Sigrid Therapeutics announces the commencement of the SHINE clinical trial for SiPore21® – an innovative medical device designed for sustained diabetes and weight control.
SiPore21® Silica “Molecular Sieves” Offer a Promising Non-Pharmaceutical Alternative
SHINE Trial Marks a Milestone in Prediabetes and Weight Control Research
STOCKHOLM, Oct. 9, 2023 /PRNewswire/ -- Sigrid Therapeutics announces the commencement 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 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.
For more information, please contact:
Professor Kirsi Pietiläinen, University of Helsinki, Principal Investigator SHINE
Phone: +358 50 5992295
Email: kirsi.pietilainen@helsinki.fi
Sana Alajmovic, Co-founder & CEO, Sigrid Therapeutics
Phone: +46 72 3893396
Email: sana@sigridthx.com
https://www.sigridthx.com/
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SOURCE Sigrid Therapeutics
