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# FDA Slaps Hold on Diabetes Investigational Drug
- URL: https://www.fdaweb.com/fda-slaps-hold-on-diabetes-investigational-drug/
- Published: 2024-07-26T12:00:00.000Z
- Updated: 2026-09-14T14:36:36.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5157444

FDA has placed a clinical hold on a vTv Therapeutics Phase 3 trial (CATT1) involving cadisegliatin and its use in improving glycemic control in Type 1 diabetes patients. Cadisegliatinis an oral, liver-selective, glucokinase activator that the company says has been well-tolerated in over 500 subjects to date with up to six months of treatment. Selectively acting on the liver, cadisegliatin is said to increase the activity of glucokinase independently from insulin to improve glycemic control.

“The clinical hold was based on the discovery of a chromatographic signal in a recent human absorption, distribution, metabolism, and excretion (ADME) study of cadisegliatin that could not be resolved by standard mass spectroscopy,” the company says. “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.”

vTv says cadisegliatin demonstrated “compelling efficacy and a favorable safety profile” in previous subjects dosed to date.