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A Phase 1/2/3 Study to Evaluate the Safety, Tolerability, and Efficacy of VX-880 in Subjects Who Have Type 1 Diabetes Mellitus With Impaired Hypoglycemic Awareness and Severe Hypoglycemia

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Trial Profile

A Phase 1/2/3 Study to Evaluate the Safety, Tolerability, and Efficacy of VX-880 in Subjects Who Have Type 1 Diabetes Mellitus With Impaired Hypoglycemic Awareness and Severe Hypoglycemia

Status: Active, no longer recruiting
Phase of Trial: Phase II/III

Latest Information Update: 25 Nov 2025

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At a glance

  • Drugs Zimislecel (Primary)
  • Indications Hypoglycaemia; Type 1 diabetes mellitus
  • Focus Adverse reactions; Proof of concept; Registrational; Therapeutic Use
  • Acronyms FORWARD-101
  • Sponsors Vertex Pharmaceuticals

Most Recent Events

  • 03 Nov 2025 According to a Vertex Pharmaceuticals media release, company has completed enrollment in the trial. And, has temporarily postponed completion of dosing in the study, pending an internal manufacturing analysis.
  • 20 Jun 2025 According to a Vertex Pharmaceuticals media release, the company has delivered an oral presentation featuring updated data of 12 patients from the Phase 1/2 portion of this study at the American Diabetes Association (ADA) annual conference in Chicago as part of the symposium from 6:15-6:30 p.m. CT (abstract 2025-A-1921). This data was simultaneously published online by the New England Journal of Medicine.
  • 20 Jun 2025 Results presented in the Vertex Pharmaceuticals Media Release.

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