09:05 AM EDT, 03/17/2025 (MT Newswires) -- Vtv Therapeutics ( VTVT ) said Monday that the US Food and Drug Administration has lifted a clinical hold on its cadisegliatin clinical program, including a phase 3 trial in type 1 diabetes.

The company said it plans to resume the trial after submitting a protocol amendment to reduce its duration from 12 months to 6 months, accelerating the initiation of more extensive pivotal studies for a future marketing submission.

The primary endpoint of assessing certain hypoglycemia rates at 6 months will remain unchanged, Vtv Therapeutics ( VTVT ) said.

The biopharmaceutical company said the FDA imposed a clinical hold last July due to an unresolved chromatographic signal in a study, and that the hold was lifted after it submitted a response confirming the signal was an experimental artifact.

Shares were over 13% higher in recent premarket activity.