The safety and efficacy of extended use of an oral shape-shifting superabsorbent hydrogel capsule for weight loss: The ELECT extension study.

Abstract

Long-term weight-loss maintenance remains challenging despite of the numerous available treatments. The previously published pivotal randomized RESET study demonstrated a mean weight reduction from baseline of 6.6 % with Epitomee and a mean weight reduction of 4.6 % with placebo (p < 0.001). In this study we investigated the efficacy and safety of the extended use of Epitomee, an FDA cleared, non-pharmacological treatment for weight management. In this open label extension study, a subset of par