Sigrid Therapeutics has initiated the SHINE clinical trial for SiPore21®, a novel medical device designed for sustained diabetes and weight control. SiPore21® is based on Mesoporous Silica particles (MSPs) and is administered orally in gel form.
MSPs act as “molecular sieves,” physically preventing digestive enzymes from interacting with food, which reduces the breakdown of carbohydrates and fats.
The SHINE trial is currently the largest commercial prediabetes study and aims to assess the effectiveness of SiPore21®. The primary endpoint is to determine if SiPore21® treatment leads to significantly lower HbA1c levels compared to a placebo in overweight or obese individuals with elevated blood glucose levels.
Successful trial results could lead to the registration of SiPore21® as a Class IIb medical device, offering a non-pharmaceutical tool to address the global health crisis of diabetes and obesity.
The SHINE trial is a randomized, double-blinded, placebo-controlled, multicenter clinical investigation, with secondary endpoints including body weight, insulin resistance, lipid levels, and more.
The trial plans to recruit 288 male and female participants aged 18-70 at 20 sites across three European countries. Participants will consume SiPore21® gel packs orally before their main meals for 12 weeks, following specific instructions for water intake.
Sana Ajamovic, CEO of Sigrid Therapeutics, expressed excitement about the SHINE trial and SiPore21®, highlighting the device’s user-friendly, natural approach to blood sugar control and obesity management. The trial is expected to complete recruitment in the first half of 2024, with preliminary reporting anticipated by the end of Q2, 2024.