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Procedure

ESG + GLP-1RA for Obesity and Liver Fibrosis

Phase 4

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 1, 3, 6, 9 and 12 months

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 1, 3, 6, 9 and 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 1, 3, 6, 9 and 12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 1, 3, 6, 9 and 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in Liver Fibrosis measurement at 12 months compared to baseline

Secondary outcome measures

Change in %TBWL compared to baseline for ESG + GLP-1RA compared to ESG

Change in %TBWL compared to baseline for ESG + GLP-1RA compared to GLP-1RA

Change in Liver stiffness at 12 months compared to baseline

+4 more

Trial Design

3Treatment groups

Active Control

Group I: ESG OnlyActive Control1 Intervention

Endoscopic sleeve gastroplasty suturing procedure.

Group II: GLP-1RA OnlyActive Control1 Intervention

Semaglutide prescription (2.4mg injection per week) regimen for 12 months.

Group III: ESG + GLP-1RA treatmentActive Control2 Interventions

Endoscopic sleeve gastroplasty suturing procedure with a prescription regimen of semaglutide (2.4 mg injection per week) for 12 months.

0 / 2Eligibility 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is ESG + GLP-1RA administered with minimal risks for patients?

"Our internal analysis at Power has determined that combination of ESG and GLP-1RA treatment is safe, awarding it a score of 3. This conclusion was drawn from Phase 4 trial data which indicates the therapy has been approved for use."

Answered by AI

Am I eligible to join the investigation of this trial?

"To be considered for entry, trial candidates should have obesity and fall within the 21 - 65 year old age range. There are currently 30 openings available for this study."

Answered by AI

Does this research involve individuals aged 55 and older?

"This trial seeks out participants aged between 21 and 65 years old."

Answered by AI

Are there still openings available for this experimental research?

"According to clinicaltrials.gov, this experiment is no longer actively recruiting participants. The trial was initially shared on July 1st 2024 and the last update was made November 14th 2023. Although not currently searching for volunteers, there are 3750 other clinical studies in need of research subjects at present."

Answered by AI

Recent research and studies

Clinical Gastroenterology and HepatologyJournal

Endoscopic Sleeve Gastroplasty Alters Gastric Physiology and Induces Loss of Body Weight in Obese Individuals

Abu Dayyeh, Barham K., Andres Acosta, Michael Camilleri, Manpreet S. Mundi, Elizabeth Rajan, Mark D. Topazian, and Christopher J. Gostout. 2017. “Endoscopic Sleeve Gastroplasty Alters Gastric Physiology and Induces Loss of Body Weight in Obese Individuals”. Clinical Gastroenterology and Hepatology. Elsevier BV. doi:10.1016/j.cgh.2015.12.030.

clinicaltrials.govStudy

ESG vs GLP-1RA vs ESG + GLP-1RA in Patients With Obesity, NAFLD and Advanced Fibrosis: A Randomized Controlled Trial

Pichamol Jirapinyo, MD, MPH 2024. "ESG vs GLP-1RA vs ESG + GLP-1RA in Patients With Obesity, NAFLD and Advanced Fibrosis: A Randomized Controlled Trial". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06138821.

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