Trial results for the EndoZip System, an intervention for obesity, were posted on ClinicalTrials.gov on 2025-08-13. The study reported a mean total body weight loss of 13.2 kg from baseline at 12 months among participants.
Background
Obesity is a complex chronic disease characterized by excessive body fat, posing significant health risks including type 2 diabetes, heart disease, and certain cancers. Despite various non-surgical weight-loss methods available, many individuals struggle to achieve and maintain substantial weight reduction. For patients with a Body Mass Index (BMI) between 30-40 kg/m2, who have not succeeded with conventional approaches, novel interventions are continually being explored to provide effective and sustainable weight management solutions.
Trial design
This completed study, titled "Evaluation of EndoZip System in Obese Patients Who Failed to Reduce Weight With Non-surgical Weight-loss Methods," was a multicenter, prospective, single-arm, open-label, controlled clinical trial. It enrolled 48 participants with Obesity, specifically those with a BMI of 30-40 kg/m2 who had not achieved weight reduction through non-surgical methods. The trial aimed to evaluate the safety and effectiveness of the EndoZip system procedure, coupled with lifestyle modifications, for weight reduction. The study was designated as Phase NA.
Key results
The trial reported key measurements related to weight loss at 12 months:
- For the outcome "Change in Body Total Body Weight Loss (kg) From Baseline to 12 Months" in the EndoZip System group, the mean change was 13.2 kg, with a Standard Error of 1.5.
- Regarding the "Percentage of Patients With a Reduction in %TBWL of at Least 5% From Baseline to 12 Months," a total of 34 participants achieved this reduction.
What this means
The results indicate that the EndoZip System, when combined with lifestyle modifications, led to a mean total body weight loss of 13.2 kg at 12 months for obese patients who had previously struggled with non-surgical weight-loss methods. The finding that 34 out of 48 participants achieved at least a 5% reduction in total body weight loss suggests a notable proportion of patients responded to the intervention. These findings offer preliminary insights into the potential effectiveness of the EndoZip System for managing obesity in this specific patient population.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for the study NCT04773795, titled "Evaluation of EndoZip System in Obese Patients Who Failed to Reduce Weight With Non-surgical Weight-loss Methods," were posted on 2025-08-13 on clinicaltrials.gov.