Quality of life improvements associated with weight loss using a novel shape-shifting hydrogel capsule: RESET study results.

Objective: To evaluate the impact of the Epitomee capsule on quality of life (QOL) and its association with weight loss in adults with overweight and obesity.

Methods: This study analyzed the RESET double-blind, placebo-controlled results, focusing on predefined QOL endpoints and post hoc analyses. A total of 279 participants with a BMI of 27-40 kg/m² were treated for 24 weeks with Epitomee or placebo, along with lifestyle intervention. Statistical analyses examined changes in IWQOL-Lite-CT scores, their relationship with weight loss, and subgroup differences.

Results: Compared to the placebo group, the Epitomee group consistently showed improved outcomes in total IWQOL-Lite-CT score and Physical Function sub-score (p < 0.05), as well as numerically higher improvements in the Physical and Psychosocial sub-scores, although these did not reach statistical significance. Both treatment groups showed a significant improvement (p < 0.05) from baseline in the IWQOL-Lite-CT total score, as well as in Physical, Physical Function, and Psychosocial sub-scores over the 24-week period. A stronger correlation between weight loss and QOL improvements was observed with Epitomee vs. placebo.

Conclusions: The Epitomee capsule, with lifestyle intervention, is associated with IWQOL-Lite-CT improvement, highlighting its potential as an effective non-pharmaceutical adjunct to lifestyle intervention for enhancing health outcomes in individuals with overweight and obesity.