Epitomee® Announces Successful Completion of Pivotal Clinical Trial for Innovative Weight Loss Capsule

(Adnkronos) – CAESAREA, Israel, Jan. 16, 2024 /PRNewswire/ — Epitomee® announces the successful completion of the RESET pivotal clinical trial, for its weight loss capsule. The randomized placebo controlled, double blind trial, investigated the safety and efficacy of Epitomee® capsule versus the sham capsule control, alongside lifestyle interventions, for reducing body weight, in overweight or obese adults, with BMI of 27-40 without comorbidities, The trial was conducted in 9 different centers across the United States. The primary objective of the RESET trial was to collect data to support a planned FDA regulatory submission, paving the way for the marketing and distribution of the Epitomee® capsule in the USA. The RESET included 279 participants and was carried on for 24 weeks of treatment, followed by additional 4-week monitoring period. The study successfully met both co-primary endpoints: with Epitomee®, majority of patients, 56%, achieved 5% or greater weight loss from baseline, with a p-val