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

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.

Conditions

ObesityLiver DiseasesLiver FibrosisLiver FatMetabolic Dysfunction-Associated Steatotic Liver DiseaseMetabolic Dysfunction-Associated SteatohepatitisMASLDMASHWeight LossInsulin ResistanceInsulin SensitivityInsulin Sensitivity/ResistanceMetabolic DiseaseDiabetesDiabetes Mellitus, Type 2NASH With FibrosisNon-Alcoholic Fatty Liver DiseaseNon Alcoholic Fatty LiverNon-alcoholic Steatohepatitis
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Related Conditions:

ObesityLiver DiseasesLiver FibrosisLiver FatMetabolic Dysfunction-Associated Steatotic Liver DiseaseMetabolic Dysfunction-Associated SteatohepatitisMASLDMASHWeight LossInsulin ResistanceInsulin SensitivityInsulin Sensitivity/ResistanceMetabolic DiseaseDiabetesDiabetes Mellitus, Type 2NASH With FibrosisNon-Alcoholic Fatty Liver DiseaseNon Alcoholic Fatty LiverNon-alcoholic Steatohepatitis

Study Overview

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Study Details

Study overview

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.

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

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

Condition
Obesity
Intervention / Treatment

-

Contacts and Locations

Boston

Brigham and Women's Hospital, Boston, Massachusetts, United States, 02115

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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%

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Pichamol Jirapinyo, MD, MPH,

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

Study Record Dates

2028-06