Clinical Trials

We have conducted two clinical studies supporting the safety and efficacy of our device, and a third and final study is upcoming

STAR study

The most recently completed clinical trial was The STAR (Sigrid Therapeutics HbA1c Reduction) study.  An open-label, single-arm, multicentre study with the objective of demonstrating the safety and efficacy of SiPore15® 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.

Read more about STAR

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.

Read more about FIM

SiPore15® represents an entirely new approach to reducing blood sugar levels and other cardio-metabolic risk factors. The excellent safety profile of the device makes it especially suitable for people at risk of developing type 2 diabetes. We are excited for the STAR study and anticipate the device to show robust safety data and clinically significant results as seen in previous clinical trials with the device.

Professor, MD, Kirsi PietiläinenLeading obesity expert & Coordinating Investigator STAR