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Procedure

ESG + GLP-1RA for Obesity and Liver Fibrosis

N/A

Waitlist Available

Research Sponsored by Pichamol Jirapinyo, MD, MPH

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age 21-65

History of failure with non-surgical weight-loss methods

Must not have

Subjects who are taking corticosteroids, immunosuppressants, and narcotics

History of foregut or gastrointestinal (GI) surgery (except uncomplicated cholecystectomy or appendectomy)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 1, 3, 6 and 12 months

Awards & highlights

Summary

This trial tests a non-invasive, FDA-approved gastric procedure combined with an FDA-approved weight loss medication to see if it can help people with obesity and liver issues lose weight and improve their liver health.

Who is the study for?

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.

What is being tested?

The 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.

What are the potential side effects?

Potential side effects include gastrointestinal discomfort due to the ESG procedure or reactions related to Semaglutide such as nausea, digestive issues, or low blood sugar levels. The exact side effects will vary by individual.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 21 and 65 years old.

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I have tried losing weight without surgery and it didn't work.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am currently taking corticosteroids, immunosuppressants, or narcotics.

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I have had surgery on my upper digestive tract, not including simple gallbladder or appendix removal.

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I have had stomach or intestine surgery that caused complications like blockage or internal scarring.

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I have had weight loss surgery before.

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I do not have severe inflammation or ulcers in my digestive system.

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I have a condition that could cause bleeding in my upper digestive system.

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I have a history of stomach tumors or genetic conditions that increase cancer risk.

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I have a stomach mass or polyps larger than 1 cm.

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I have a severe swallowing disorder.

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I have a severe blood clotting disorder.

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I have diabetes that requires insulin or my HgbA1C is 9 or higher.

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I have a severe movement disorder in my digestive system.

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I do not have serious heart problems like heart failure, irregular heartbeat, or unstable heart disease.

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I have a serious lung condition that needs steroids.

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I have an autoimmune disorder or a weakened immune system.

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I have been diagnosed with a specific genetic disorder like Prader Willi syndrome.

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I have an eating disorder such as bulimia or binge eating.

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I have a thyroid problem that is not well-controlled and affects my weight.

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I have a blockage or abnormal shape in my throat or esophagus that could make it hard for a doctor to use a scope on me.

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I am on daily medication like high dose aspirin or blood thinners.

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I cannot or will not take proton pump inhibitor medication.

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I have long-term pain in my stomach area.

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I have liver problems or cirrhosis.

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I have had surgery on my esophagus, stomach, or for a hiatal hernia.

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I have a serious health condition that makes endoscopy risky for me.

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I have a large hiatal hernia or severe acid reflux that doesn't get better with treatment.

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I have used a stomach device before this study due to thick stomach walls.

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I do not have severe heart or lung disease, recent heart attacks, uncontrolled high blood pressure, or need NSAIDs regularly.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 1, 3, 6 and 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 1, 3, 6 and 12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 1, 3, 6 and 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

MASH resolution without worsening of liver fibrosis at 12 months

Secondary study objectives

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

Change in eating behaviors at 12 months

Change in insulin resistance at 12 months

+10 more

Trial Design

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Lifestyle modification

2019

Completed Phase 4

~3390

0 / 30Eligibility criteria met

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Who is running the clinical trial?

Pichamol Jirapinyo, MD, MPHLead Sponsor

1 Previous Clinical Trials

500 Total Patients Enrolled

~67 spots leftby Dec 2027

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