Sigrid Therapeutics to Present SHINE Trial Results at EASD 2025 Annual Meeting
Oral presentation to highlight the safety and efficacy of gut-targeted SiPore® technology in blood glucose and weight management at Europe’s premier diabetes research conference
Stockholm, Sweden – June 3, 2025 – Sigrid Therapeutics (Sigrid), a Swedish commercial-stage healthtech company, today announced that it will present results from its pivotal SHINE trial in an oral presentation at the 61st Annual Meeting of the European Association for the Study of Diabetes (EASD), to be held 15–19 September 2025 in Vienna, Austria.
The SHINE (SiPore® Halts Intermediate Hyperglycemia) trial evaluated SiPore21, a novel medical device candidate composed of mesoporous silica particles designed to support blood glucose control in individuals with prediabetes and newly diagnosed type 2 diabetes. Consumed orally as a liquid formula with meals, SiPore21 acts locally in the gut by physically separating digestive enzymes from food, thereby slowing digestion, reducing caloric absorption, and helping improve glycaemic control—without systemic absorption.
“We’re honored that SHINE has been selected for oral presentation at EASD, one of the most prestigious forums for metabolic health science,” said Prof. Tore Bengtsson, Co-founder and Chief Scientific Officer at Sigrid Therapeutics. “This recognition supports the clinical relevance of our gut-targeted approach and highlights its potential to offer a safe, drug-free strategy for managing early-stage metabolic disease.”
The SHINE trial was a randomized, double-blind, placebo-controlled multicenter trial that enrolled 318 adults with elevated blood sugar and excess weight across 27 clinics in three European countries. Over a 12-week period, participants consumed either SiPore21 or placebo with their main meals. The study assessed changes in HbA1c, body weight, lipid profiles, and additional metabolic parameters, along with safety and tolerability.
As outlined in the abstract accepted for presentation, SiPore21 led to significant improvements in glycaemic control and multiple metabolic measures, while demonstrating an excellent safety profile with no serious adverse device effects reported. These findings build upon two prior clinical trials that established the safety and tolerability of SiPore®-based formulations and reinforce the platform’s potential in prediabetes and early type 2 diabetes.
Sigrid’s oral presentation titled Efficacy and safety of mesoporous silica particles for blood glucose control – randomized, double-blind, placebo-controlled multicenter trial (SHINE) will be featured in the Short Oral Discussion programme at EASD 2025, a curated track highlighting innovative technologies with clinical relevance. Full results from the SHINE trial will be presented at the meeting. Additional data may be made available to partners under CDA.
About SHINE
The SHINE trial is the largest study of its kind in prediabetes. Conducted under Medical Device Regulation (MDR) standards, the trial supports CE-mark approval for SiPore21 as a medical device in the EU. This robust clinical validation also supports Carb Fence™ as the first clinically validated medical food for prediabetes in the U.S., qualifying for FDA medical food status.
About Sigrid Therapeutics
Sigrid Therapeutics is a commercial-stage healthtech company developing non-pharmaceutical, gut-targeted solutions for metabolic diseases such as type 2 diabetes and obesity. Its proprietary SiPore® platform is backed by 15 years of research, four clinical trials, and a growing international patent portfolio. The platform powers both SiPore21 and Carb Fence™:
- SiPore21 is currently undergoing CE-mark approval as a medical device in the EU.
- Carb Fence™, a fast-acting oral liquid formula, is cleared as a medical food in the U.S.
Both products are taken with meals and work locally in the gut to trap digestive enzymes, slow the breakdown of carbohydrates and fats, and help manage blood sugar and weight—without being absorbed into the body.
About the European Association for the Study of Diabetes (EASD)
Founded in 1965, the EASD Annual Meeting is one of the world’s largest and most respected scientific conferences focused on diabetes and metabolic health. The annual event attracts more than 15,000 participants from over 130 countries and features over 1,200 peer-reviewed presentations, making it a premier platform for unveiling cutting-edge research and shaping the future of diabetes care.