The first patient has been treated with Sigrid Therapeutics’ SiPore21, an innovative medical device designed for sustained diabetes and weight control. The patient is part of the SHINE clinical trial for SiPore21 – an innovative medical device designed for sustained diabetes and weight control. Based on Mesoporous Silica particles (MSPs), SiPore21 represents a groundbreaking approach to managing these pressing health concerns. Administered orally in gel form, MSPs act as "molecular sieves," physically preventing digestive enzymes from interacting with food, thereby reducing the breakdown of carbohydrates and fats.
The SHINE trial, the largest commercial prediabetes study currently underway, aims to evaluate the effectiveness of SiPore21. The primary endpoint is to assess whether SiPore21 treatment leads to significantly lower HbA1c levels, compared to a placebo, in people living with obesity or overweight individuals with elevated blood glucose levels. The trial's secondary endpoints encompass a wide range of health parameters, including body weight, insulin resistance, lipid levels and more.
SHINE seeks to recruit 288 male and female patients aged between 18-70 at 20 sites in three European countries. Participants will undergo a 12-week routine of orally consuming SiPore21 gel packs at the start of their main meals, along with specific instructions for water intake. With successful trial results, SiPore21 is poised to be registered as a Class IIb medical device. This milestone paves the way for a powerful and accessible non-pharmaceutical tool to combat the growing global diabetes and obesity health crisis.
"At Sigrid, we are entering an exciting phase of development with the launch of the SHINE clinical trial for SiPore21. Our innovative technology represents a user-friendly, natural approach to blood sugar control and obesity management, setting it apart from modern-day diabetes and obesity pharmaceuticals,” explained Sana Ajamovic, CEO of Sigrid Therapeutics. “We truly believe SiPore21® is going to make a positive impact on the healthcare landscape by preventing diabetes and improving human health worldwide."
SHINE is scheduled to complete recruitment in the first half of 2024, with preliminary reporting expected end of the second quarter in 2024.