Randomized Double-blind Sham-controlled Trial of a Novel Silicone-filled Endoscopically Placed Device for Weight Loss

Abstract

Background and AimsAlthough obesity affects over 40% of adults in the United States and is a driver of preventable chronic diseases and health care costs, most patients are left untreated. MethodsThis was a randomized, double-blind, sham-controlled trial to investigate the safety and efficacy of a novel, endoscopically placed intragastric device for weight reduction, the TransPyloric Shuttle, implanted for 1 year in 270 patients with Class I and II obesity. An additional 32 treatment patients were enrolled in an Open-Label group. The co-primary efficacy endpoints were percent total body weight loss (%TBWL) in the Treatment group compared with the Sham group and a proportion of treatment patients achieving ≥5% TBWL at 12 months. ResultsThe mean %TBWL at 12 months was 9.5% (95% CI, 8.2-10.8) in the Treatment group (n = 181) compared with 2.8% (95% CI, 1.1-4.5) in the Sham group (n = 89). In the Treatment group, 67.0% (95% CI, 59.3-74.4) of patients achieved ≥5% TBWL compared with 29.3% (95% CI, 19.3-39.4) in the Sham group. Patients in the Treatment group achieved lower blood pressure, total cholesterol, and low-density lipoprotein cholesterol compared with the Sham group. Early withdrawals occurred in 22% and 11% patients in the Treatment and Sham groups, respectively. Device- or procedure-related serious adverse events occurred in 6 patients (2.8%), and no deaths occurred. ConclusionTreatment with a novel endoscopically placed intragastric device resulted in meaningful weight loss and improvement in cardiometabolic outcomes in patients with Class I and II obesity (ClinicalTrials.gov number NCT02518685).