Epitomee Medical Ltd. has unveiled impressive findings from its RESET study, which evaluated the effectiveness of its novel, drug-free hydrogel capsule for weight loss. The results were presented at ObesityWeek® 2024, a major annual event organized by The Obesity Society, held in San Antonio, Texas, from November 2-6, 2024.
The RESET study, a randomized, double-blind, placebo-controlled trial, tested the Epitomee® Capsule’s ability to help individuals lose weight through a non-pharmacological mechanism. The capsule expands in the stomach into a triangular shape, promoting a feeling of fullness, reducing appetite, and decreasing calorie intake. The study’s findings, shared by Professor Jamy D. Ard MD, a leading obesity expert from Wake Forest University School of Medicine, suggest that the Epitomee capsule could provide a safe and effective solution for weight loss.
Key Results from the RESET Study
The study, which involved 279 participants (138 in the Epitomee group and 141 in the placebo group), demonstrated significant weight loss in those using the Epitomee capsule. The co-primary endpoint of the study was to measure the percentage of participants who lost at least 5% of their body weight after 24 weeks. Among the Epitomee-treated participants, 55.5% achieved this goal, far exceeding the study’s benchmark of 35% (p<0.0001).
Early responders—those who lost at least 2% of their body weight by week 8—accounted for nearly 60% of the Epitomee group, and they achieved an average weight loss of around 10% by the end of the study at week 24.
In addition to weight loss, participants who received the Epitomee capsule also showed significant improvements in insulin resistance and insulin levels, particularly those with prediabetes. The capsule also led to notable improvements in quality of life (QOL), with significant enhancements in both total QOL and physical function scores when compared to the placebo group.
The study found no serious adverse events related to the device, and there were no significant differences between the Epitomee and placebo groups in terms of gastrointestinal side effects.
A New Tool for Weight Management
Dr. Donna H. Ryan, a respected obesity researcher and Professor Emerita at Pennington Biomedical Research Center, praised the Epitomee capsule as a safe and effective weight loss tool. “Epitomee offers a very safe approach for patients who need help with appetite control. Since it’s not absorbed and works in the stomach, it avoids the side effects typically seen with other weight loss medications like GLP-1 agonists,” she said. “Epitomee is a valuable addition to our weight loss toolbox, especially for patients with a BMI starting at 25, where most anti-obesity medications are not approved.”
Professor Ard also highlighted the capsule’s potential for broad use across various patient groups. “The Epitomee capsule offers a safe and effective, non-pharmacological option for weight management,” he said. “Its safety and tolerability make it suitable for a wide range of patients, including those who may not be able to use other medications due to contraindications or side effects.”
A Drug-Free Solution with Strong Potential
As the obesity epidemic continues to challenge healthcare systems worldwide, Epitomee’s hydrogel capsule offers a promising alternative to traditional weight loss methods. The RESET study’s positive results further establish the Epitomee capsule as a strong contender in the weight loss market, especially for patients looking for non-drug solutions.
With no serious side effects reported and significant improvements in both weight loss and quality of life, Epitomee’s drug-free approach to weight management is poised to become an important tool in the fight against obesity. The company’s innovative technology could offer patients a new, effective way to achieve sustainable weight loss without relying on traditional medications.
