Hypercholesterolemia: Valbiotis announces the major success of the Phase II HEART clinical study.
Valbiotis, a Research and Development company committed to scientific innovation for preventing and combating metabolic diseases, announces the major success of the Phase II HEART clinical study, which achieved its objective of reducing blood LDL cholesterol level (primary endpoint) with TOTUM•070 and confirmed the very good tolerance of this active substance. This multicentric, randomized, placebo-controlled, double-blind study was conducted in 120 volunteers with mild to moderate untreated hypercholesterolemia and tested a daily dose of 5 g in two intakes for 6 months.
As early as three months of supplementation, TOTUM•070 significantly reduced blood levels of LDL cholesterol (-13%, p<0.01), and triglycerides (-14%, p<0.05), compared to placebo. Excess of these blood lipid markers is a cardiovascular risk factor.
Thanks to these very good clinical results, TOTUM•070, an innovative patented active substance derived from food plant extracts becomes a clinically proven non-drug option for people with untreated mild to moderate LDL hypercholesterolemia, as a complement to lifestyle and dietary recommendations.
Valbiotis sets the objective of commercialization based on these Phase II results, no later than the first half of 2024, and is intensifying its discussions with major health and nutrition players.
Hypercholesterolemia is one of the major and most widespread cardiovascular risk factors, with a prevalence of 39% in the adult population worldwide, 48% in North America, 54% in Europe and 62% in France, 174 million adults in the United States and the 5 major European countries alone.
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