The University of North Carolina will serve as a study site for the vTv Therapeutics Inc. 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.
“Although there have been major advances in medical devices for the treatment of type 1 diabetes, there is a huge unmet need to identify therapies that improve glycemia without increasing the risk of ketosis or hypoglycemia,” said diabetes expert, Klara Klein, MD, PhD, who is Assistant Professor of Medicine in the UNC Division of Endocrinology and Metabolism. “People with type 1 diabetes continue to walk a tightrope between hyper- and hypoglycemia. There’s real potential for glucokinase activators not only to improve glycemia overall but to do so while providing some protection against hypoglycemia and, potentially, diabetic ketoacidosis, which could ease some of the mental burden of type 1 diabetes care.”
The Phase 3 CATT1 trial (NCT06334133) is being conducted at up to 25 sites in the U.S. Dr. Klein is the Principal Investigator of the UNC study site. 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.