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

ConditionsObesityLiver 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
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorPichamol Jirapinyo, MD, MPH

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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

Treatment groups

132 Participants
are divided into 2 treatment groups
Group A: ESG + lifestyle modificationExperimental treatment 2 interventions
Group B: Lifestyle modificationActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

MASH resolution without worsening of liver fibrosis at 12 months

Comparison of endoscopic ultrasound (EUS)-guided liver biopsy results to assess MASH resolution at 12 months compared to baseline in the ESG + lifestyle modification (LM) group compared to LM alone group.

Time frame
Baseline, 12 months

Secondary outcomes

1

An improvement of liver fibrosis by at least one stage without worsening of MASH at 12 months

Comparison of endoscopic ultrasound (EUS)-guided liver biopsy results to assess an improvement of liver fibrosis at 12 months compared to baseline in the ESG + lifestyle modification (LM) group compared to LM alone group.

Time frame
Baseline, 12 months
2

Change in liver stiffness on MRE at 12 months

Comparison of liver stiffness measurement on magnetic resonance elastography (MRE) at 12 months compared to baseline in the ESG + lifestyle modification (LM) group compared to LM alone group.

Time frame
Baseline, 12 months
3

Change in liver stiffness on VCTE at 12 months

Comparison of liver stiffness measurement on vibration-controlled transient elastography (VCTE) at 12 months compared to baseline in the ESG + lifestyle modification (LM) group compared to LM alone group.

Time frame
Baseline, 12 months
4

Change in liver fibrosis using NFS at 12 months

Comparison of NAFLD fibrosis score (NFS) at 12 months compared to baseline in the ESG + lifestyle modification (LM) group compared to LM alone group.

Time frame
Baseline, 12 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Pichamol Jirapinyo, MD, MPH

Lead sponsor

Brigham and Women's Hospital

Sponsor institution

Boston Scientific Corporation

Collaborator

Cook Group Incorporated

Collaborator

Source ClinicalTrials.gov
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