Actively Recruiting
Effect of Endoscopic Sleeve Gastroplasty in Patients With Obesity and MASH: A Randomized Controlled Trial
Led by Pichamol Jirapinyo, MD, MPH · Updated on 2025-12-02
132
Participants Needed
2
Research Sites
153 weeks
Total Duration
On this page
Sponsors
P
Pichamol Jirapinyo, MD, MPH
Lead Sponsor
B
Boston Scientific Corporation
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Effect of Endoscopic Sleeve Gastroplasty in Patients With Obesity and MASH: A Randomized Controlled Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Body mass index (BMI) of 30 kg/m2 or higher
- Stable weight with no change greater than 5% for 6 months prior to first study visit
- Willingness to follow study requirements including informed consent, follow-up schedule, and tests
- Willingness not to start new anti-obesity medications for 12 months
- Residence within reasonable travel distance to study site for follow-up visits
- Ability to give informed consent
- Women of childbearing potential must agree to use effective birth control methods
You will not qualify if you...
- History of other chronic liver diseases such as viral hepatitis, autoimmune hepatitis, drug-induced hepatitis, or genetic liver diseases
- Use of vitamin E (≥800 IU/day), pioglitazone, obeticholic acid, or resmetirom within 90 days before first study visit
- History of foregut or gastrointestinal surgery (except uncomplicated fundoplication, cholecystectomy, or appendectomy)
- Prior bariatric surgery or prior endoscopic sleeve gastroplasty
- Inflammatory gastrointestinal diseases including severe esophagitis, Barrett's esophagus with dysplasia, gastric or duodenal ulcers, cancer, or Crohn's disease
- Conditions causing potential upper gastrointestinal bleeding such as varices or congenital anomalies
- Severe gastroesophageal reflux disease (GERD)
- Structural abnormalities in esophagus or pharynx that impede endoscope passage
- Severe esophageal motility disorders such as achalasia
- Chronic abdominal pain, gastroparesis, or intractable constipation
- Hepatic insufficiency or cirrhosis
- Severe blood clotting disorders
- Insulin-dependent diabetes or likely need for insulin treatment within 12 months or hemoglobin A1C ≥10%
- Use of anti-platelet, anticoagulant, corticosteroids, immunosuppressants, narcotics, anti-seizure, or anti-arrhythmic medications
- Pregnancy or breastfeeding
- Excessive alcohol use (more than 20 g/day for women, 30 g/day for men)
- Active smoking
- History of poorly controlled hypertension, coronary artery disease, heart failure, or arrhythmia
- History of respiratory diseases requiring steroids, pneumonia, or cancer
- History of autoimmune connective tissue disorders or immunocompromised states
- History of active cancer
- Genetic or hormonal causes for obesity such as Prader Willi syndrome
- Endocrine disorders affecting weight such as uncontrolled hypothyroidism
- Eating disorders including night eating syndrome, bulimia, binge eating, or compulsive overeating
- Active psychological issues preventing participation in lifestyle modification program as determined by a psychologist
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Actively Recruiting
2
West Virginia University
Morgantown, West Virginia, United States, 26506
Actively Recruiting
Research Team
M
Michele Research Manager, MS
CONTACT
S
Samantha Clinical Research Coordinator
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here