vTv Therapeutics completes Phase 3 CATT1 enrollment, gets orphan drug status for HPPD

vTv Therapeutics Inc. said on November 5, 2026 that its Phase 3 CATT1 trial evaluating cadisegliatin for type 1 diabetes completed enrollment with 166 participants randomized, with topline results expected mid 2027.¹ The trial randomized participants to receive cadisegliatin 800 mg once daily, cadisegliatin 800 mg twice daily, or placebo over six months.¹ The primary efficacy endpoint will assess the incidence of level 2 and level 3 hypoglycemic events.¹

The company also said it randomized the first participant in its Phase 2a Hybrid CATT1 pilot study evaluating cadisegliatin in individuals with T1D who use hybrid closed-loop insulin delivery systems¹ on October 27, 2026. That study is a randomized, double-blind, crossover, multicenter study that will evaluate cadisegliatin in T1D participants using hybrid closed-loop insulin delivery systems to inform the design and operational aspects of future Phase 3 research in this population.¹

On the regulatory front, the FDA on October 6, 2026 granted orphan drug designation to HPPD, described as an oral, first-in-class Nrf2/Bach1 modulator being investigated as a treatment for sickle cell disease.¹ Supporting preclinical work, conducted at Augusta University using a mouse model of sickle cell disease, found the compound was orally active and well tolerated, increased fetal hemoglobin, and reduced oxidative stress and red blood cell sickling.¹ The company said the designation would support partnering discussions for HPPD as the Company continues to prioritize cadisegliatin in T1D.¹

On the balance sheet, cash and cash equivalents as of September 30, 2026, were $77.2 million compared to $88.9 million as of December 31, 2025.¹ The company said it expects to have sufficient cash to fund operations well through the anticipated CATT1 topline data readout.¹