Endoscopic Sleeve Gastroplasty Versus GLP-1 Analogue for Class 1 and 2 Obesity Study

Study Overview
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Brief Summary
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The aim of this study is to compare the 1-year total body weight loss outcomes for Class 1 and Class 2 Obesity patients who have undergone endoscopic sleeve gastroplasty (ESG) in contrast to medical treatment with glucagon-like peptide-1 (GLP-1) analogues.

Detailed Description
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Endoscopic sleeve gastroplasty (ESG) was developed with the aim of emulating the successful outcomes observed with sleeve gastrectomy, while obviating the need to permanently remove a large portion of the stomach. The recent MERIT trial reported that the estimated total body weight loss after ESG at 1-year was 13.6%, demonstrating superiority over lifestyle modifications alone. Glucagon-like peptide-1 (GLP-1) analogues such as liraglutide or semaglutide are currently approved for the treatment of obesity and type 2 diabetes mellitus. Evidence supports the use of these medications in weight loss. The total body weight loss from GLP-1 analogues reportedly range between 7.8-13.8%. As such, for patients with type 1 or 2 obesity who may not be candidates for bariatric surgery, the reported total body weight loss attainable by ESG and GLP-1 analogues appear comparable. In this study, patients eligible and consented for ESG will be retrospectively matched against a group of patients who were previously placed on GLP-1 analogue treatment for class 1 and 2 obesity. The primary outcome of the study will be total body weight loss at 1-year. We will also examine the short-term weight loss outcomes, metabolic outcomes, as well as healthcare costs between the 2 groups. Our hypothesis is that ESG will be non-inferior to GLP-1 analogues in weight loss and metabolic outcomes, with reduced healthcare costs, given the avoidance of repeated dosing.

Official Title
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Endoscopic Sleeve Gastroplasty Versus GLP-1 Analogue for Class 1 and 2 Obesity Study (EGG Study)

Conditions
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Obesity

Intervention / Treatment
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* Procedure: Endoscopic sleeve gastroplasty


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with classes 1 (BMI 27.5 to 34.9) and 2 (BMI 35 to 39.9) obesity in accordance with the World Health Organisation recommendations but modified to the interventional thresholds recommended for Asian populations Exclusion Criteria: Patients with class 3 obesity and above (BMI > 40.0) Patients with contraindications to GLP-1 analogues Patients with contraindications to endoscopic sleeve gastroplasty Patients with previous bariatric or upper gastrointestinal surgery

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Endoscopic Sleeve Gastroplasty Arm<br>Prospective cohort of patients with classes 1 and 2 obesity that had consented to undergo endoscopic sleeve gastroplasty. | Procedure: Endoscopic sleeve gastroplasty<br>* Endoscopic sleeve gastroplasty<br>|
| No Intervention: Retrospective cohort<br>Retrospective cohort of patients with classes 1 and 2 obesity who did not undergo endoscopic sleeve gastroplasty and had been put on GLP-1 analogues | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total body weight loss | Percentage total body weight loss | 1-year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Short-term weight loss | Percentage total body weight loss | 3-months | 
| Short-term weight loss | Percentage total body weight loss | 6-months | 
| Short-term weight loss | Percentage total body weight loss | 9-months | 
| Healthcare costs | Patient costs associated with procedure, hospital stay, outpatient visits and pharmacological treatment | 1-year | 
| Metabolic outcomes | HbA1c values | 3-months, 6-months, 9-months, 12-months |