Sigrid Therapeutics Builds Momentum: Positive SHINE Trial, Early Real-World Evidence, and CE-Mark Submission in Progress
Stockholm, Sweden – September 8, 2025 – Sigrid Therapeutics, the innovative Swedish consumer care company, today reiterates the strength of its pivotal SHINE trial and announces continued regulatory progress as it advances its CE-mark submission for approval of its first medical device in Europe. The company will present SHINE results at the 61st Annual Meeting of the European Association for the Study of Diabetes (EASD), taking place 15–19 September 2025 in Vienna. The presentation is scheduled for 17 September at 13:00 in Hall C, Station 03, under the title: “Efficacy and safety of mesoporous silica particles for blood glucose control – randomized, double-blind, placebo-controlled multicenter trial (SHINE).”
“I’m thrilled to present our data at EASD, where leading experts come together to advance diabetes care. This is a unique opportunity to highlight how our science can open new pathways for people at risk of, or already living with, type 2 diabetes. By engaging with physicians, researchers, and partners, we can accelerate access to truly innovative solutions that address one of today’s most urgent health challenges,” said Dr. Jeanha Baek, Head of Preclinical Development at Sigrid Therapeutics.
SHINE Trial: Strong Clinical Foundation
The SHINE trial - a randomized, double-blind, placebo-controlled study conducted across 27 European clinics - delivers the largest MDR-standard clinical evidence in prediabetes to date. Results demonstrate that Sigrid’s SiPore® technology significantly improves weight and glucose-related outcomes, supporting its intended use in reducing body weight and improve metabolic health. Recognized for both quality and clinical impact, SHINE sets a new benchmark in the field.
Early Real-World Evidence Strengthens the Case
Building on SHINE, Sigrid reports early real-world evidence from its U.S. medical food Carb Fence™, powered by SiPore® technology. Results show appetite control and improved body composition, with participants losing weight while maintaining lean muscle mass.
Sigrid Advances Toward CE-Mark Approval
Following a successful clinical pre-assessment with its Notified Body, Sigrid is proceeding with its CE-mark submission—the next major step toward launching its first medical device in Europe. This milestone complements the company’s U.S. medical food strategy and strengthens ongoing partnership discussions.
About Sigrid Therapeutics
Sigrid Therapeutics is a Swedish innovative consumer care company redefining metabolic health with its patented SiPore® technology. Backed by over 15 years of research, SiPore® is a 100% natural mineral that works locally in the gut — mechanically capturing digestive enzymes to slow carbohydrate and fat breakdown, reducing calorie absorption without affecting essential micronutrients. This purely local, non-systemic mode of action is designed to help manage blood sugar levels, supports healthy weight management, and promotes overall metabolic health— all without entering the bloodstream or causing systemic side effects.
The SiPore® portfolio includes:
Carb Fence™ – a fast-acting, medical food formulated for the dietary management of impaired glucose tolerance and related metabolic conditions, to be used under medical supervision.
Glucose Stabiliser – a daily dietary supplement for health-conscious consumers seeking long-term metabolic balance