Stockholm, Sweden, March 10, 2025 – Sigrid Therapeutics (Sigrid) is excited to announce that it has secured U.S. market access for its proprietary SiPore® technology, following the success of the SHINE study, the largest of its kind in prediabetes. The study demonstrated that Carb Fence™, a medical-grade, fast-acting liquid formula powered by SiPore®, effectively reduces long-term blood sugar levels HbA1c (A1C), improves glucose metabolism, and reduces body weight – while preserving muscle mass. These robust findings position Carb Fence™ as a pioneering medical food in the U.S., a category recognized by the FDA for the dietary management of diseases or conditions under physician supervision, as defined by the Orphan Drug Act.
With the U.S. medical food market experiencing rapid growth, Carb Fence™ stands out as the first clinically validated medical food specifically developed for prediabetes—a condition affecting one in three U.S. adults. [1] Convenient and stable, Carb Fence™ boasts a two-year shelf life at room temperature, making it easy to incorporate into daily routines, whether at home or on the go.
SiPore® is a versatile platform technology that underpins Sigrid’s growth across multiple business verticals, including medical-grade liquid formulas, food additives, nutraceuticals, veterinary products, and oral care solutions.
“The successful execution of the SHINE study and the subsequent U.S. market access mark a significant milestone in Sigrid’s history. These achievements not only validate SiPore® as a safe, effective, and accessible solution to the diabetes and obesity crises but also position the platform for growth across multiple industries.,”
— says Sana Alajmovic, Co-Founder & CEO of Sigrid Therapeutics.
The SHINE study[2], designed as a double-blind, placebo-controlled, randomized trial, aimed to assess the safety and tolerability of SiPore®-powered Carb Fence™ while confirming its efficacy across key metabolic markers. Conducted across 27 clinics in three European countries, SHINE enrolled 318 participants with elevated blood sugar levels and excess body weight. Of these, 228 participants (116 in the active arm, 112 in the placebo group) strictly adhered to the protocol and were included in the primary analysis, which was based on the per protocol population. The study required no dietary or exercise interventions, allowing participants to maintain their normal lifestyle throughout the trial.
Carb Fence™ significantly reduced A1C from baseline in both males and females, with the female group achieving a clinically relevant, statistically significant, placebo-adjusted reduction—delivering clear evidence of the product’s mechanism of action.While males experienced comparable, clinically meaningful A1C reductions, statistical significance versus placebo was not reached due to a stronger placebo response—a well-documented occurrence in clinical research.[3] Among the male placebo group, many participants showed a notable improvement in liver health, as measured by gamma-glutamyl transferase (GGT) levels, likely due to reduced alcohol consumption. This suggests unintended lifestyle changes, despite being instructed to maintain their usual habits. Excluding participants with significant GGT improvements from the analysis removed the placebo effect on A1C.
SHINE Study Validates SiPore®-Powered Medical Food
Carb Fence™ is a clinically proven medical food for managing elevated blood sugar and excess body weight, without restrictive diets or costly pharmaceuticals. Validated by the SHINE study, Carb Fence™ showed significant improvements in key metabolic parameters for both males and females:
