ESG + GLP-1RA for Obesity and Liver Fibrosis

Recruiting at 1 trial location

Overseen By Samantha Clinical Research Coordinator

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Pichamol Jirapinyo, MD, MPH

Must not be taking: Anticoagulants, GLP-1RAs, SGLT2 inhibitors

Disqualifiers: Cirrhosis, Alcohol, Smoking, Malignancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 13

Duration: 12 months

132 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a minimally invasive weight loss procedure, endoscopic sleeve gastroplasty (ESG), combined with lifestyle changes, can improve liver health in people with metabolic dysfunction-associated steatohepatitis (MASH), a type of fatty liver disease. Participants will divide into two groups: one will receive the ESG procedure plus lifestyle changes, while the other will follow lifestyle changes alone. The goal is to determine if adding ESG reduces liver damage more effectively than lifestyle changes alone. This trial may suit individuals with obesity (BMI 30-50) diagnosed with MASH who have not undergone bariatric surgery or used certain weight loss medications recently.

As an unphased trial, this study provides a unique opportunity to contribute to understanding how ESG can benefit liver health, potentially improving treatment options for others with MASH.

Will I have to stop taking my current medications?

If you are currently taking an anticoagulant, anti-platelet medication, GLP-1RA, or SGLT2 inhibitor, you will need to stop these medications to participate in the trial. The protocol does not specify about other medications, so it's best to discuss with the trial team.

What prior data suggests that endoscopic sleeve gastroplasty is safe for weight loss?

Research has shown that Endoscopic Sleeve Gastroplasty (ESG) is generally safe. Studies indicate that serious side effects occur in about 1.25% of cases, meaning only a few people experience major issues after the procedure. Most patients lose a significant amount of weight—around 15.66% of their total body weight in the first year. The procedure uses a device to make the stomach smaller, making it less invasive than traditional surgery.

Although there is no specific mention of safety concerns related to the liver condition being studied, ESG is known to aid in weight loss, which benefits liver health. Overall, ESG is considered a well-tolerated option for losing weight. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about the combination of Endoscopic Sleeve Gastroplasty (ESG) and GLP-1RA for obesity and liver fibrosis because it offers a unique approach that targets both weight loss and liver health. Unlike traditional treatments that often rely on surgical interventions or solely lifestyle changes, ESG is a minimally invasive procedure that reduces stomach size, potentially leading to significant weight loss. Additionally, the use of GLP-1 receptor agonists (GLP-1RA) complements this by enhancing satiety and improving metabolic health. This combination not only addresses weight management but also has potential benefits for liver fibrosis, setting it apart from existing options.

What evidence suggests that this trial's treatments could be effective for obesity and liver fibrosis?

Research has shown that Endoscopic Sleeve Gastroplasty (ESG), which participants in this trial may receive, effectively promotes weight loss, with individuals losing about 18.2% of their body weight after one year. This weight loss can persist for at least 10 years. Some studies suggest ESG may also help with liver-related metabolic issues, but more research is needed to understand its effects on MASH, a specific liver disease. ESG is less invasive than surgery, making it a suitable option for those who want to avoid more complex procedures. While ESG appears promising, its direct impact on MASH remains under study. ^{1 2 3 4 6}

Who Is on the Research Team?

Pichamol Jirapinyo, MD, MPH

Principal Investigator

Brigham and Women's Hospital

Are You a Good Fit for This Trial?

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.

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo endoscopic sleeve gastroplasty (ESG) and lifestyle modification or lifestyle modification alone for 12 months

12 months

Regular visits throughout the 12 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

Visits at 1, 3, 6, 9, and 12 months

What Are the Treatments Tested in This Trial?

Interventions

• Endoscopic Sleeve Gastroplasty (ESG)
• GLP1-RA

Trial Overview

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.

How Is the Trial Designed?

Group I: ESG + lifestyle modification Experimental Treatment 2 Interventions

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

Group II: Lifestyle modification Active Control 1 Intervention

Lifestyle modification program for 12 months.

Endoscopic Sleeve Gastroplasty (ESG) is already approved in United States for the following indications:

Approved in United States as Endoscopic Sleeve Gastroplasty (ESG) for:

• Obesity in patients with a body mass index (BMI) 30-50 kg/m2

Who Is Running the Clinical Trial?

Pichamol Jirapinyo, MD, MPH

Lead Sponsor

Trials

2

Recruited

600+

Boston Scientific Corporation

Industry Sponsor

Trials

758

Recruited

867,000+

Michael F. Mahoney

Boston Scientific Corporation

Chief Executive Officer since 2016

MBA from Wake Forest University, BBA in Finance from the University of Iowa

Kenneth Stein

Boston Scientific Corporation

Chief Medical Officer since 2020

MD from Harvard Medical School, MMSc in Clinical Investigation from Harvard-MIT Division of Health Sciences and Technology

Cook Group Incorporated

Industry Sponsor

Trials

92

Recruited

15,500+

Carl Cook

Cook Group Incorporated

Chief Executive Officer since 2011

Bachelor's degree in Engineering from Purdue University, MBA from the University of Iowa

Dr. John A. Kaufman

Cook Group Incorporated

Chief Medical Officer since 2023

MD

Published Research Related to This Trial

Endoscopic sleeve gastroplasty (ESG) is a safe and effective procedure for obesity, showing significant weight loss results with a mean BMI reduction of 9.3 kg/m2 at 6 months and sustained excess body weight loss of 35.6% at 6 months post-procedure.

The study involved 91 patients across six centers, demonstrating that ESG can be successfully implemented in new endobariatric programs, with a mean procedure duration of 85.1 minutes and a short hospital stay of about 27 hours.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and efficacy of endoscopic sleeve gastroplasty for obesity management in new bariatric endoscopy programs: a multicenter international study. Sarkar, A., Tawadros, A., Andalib, I., et al.[2022]

Endoscopic sleeve gastroplasty (ESG) was successfully performed on 10 patients in a Norwegian center, demonstrating its feasibility as a less invasive weight loss procedure compared to traditional bariatric surgery.

The procedure resulted in a mean total body weight loss of 12.2% at 26 weeks and 9.1% at 52 weeks, with acceptable safety, although one patient experienced a minor complication that was managed without further issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A pilot study of implementation of endoscopic sleeve gastroplasty (ESG) in Norway. Tønnesen, CJ., Hjelmesæth, J., Aabakken, L., et al.[2023]

Endoscopic sleeve gastroplasty (ESG) resulted in a lower percentage of total body weight loss (17.57%) compared to laparoscopic sleeve gastrectomy (LSG) (29.28%) at 12 months, but it was associated with significantly lower morbidity and shorter hospital stays.

ESG demonstrated a mean length of stay of just 0.34 days, much shorter than LSG (3.09 days) and laparoscopic adjustable gastric banding (LAGB) (1.66 days), making it a safer and more convenient option for select patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Endoscopic Sleeve Gastroplasty, Laparoscopic Sleeve Gastrectomy, and Laparoscopic Band for Weight Loss: How Do They Compare? Novikov, AA., Afaneh, C., Saumoy, M., et al.[2019]

Endoscopic sleeve gastroplasty (ESG) is an effective and safe procedure for weight loss, achieving an average total weight loss of 16.3% at 12 months, which is significantly greater than that from intragastric balloon insertion and high-intensity diet therapy.

ESG has a lower rate of adverse events (5.2%) compared to laparoscopic sleeve gastrectomy (16.9%) and intragastric balloon placement (17%), making it a safer option for obesity treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect and safety of endoscopic sleeve gastroplasty for treating obesity - a systematic review. Due-Petersson, R., Poulsen, IM., Hedbäck, N., et al.[2021]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12566468/

Outcomes of Endoscopic Sleeve Gastroplasty

ESG found to be an effective treatment for obesity and non-alcoholic fatty liver disease. Brunaldi et al. (2022) [39], Retrospective, 100, BMI ...

2.

sciencedirect.com

sciencedirect.com/science/article/pii/S2949708625000408

Safety and efficacy of endoscopic sleeve gastroplasty after ...

Median follow-up after ESG was 18.8 months (IQR, 8.2-19.8 months). Median total body weight loss was 27.2% (IQR, 8.0%-30.0%) at the end of follow-up. Weight ...

3.

journals.lww.com

journals.lww.com/ajg/fulltext/2024/10001/s2063_ten_year_outcomes_of_endoscopic_sleeve.2064.aspx

S2063 Ten-Year Outcomes of Endoscopic Sleeve ...

Our results suggest that ESG is effective and safe for treatment of obesity, with durable long- term results for at least up to 10 years after the procedure.

4.

cghjournal.org

cghjournal.org/article/S1542-3565(24)01080-2/fulltext

Endoscopic Sleeve Gastroplasty Plus Lifestyle Intervention ...

Endoscopic sleeve gastroplasty (ESG) has been shown to be an effective technique to promote weight loss and consequeBntly metabolic dysfunction ...

5.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/39234763/

Endoscopic sleeve gastroplasty for metabolic dysfunction- ...

ESG has shown promising results in treating MASLD evaluated by noninvasive tests, but current data is limited to small, nonrandomized studies.

6.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06339320

Endoscopic Sleeve Gastroplasty (ESG) for the Treatment of ...

This study aims to perform ESG for patients with obesity, defined as a BMI 30-50 kg/m2. Additionally, data collection of relevant weight-related and metabolic ...