vTv Therapeutics completes Phase 3 enrollment for T1D drug

vTv Therapeutics, a biopharmaceutical company, has successfully enrolled 166 patients in its Phase 3 clinical trial for a new diabetes medication. The study, known as CATT1, is examining cadisegliatin, an oral glucokinase activator, as an additional treatment for type 1 diabetes when used alongside insulin injections or continuous subcutaneous insulin infusion.

The drug, which has received Breakthrough Therapy designation from the FDA, is administered orally in three different dosages: 800 mg once daily, 800 mg twice daily, or a placebo. The primary goal of the study is to determine the incidence of hypoglycemic events over a six-month period, while secondary endpoints include changes in hemoglobin A1c levels, time spent within a target glucose range, and the occurrence of diabetic ketoacidosis compared to placebo.

The company anticipates releasing initial results in mid-2027. The study's participants are individuals aged 18 and above who have been diagnosed with type 1 diabetes and are currently on insulin therapy. Cadisegliatin, a novel drug candidate, is being investigated as a potential first-in-class adjunctive treatment for type 1 diabetes, but its safety and efficacy have yet to be established.