From Lab Bench to Clinical Validation
Our SiPore® technology has progressed from lab research to multiple clinical trials, proving its efficacy in blood sugar regulation, weight management, and energy support. Backed by 13+ years of science, it delivers trusted, real-world results.
SHINE Study
Our latest study takes in 318 obese and overweight subjects with prediabetes or newly diagnosed type 2 diabetes from 27 sites in Slovakia, Poland, and Romania. To minimize placebo effects, participants were explicitly instructed not to change their lifestyle and advised to maintain their usual eating habits and physical activity levels throughout the study. The randomized, double-blind, placebo-controlled monitors HbA1c levels primarily over a 12-week period.
To read more about the SHINE clinical trial, click below.
The STAR (Sigrid Therapeutics HbA1c Reduction) study is an open-label, single-arm, multicentre study with the objective of demonstrating the safety and efficacy of SiPore® in subjects with prediabetes or newly diagnosed type 2 diabetes. The goal of the clinical trial was to demonstrate an improvement in cardio-metabolic risk factors in the target population.
The trial was completed in the Fall of 2019 and results from the trial were presented at the American Diabetes Association’s 80th Scientific Sessions, June 12-16, 2020 in Chicago, Illinois. Discover how silica is safe for use in humans with these published articles here and here.
To read more about the clinical trial STAR, click below.
Star Study
FIM Study
Prior to the STAR study, the First-in-man (FIM) trial was completed in 2015. This single blinded safety study consisted of two study arms, each including 10 male participants (18–35 years). One arm consisted of participants with normal weight and one with obesity. The aim of the study was to determine whether oral dosing, of precisely engineered mesoporous silica as a food additive can be used safely in male humans.
To read more about clinical trial FIM, click below.