VTv Therapeutics Says FDA Lifted Clinical Hold On Cadisegliatin Program For Diabetes

(RTTNews) - vTv Therapeutics Inc. (VTVT), a clinical stage biopharmaceutical company, Monday said that the United States Food and Drug Administration (FDA) has lifted the clinical hold on the cadisegliatin program, which includes the CATT1 Phase 3 study in type 1 diabetes (T1D).

On July 26, 2024, vTv had announced a clinical hold on the CATT1 Phase 3 study based on the discovery of a chromatographic signal in a human absorption, distribution, metabolism, and excretion (ADME) study of cadisegliatin that could not be resolved by standard mass spectroscopy. The clinical hold was lifted as of March 14, 2025, following submission of a complete response letter by the company which concluded that the chromatographic signal was an experimental artifact.

vTv Therapeutics expects to resume the study following submission of a protocol amendment to reduce the overall duration of the CATT1 study from 12 months to 6 months, that will help to expedite the initiation of required larger pivotal studies for future New Drug Application (NDA) submission. The company noted that the original primary endpoint of ascertaining level 2 and 3 hypoglycemia rates at 6 months will not change.