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.
July 26, 2024
5 Articles