Valbiotis announces approval to launch the two Phase II/III INSIGHT and INSIGHT 2 clinical studies, the last step in the development of TOTUM•854 for the reduction of blood pressure.
Valbiotis, a Research and Development company committed to scientific innovation for preventing and combating metabolic diseases, announces that it has received approval to launch the two international multicenter Phase II/III INSIGHT and INSIGHT 2 clinical studies on TOTUM•854, for the reduction of blood pressure. These two trials will include 800 volunteers with mild to moderate elevated blood pressure, a risk factor for cardiovascular diseases, with 400 volunteers in each study. The authorizations received enable the launch of clinical recruitment, scheduled to be completed in the first half of 2023.
- The INSIGHT Phase II/III international, multicenter, randomized, placebo-controlled clinical study will be conducted on a population of 400 volunteers with mild to moderate elevated blood pressure (systolic blood pressure between 130 mmHg and 159 mmHg and diastolic blood pressure < 100 mmHg). It will include two groups: a TOTUM•854 group with a dose of 3.7 g/day and a placebo group. The primary endpoint will be a reduction in systolic blood pressure, after 3 months of supplementation, between the TOTUM•854 group and the placebo group. In addition, 24-hour ambulatory blood pressure measurement will be performed and will be one of the secondary endpoints of the study.
- The INSIGHT 2 clinical study, also international, multicenter, randomized and placebo-controlled, will be carried out on 400 other subjects with the same inclusion criteria. There will be two groups: a TOTUM•854 group receiving a reduced dose (2.6 g/day) and a placebo group. The primary endpoint will be a reduction in systolic blood pressure, after 3 months of supplementation, between the TOTUM•854 group and the placebo group.
In addition to these clinical efficacy studies, the development plan for TOTUM•854 includes a bioavailability and mode of action study in 10 volunteers to characterize TOTUM•854 metabolites and identify their effects on human cell lines. The results are expected by the end of 2022.
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