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

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Pichamol Jirapinyo, MD, MPH
Study ID
NCT06138821
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • ESG + lifestyle modification — DEVICE
    Endoscopic sleeve gastroplasty - an endoscopic weight loss procedure where an endoscopic suturing device is utilized to reduce the size of the stomach by 70%.
  • Lifestyle modification — BEHAVIORAL
    Lifestyle modification program consisting of diet and exercise therapy

Study Details

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 Dates

Start date
Jun 24, 2025
Status verified
Nov 2025
Primary completion
Dec 31, 2027
Completion
Jun 30, 2028

Study Design

Enrollment
132 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: ESG + lifestyle modification
    Endoscopic sleeve gastroplasty weight loss procedure with a lifestyle modification program for 12 months.
  • Active Comparator: Lifestyle modification
    Lifestyle modification program for 12 months.

Primary Outcome Measure

MASH resolution without worsening of liver fibrosis at 12 months [ Time Frame: Baseline, 12 months ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Brigham and Women's HospitalBostonMassachusetts02115
Michele B. Ryan, MS
[email protected]
617-525-8266
Pichamol Jirapinyo, MD, MPH (PRINCIPAL_INVESTIGATOR)
West Virginia UniversityMorgantownWest Virginia26506
Soban Researcher
[email protected]
304-293-4946
Shailendra Singh, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Boston, MA

By condition
Type 2 diabetesObesity / overweight
By specialty
EndocrinologyMetabolic healthWeight loss
By research site
Brigham and Women's Hospital· Boston, MAWest Virginia University· Morgantown, WV

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