Oxford Medical Products is thrilled to report positive topline results from the first randomised controlled trial (RCT) of Sirona, their groundbreaking non-invasive and non-pharmaceutical weight loss solution.
In a 12-week randomised controlled trial (RCT), Sirona displayed a favourable safety profile and was well tolerated by participants, demonstrating a significant treatment effect. Participants using Sirona experienced greater weight loss compared to those on a placebo, with up to 10% total body weight loss (TBWL) in the treatment group. Remarkably, 25% of participants on Sirona lost over 5% of their total body weight (TBW).
Introducing Sirona: A Novel Appetite Suppressant
Sirona’s innovative approach involves a dual-polymer hydrogel pill that expands in the stomach, creating a sensation of fullness to help control appetite. Once in the stomach, Sirona maintains its expanded size for several days, providing sustained appetite suppression without the need for invasive procedures or pharmaceuticals. The mechanical mode of action ensures it remains safe and well tolerated, while also being significantly more cost-effective than existing options.
With obesity affecting more than 2 billion people worldwide and costing the NHS £18 billion annually, effective solutions like Sirona are vital. Analysts at JP Morgan forecast that the obesity treatment market could reach $100 billion by 2030, largely due to GLP-1 pharmacotherapies. Sirona complements GLP-1 therapies but also stands alone in segments these medications may not address. Its safety profile makes it suitable for weight maintenance as well as for individuals transitioning off GLP-1s, enabling them to sustain weight loss.
A Comprehensive Clinical Trial to Assess Safety and Efficacy
The double-blind, randomised controlled trial (ISRCTN14083641) was designed to evaluate Sirona’s safety, feasibility, and tolerability. Conducted with around forty adults with a BMI between 30 and 41, the study split participants into two groups, with a 3:1 ratio of Sirona to placebo. Weight loss was measured as an exploratory endpoint across the 12 weeks, with no serious adverse events (SAEs) reported. Most reported adverse effects were mild, and no participants withdrew due to product-related issues, reinforcing Sirona’s strong safety and tolerability profile. Participants receiving Sirona achieved up to 10% total body weight loss, with notable effects seen among those with lower BMIs.
Interestingly, initial analysis showed that participants with class I obesity (BMI 30-34.9) experienced greater weight loss than those with class II obesity (BMI ≥35). This finding differs from current literature on GLP-1 receptor agonists, which tend to show greater efficacy at higher BMIs. This outcome suggests Sirona could be especially valuable for individuals with overweight BMIs, offering a novel solution for those with limited weight-loss options.
CEO and Clinical Experts Emphasise Potential of Sirona
Dr Camilla Easter, CEO of Oxford Medical Products, shared her enthusiasm: “These results validate our belief that Sirona offers a safe and effective approach to weight loss. With more than 8,000 doses delivered, Sirona’s safety profile and non-pharmacological design position it to transform the overweight and obesity treatment landscape.”
She continued, “The early results in participants with BMIs of 30-34.9 point to Sirona’s potential as an effective option for those with overweight BMIs, where alternatives are limited. The obesity crisis demands diverse solutions, and we’re excited to offer Sirona as a standalone or complementary treatment for those managing their weight.”
With these promising findings, Oxford Medical Products plans to commence a pivotal trial of Sirona in Q2 2025. Additionally, the company is developing Sirona as a gastroretentive drug delivery system to enhance the pharmacokinetics of oral anti-obesity and metabolic drugs, improving their bioavailability.
Collaborative Research for a Groundbreaking Solution
Oxford Medical Products partnered with the NIHR Southampton Biomedical Research Centre (BRC) and the NIHR Bristol Biomedical Research Centre to conduct this trial. The BRCs focus on bridging early scientific discoveries with large-scale studies. The study also received support from the NIHR Southampton Clinical Research Facility.
Professor James Byrne, Chief Investigator from the NIHR Southampton BRC, expressed optimism: “This study marks an exciting collaboration, demonstrating Sirona’s safety and efficacy as a new approach for weight management. We are eager to move forward with the upcoming multinational trial in 2025 to further assess Sirona’s impact on weight loss.”