vTv Therapeutics reports reinitiation of screening in CATT1 Phase 3 trial

vTv Therapeutics (VTVT) announced that screening has been reinitiated in the company’s CATT1 Phase 3 trial investigating cadisegliatin as an adjunctive treatment of type 1 diabetes. Cadisegliatin is a potential first-in-class, oral, liver-selective glucokinase activator for T1D that has been granted Breakthrough Therapy designation by the FDA. “We are thrilled that we have resumed our CATT1 Phase 3 trial and screened a subject under the amended protocol,” said Paul Sekhri, Chairman, President and CEO of vTv Therapeutics. “The amendment to the protocol will help expedite time to both topline data and the initiation of required larger pivotal studies moving us one step closer to the future New Drug Application submission. We look forward to reporting topline Phase 3 data from CATT1 in the second half of 2026.” vTv Therapeutics reinitiated the CATT1 study and has screened a subject under a recently submitted protocol amendment that reduced the overall duration of the trial from 12 to 6 months, which will expedite time to topline data with no impact on the key study endpoints. Under the protocol amendment, continuous glucose monitors will now be provided to all participants to inform the primary study endpoint, which is the number of level 2 and level 3 hypoglycemic events. CATT1 is a randomized, double-blind, placebo-controlled Phase 3 study evaluating the efficacy and safety of cadisegliatin over 6 months in adults 18 years or older diagnosed with T1D. The trial is expected to enroll approximately 150 patients at 20-25 sites in the U.S. Two doses of orally administered cadisegliatin versus placebo will be assessed in patients currently being treated with multiple daily insulin injections and continuous subcutaneous insulin infusion who use a provided continuous glucose monitor. The primary efficacy endpoint of the study will compare the incidence of level 2 and level 3 hypoglycemic events between cadisegliatin-treated subjects and those in the placebo group.