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

Sengkang General Hospital

Status: Not yet enrolling

Conditions: Obesity

Treatments: Procedure: Endoscopic sleeve gastroplasty

Study type: Interventional

Funder types: Other

Identifiers

NCT05569304

CIRB Ref: 2022/2469

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 66 estimated patients

Sex: All

Ages: 21 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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66 participants in 2 patient groups

Endoscopic Sleeve Gastroplasty Arm

Experimental group

Description:

Prospective cohort of patients with classes 1 and 2 obesity that had consented to undergo endoscopic sleeve gastroplasty.

Treatment:

Procedure: Endoscopic sleeve gastroplasty

Retrospective cohort

No Intervention group

Description:

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