SiPore21® Silica "Molecular Sieves" Offer a Promising Non-Pharmaceutical Alternative

SHINE Trial Marks a Milestone in Prediabetes and Weight Control Research

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 obese or overweight individuals with elevated blood glucose levels.

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.

SHINE is a randomized, double-blinded, placebo-controlled, multicenter clinical investigation in accordance with MDR article 62. 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.

Sana Ajamovic, CEO of Sigrid Therapeutics, comments: "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. We truly believe SiPore21® is going to make a positive impact on the healthcare landscape by preventing diabetes and improving human health worldwide."

Anticipated Milestones: SHINE is scheduled to complete recruitment in the first half of 2024, with preliminary reporting expected end of Q2, 2024.