MedTrace Logo

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

NCT04538989 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 23

Last updated 2025-05-28

Study results available
· View outcomes & findings →

Summary

The objective of this trial is to evaluate the safety, tolerability and glucose-raising effects of RZ358 in patients with Congenital Hyperinsulinism (HI).

Conditions

  • Congenital Hyperinsulinism

Interventions

DRUG

RZ358 Sequential Group Cohort 1

IV infusion for 8 weeks (3 mg/kg bi-weekly for 8 weeks)

DRUG

RZ358 Sequential Group Cohort 2

IV infusion for 8 weeks (6 mg/kg bi-weekly for 8 weeks)

DRUG

RZ358 Sequential Group Cohort 3

IV infusion for 8 weeks (9 mg/kg bi-weekly for 8 weeks)

DRUG

RZ358 Sequential Group Cohort 4

IV infusion for 8 weeks (bi-weekly fixed dose-titration from 3 to 9 mg/kg for the first 4 weeks, followed by a fixed 9 mg/kg dose amount thereafter for the remaining 4 weeks)

Sponsors & Collaborators

  • Rezolute

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
2 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-02-24
Primary Completion
2022-04-05
Completion
2022-08-19
FDA Drug
Yes

Countries

  • United States
  • Bulgaria
  • Canada
  • Denmark
  • Georgia
  • Germany
  • Israel
  • Russia
  • Spain
  • Turkey (Türkiye)
  • United Kingdom

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04538989 on ClinicalTrials.gov