ESG + GLP-1RA for Obesity and Liver Fibrosis

Recruiting in Palo Alto (17 mi)

Overseen byPichamol Jirapinyo, MD, MPH

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Pichamol Jirapinyo, MD, MPH

No Placebo Group

Trial Summary

What is the purpose of 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.

Research Team

Pichamol Jirapinyo, MD, MPH

Principal Investigator

Brigham and Women's Hospital

Eligibility Criteria

This trial is for adults aged 21-65 with obesity (BMI between 30 and 40), liver fibrosis, and NAFLD who have tried non-surgical weight-loss methods without success. Participants must be willing to follow a strict diet, attend regular follow-ups, complete tests, and live near the investigator's office. Women of childbearing age should agree to use birth control.

Inclusion Criteria

Your body mass index (BMI) is between 30 and 40.

I am between 21 and 65 years old.

I live close enough to the doctor's office to attend all my appointments.

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Exclusion Criteria

I am currently taking corticosteroids, immunosuppressants, or narcotics.

Patients unwilling to participate in an established medically-supervised diet and behavior modification program, with routine medical follow-up

Patients who are pregnant or breast-feeding

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Treatment Details

Interventions

Endoscopic Sleeve Gastroplasty (ESG) (Procedure)
GLP1-RA (Drug)

Trial OverviewThe study compares three treatments: ESG only, GLP-1RA (Semaglutide) only, or both combined in patients with obesity and advanced liver issues due to NAFLD. It aims to see if combining these FDA-approved treatments improves weight loss and liver health more than each treatment alone.

Participant Groups

2Treatment groups

Experimental Treatment

Active Control

Group I: ESG + lifestyle modificationExperimental Treatment2 Interventions

Endoscopic sleeve gastroplasty weight loss procedure with a lifestyle modification program for 12 months.

Group II: Lifestyle modificationActive Control1 Intervention

Lifestyle modification program for 12 months.