vTv Therapeutics Inc. VTVT

We are a late-stage biopharmaceutical company focused on developing orally administered therapies for metabolic and inflammatory diseases with the goal of improving patient outcomes. Our lead product candidate, cadisegliatin (TTP399), is a novel, small-molecule, liver-selective glucokinase activator (GKA) currently being evaluated in a Phase 3 clinical trial as a potential oral adjunctive therapy to insulin for the treatment of type 1 diabetes (T1D). The Cadisegliatin as Adjunctive Therapy to Insulin in Participants with Type 1 Diabetes ("CATT1") Phase 3 clinical trial is a randomized, double-blind, placebo-controlled trial designed to evaluate the effect of cadisegliatin on hypoglycemia outcomes in patients with T1D. The primary endpoint is the reduction in the frequency of Level 2 hypoglycemia (blood glucose <54 mg/dL) and Level 3 (severe) hypoglycemia over a six-month treatment period. A key secondary endpoint is change in hemoglobin A1c (HbA1c), a standard measure of glycemic control, to assess cadisegliatin's potential to reduce hyperglycemia. The CATT1 trial will randomize 150 patients with T1D on a 1:1:1 basis (50 patients per study arm) to receive 800 mg cadisegliatin daily, 800 mg cadisegliatin twice daily, or placebo.