Sigrid Therapeutics Secures U.S. Market Access for SiPore® Technology Following SHINE Prediabetes Study Success
STOCKHOLM, March 10, 2025 /CNW/ -- 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™, an 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.
'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 study1, 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. The SHINE study, a randomized, placebo-controlled trial, enrolled 318 participants with elevated blood sugar levels and excess body weight and was conducted across 27 clinics in three European countries.
Carb Fence™ significantly reduced A1C from baseline in both males and females. The female group achieved a clinically relevant, statistically significant, placebo-adjusted reduction, providing strong 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—an occurrence well-documented in clinical research.2 Notably, many participants in the male placebo group showed significant improvements in liver health, likely due to reduced alcohol consumption. This suggests unintended lifestyle changes, despite instructions to maintain their usual habits. Excluding participants with substantial liver health improvements from the analysis eliminated the placebo effect on A1C.
2 Vambheim SM, Flaten MA. A systematic review of sex differences in the placebo and the nocebo effect. J Pain Res. 2017 Jul 31;10:1831-1839.
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