vTv Therapeutics Announces First Participant Has Been Randomized In Its Phase 3 Catt1 Trial Evaluating Cadisegliatin As An Adjunctive Oral Treatment To Insulin In Adults With Type 1 Diabetes

vTv Therapeutics Inc. (NASDAQ:VTVT), a late-stage biopharmaceutical company with an innovative clinical portfolio of small molecules and lead program in diabetes, today announced the first study participant has been randomized in the Company's CATT1 Phase 3 trial investigating cadisegliatin as an adjunctive treatment to insulin in adults with type 1 diabetes (T1D). Cadisegliatin is a potential first-in-class, oral, liver-selective glucokinase activator for T1D that has been granted Breakthrough Therapy designation by the U.S. Food and Drug Administration (FDA) and has been well-tolerated in over 500 subjects to date with up to six months of treatment.

Despite major advances made in medical devices used to help manage blood glucose levels in people living with T1D, there have been few therapeutic advances. To date, there has not been any FDA-approved oral adjunct therapy to insulin to treat T1D. "Randomizing the first participant in CATT1 represents another key milestone for vTv's development of cadisegliatin as a potential therapy to improve glycemic control for the nearly 1.6 million Americans living with T1D," said Dr. Thomas Strack, Chief Medical Officer of vTv Therapeutics. "We look forward to reporting topline Phase 3 data from CATT1 in the second half of 2026."

The Phase 3 CATT1 trial (NCT06334133) is being conducted at up to 25 sites in the U.S. Recruitment is ongoing, and the trial is expected to enroll approximately 150 participants. The trial is a randomized, double-blind, placebo-controlled study evaluating the efficacy and safety of cadisegliatin over six months in adults 18 years or older diagnosed with T1D. Two different dose regimens (800 mg once or twice daily) of orally administered cadisegliatin versus placebo will be assessed in participants currently being treated with multiple daily insulin injections or continuous subcutaneous insulin infusion. Per the protocol, continuous glucose monitors (CGM) will now be provided to all participants to inform the primary study endpoint, which is the incidence of level 2 and 3 hypoglycemic events in cadisegliatin-treated participants compared to those in the placebo group (insulin alone). Select secondary endpoints include reduction in hemoglobin A1C (HbA1c), time in target range of glycemic control, and incidence of diabetic ketoacidosis.