Sigrid Therapeutics secures US market approval for SiPore® technology following successful SHINE prediabetes study

Stockholm, Sweden, March 10, 2025 – Sigrid Therapeutics (Sigrid) today announced that it has secured U.S. marketing approval for its patented SiPore® technology, following the successful SHINE study, the largest study of its kind in prediabetes. The study demonstrated that Carb Fence™, a medically graded, fast-acting gel based on SiPore®, effectively reduces long-term blood sugar levels HbA1c (A1C), improves glucose metabolism and reduces body weight – while preserving muscle mass. These robust results position Carb Fence™ as a breakthrough medical food in the U.S., a category of medical food recognized by the U.S. Food and Drug Administration (FDA) for the management of diseases or health conditions under the supervision of a physician, in line with the U.S. Orphan Drug Act.

In the rapidly growing medical food market in the United States, Carb Fence™ stands out as the first clinically validated medical food product specifically developed for prediabetes – a condition that affects one in three adults in the United States. ^[1] Carb Fence™ is convenient and stable, with a two-year shelf life at room temperature, making it easy to use in everyday life both at home and on the go. While Sigrid accelerates the North American commercialization of Carb Fence™ as a breakthrough medical food towards the end of the year, regulatory discussions are also underway in Europe to secure CE marking as a Class IIb medical device.

SiPore® is a versatile platform technology that supports Sigrid's growth in multiple business areas, including medical gels, food additives, dietary supplements, veterinary products and oral care products.

“ The successful SHINE study and subsequent market approval in the US mark a significant milestone in Sigrid’s history. These milestones not only confirm that SiPore® is a safe, effective and accessible solution to the diabetes and obesity epidemics, but also position the platform for growth across multiple industries,” says Sana Alajmovic, co-founder and CEO of Sigrid Therapeutics.

The SHINE study ^[2] – a double-blind, placebo-controlled, randomized trial – aimed to assess the safety and tolerability of Carb Fence™ and to confirm its efficacy on key metabolic markers. The study was conducted at 27 clinics in three European countries and included 318 participants with elevated blood glucose levels and overweight. Of these, 228 participants (116 in the active group, 112 in the placebo group) strictly adhered to the protocol and were included in the primary analysis. The study did not require any dietary or exercise interventions, allowing participants to maintain their usual lifestyle throughout the study.

Carb Fence™ significantly reduced A1C from baseline in both men and women, with the female group achieving a clinically relevant, statistically significant, placebo-adjusted reduction—providing clear evidence of the product’s mechanism of action. While men experienced comparable, clinically meaningful reductions in A1C, statistical significance was not achieved compared to placebo due to a stronger placebo response—a well-documented phenomenon in clinical research. ^[3] Among the male placebo group, many participants showed significant improvements in liver health, as measured by gamma-glutamyltransferase (GGT) levels, likely due to reduced alcohol intake. This suggests unintended lifestyle changes, despite participants being instructed to maintain their usual habits. By excluding participants with significant GGT improvements from the analysis, the placebo effect on A1C was removed.

SHINE study validates SiPore®-powered medical nutrition

Carb Fence™ is a clinically proven medical food for managing high blood sugar and obesity, without restrictive diets or expensive medications. The SHINE study showed that Carb Fence™ leads to significant improvements in key metabolic parameters for both men and women:

Blood sugar control

• Participants experienced a statistically significant A1C reduction of -0.91 mmol/mol ( P = 0.001 ) from baseline in just three months—a greater reduction than typically seen with metformin in prediabetes.
• In comparison, an earlier groundbreaking study, the Diabetes Prevention Program (DPP), showed that metformin lowered A1C by -0.6 mmol/mol from baseline over six months, reducing the risk of diabetes by 31%. ^[4]
• Carb Fence™ showed a faster and more powerful effect after half the time, without the risk of drug-related side effects.
• As a first-line treatment for type 2 diabetes, metformin generated global sales of $17.78 billion in 2023, with a compound annual growth rate (CAGR) of 6.8%, reaching $34.33 billion by 2033. ^[5]

Improved glucose metabolism

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

Cholesterol lowering

Statistically significant reductions in LDL cholesterol by -4.41 mg/dL ( P = 0.0172 ) from baseline, reducing the risk of cardiovascular events such as heart attack and stroke.

Weight loss while maintaining muscle mass

• Participants lost -1.21% of body weight ( P < 0.0001 ) from baseline while maintaining muscle mass.
• 20% of participants lost 3 kg or more from baseline.
• Reductions in visceral fat from baseline:

• Sagittal abdominal diameter: -1.92% ( P = 0.0008 )
• Waist circumference: -1.49% ( P < 0.0001 )

• In comparison, up to 40% of weight loss with GLP-1 drugs comes from muscle mass, which is crucial for long-term metabolic health and weight maintenance. ^[6]

Security and user satisfaction

• No serious side effects were reported, reinforcing the product's excellent safety profile.
• Participants expressed high satisfaction:

• 97% found it easy to use.
• 95% felt safe when using it.
• 86% would recommend the product to others with prediabetes or diabetes.

" The SHINE study confirms that SiPore® is an innovative solution that helps balance blood sugar, control weight and strengthen heart health. In addition, the results show that it reduces fat while preserving muscle mass – an important benefit in the fight against obesity and diabetes, " says Kirsi Pieeläinen, Gyllenberg Professor of Clinical Metabolism at the Obesity Research Unit, University of Helsinki, who is the principal investigator of the SHINE study.

A timely US launch
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 diseases such as prediabetes and type 2 diabetes. Carb Fence™ is launching in the US market at a crucial time, offering a clinically validated metabolic health solution that aligns with global efforts to slow this worrying trend. ^[7]

With robust clinical evidence, a clear regulatory path and assured manufacturing through an exclusive partnership with a global silicon producer, Sigrid is positioned for significant growth across all SiPore®-powered business areas. As Sigrid prepares for the planned launch of Carb Fence™ in the US, the company is actively engaging with healthcare providers, metabolic health specialists and clinicians, particularly those seeking non-pharmaceutical alternatives or helping patients taper off GLP-1 medications. With its non-systemic, gut-localized mechanism of action, Carb Fence™ offers a safe solution for those unable to manage drug side effects, making it an ideal stand-alone or adjunctive therapy in metabolic care.