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A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Parallel-Arm Study to Evaluate the Efficacy and Safety of RZ358 in Patients with Congenital Hyperinsulinism

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Trial Profile

A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Parallel-Arm Study to Evaluate the Efficacy and Safety of RZ358 in Patients with Congenital Hyperinsulinism

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

Latest Information Update: 12 Jan 2026

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At a glance

  • Drugs Ersodetug (Primary)
  • Indications Congenital hyperinsulinism
  • Focus Registrational; Therapeutic Use
  • Acronyms sunRIZE
  • Sponsors Rezolute

Most Recent Events

  • 08 Jan 2026 Planned End Date changed from 28 Sep 2026 to 14 Nov 2027.
  • 07 Jan 2026 According to a Rezolute media release, as of to date, 57 participants remain enrolled in the OLE, with exposure durations ranging from approximately six weeks for the most recently enrolled patients to approximately 18 months. These data, together with clinical outcomes, will inform a review of the full sunRIZE dataset with the intent of exploring options for this indication.
  • 07 Jan 2026 According to a Rezolute media release, company believes that data from the sunRIZE study and the Expanded Access Program (EAP) provide evidence of activity of ersodetug in both indications. Company plans to meet with the FDA to align on a path forward for congenital hyperinsulinism (HI).

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