vTv Therapeutics (VTVT) 38th Annual Roth Conference summary

Key clinical and scientific updates

• Lead asset cadisegliatin (CADI) is in phase III for Type 1 diabetes, with enrollment completion expected in Q3 and top-line data 7–8 months after enrollment closes.

• CADI targets a major unmet need: 75% of U.S. T1D patients do not meet ADA glycemic targets, and hypoglycemia is a primary barrier.

• CADI has shown clinically meaningful reductions in hypoglycemia and A1c, with a strong safety profile in over 500 patients and FDA Breakthrough Therapy designation.

• The CATT1 trial uses CGM for more reliable hypoglycemia data and includes both once and twice daily dosing arms to optimize efficacy and patient experience.

• CADI’s mechanism restores hepatic glucokinase activity, addressing the physiological limitations of exogenous insulin and reducing both hyper- and hypoglycemia.

Operational and enrollment progress

• Trial sites expanded from 25 to 51 to accelerate enrollment, with improved pace and Q3 completion guidance.

• The trial design includes a rigorous run-in period and baseline data collection to ensure robust results.

• CGM use in CATT1 enhances data completeness and statistical power compared to prior patient-reported methods.

Safety, risk, and regulatory considerations

• CADI does not share the DKA risk pathway of SGLT2 inhibitors and has shown no increase in DKA incidence versus placebo in over 500 patients.

• CATT1 protocol includes exclusion of recent DKA, ketone monitoring, and adjudicated review of DKA events; DKA is a key secondary endpoint.