drugset / Trial / NCT06208215
RZ358 Treatment for Congenital Hyperinsulinism
RandomizedParallel-groupTriple-blindTreatment
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.
Timeline
- Start
- 2024-01-11
- Primary completion
- 2025-11-14
- Completion
- 2027-11-14
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Ersodetug | Monoclonal antibody | 5 mg/kg | — |
| Comparator | Ersodetug | Monoclonal antibody | 10 mg/kg | — |