Sigrid Therapeutics is pleased to announce the commencement of the SHINE clinical trial for SiPore21®. SiPore21® is an innovative medical device designed to provide sustained control over diabetes and weight management. This groundbreaking approach utilizes Mesoporous Silica particles (MSPs), administered orally in gel form. MSPs act as "molecular sieves," effectively preventing digestive enzymes from interacting with food, thereby reducing the breakdown of carbohydrates and fats.

The SHINE trial, which is currently the largest commercial prediabetes study in progress, aims to evaluate the effectiveness of SiPore21®. The primary goal of the trial is to assess whether SiPore21® treatment can significantly lower HbA1c levels compared to a placebo in obese or overweight individuals with elevated blood glucose levels.

Successful trial results will enable SiPore21® to be registered as a Class IIb medical device, offering a potent and easily accessible non-pharmaceutical tool to address the escalating global health crisis related to diabetes and obesity.

SHINE is a randomized, double-blinded, placebo-controlled, multicenter clinical investigation conducted in accordance with MDR article 62. The trial's secondary endpoints encompass a broad range of health parameters, including body weight, insulin resistance, lipid levels, and more.

SHINE aims to recruit 288 male and female patients aged between 18-70 at 20 sites across three European countries. Participants will follow a 12-week regimen of orally consuming SiPore21® gel packs before their main meals, along with specific instructions for water intake.

Sana Ajamovic, CEO of Sigrid Therapeutics, expresses excitement about the launch of the SHINE clinical trial for SiPore21®, stating, "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 at the end of Q2, 2024.

 

Source: prnewswire.com

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