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

Recruiting now · Not applicable

Conditions studied: Obesity, Liver Diseases, Liver Fibrosis, Liver Fat, Metabolic Dysfunction-Associated Steatotic Liver Disease, Metabolic Dysfunction-Associated Steatohepatitis, MASLD, MASH, Weight Loss, Insulin Resistance, Insulin Sensitivity, Insulin Sensitivity/Resistance, Metabolic Disease, Diabetes, Diabetes Mellitus, Type 2, NASH With Fibrosis, Non-Alcoholic Fatty Liver Disease, Non Alcoholic Fatty Liver, Non-alcoholic Steatohepatitis

In brief

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.

Key facts

Study ID: NCT06138821
Run by: Pichamol Jirapinyo, MD, MPH
People needed: 132
Starts: 2025-06-24
Expected to finish: 2028-06-01
Last updated by the study team: 2026-06-25

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

Known history of other chronic liver diseases (viral hepatitis, autoimmune hepatitis, drug-induced hepatitis, and genetic)
Treatment with vitamin E (at doses ≥800 IU/day), pioglitazone, obeticholic acid, or resmetirom <90 days before the first study visit
History of foregut or gastrointestinal (GI) surgery (except uncomplicated fundoplication, cholecystectomy or appendectomy)
Prior bariatric surgery
Prior endoscopic sleeve gastroplasty
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
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
Severe gastroesophageal reflux disease (GERD)
A structural abnormality in the esophagus or pharynx, such as a stricture or diverticulum, that could impede passage of the endoscope.
Achalasia or any other severe esophageal motility disorder
Chronic abdominal pain
Gastroparesis or intractable constipation
Hepatic insufficiency or cirrhosis
Severe coagulopathy
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%
Patients on an anti-platelet agent, anticoagulant agent or chronic/routine use of NSAIDs
Patients on corticosteroids, immunosuppressants, or narcotics
Patients on an anti-seizure or anti-arrhythmic medication
Patients who are pregnant or breastfeeding
Excessive alcohol consumption (>20 g per day for women; >30 g per day for men)
Active smoking
History of poorly controlled hypertension, coronary artery disease, congestive heart failure, cardiac arrhythmia
History of respiratory diseases such as chronic obstructive pulmonary disease (COPD) requiring steroids, pneumonia, or cancer
History of autoimmune connective tissue disorder such as lupus, scleroderma or immunocompromised disease
History of active malignancy

Where it is running

Brigham and Women's Hospital — Boston, Massachusetts, United States (enrolling)
West Virginia University — Morgantown, West Virginia, United States (enrolling)

Full record on ClinicalTrials.gov

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