Conceptually new, potentially safer obesity treatment:clinical safety trial with precisely engineered silica
| Reference number | |
| Coordinator | Sigrid Therapeutics AB - Sigrid Therapeutics |
| Funding from Vinnova | SEK 1 143 500 |
| Project duration | June 2015 - March 2016 |
| Status | Completed |
Important results from the project
Sigrid Therapeutics is developing a medical treatment for obesity, based on precisely engineered porous silica particles. Determining the clinical safety profile of the product particle was the purpose of this Vinnova funded application. The aim was to study potential side effects of the compound in increasing doses, 3,6 and up to 9 grams daily in both obese and health male individuals. The goal was successfully carried out.
Expected long term effects
The compiled data of the approximately 3 months long clinical trial reveals that Sigrid´s specifically engineered porous silica particles are safe and well tolerated at higher doses. No related side effects of porous silica have been observed. A number of interesting biomarkers have been observed but these will be discussed in upcoming publications.
Approach and implementation
The project was divided into three work packages: I) Production and Formulation of material for the clinical safety trial, performed in collaboration with SP Process Development. II) A Two-Phase Clinical Study at Karolinska Institute. Effects on the gastrointestinal function, blood levels of lipophilic vitamins, trace elements, blood lipids and inflammation markers were measured and silica levels traced in faeces and urine samples throughout the study. III) Analysis and Compilation of data collected from the participants. All three work packages were successfully carried out.