A new weight loss medication that expands in the stomach to maintain a lasting sense of fullness has demonstrated encouraging results in its Phase 2 clinical trial, suggesting potential as a valuable tool for weight management.
The drug, called Sirona, is designed for individuals with overweight conditions (those with a body mass index (BMI) of 25–29.9 kg/m²) or class I obesity (BMI of 30–34.9 kg/m²). Additionally, it aims to support patients transitioning off glucagon-like peptide-1 (GLP-1) receptor agonists, a popular class of weight loss drugs.
As of 2030, an estimated 30 million Americans are expected to use GLP-1 medications, underscoring the need for alternative, sustainable weight management solutions for those moving off these drugs. Early findings from the ongoing trial (ISRCTN14083641) reveal that Sirona continues to deliver consistent weight loss results at the three-month mark. According to Oxford Medical Products (OMP), the company behind Sirona, preliminary data suggests that the drug could help patients lose between 10% and 12% of their total body weight over the course of one year.
A Complementary Option for Weight Loss Drugs
GLP-1 receptor agonists, such as Wegovy™ (semaglutide) and Zepbound™ (tirzepatide), are primarily used to treat type 2 diabetes and obesity in individuals with a BMI of 30 kg/m² or greater, or 27 kg/m² with associated health complications. Sirona, on the other hand, is aimed at those with a BMI between 25 and 40 kg/m², including the nearly half of the global adult population considered overweight (BMI 25–29.9 kg/m²).
These GLP-1 drugs work by mimicking the natural GLP-1 hormone in the body, enhancing insulin secretion, suppressing appetite, and slowing gastric emptying. Although the hormone typically acts briefly in the body, these medications are engineered to have longer-lasting effects, helping patients control their hunger.
OMP presents Sirona as a complementary option to GLP-1 therapies, particularly for people who are discontinuing their use. Research shows that after a year of using GLP-1 medications like semaglutide, many patients regain a significant portion of their lost weight after stopping the treatment. Sirona, with its unique mechanism, is aimed at preventing this weight rebound.
How Sirona Works
The Sirona capsule uses an oral hydrogel technology that expands once it reaches the stomach, remaining there for several days before naturally breaking down. This expansion reduces the stomach’s available volume, which in turn decreases hunger, mimicking the effects of weight loss surgeries and gastric balloons.
The Phase 2 trial of Sirona, conducted across three NHS hospitals in the UK, focused on evaluating the drug’s safety and acceptability in healthy individuals with a BMI between 30 and 40 kg/m². The study found that participants with class I obesity lost, on average, more than 6.3% of their body weight without any active lifestyle changes, such as dieting or exercising. Participants taking Sirona also consumed about 400 fewer calories per day compared to those on a placebo.
Safety and Future Plans
Notably, OMP reported no serious adverse events in the trial, with 96% of participants adhering to the prescribed dosing regimen over 12 weeks.
“We believe Sirona presents a unique, highly tailored solution, especially for those in the overweight category, providing a safe and cost-effective approach to weight loss,” said Dr. Camilla Easter, CEO of Oxford Medical Products. “In the years ahead, we plan to move forward with pivotal trials focused on both weight loss and long-term maintenance.”
Oxford Medical Products intends to advance Sirona into a larger pivotal trial later this year, with plans to expand the research to the U.S. and the U.K.
Related Topics: