A first trial of an expanding pill has demonstrated the technology’s potential as a weight-loss treatment.
The Sirona capsule is designed to aid weight loss by reducing hunger.
Oxford Medical Products (OMP) partnered with the NIHR Southampton Biomedical Research Centre on the first-in-human trial.
It was led by chief investigator Mr James Byrne, consultant surgeon at University Hospital Southampton.
OMP reports the pill was safe and well tolerated by participants in the 12-week trial. A quarter of all participants who took the treatment lost over five percent of their body weight.
The trial took place at the NIHR Southampton Clinical Research Facility.
Tackling rising obesity
Around one in four adults in the UK are now living with obesity, which means having a BMI of 30 or above.
Obesity increases the risk of many other health conditions, including type 2 diabetes and some types of cancer. It costs the NHS billions of pounds each year.
However, current treatments are expensive and resource-intensive in tackling the scale of the problem.
The Sirona capsule works like a gastric balloon, but is designed to be safe to take at home. It aids weight loss by taking up space in the stomach to make the person feel full.
Promising early results
Overall, 40 adults with a BMI between 30 and 41 took part in the trial. They were randomly assigned to two groups, which took either Sirona or a placebo for 12 weeks.
The researchers found the treatment was safe, with no participants reporting any serious side effects. Any side effects they did have were mild.
One in four participants taking the treatment lost between five and 10 percent of their body weight. However, this result will need to be confirmed in larger trials.
Moving onto larger trials
Following these initial promising results, the researchers now plan to test Sirona in a much larger trial. This will recruit participants at sites located in many different countries.
“This first-in-human study of Sirona is a really exciting collaboration between the team at the NIHR Southampton Biomedical Research Centre and Oxford Medical Products,” said Mr Byrne.
“Working with clinical research colleagues in Bristol 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 study.”
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