{"id":2738,"date":"2022-02-14T14:41:10","date_gmt":"2022-02-14T13:41:10","guid":{"rendered":"https:\/\/www.biopole-clermont.com\/?p=2738"},"modified":"2022-03-04T14:43:13","modified_gmt":"2022-03-04T13:43:13","slug":"valbiotis-announces-approval-to-launch-the-two-phase-ii-iii-insight-and-insight-2-clinical-studies-the-last-step-in-the-development-of-totum854-for-the-reduction-of-blood-pressure","status":"publish","type":"post","link":"https:\/\/www.biopole-clermont.com\/en\/valbiotis-announces-approval-to-launch-the-two-phase-ii-iii-insight-and-insight-2-clinical-studies-the-last-step-in-the-development-of-totum854-for-the-reduction-of-blood-pressure\/","title":{"rendered":"Valbiotis announces approval to launch the two Phase II\/III INSIGHT and INSIGHT 2 clinical studies, the last step in the development of TOTUM\u2022854 for the reduction of blood pressure."},"content":{"rendered":"<p>&nbsp;<\/p>\n<p>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\u2022854, 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.<\/p>\n<ul>\n<li><\/li>\n<li>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 &lt; 100 mmHg). It will include two groups: a TOTUM\u2022854 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\u2022854 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.<\/li>\n<li>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\u2022854 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\u2022854 group and the placebo group.<\/li>\n<\/ul>\n<p>&nbsp;<\/p>\n<p>In addition to these clinical efficacy studies, the development plan for TOTUM\u2022854 includes a bioavailability and mode of action study in 10 volunteers to characterize TOTUM\u2022854 metabolites and identify their effects on human cell lines. The results are expected by the end of 2022.<\/p>\n<p><strong>VALBIOTIS<\/strong><br \/>\n<strong>Biop\u00f4le Clermont-Limagne<\/strong><br \/>\nPhone: +33\u00a0546\u00a0284 567<br \/>\nContact: Marc Delaunay |\u00a0<a href=\"mailto:marc.delaunay@valbiotis.com\">marc.delaunay@valbiotis.com<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Valbiotis announces approval to launch the two Phase II\/III INSIGHT and INSIGHT 2 clinical studies, the last step in the development of TOTUM\u2022854 for the reduction of blood pressure.<\/p>\n","protected":false},"author":2,"featured_media":2739,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[8],"tags":[],"class_list":["post-2738","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-uncategorized"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.2 - 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