Non-pharmacological weight-loss treatment shows promising results during trial

Sirona, a non-invasive and non-pharmaceutical weight loss technology demonstrated a good side effect profile and was well tolerated by participants during a 12-week trial. Participants on Sirona experienced greater weight loss compared to those receiving a placebo. Those using the technology lost up to 10 per cent of their total body weight, with a quarter of them losing more than 5 per cent.

During the trial some participants were given Sirona, a pill that rapidly expands in the stomach. Once in the stomach, Sirona stays there for several days. It takes up space and mechanically suppresses a user’s appetite. It is non-invasive, safe, well tolerated, and comes at a fraction of the cost of existing treatments.

Approximately 40 adults with a body mass index (BMI) between 30-41 were split into two groups during the trial. Their weight loss was measured over the 12 weeks. Participants didn’t report experiencing any serious adverse events and no one withdrew from the study due to product-related complications.

Participants living with class I obesity (BMI of 30-34.9) lost more of their total body weight than those with class II obesity (BMI over 35). This differed from the results of research into GLP-1 receptor agonists (a medication used to treat type 1 diabetes and obesity), as research into GLP-1 receptor agonists shows they are more effective in people with higher BMIs.

Oxford Medical Products partnered with the National Institute for Health and Care Research (NIHR) Southampton Biomedical Research Centre (Southampton BRC) and the NIHR Bristol Biomedical Research Centre (Bristol BRC) for the clinical trial. The study also received support from the NIHR Southampton Clinical Research Facility.

Oxford Medical Products’ CEO, Dr Camilla Easter, said:

“Data like these prove our initial belief – that Sirona represents a safe approach to weight loss. We are extremely pleased that the participants in our study responded well to Sirona, and we have now delivered over 8,000 doses.

“With our fantastic safety profile and non-pharmacological approach, we are uniquely positioned to disrupt the overweight and obesity treatment market.

“Sirona’s effect in the BMI category 30-34.9 may also indicate its potential as an effective treatment option for people with an overweight BMI (25-30) who currently have very few treatment options available.”

Professor James Byrne, Chief Investigator of the study from the NIHR Southampton BRC, added:

 “This first-in-human study of Sirona is a really exciting collaboration between the team at the NIHR Southampton BRC and Oxford Medical Products.

“Working with clinical research colleagues at the Bristol BRC and Milton Keynes, we have delivered a randomised study confirming safety, feasibility and tolerability of this completely new and first in class product as a tool to support those living with overweight and obesity.

“I am delighted that our results clearly also demonstrate the potential of Sirona as an entirely new approach to weight loss and weight management. Our team is looking forward now to the pivotal study planned for 2025 as the next step that will further assess the effectiveness of Sirona in a larger multinational randomised trial.”