# RZ358 Treatment for Congenital Hyperinsulinism

> **NCT06208215** · PHASE3 · ACTIVE_NOT_RECRUITING · sponsor: **Rezolute** · enrollment: 56 (estimated)

## Conditions studied

- Congenital Hyperinsulinism

## Interventions

- **DRUG:** RZ358 (5 mg/kg) + SOC (Standard-of-Care) or Placebo + SOC
- **DRUG:** RZ358 (10 mg/kg) or Placebo + SOC
- **DRUG:** RZ358 (5-10 mg/kg) + SOC

## Key facts

- **NCT ID:** NCT06208215
- **Lead sponsor:** Rezolute
- **Sponsor class:** OTHER
- **Phase:** PHASE3
- **Study type:** INTERVENTIONAL
- **Status:** ACTIVE_NOT_RECRUITING
- **Start date:** 2024-01-11
- **Primary completion:** 2025-11-14
- **Final completion:** 2027-11-14
- **Target enrollment:** 56 (ESTIMATED)
- **Last updated:** 2026-01-08


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT06208215

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT06208215, "RZ358 Treatment for Congenital Hyperinsulinism". Retrieved via AI Analytics 2026-06-24 from https://api.ai-analytics.org/clinical/NCT06208215. Licensed CC0.

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*[Clinical trials dataset](/datasets/clinical-trials) · CC0 1.0*