vTv Therapeutics completes Phase 3 enrolment for cadisegliatin
vTv Therapeutics has completed enrolment in its Phase 3 CATT1 study of cadisegliatin, a small-molecule glucokinase activator being investigated as an adjunctive oral therapy for type 1 diabetes. A total of 166 patients have been randomised across three arms: cadisegliatin 800 mg once daily, cadisegliatin 800 mg twice daily, or placebo. The company expects to report topline results in mid-2027.
Cadisegliatin carries FDA Breakthrough Therapy designation as an adjunctive therapy to insulin in T1D, a designation that reflects the agency's view that preliminary clinical evidence suggests the drug may offer a substantial improvement over available therapy for a serious condition. The primary efficacy endpoint for CATT1 is the incidence of level 2 and level 3 hypoglycaemic events, with secondary endpoints covering HbA1c, time in target glucose range, and incidence of diabetic ketoacidosis.
Addressing a persistent unmet need
Hypoglycaemia remains a central burden for people managing T1D, even as insulin pump technology and continuous glucose monitoring have improved overall control. vTv positions cadisegliatin as a liver-selective activator of glucokinase, an enzyme that regulates hepatic glucose uptake, meaning it works independently of insulin rather than amplifying insulin's own action. That selectivity is the mechanism the company argues should reduce hypoglycaemia risk without the off-target pancreatic effects that limited earlier, non-selective glucokinase activators in clinical development.
Thomas Strack, Chief Medical Officer at vTv, said the company's focus is now "maintaining the quality and integrity of the study through completion and continuing the important work of advancing cadisegliatin development toward potential approval."
Market context and competitive landscape
The T1D adjunctive therapy space has seen sustained interest from both developers and regulators. Sodium-glucose cotransporter inhibitors, including empagliflozin and sotagliflozin, have been studied in T1D, but concerns over diabetic ketoacidosis risk have constrained their use in the indication. A liver-selective mechanism that avoids renal glycosuria sidesteps that particular safety concern, which could prove commercially significant if the CATT1 data are positive.
vTv estimates the global T1D population will grow from roughly 9.5 million today to 14.7 million by 2040, figures drawn from the International Diabetes Federation Atlas. That trajectory points to a large and expanding addressable market for any adjunct that demonstrably reduces hypoglycaemic burden.
The company is small by industry standards, listed on Nasdaq under the ticker VTVT, and cadisegliatin is its lead asset. A positive Phase 3 readout in mid-2027 would open the path to an NDA filing and likely trigger partnership or licensing discussions. A negative result, by contrast, would leave the pipeline with limited near-term clinical optionality. Investors and analysts following the company will monitor enrolment retention and any interim safety signals between now and the topline readout.