Clinical Trial

RZ358 Treatment for Congenital Hyperinsulinism

Study acronym: sunRIZE
Active, Not Recruiting Phase 3
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Summary
The Phase 3 pivotal study is designed to evaluate the efficacy and safety of RZ358 for the treatment of congenital hyperinsulinism (HI) as add-on to standard-of-care (SOC) therapy compared to SOC alone over 24 weeks and to evaluate the longer-term safety and efficacy of RZ358 during a subsequent open-label extension (OLE) period.
Protocol Amendment History 4 amendments
This ClinicalTrials.gov record has been amended 4 times since 2024-01-11; most recent amendment 2026-01-06.
Status change: Recruiting → Active, Not Recruiting 2026-01-06
Status change: Not Yet Recruiting → Recruiting 2024-02-12
Trial Details
NCT Number NCT06208215
Lead Sponsor Rezolute
Conditions Congenital Hyperinsulinism
Enrollment 56 participants
Start Date 2024-01-11
Primary Completion 2025-11-14 (estimated)
Study Completion 2027-11-14 (estimated)
Updated on ClinicalTrials.gov 2026-01-08