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

Obesity Clinical Trial

— EGG  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05569304
• Other study ID #: CIRB Ref: 2022/2469
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 7, 2022
• Est. completion date: December 31, 2025

Study information

• Verified date: October 2022
• Source: Sengkang General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 66
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Obesity

Intervention

Procedure:
• Endoscopic sleeve gastroplasty
Endoscopic sleeve gastroplasty

Locations

Country	Name	City	State
Singapore	Sengkang General Hospital	Singapore

Sponsors (1)

Lead Sponsor	Collaborator
Sengkang General Hospital

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total body weight loss	Percentage total body weight loss	1-year
Secondary	Short-term weight loss	Percentage total body weight loss	3-months
Secondary	Short-term weight loss	Percentage total body weight loss	6-months
Secondary	Short-term weight loss	Percentage total body weight loss	9-months
Secondary	Healthcare costs	Patient costs associated with procedure, hospital stay, outpatient visits and pharmacological treatment	1-year
Secondary	Metabolic outcomes	HbA1c values	3-months, 6-months, 9-months, 12-months