Sigrid Therapeutics Secures U.S. Market Access for SiPore® Technology Following SHINE Prediabetes Study Success

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.

As Sigrid accelerates the U.S. commercialization of Carb Fence™ as a breakthrough medical food by year-end, the company is also in advanced regulatory discussions to secure CE-mark approval as a class IIb medical device in Europe, unlocking unmatched medical claims in the European market.

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:

Blood Sugar Control

• Participants experienced a statistically significant A1C reduction of -0.91 mmol/mol (P = 0.001) from baseline within just three months—a greater decrease than typically seen with metformin in prediabetes.

• In comparison, the landmark Diabetes Prevention Program (DPP) study showed metformin lowered A1C by -0.6 mmol/mol from baseline over six months, reducing diabetes risk by 31%.[4]

• Carb Fence™ demonstrated a more rapid and potent effect — delivering results in half the time, without the risk of drug-related side effects.

• As a first-line treatment for type 2 diabetes, metformin generated USD 17.78 billion in global sales in 2023, with an expected CAGR of 6.8%, reaching USD 34.33 billion by 2033. [5]

Enhanced Glucose Metabolism

• Participants stabilized their HOMA-B (P = 0.0005), a key indicator of pancreatic function and blood sugar regulation, reinforcing Carb Fence™’s role in metabolic health.

Cholesterol Management

• Statistically significant reductions in LDL cholesterol -4.41 mg/dL (P = 0.0172) from baseline, lowering the risk of cardiovascular events such as heart attacks and strokes.

Weight Loss While Preserving Muscle Mass

• Participants lost -1.21% of body weight (P < 0.0001) from baseline while maintaining lean mass.

• 20% of participants lost 3 kg or more of body weight from baseline.

• Targeted reductions in visceral fat from baseline:

-       Sagittal abdominal diameter: -1.92% (P = 0.0008)

-       Waist circumference: -1.49% (P < 0.0001)

• In contrast, up to 40% of weight lost with GLP-1 medications comes from lean mass, crucial for long-term metabolic health and weight maintenance. [6]

Safety & User Satisfaction

• Zero severe adverse device effects reported, reinforcing the excellent safety profile.

• Participants expressed high satisfaction:

-       97% found it easy to use

-       95% felt safe using it

-       86% would recommend it to others with prediabetes or diabetes

"The SHINE study validates SiPore® as an innovative approach to metabolic health, supporting blood sugar regulation, weight management, and cardiovascular health. The findings confirm that it preserves muscle mass while promoting fat loss, which is a significant advantage in tackling obesity and diabetes.,"

 — says Kirsi Pietiläinen, Gyllenberg Professor in Clinical Metabolism at the Obesity Research Unit, University of Helsinki, and Principal Investigator for the SHINE study.

Timely Strategic U.S. Market Rollout and Production Readiness
A recent study published in The Lancet predicts that over 50% of adults worldwide will be overweight or obese by 2050, further straining healthcare systems and increasing the prevalence of metabolic disorders such as prediabetes and type 2 diabetes. Carb Fence™ enters the U.S. market at a critical moment, offering a clinically validated approach to metabolic health that aligns with global efforts to curb this alarming trend.[7]

With robust clinical evidence, a clear regulatory pathway, and secured production through an exclusive partnership with a global silica manufacturer, Sigrid is positioned for significant growth across all SiPore®-powered business verticals. While preparing for the targeted U.S. launch of Carb Fence™, Sigrid is actively engaging with healthcare providers, metabolic health specialists, and clinics, particularly those seeking non-pharmaceutical alternatives or transitioning patients off GLP-1 medications. With its non-systemic, gut-localized mechanism, Carb Fence™ offers a well-tolerated solution for those unable to manage pharmaceutical side effects, making it an ideal standalone or adjunct therapy in metabolic care.

For more information, please contact:
Sana Alajmovic, Co-founder & CEO, Sigrid Therapeutics
Phone: +46 72 3893396
Email: sana@sigridthx.com

About Sigrid Therapeutics

Sigrid Therapeutics (Sigrid) is a clinical-stage healthtech company pioneering non-pharmaceutical solutions for metabolic diseases like type 2 diabetes and obesity. Backed by over 15 years of research, 10+ patents, and four clinical studies, Sigrid’s proprietary SiPore® platform powers Carb Fence™, a medical-grade, fast-acting liquid formula designed to promote better metabolic health without systemic absorption. Carb Fence™ leverages micron-sized mesoporous silica particles (MSPs) with tailored porosity to physically hinder digestive enzymes from breaking down carbohydrates and fats, helping to regulate blood sugar, support weight management, and improve metabolic function.

About Mesoporous Silica Particles (MSPs)

MSPs are an innovative, ingestible material engineered for metabolic health applications. Research published in Nanomedicine shows MSPs can reduce food efficiency by 33%, lower insulin levels, and decrease leptin, contributing to a healthier metabolic profile. Additional studies in Advanced Healthcare Materials confirmed MSPs physically trap digestive enzymes, reducing carbohydrate and fat breakdown.

Sources

[1] https://www.cdc.gov/diabetes/communication-resources/prediabetes-statistics.html

[2] https://clinicaltrials.gov/study/NCT06087822?term=shine%20sigrid%20therapeutic&rank=1

[3] 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. doi: 10.2147/JPR.S134745. PMID: 28831271; PMCID: PMC5548268.

[4] https://pmc.ncbi.nlm.nih.gov/articles/PMC6243218/

[5] https://www.sphericalinsights.com/reports/metformin-hydrochloride-market

[6] Muscle matters: the effects of medically induced weight loss on skeletal muscle, Prado, Carla M et al.The Lancet Diabetes & Endocrinology, Volume 12, Issue 11, 785 – 787

[7] Global, regional, and national prevalence of adult overweight and obesity, 1990–2021, with forecasts to 2050: a forecasting study for the Global Burden of Disease Study 2021, Ng, Marie et al.The Lancet, Volume 0, Issue 0

References

1. Large pore mesoporous silica induced weight loss in obese mice, Nanomedicine, 2014, https://www.futuremedicine.com/doi/10.2217/nnm.13.138.

2. Mesoporous Silica with Precisely Controlled Pores Reduces Food Efficiency and Suppresses Weight Gain in Mice, Nanomedicine, 2020, https://www.futuremedicine.com/doi/10.2217/nnm-2019-0262.

3. Entrapping Digestive Enzymes with Engineered Mesoporous Silica Particles Reduces Metabolic Risk Factors in Humans, Advanced Healthcare Materials,2020, https://doi.org/10.1002/adhm.202000057.

4. Towards mesoporous silica as a pharmaceutical treatment for obesity - impact on lipid digestion and absorption, European Journal of Pharmaceutics and Biopharmaceutics, 2022, https://doi.org/10.1016/j.ejpb.2022.02.001.

5. Activity and Stability of Nanoconfined Alpha-Amylase in Mesoporous Silica ACS MATERIAL Au, 2023, https://doi.org/10.1021/acsmaterialsau.3c00028. Publication date: August 4, 2023

6. Oral intake of mesoporous silica is safe and well tolerated in male humans, PLoSONE, 2020, DOI: 10.1002/adhm.202000057. https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0240030

7. Engineered mesoporous silica reduces long-term blood glucose, HbA1c, and improves metabolic parameters in prediabetics, Nanomedicine, 2021,https://doi.org/10.2217/nnm-2021-0235.

8. Mesoporous Silica Particles Retain their Structure and Function While Passing Through the Gastrointestinal Tracts of Mice and Humans, ACS Applied Materials & Interfaces, 2023, https://doi.org/10.1021/acsami.2c16710.