vTv Fully Enrolls Phase 3 Cadisegliatin Trial in Type 1 Diabetes

Key Points

• vTv Therapeutics has completed enrollment in its Phase 3 CATT1 study of cadisegliatin as an add-on treatment to insulin for adults with type 1 diabetes.
• The trial randomized 166 patients and is expected to report topline results in mid-2027.
• Cadisegliatin is an investigational oral, liver-selective glucokinase activator that has received FDA Breakthrough Therapy designation.
• The six-month study will assess whether cadisegliatin reduces clinically significant hypoglycemia while supporting overall glucose control.
• Cadisegliatin is not FDA approved, and its safety and effectiveness have not been established.

vTv Therapeutics (NASDAQ: VTVT) has completed enrollment in CATT1, its pivotal Phase 3 study of cadisegliatin in type 1 diabetes. The milestone shifts the program from recruitment to study completion, with the company targeting topline data in mid-2027.

CATT1 Study Tests Cadisegliatin as an Insulin Add-On Therapy

CATT1 is a randomized, double-blind, placebo-controlled Phase 3 study in adults age 18 and older with type 1 diabetes who use either multiple daily insulin injections or continuous subcutaneous insulin infusion, along with continuous glucose monitoring.

Participants were randomized to receive cadisegliatin 800 mg once daily, cadisegliatin 800 mg twice daily or placebo for six months. The trial enrolled 166 patients.

Main Goal Is Reducing Clinically Significant Hypoglycemia

The primary efficacy endpoint is the occurrence of Level 2 and Level 3 hypoglycemic events. In practical terms, the study is designed to evaluate whether cadisegliatin can reduce meaningful low-blood-sugar episodes in people already using insulin.

Secondary measures include changes in hemoglobin A1c, time spent in the target glucose range and diabetic ketoacidosis incidence compared with placebo. These outcomes will help determine whether any reduction in hypoglycemia comes alongside improved or maintained overall glucose control.

Cadisegliatin Targets Liver Glucokinase Activity

Cadisegliatin, also known as TTP399, is a small-molecule oral drug candidate designed to activate glucokinase selectively in the liver. In nonclinical research, vTv said the candidate increased glucokinase activity independently of insulin, supporting investigation of its potential effect on hepatic glucose uptake and glycogen storage.

The FDA has granted cadisegliatin Breakthrough Therapy designation as an adjunctive treatment to insulin for type 1 diabetes. That designation can support more intensive FDA interaction during development, but it does not constitute approval or guarantee a favorable review.

Investor Takeaway: Results in Mid-2027 Are the Decisive Catalyst

For VTVT investors, completing enrollment removes a key execution risk and sets a clear timeline for the program’s next major value-driving event: Phase 3 results expected in mid-2027. The data will need to show a clinically meaningful reduction in hypoglycemia with an acceptable safety profile, while preserving or improving broader glucose-control measures.

Until results are available, cadisegliatin remains investigational. Enrollment completion does not indicate trial success, FDA approval or eventual commercial availability