# An Open-Label Multiple Dose Study of RZ358 in Patients With Congenital Hyperinsulinism

> **NCT04538989** · PHASE2 · COMPLETED · sponsor: **Rezolute** · enrollment: 23 (actual)

## Conditions studied

- Congenital Hyperinsulinism

## Interventions

- **DRUG:** RZ358 Sequential Group Cohort 1
- **DRUG:** RZ358 Sequential Group Cohort 2
- **DRUG:** RZ358 Sequential Group Cohort 3
- **DRUG:** RZ358 Sequential Group Cohort 4

## Key facts

- **NCT ID:** NCT04538989
- **Lead sponsor:** Rezolute
- **Sponsor class:** OTHER
- **Phase:** PHASE2
- **Study type:** INTERVENTIONAL
- **Status:** COMPLETED
- **Start date:** 2020-02-24
- **Primary completion:** 2022-04-05
- **Final completion:** 2022-08-19
- **Target enrollment:** 23 (ACTUAL)
- **Last updated:** 2025-05-28


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT04538989

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT04538989, "An Open-Label Multiple Dose Study of RZ358 in Patients With Congenital Hyperinsulinism". Retrieved via AI Analytics 2026-05-27 from https://api.ai-analytics.org/clinical/NCT04538989. Licensed CC0.

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