NCT06138821 · Pichamol Jirapinyo, MD, MPH
Effect of Endoscopic Sleeve Gastroplasty in Patients With Obesity and MASH: A Randomized Controlled Trial
What this study 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.
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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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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
Exclusion criteria
- 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
- History of genetic or hormonal causes for obesity, such as Prader Willi syndrome
- History of endocrine disorders affecting weight, such as uncontrolled hypothyroidism
- Eating disorders, including night eating syndrome, bulimia, binge eating disorder or compulsive overeating
- Active psychological issues preventing participation in a lifestyle modification program as determined by a psychologist
Where
- Boston, Massachusetts
- Morgantown, West Virginia
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 25, 2026 · Source of record for eligibility and locations