MUSC involved in study on device that caused 'statistically significant weight loss'

A device called Epitomee caused “statistically significant weight loss” in a 24-week trial involving nine study sites, including the Medical University of South Carolina. Patrick O’Neil, Ph.D., led MUSC’s involvement in the study. He described how the device works.

“It's a capsule that you swallow, and it changes shape. The outer part of the capsule dissolves very quickly, as soon as it gets in the stomach. The inside of the capsule is this very absorbent polymer with some bonding materials. This can absorb about 100 times its weight in water from the stomach. So that causes the device to expand into a rigid triangular shape. And it stays in the stomach like that for a while,” O’Neil said.

 

The device gives a feeling of fullness. “It occupies space and mechanically stimulates receptors in the stomach during the few hours that it's there. And so that can produce some stimuli that are associated with eating more food than you will have eaten,” O’Neil said.

It dissolves in about six hours and passes out of the body through the digestive system. 

The study had about 280 participants across its nine locations. They took a capsule with two cups of water a half hour before a meal, two times a day. Half got Epitomee; half got a placebo capsule. 

They all used an app to log every time they took a capsule, along with what they ate and drank. They also had activity monitors and smart scales that were connected to the app. And everyone got what O’Neil called state-of-the-art behavioral, dietary and exercise lifestyle coaching for weight loss by registered dietitians, using the data the participant uploaded to the app.

All participants were overweight at the start, with a body mass index ranging from 27 to 40. An average healthy body mass index is anywhere from 18.5 to less than 25, according to the Centers for Disease Control and Prevention. They could be prediabetic but not diabetic.

O’Neil, a professor in the Department of Psychiatry and Behavioral Sciences at MUSC, director of MUSC’s Weight Management Center and a former president of the Obesity Society, was pleased with the results. The average loss in the Epitomee group was 6.6% of start weight, compared with 4.6% in the placebo group, with substantial variability within each group. Fifty-six percent of the people in the Epitomee group lost at least 5% of their body weight in six months compared with 44% of the people in the placebo group. Some participants lost more than 15% of their body weight.

 

“If you look at it in comparison to what we see with semaglutide and tirzepatide these days, of course, it's nowhere near that. But it’s not meant to compete with that. This is meant to fill a different need,” O’Neil said. Semaglutide is the key ingredient in some of the prescription diabetes and weight loss drugs that have come out in recent years, including Ozempic and Wegovy. Tirzepatide is in Mounjaro and Zepbound.

Unlike those products, O’Neil said the Epitomee capsule isn’t considered a medication but a device. The company that makes it, Epitomee Medical Ltd., calls it drug-free and easy to use. It announced Food and Drug Administration clearance of the device in September. 

O’Neil was part of a team that presented the Epitomee study results at the Obesity Week 2024 conference in Texas this week, an event focused on science and treatment. He said he has no stake in the company. “They funded our site research site as they did all the other sites.”

O’Neil said the study found no serious adverse side effects in people who took Epitomee. It’s expected to become available in the U.S. next fall. It’s unclear what it will cost.