Efficacy and safety of a novel oral hydrogel capsule in adults with overweight or obesity: the pivotal randomized RESET study

Authors

• Jamy D. Ard, Wake Forest University School of Medicine, Winston-Salem, NC
• Donna H. Ryan, Pennington Biomedical Research Center, Baton Rouge, LA
• Patrick M. O'Neil, Medical University of South Carolina, Charleston, SC
• Robert F. Kushner, Northwestern University Feinberg School of Medicine, Chicago, IL
• Holly R. Wyatt, The University of Alabama at Birmingham, Birmingham, AL
• Harold E. Bays, Louisville Metabolic and Atherosclerosis Research Center, Louisville, KY
• Frank L. Greenway, Pennington Biomedical Research Center, Baton Rouge, LA
• John M. Jakicic, University of Kansas Medical Center, Kansas City, KS
• Sharon Leonard, University of Pennsylvania Perelman School of Medicine, Philadelphia, PA
• Yael Kenan, Epitomee Medical Ltd., Caesarea, Israel
• Eti Ganon-Elazar, Epitomee Medical Ltd., Caesarea, Israel
• Thomas A. Wadden, University of Pennsylvania Perelman School of Medicine, Philadelphia, PA

Document Type

Article

Publication Date

3-12-2025

Publication Title

Obesity

Abstract

Objective: The objective of this study was to investigate the efficacy and safety of the Epitomee capsule versus placebo as an adjunct to high-intensity lifestyle intervention in participants with overweight or obesity. Methods: The Randomized Evaluation of Efficacy and Safety of the Epitomee Capsule Trial (RESET) was a prospective, double-blind, placebo-controlled pivotal trial in adults with baseline BMI of 27.0 to 40.0 kg/m2. The co-primary endpoints at week 24 were percentage change from baseline in body weight for the Epitomee and placebo groups and proportion of Epitomee-treated patients achieving ≥5% weight loss compared with a 35% threshold. The primary safety endpoint was the incidence of device-related serious adverse events. Results: A total of 138 participants received Epitomee and 141 received placebo. Mean (SD) change in body weight from baseline was -6.6% (6.5%) with Epitomee and -4.6% ( 4.7%) with placebo; least-squares means were -6.1% (0.6%) and -4.2% (0.6%), respectively (p = 0.0054). Fifty-six percent of Epitomee-treated participants attained ≥5% weight loss from baseline, which was significantly greater than the 35% predefined threshold (p < 0.0001). Twenty-seven percent of Epitomee-treated and eleven percent of placebo-treated participants achieved ≥10% weight loss. Adverse event rates were similar between the groups. No device-related serious adverse events occurred. Conclusions: The Epitomee capsule is a safe and efficacious nonpharmacological option for weight management with potential broad application in participants with overweight or obesity.

First Page

500

Last Page

511

DOI

10.1002/oby.24240

Creative Commons License

This work is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License

Recommended Citation

Ard, Jamy D.; Ryan, Donna H.; O'Neil, Patrick M.; Kushner, Robert F.; Wyatt, Holly R.; Bays, Harold E.; Greenway, Frank L.; Jakicic, John M.; Leonard, Sharon; Kenan, Yael; Ganon-Elazar, Eti; and Wadden, Thomas A., "Efficacy and safety of a novel oral hydrogel capsule in adults with overweight or obesity: the pivotal randomized RESET study" (2025). LSU-LCMC Cancer Center Faculty Publications. 163.
https://digitalscholar.lsuhsc.edu/llcc_facpubs/163
10.1002/oby.24240