NCT06087822

Multicenter Trial Investigating Performance and Safety of the Medical Device SiPore21®

Randomized, Double-blinded, Placebo-controlled, Multicenter Trial Investigating Performance and Safety of the Medical Device SiPore21® in Obese or Overweight Subjects With Elevated Blood Glucose Levels

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 318 (actual)
• Sponsor: Sigrid Therapeutics AB · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The present clinical investigation is a randomized, double-blinded, placebo-controlled, multicenter international trial, planned to be conducted in Poland, Romania and Slovakia. The investigation will be performed to establish clinical evidence regarding the performance and safety of the IMD and is aiming at evaluating the suitability of the IMD for the intended purpose and population.

Detailed description

The proposed investigation is set out to be a randomized, double blind, placebo-controlled, multicenter study according to MDR Article 62 to investigate performance and safety of the medical device SiPore21® in subjects with obesity or overweight and elevated blood glucose levels. The aim of this clinical investigation is to evaluate the clinical performance of the IMD for blood glucose control and its clinical safety. The endpoints selected to evaluate the effects of the IMD are based on the state-of-the-art assessments of blood glucose control (ADA, 2022). The main hypothesis is that treatment with SiPore21® for 12 weeks will reduce the HbA1c in obese or overweight subjects with elevated blood glucose levels. It is further hypothesized that treatment with SiPore21® for 12 weeks will result in a reduction in body weight and influence metabolic control parameters and lipid levels.

Conditions

• Overweight or Obesity

Interventions

Type	Name	Description
DEVICE	IMD SiPore21®	The intended use/purpose to improve blood glucose control, as measured by a reduction in HbA1c

Timeline

• Start date: 2023-10-05
• Primary completion: 2024-07-30
• Completion: 2024-07-30
• First posted: 2023-10-18
• Last updated: 2024-12-09

Locations

27 sites across 3 countries: Poland, Romania, Slovakia