Sirona
Research type
Research Study
Full title
First in human study of Sirona: A study to determine safety, feasibility and tolerability of an expanding hydrogel tablet, designed to promote weight loss in adults with a body mass index of 30-40.
IRAS ID
307759
Contact name
Camilla Easter
Contact email
Sponsor organisation
Oxford Medical Products
ISRCTN Number
ISRCTN12345678
Duration of Study in the UK
1 years, 0 months, 30 days
Research summary
Obesity is one of the most serious public health problems in the UK and developed world, reducing quality of life and the life span. There is an urgent need for a safe, effective and affordable therapy to aid weight loss. A novel, reversible product (Sirona, an expanding hydrogel capsule-shaped pill) has been developed which swells on contact with the stomach and stays there for several weeks, before breaking up. The aim is this product will lead to an increased feeling of fullness and reduce food intake. The proposed study will evaluate the safety and acceptability of Sirona in healthy individuals with a BMI of 30-40 seeking to lose weight. The first phase (WP1) will involve testing the product in ten individuals, to measure safety, acceptability, appropriate dosing and retention of the product in the stomach over two months. The second phase (WP2) will test these parameters further over a period of six months in 36 participants. In both phases, safety will be assessed through close monitoring for side effects, gastroscopy (camera into the stomach), imaging of the stomach (MRI), blood and stool samples. Feasibility will be assessed through measures of whether the product is retained in stomach for the required period, how many people are willing to take part, whether they are able to stick to the planned dosing of the product, as well as information from one to one, recorded telephone interviews at the end of the study. The study will also include secondary measures of whether target body weight is achieved, changes in body mass index, blood glucose levels, and insulin resistance (HbA1c). These outcomes will be used to inform the design of larger studies in the future. The study is led by University Hospital Southampton NHS Trust and Bristol NHS Trust.
Summary of study results:
First in human study of Sirona: A study to determine safety, feasibility and tolerability of an expanding hydrogel pills, designed to promote weight loss in adults with a body mass index of 30-40.
Why was our trial needed?
Obesity is a complex, long-term disease with many factors involved in its development. There is an urgent need for safe, effective and affordable new therapies to aid weight loss. This will allow people living with obesity to lose weight earlier, and to prevent further weight gain.What did we do?
Oxford Medical Products has developed Sirona. Sirona is a hydrogel, in pill form, that expands when it reaches the stomach, where it occupies space for 2-5 days. Sirona has been designed so that while it is in the stomach, it may lead to less hunger and eating, such that the person may lose weight over time.Where did the study take place?
This study was sponsored and funded by Oxford Medical Products Ltd, with Professor Bryne as Chief Investigator at University Hospitals Southampton and NIHR Southampton Biomedical Research Centre. Two other study sites were included at North Bristol NHS Trust led by Mr Pournaras and Milton Keynes University Hospital NHS Foundation Trust led by Dr Humayun. NIHR Bristol Biomedical Research Centre Diet and Physical Activity theme led on the collection of dietary intake and appetite data.Who made sure it was safe?
The Sponsor Steering Committee, led by an independent bariatric surgeon and included a patient representative with lived experience, met regularly throughout to review safety and study progress. The study ran from November 2022 to December 2024.How did we run the study?
The study was made up of three work packages (WPs). First, three healthy-weight adults took one and then two pills over two months as an initial safety check (WP0). Next, ten adults living with obesity (body mass index, BMI, of 30-40 kg/m2) took increasing doses of Sirona over two months with periods without Sirona in between (WP1). This part was to test how safe the product was and acceptable the participants found the pills and the study procedures. The final part of the study tested daily dosing with Sirona with 39 participants living with obesity (BMI 30-40) and assessed side-effects and how tolerable the pills were over a 24-week period (WP2).What did we want to find out?
Through this study, we wanted to understand the possible effects of Sirona on feelings of hunger, eating and weight loss. To do this, the study compared people who took Sirona with people who took placebo pills for the first 12 weeks.How did it work?
Participants were randomly allocated to be part of the Sirona group or the placebo group. Participants attended clinic visits regularly for blood tests and to have measurements taken and completed online measures of food intake and appetite.What happened in the trial?
The Sponsor Steering Committee concluded that there had been no clinically concerning findings in the initial safety check (WP0), and it was safe to proceed to the next stage. The target of 10 participants was met in WP1. Nine participants took Sirona for the whole study and all 10 participants completed the follow-up measures. The safety results showed that Sirona led to nausea and stomach discomfort, but this was mostly mild and went away quickly in most participants. The magnetic resonance imaging showed that Sirona remained in the stomach for at least three days after dosing. Appetite was reduced in the two hours after dosing, and this suppression of hunger and desire to eat was sustained throughout the dosing periods. In the final stage (WP2), Sirona was well tolerated, with mainly mild, stomach-related side effects reported that got better without further treatment.Did it work?
Body weight loss was greater for those on Sirona compared to those on Placebo, and daily food intake was reduced by approximately 400 calories after taking Sirona, compared to no change for those on Placebo.How have participants and the public been involved?
Patient and public involvement (PPI) has been central to the development of Sirona. Early sessions were conducted to get patient opinion on the product and design of this study. We published some of the results of this study in Health Expectations (doi:10.1111/hex.13731). Our patient representative has been involved throughout the study, including making improvements to this lay summary. After this study was complete, PPI sessions were held with six participants to guide the design of future studies and on the future use of Sirona. Patients were keen to be allowed to continue taking the product to maintain their weight loss, and others voiced that a higher dose (up to 3 pills) would be preferable. These changes have been incorporated into our future plans.What are our main findings?
In summary, this study as a whole has showed that the Sirona hydrogel is both safe and tolerable for adults living with obesity. The MRI data showed that Sirona can remain in the stomach for 2-5 days, allowing hunger, desire to eat, food intake, and body weight, to be reduced by an average of 4.4% over 24 weeks, with a maximum body weight loss of 13.5%. These findings have helped us to weigh up the benefits and risks of Sirona, and regulatory authorities have concluded that we can move forward to conduct a ‘pivotal’ study with many more participants. We are also planning other uses of Sirona, including as a treatment for overweight and weight-loss maintenance.REC name
South Central - Hampshire B Research Ethics Committee
REC reference
22/SC/0081
Date of REC Opinion
16 May 2022
REC opinion
Further Information Favourable Opinion