Hold Removed on vTv Therapeutics Diabetes Trial

FDA has lifted a clinical hold against vTv Therapeutics’ cadisegliatin clinical program (CATT1 Phase 3 trial) evaluating the first-in-class oral adjunctive therapy to insulin for treating Type 1 diabetes. Cadisegliatin is described by the company as a liver-selective glucokinase activator that has been well tolerated in over 500 subjects to date with up to six months of treatment.

The clinical hold was ordered 7/2024 and was based on the discovery of a chromatographic signal in a recent human absorption, distribution, metabolism, and excretion study of cadisegliatin that could not be resolved by standard mass spectroscopy, the company said at the time. “The agency requires a single in vitro study to characterize this signal before the cadisegliatin program can resume. No patient had been dosed in CATT1 at the time of the clinical hold, and past clinical studies did not reveal any clinically concerning safety issues,” it said.