Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 9:12 PM
Ignite Modification Date:
2025-12-24 @ 9:12 PM
NCT ID:
NCT05569304
Brief 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.
Study:
NCT05569304
Study Brief:
Protocol Section:
NCT05569304