The SiPore21 device, if cleared, will be registered as a Class IIb medical device. Image Credit: Mikhailava Alesia / Shutterstock.

Sigrid Therapeutics has started the Shine clinical trial for SiPore21, a device designed to control diabetes and obesity.

SiPore technology is based on mesoporous silica particles (MSPs), a colloidal amorphous silicon dioxide matrix. It acts like a “molecular sieve” to physically prevent the interaction between digestive enzymes and food, thereby reducing food breakdown into basic absorbable units. The SiPore21 device, if cleared, will be registered as a Class IIb medical device.

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Most diabetes control devices are either continuous glucose monitors or insulin pumps. The market for these devices is forecasted to be worth around $20.8bn in 2033, as per GlobalData. With such a huge diabetes device market, many companies have alternative means to manage/control diabetes, such as information apps to increase disease awareness and scheduling apps to remind people about their medications.

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The placebo-controlled Shine trial will evaluate the safety and efficacy of SiPore21 in people with elevated blood glucose levels who are either obese or overweight.

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The primary endpoint for the trial is lowering of the blood sugar, measured using haemoglobin A1c (HbA1c), compared with the placebo. The study’s secondary endpoints measure a wide range of health parameters such as body weight, insulin resistance and others.

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The trial expects to enrol around 288 patients aged between 18 and 70 across three European countries. The recruitment is expected to be completed in H1 2024, with preliminary data expected in Q2 2024.

In January, Sigrid raised SKr10.6m ($0.96m) to fund the commercialisation of the previous version of the SiPore device, SiPore15. The company is seeking a market registration in the EU for the diabetes control device.