Clinical trialsCompany release

vTv completes Phase 3 enrolment for cadisegliatin in type 1 diabetes; HPPD gets orphan status

🇺🇸 vTv Therapeutics Inc. (VTVT) · Thu 05 Nov 2026

vTv Therapeutics says 166 participants are randomised in its Phase 3 CATT1 trial, with topline data expected mid-2027, as the FDA grants orphan designation to HPPD for sickle cell disease.

vTv Therapeutics has completed enrolment in CATT1, its Phase 3 trial of cadisegliatin in type 1 diabetes. The company reported the milestone alongside its third-quarter 2026 results on 5 November 2026, saying 166 participants have been randomised.

Topline data from the study are expected in mid-2027. The company has also started a Phase 2a study of cadisegliatin in people who use hybrid closed-loop insulin delivery systems.

In October, the US Food and Drug Administration granted Orphan Drug Designation to HPPD for sickle cell disease. As general context, orphan designation in the US is given to medicines intended for rare diseases and can bring development incentives, but it is not a marketing authorisation.

vTv reported cash of $77.2 million at the end of the quarter. The company expects this to fund operations through the Phase 3 readout.

What it means for your team

  • Regulatory teams tracking type 1 diabetes pipelines can pencil in mid-2027 for CATT1 topline data from vTv.
  • The Phase 2a study in hybrid closed-loop users points to the company exploring cadisegliatin alongside automated insulin delivery.
  • The orphan designation for HPPD in sickle cell disease is an early regulatory step only; no approval or efficacy conclusion is implied.
  • Market-access watchers may note that the company's stated cash runway covers only the period to the Phase 3 readout.

Company's press release (SEC filing): vTv Therapeutics Inc. ↗

Article written by VigiEye from the official source (vTv Therapeutics Inc.). Claims are the company's own. AI-assisted; check the source before acting.

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