vTv Therapeutics Announces FDA has Lifted Clinical Hold on Cadisegliatin Program for Diabetes

Core Viewpoint - vTv Therapeutics has received FDA approval to lift the clinical hold on its cadisegliatin program, allowing the resumption of the CATT1 Phase 3 trial for type 1 diabetes, with a protocol amendment to shorten the trial duration from 12 months to 6 months [1][3][2] Group 1: Clinical Trial Updates - The CATT1 Phase 3 trial will now be conducted over 6 months instead of the original 12 months, expediting the process for larger pivotal studies necessary for future New Drug Application (NDA) submission [2][3] - The primary endpoint of assessing level 2 and 3 hypoglycemia rates at 6 months remains unchanged, while the additional 6-month period for safety data collection will be omitted [2][3] Group 2: Cadisegliatin Overview - Cadisegliatin (TTP399) is a novel oral small molecule that acts as a liver-selective glucokinase activator, being investigated as a potential first-in-class oral adjunctive treatment to insulin for type 1 diabetes [4][6] - In nonclinical studies, cadisegliatin has shown the ability to increase glucokinase activity independently from insulin, suggesting potential improvements in glycemic control through enhanced hepatic glucose uptake and glycogen storage [4] Group 3: Company Background - vTv Therapeutics Inc. is a late-stage biopharmaceutical company focused on developing novel oral, small molecule drug candidates aimed at treating chronic diseases, with cadisegliatin as the lead candidate in its clinical pipeline [6]