HIGH POINT, N.C. — October 5, 2026
vTv Therapeutics Inc. announced that it has completed enrollment in the Phase 3 CATT1 clinical trial evaluating cadisegliatin (TTP399) as an adjunctive therapy to insulin for adults with type 1 diabetes (T1D). A total of 166 patients have been randomized in the study, which is evaluating the oral investigational therapy for its potential to reduce clinically significant hypoglycemia while improving overall glycemic control. Cadisegliatin is a potential first-in-class, liver-selective glucokinase activator that has received U.S. FDA Breakthrough Therapy designation as an adjunctive treatment for T1D. With enrollment complete, vTv expects to report topline results from the CATT1 study in mid-2027.
Cadisegliatin Targets Liver Glucose Regulation
Cadisegliatin is an oral small-molecule glucokinase activator designed to selectively increase glucokinase activity in the liver independently of insulin. Preclinical studies indicated that the therapy may enhance hepatic glucose uptake and glycogen storage, providing a potential mechanism for improving glucose regulation in people with T1D. The development program is focused particularly on the persistent burden of hypoglycemia, which remains an important challenge despite advances in insulin delivery and glucose-monitoring technologies. vTv is investigating whether cadisegliatin can provide additional glycemic control when used alongside insulin while potentially reducing clinically significant hypoglycemic events. The candidate remains investigational, and its safety and efficacy for T1D have not yet been established.
CATT1 Evaluates Two Cadisegliatin Doses
The CATT1 study is a randomized, double-blind, placebo-controlled Phase 3 trial evaluating cadisegliatin over six months in adults aged 18 years and older with T1D. Participants use either multiple daily insulin injections or continuous subcutaneous insulin infusion together with continuous glucose monitoring and were randomized to receive cadisegliatin 800 mg once daily, cadisegliatin 800 mg twice daily, or placebo. The primary efficacy endpoint is the incidence of Level 2 and Level 3 hypoglycemic events, while secondary endpoints include changes in hemoglobin A1c, time in target glucose range and the incidence of diabetic ketoacidosis. The completed enrollment provides the basis for the planned efficacy and safety assessment as the study progresses toward its expected mid-2027 topline readout.
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vTv Advances Cadisegliatin Toward Potential Approval
Completion of CATT1 enrollment marks an important development milestone for vTv Therapeutics as it advances cadisegliatin through late-stage clinical testing in T1D. The company is developing the candidate to address persistent gaps in day-to-day glucose management despite modern diabetes technologies and insulin therapies. An estimated 9.5 million people worldwide live with T1D, with that number projected to increase to 14.7 million by 2040, according to the company. The Phase 3 program is intended to determine whether cadisegliatin can demonstrate a clinically meaningful benefit on hypoglycemia and other measures of glycemic control. With enrollment now complete and topline results expected in mid-2027, vTv Therapeutics is moving cadisegliatin closer to a potential regulatory submission while the therapy remains investigational.
Source:vTv Therapeutics, press release
