vTv Therapeutics Finishes Enrollment in Phase 3 CATT1 Trial

vTv Therapeutics has completed patient enrollment for its Phase 3 CATT1 study evaluating cadisegliatin as an adjunctive treatment for type 1 diabetes, with topline results from the six-month trial anticipated in mid-2027.

The milestone moves the experimental therapy closer to potential regulatory filings as researchers monitor 166 enrolled participants in the randomized, double-blind, placebo-controlled trial.

"Completing enrollment for the CATT1 study is a significant milestone for vTv, and we're deeply grateful to the study participants whose commitment made this possible," said Paul Sekhri, Chairman, President and Chief Executive Officer of vTv Therapeutics.

Trial Parameters and Dosing Regimens

Participants in the CATT1 study are assigned to one of three cohorts. Patients receive either 800 mg of cadisegliatin once daily, 800 mg twice daily, or a placebo, administered alongside their standard insulin regimens.

Cadisegliatin has previously earned Breakthrough Therapy designation from the U.S. Food and Drug Administration. The designation is intended to expedite the development and review of drugs designed to treat serious conditions where preliminary clinical evidence indicates substantial improvement over existing therapies.

"This milestone is an important step forward for the cadisegliatin program," said Thomas Strack, MD, Chief Medical Officer of vTv Therapeutics. "Our focus now is maintaining the quality and integrity of the study through completion and continuing the important work of advancing cadisegliatin development toward potential approval."

Understanding Adjunctive T1D Therapies

Type 1 diabetes is an autoimmune condition where the pancreas produces little or no insulin, requiring patients to rely on lifelong insulin replacement therapy to manage blood glucose levels. Adjunctive treatments like cadisegliatin are developed to be used alongside insulin to help achieve better glycemic control without increasing the risk of hypoglycemia or excessive weight gain.

The six-month duration of the CATT1 trial will measure key efficacy and safety endpoints before researchers compile the data for the anticipated mid-2027 topline readout.