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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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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: 20 Mar 2025

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At a glance

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

    • Most Recent Events

    • 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.
    • 19 Sep 2024 According to Rezolute media release, company announced FDA clearance of Investigational New Drug (IND) application for Phase 3 registrational study for ersodetug for the treatment of hypoglycemia caused by tumor HI.

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