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

Background: 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. Methods: In this open label extension study, a subset of participants in the RESET study who lost ≥3 % of initial body weight during a 24-week treatment with Epitomee capsule or placebo, as an adjunct to lifestyle counseling, were eligible for a 24-week open-label extension study (ELECT). Results: Continuous treatment with Epitomee and lifestyle counseling for 48 weeks was associated with sustained reduction in body weight of 11.2 ± 8.4 % (p < 0.001) and sustained prior improvements in cardiometabolic risk factors and quality of life (QOL). Taking the Epitomee capsule for 24 weeks, after previous weight loss with the placebo treatment, was associated with an additional 1.5 ± 4.2 % weight loss, yielding a total 7.5 ± 5.5 % reduction at 48 weeks and additional improvements in QOL. Capsule adherence exceeded 94 %. Extended use of Epitomee had a favorable safety profile, with no serious adverse device-related events and no discontinuation due to adverse events. Conclusions: In this open-label study, extended use of Epitomee, combined with lifestyle counseling, was associated with maintenance of prior weight loss and favorable safety profile (NCT04994769).