GlobeNewswire News Room·2025-06-23 11:30Core Insights - Fractyl Health, Inc. announced new preclinical data demonstrating that a single dose of Rejuva is well tolerated in healthy animals and prevents weight gain and hyperglycemia when exposed to a high-fat diet [1][2][4] - The findings support the advancement of RJVA-001 toward first-in-human studies, with preliminary clinical data expected in 2026 [1][5] Group 1: Study Findings - Rejuva treatment resulted in a 20% reduction in body weight and a 38% decrease in blood glucose in a diet-induced obesity model by day 21, effects maintained through day 37 despite continued high-fat diet exposure [7] - In lean animals, Rejuva prevented weight gain and hyperglycemia, maintaining baseline body weight and showing an 8% reduction in blood glucose relative to baseline [7] - Rejuva was well-tolerated across all treatment groups, with no signs of toxicity or excessive weight loss [7] Group 2: Mechanism of Action - Rejuva's Smart GLP-1 design allows for nutrient-responsive secretion, activating only under metabolic stress and remaining inactive under healthy conditions, which may offer superior potency and tolerability compared to systemic GLP-1 receptor agonists [2][3] - The treatment localizes to the pancreas, enabling nutrient-stimulated GLP-1 secretion from beta cells, mimicking natural hormone regulation [3][9] Group 3: Clinical Development - Fractyl has completed key in vivo studies for RJVA-001, its first clinical candidate targeting type 2 diabetes, and expects to dose the first patients pending regulatory authorization [5][11] - The company aims to transform metabolic disease treatment from chronic management to durable disease-modifying therapies targeting root causes [10][11] Group 4: Scientific Validation - The study was led by a team from Fractyl Health and the University of Michigan, including experts in metabolic diseases, underscoring the scientific momentum behind Rejuva's differentiated approach [6][8]