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Trials / Unknown

UnknownNCT05569304

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

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

Status
Unknown
Phase
N/A
Study type
Interventional
Enrollment
66 (estimated)
Sponsor
Sengkang General Hospital · Academic / Other
Sex
All
Age
21 Years – 65 Years
Healthy volunteers
Not accepted

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.

Detailed 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.

Conditions

Interventions

TypeNameDescription
PROCEDUREEndoscopic sleeve gastroplastyEndoscopic sleeve gastroplasty

Timeline

Start date
2022-10-07
Primary completion
2025-12-31
Completion
2025-12-31
First posted
2022-10-06
Last updated
2022-10-06

Locations

1 site across 1 country: Singapore

Source: ClinicalTrials.gov record NCT05569304. Inclusion in this directory is not an endorsement.