FDA lifts clinical hold on vTv Therapeutics' cadisegliatin Phase 3 diabetes trial

vTv Therapeutics Inc.

FDA lifted clinical hold effective March 14, 2025; CATT1 trial to resume after protocol amendment.
Protocol amendment shortens trial from 12 to 6 months; primary endpoint (hypoglycemia rates) unchanged.
Hold imposed July 26, 2024 due to chromatographic signal later found to be experimental artifact; no patients dosed.
Cadisegliatin is a potential first-in-class oral adjunctive therapy to insulin for type 1 diabetes.
Company expects shorter trial to expedite initiation of larger pivotal studies for NDA submission.

This headline and bullets were generated automatically by deepseek-v4-flash:cloud@v2 from the public filing. Read the source on SEC.gov before relying on any specific claim. Not investment advice. See methodology for how this pipeline works.