Swallowable capsule that expands in stomach shows weight-loss, cardiometabolic benefit
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Key takeaways:
- An ingestible stomach-expandable capsule showed weight-loss benefits in people with overweight or obesity.
- The capsule conferred at least a 5% weight loss at 24 weeks among more than half of trial participants.
SAN ANTONIO — A swallowable hydrogel capsule that expands in the stomach demonstrated significant weight-loss, cardiovascular, glycemic and quality of life benefits for patients with overweight or obesity, a speaker reported.
Jamy Ard, MD, clinical researcher and obesity medicine specialist at Wake Forest School of Medicine, co-director of the Wake Forest Baptist Health Weight Management Center and professor in the department of epidemiology and prevention and internal medicine, presented the results of the prospective, randomized, double-blind, placebo-controlled RESET trial at ObesityWeek.
“We all understand and know that overweight and obesity are associated with increased risk of morbidity and complications, and we know that modest reduction of weight leads to improvement in that risk, lowers the risk of complications and improves health. We also know that in any number of our treatments, there’s always a heterogeneous response,” Ard said during the presentation. “It’s just a matter of where you start in terms of the weight-reduction percentage and the average weight reduction that happens with any given treatment. That starts from lifestyle all the way through to our latest generation of obesity medications. Considering that there’s a heterogeneous response, no one treatment fits every patient, we need to be able to have additional treatment strategies that are useful for different patients, meeting different needs and perspectives and preferences.”
The hydrogel capsule (Epitomee) is a swallowable capsule that expands into a rigid isosceles triangular shape with 62 mm long sides 12 mm in diameter. The hydrogel triangle resists motility waves to mimic solid food digestion and, after several hours, dissolves and disintegrates in the small intestine, according to the presentation.
The capsule is meant to be taken 30 minutes before meals with 2 cups of water, which is absorbed by the capsule, causing it to expand to approximately 100 times its dry weight.
The capsule is self-administered, self-clearing and short term. Its physical structure exerts pressure on the stomach wall, affecting appetite and satiety signaling via the “gut-brain axis” and occupies a smaller volume in the stomach — 17 mL — compared with other contemporary balloon-based or gel-based solutions, such as Gelesis100 (Plenity, Gelesis), according to the presentation.
In September, the FDA cleared the hydrogel capsule for the treatment of overweight or obesity for adults with BMI of 25 kg/m² to 40 kg/m² on top of diet and exercise.
For the RESET trial, the researchers enrolled 279 patients with BMI between 27 kg/m² and 40 kg/m2 and either normoglycemia or prediabetes and assigned them to a hydrogel balloon or placebo (mean age, 49 years; 80% women; 68% white).
The average weight of patients in both arms was 96 kg and the majority had normoglycemia. There were no significant differences between groups for any baseline characteristics including glycemic status, waist circumference and obesity class.
The coprimary efficacy endpoints were the difference in average total weight loss from baseline and the proportion of hydrogel-treated patients achieving 5% or more body weight reduction by week 24. Secondary endpoints included impact of the hydrogel capsule on CV risk factors, glycemic control and quality of life. The primary safety endpoint was incidence of device-related serious adverse events.
People assigned to the hydrogel capsule had significantly reduced mean body weight compared with placebo (6.6% vs. 4.6%) and 56% of participants assigned to the hydrogel capsule lost at least 5% of their body weight by week 24 compared with 35% of the placebo group (P < .0001).
Additionally, 27% of the hydrogel group lost at least 10% of their body weight at week 24 compared with 11% of the placebo arm (P < .002), according to the presentation.
Ard and colleagues observed that early responders assigned to the hydrogel capsule who lost at least 2% of their body weight by week 8 had even greater weight loss compared with placebo at 24 weeks (9.3% vs. 6.9%).
Improvements in systolic blood pressure, diastolic BP and waist circumference were also greater among participants assigned to the hydrogel capsule compared with placebo as well as homeostatic model assessment for insulin resistance and insulin among those with prediabetes (P for all < .05).
Moreover, quality of life as assessed by the Impact of Weight on Quality of Life-Lite Clinical Trials score was also greater for patients assigned to the hydrogel capsule across domains such as the physical function score (P = .044) and the total quality of life score (P = .049).
There was no device-related serious adverse events in either arm of the study and the difference in any adverse events was not different between the device and placebo arms, according to the presentation.
“This trial demonstrates that the Epitomee capsule has clinically meaningful significance in terms of efficacy over placebo in the setting of an intensive lifestyle intervention at 24 weeks, with about a 2% difference compared to placebo,” Ard said during the presentation. “When we look at individuals who respond early to treatment ... we see a slightly higher treatment response that favors the Epitomee capsule. It’s well tolerated, the safety profile looks good, and we see improvements in terms of health risk factors that we would expect to see within individuals who have normal glycemia as well as individuals with prediabetes that favor improvement in glycemic control.
“This device demonstrates efficacy for a population of individuals who have overweight or obesity with health risk associated with that. Nearly 40% had prediabetes and it was safe and well tolerated. This now becomes a new tool that can be added to our armamentarium for individuals who would benefit from treatment that starts with lifestyle therapy and want to get augmented treatment efficacy as a result of using this type of device,” Ard said.
Reference:
- Epitomee Medical announces FDA clearance of its capsule, weight management device. https://www.prnewswire.com/news-releases/epitomee-medical-announces-fda-clearance-of-its-capsule-weight-management-device-302249164.html. Published Sept. 16, 2024. Accessed Nov. 7, 2024.
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Ard J. Oral 101. Presented at: ObesityWeek; Nov. 3-6, 2024; San Antonio.
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