RECRUITING

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Effect of Endoscopic Sleeve Gastroplasty on Patients With Obesity and Concomitant Metabolic Dysfunction-Associated Steatohepatitis (MASH): A Multicenter, Open-label, Randomized Controlled Trial

Quick Facts

Study Start:2025-06-24

Study Completion:2028-06

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06138821

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	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%

Inclusion Criteria

Exclusion 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.

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%

Contacts and Locations

Study Contact

Michele Ryan, MS

CONTACT

6175258266

mryan@bwh.harvard.edu

Principal Investigator

Pichamol Jirapinyo, MD, MPH

PRINCIPAL_INVESTIGATOR

Brigham and Women's Hospital

Study Locations (Sites)

Brigham and Women's Hospital

Boston, Massachusetts, 02115

United States

Collaborators and Investigators

Sponsor: Pichamol Jirapinyo, MD, MPH

Pichamol Jirapinyo, MD, MPH, PRINCIPAL_INVESTIGATOR, Brigham and Women's Hospital

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-06-24

Study Completion Date2028-06

Study Record Updates