FDA places clinical hold on vTv Therapeutics' cadisegliatin diabetes trial due to unresolved chromatographic signal.

The FDA has placed a clinical hold on vTv Therapeutics' cadisegliatin clinical program, including the ongoing CATT1 Phase 3 trial for type 1 diabetes. This follows an unresolved chromatographic signal in a human ADME study of cadisegliatin, which requires a single in vitro study before the program can resume. The company, working closely with the FDA, aims to resolve the clinical hold and resume enrollment as soon as possible.