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RZ358 Treatment for Congenital Hyperinsulinism

Study acronym: sunRIZE
StatusActive, Not Recruiting
PhasePhase 3
SponsorRezolute
Started
View on ClinicalTrials.gov ↗

Record History

  1. Primary completion date changed from estimate of Apr 4, 2025 to Nov 14, 2025
    • Trial status: Recruiting to Active, Not Recruiting
    • Study sites: 24 to 18
    • Study completion date: Sep 28, 2026 to Nov 14, 2027
    v5
  2. Study sites: 21 to 24v4
  3. Site details revised at 16 of 21 sitesv3
  4. Trial status: Not Yet Recruiting to Recruiting
    • Site details revised at 21 of 21 sites
    v2
  5. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Rezolute
3 trials monitored
See all monitored trials
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.
Trial Details
NCT Number NCT06208215
Lead Sponsor Rezolute
Conditions
(from sponsor)		 Congenital Hyperinsulinism
Related terms Congenital Hyperinsulinism, Digestive System Diseases, Glucose Metabolism Disorders, Hyperinsulinism, Hypoglycemia, Metabolic Diseases, Pancreatic Diseases
Enrollment 56 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov