RESEARCH & EVIDENCE

From mechanism to human evidence.

SiPore® has been investigated across the research continuum: from preclinical studies exploring how the technology works, through controlled human clinical trials, to real-world evidence and consumer research. Together, these studies build a growing understanding of how SiPore® works, how it performs in human research, and what people report experiencing in everyday use.

The research continuum: from the laboratory to controlled human studies and everyday meals
15+
YEARS OF RESEARCH
6
CLINICAL TRIALS
9
PEER-REVIEWED PUBLICATIONS
10+
GRANTED PATENTS
UNDERSTANDING THE EVIDENCE

Not all evidence is the same.

Different types of research answer different questions. The SiPore® evidence program spans controlled clinical studies, real-world evidence, consumer research and preclinical science. Each contributes a different part of the picture.

We keep these evidence types distinct, because each supports a different level of conclusion.

CLINICAL STUDIESWhat happens under controlled human study conditions?Studies conducted according to defined clinical protocols, including randomized and placebo-controlled research.
REAL-WORLD EVIDENCEWhat is observed outside a traditional controlled trial?Research examining outcomes and experience under real-world conditions.
CONSUMER STUDIESWhat do users report experiencing?Structured surveys capturing self-reported experiences with SiPore®-powered products.
PRECLINICAL RESEARCHHow does the technology work?Laboratory and animal research used to investigate mechanism, digestion and the engineered properties of SiPore®.
CLINICAL STUDIES

Six clinical trials. A growing body of human evidence.

The SiPore® clinical program has progressed from early safety and mechanism studies into controlled studies exploring post-meal glucose, longer-term metabolic outcomes and glucose stability.

LARGE RANDOMIZED CLINICAL TRIAL

SHINE

SHINE is the largest SiPore® clinical trial conducted to date. The study evaluated engineered mesoporous silica particles in individuals with prediabetes or type 2 diabetes and was published in eClinicalMedicine in 2026. The trial reported findings across multiple metabolic markers, including body weight, fat mass and lipids, while SiPore® was generally well tolerated in the studied population.

Participants
N = 318
Design
Randomized • Double-blind • Placebo-controlled
Evidence
CLINICAL STUDY

Baek J, et al. Effect of Engineered Mesoporous Silica Particles with Tailored Pore Size on Glycaemic Control in Individuals with Prediabetes or Type 2 Diabetes: SHINE Trial. eClinicalMedicine. 2026;97:104042.

Read the paper
STARN = 43 • Prediabetes / newly diagnosed, drug-naive type 2 diabetesPROOF-OF-CONCEPT CLINICAL TRIAL
Key findings
A human clinical study evaluating longer-term metabolic effects of engineered mesoporous silica. The study reported a significant reduction in HbA1c and found SiPore® to be well tolerated in the studied population.
Publication / source
Baek J, et al. 2022. Engineered mesoporous silica reduces long-term blood glucose, HbA1c, and improves metabolic parameters in prediabetics. Nanomedicine.
Read the paper
View publication
PostprandialN = 20 • Healthy adults • Single-dose crossoverPLACEBO-CONTROLLED CROSSOVER STUDY
Key findings
A single-dose study designed to investigate the meal-level mode of action of SiPore®. In the placebo-controlled study, SiPore® significantly reduced post-meal blood glucose compared with placebo during an oral starch tolerance test.
Publication / source
Sigrid Therapeutics Study Report, 2023. Internal study report.
First-in-ManN = 20 • Male participantsFIRST HUMAN EVALUATION
Key findings
An early human clinical study evaluating the safety, tolerability and biological effects of mesoporous silica. Oral intake was generally well tolerated in the studied population. Additional analysis from the same clinical investigation contributed evidence on HbA1c, LDL cholesterol and the proposed digestive-enzyme entrapment mechanism.
Publication / source
Hagman E, et al. 2020, PLOS ONE. Waara ER, et al. 2020, Advanced Healthcare Materials.
Read the paper
Hagman et al., 2020 · PLOS ONE Waara et al., 2020 · Advanced Healthcare Materials
CGM Study 1N=20 • Lower-dose SiPore® regimen • Placebo-controlled CGM researchCONTINUOUS GLUCOSE MONITORING
Key findings
A placebo-controlled CGM study investigated glucose stability using a lower-dose SiPore® regimen. The approved analysis reported increased Time in Range, fewer hypoglycemic events and more stable glucose profiles compared with placebo.
Publication / source
Sigrid Therapeutics Study Report, 2025. Internal study report.
CGM Study 2N = 29 • Higher-dose SiPore® regimenCONTINUOUS GLUCOSE MONITORING
Key findings
A CGM study evaluating glucose variability and exposure to higher glucose ranges. The study reported reduced daytime glucose variability and lower exposure to the upper glucose range in healthy individuals using SiPore®.
Publication / source
Sigrid Therapeutics Study Report, 2026. Internal study report.
THE CLINICAL PROGRAM

From safety and mechanism to broader metabolic evaluation.

Across the clinical research program, SiPore® has been investigated in areas including:

Post-meal glucose response Longer-term glycemic markers Body weight and body composition Blood lipids Glucose variability Safety and tolerability

Different studies, doses and populations answer different questions. Findings should therefore always be understood in the context of the specific study in which they were generated.

View peer-reviewed publications
REAL-WORLD EVIDENCE

Beyond the controlled clinical setting.

Clinical trials tell us what happens under controlled research conditions. Real-world evidence adds another perspective: what is observed when an intervention is used under everyday conditions.

REAL-WORLD EVIDENCE

U.S. Real-World Evidence Study

The study evaluated appetite, weight and tolerability in adults using a SiPore®-powered intervention. It explored hunger, urge to snack, sugar cravings, post-meal fatigue, weight, tolerability, adherence and user satisfaction. The study observed changes across several appetite-related measures and weight outcomes, alongside high adherence and generally good tolerability.

Study cohort
N = 80
Year
2025
Population
Adults with overweight or obesity

Sigrid Therapeutics internal real-world evidence report, 2025. Internal study report.

Read the study
CONSUMER STUDIES

What people report experiencing.

Consumer research provides a different kind of evidence from clinical trials. It can help us understand how people describe their experience with SiPore®-powered products in everyday use, but these findings are self-reported and should not be interpreted as controlled clinical outcomes.

Real-World Insights on Weight, Appetite and Blood Sugar ControlN = 46 • 2025CONSUMER SURVEY
Key findings
Participants reported experiences across sugar cravings, urge to snack, appetite, post-meal energy, weight and perceived blood sugar control. The survey also explored taste, ease of use and overall satisfaction.
Publication / source
Consumer survey. No statistical-significance claim.
Self-Reported Benefits on Appetite, Energy and Metabolic Well-beingSurvey cohort: N = 152 • 2024CONSUMER SURVEY
Key findings
The research explored self-reported experiences relating to fullness and satiety, hunger, snacking, sugar cravings, post-meal energy, digestive comfort and perceived blood sugar management.
Publication / source
Consumer survey. Outcome-specific sample sizes vary by question.
PRECLINICAL RESEARCH

Understanding how the technology works.

Preclinical science is the foundation for understanding the SiPore® mechanism. Five key peer-reviewed preclinical publications spanning 2014–2023.

Activity and Stability of Nanoconfined Alpha-Amylase in Mesoporous SilicaIqbal et al., 2023 • ACS Materials AuPRECLINICAL RESEARCH
Objective
Mechanism
Key findings
Evidence from preclinical research showed that alpha-amylase can be physically entrapped within mesoporous silica pores while retaining enzymatic activity. The findings support a physical, local mechanism in which digestive enzymes are separated from food during part of the digestive process.
Publication / source
Iqbal et al., 2023. ACS Materials Au.
Read the paper
View publication
Mesoporous Silica Particles Retain Their Structure and Function while Passing through the Gastrointestinal Tracts of Mice and HumansIqbal et al., 2023 • ACS Applied Materials & InterfacesPRECLINICAL / TRANSLATIONAL RESEARCH
Objective
Gut-local behavior
Key findings
The study found that mesoporous silica particles retained their structure while passing through the gastrointestinal tract. Their micron-scale size helps explain why the particles are not systemically absorbed.
Publication / source
Iqbal et al., 2023. ACS Applied Materials & Interfaces.
Read the paper
View publication
Towards Mesoporous Silica as a Pharmaceutical Treatment for Obesity – Impact on Lipid Digestion and AbsorptionMay et al., 2022 • European Journal of Pharmaceutics and BiopharmaceuticsPRECLINICAL RESEARCH
Objective
Fat digestion
Key findings
Evidence from preclinical research showed adsorption of lipase and reduced lipid digestion. Animal findings also showed delayed and reduced fat uptake.
Publication / source
May et al., 2022. European Journal of Pharmaceutics and Biopharmaceutics.
Read the paper
View publication
Mesoporous Silica with Precisely Controlled Pores Reduces Food Efficiency and Suppresses Weight Gain in MiceRinde et al., 2020 • NanomedicineANIMAL RESEARCH
Objective
Metabolic effects in animal models
Key findings
In animal research, engineered mesoporous silica suppressed weight gain, reduced fat-tissue accumulation and lowered nutrient utilization.
Publication / source
Rinde et al., 2020. Nanomedicine.
Read the paper
View publication
Large Pore Mesoporous Silica Induced Weight Loss in Obese MiceKupferschmidt et al., 2014 • NanomedicineANIMAL RESEARCH
Objective
Metabolic effects in animal models
Key findings
This early animal study found that mesoporous silica reduced body weight and fat mass in obese mice, without a reduction in lean body mass.
Publication / source
Kupferschmidt et al., 2014. Nanomedicine.
Read the paper
View publication
THE RESEARCH CONTINUUM

Each layer adds to the picture.

  1. ENGINEERED MATERIAL
  2. MECHANISM
  3. CONTROLLED HUMAN STUDIES
  4. REAL-WORLD EVIDENCE
  5. CONSUMER EXPERIENCE

Preclinical research helps explain how the engineered material behaves and how the mechanism works. Clinical studies test defined questions under controlled human research conditions. Real-world evidence extends observation into everyday use. Consumer research captures the experiences people themselves report.

No single evidence type answers every question. Together, they form the SiPore® research program.

OUR APPROACH TO EVIDENCE

Study type matters.

CLINICAL STUDYHuman research conducted under a defined clinical protocol.
REAL-WORLD EVIDENCEObservational evidence generated in real-world use.
CONSUMER STUDYSelf-reported consumer experience.
PRECLINICAL RESEARCHLaboratory or animal evidence used to investigate mechanism and biological effects.
SAFETY & TOLERABILITY

Evaluated across the research program.

Safety and tolerability have been evaluated through dedicated human research as well as across the broader SiPore® clinical program. Across the human evidence base, SiPore® has been generally well tolerated.

Explore Safety & Tolerability
9 PEER-REVIEWED PUBLICATIONS

Go directly to the science.

Explore the peer-reviewed literature behind SiPore®, including human clinical studies, mechanism research, safety research and preclinical publications.

View all publications

Continue exploring the evidence.