 3 (F3) fibrosis (on a scale of 0 \[no fibrosis\] to 4 \[cirrhosis\]). MASH is defined as the nonalcoholic fatty liver disease activity score (NAS) of 4 or higher, with a score of 1 or higher for each subcomponent: steatosis, hepatocyte ballooning and lobular inflammation). Grading and staging of biopsies for the purposes of enrollment are done by a liver pathologist at the site of enrollment.
• Exclusion Criteria:
• • 1. cirrhosis
• • 2. excessive alcohol consumption (\>20 g per day for women; \>30 g per day for men)
• • 3. active smoking
• • 4. active malignancy
• • 5. being on an anticoagulant or anti-platelet medication
• • 6. being on a glucagon-like peptide-1 receptor agonist (GLP-1RA) or sodium-glucose cotransporter-2 (SGLT2) inhibitor of any dose
• • 7. being initiated on an anti-obesity medication within 6 months prior to study enrollment or 12 months after study enrollment
• • 8. history of bariatric surgery or bariatric endoscopy
• • 9. changes in weight by greater than 5% within 6 months of study enrollment
• • 10. hemoglobin A1c (HbA1c) ≥10%