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A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Ersodetug in Patients With Inadequately Controlled Hypoglycemia Due to Tumor-Associated Hyperinsulinism (tHI)

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Trial Profile

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Ersodetug in Patients With Inadequately Controlled Hypoglycemia Due to Tumor-Associated Hyperinsulinism (tHI)

Status: Not yet recruiting
Phase of Trial: Phase III

Latest Information Update: 08 May 2025

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At a glance

  • Drugs Ersodetug (Primary)
  • Indications Hypoglycaemia; Neuroendocrine tumours
  • Focus Registrational; Therapeutic Use
  • Sponsors Rezolute

Most Recent Events

  • 05 May 2025 According to Rezolute media release, company plans to initiate this registrational study of ersodetug in patients with tumor HI in the middle of 2025. Also, plans to engage further with FDA to discuss the registrational trial, including the necessary data package to support a BLA filing and potential approval for the tumor HI indication, as an expansion of the congenital HI indication.
  • 18 Mar 2025 Status changed from planning to not yet recruiting.
  • 19 Sep 2024 According to Rezolute media release, start-up activities are ongoing for the study, which will be primarily conducted in the U.S., with patient enrollment anticipated to begin in the first half of 2025. Topline results expected in the second half of 2026.

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