MedTrace Logo

RZ358 Treatment for Congenital Hyperinsulinism

NCT06208215 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 56

Last updated 2026-01-08

No results posted yet for this study

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.

Conditions

  • Congenital Hyperinsulinism

Interventions

DRUG

RZ358 (5 mg/kg) + SOC (Standard-of-Care) or Placebo + SOC

Participants ≥1 year old who receive SOC therapy and 5 mg/kg of RZ358 or placebo

DRUG

RZ358 (10 mg/kg) or Placebo + SOC

Participants ≥1 year old who receive SOC therapy and 10 mg/kg of RZ358 or placebo

DRUG

RZ358 (5-10 mg/kg) + SOC

Infant participants from ≥3 months to \<1 year old who receive SOC therapy + RZ358 starting at 5 mg/kg and increasing to 10 mg/kg of RZ358, as needed, per the protocol schedule

Sponsors & Collaborators

  • Rezolute

    lead OTHER

Principal Investigators

  • Gopal Saha, MD · Rezolute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
3 Months
Max Age
45 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-01-11
Primary Completion
2025-11-14
Completion
2027-11-14
FDA Drug
Yes

Countries

  • United States
  • Bulgaria
  • Denmark
  • France
  • Georgia
  • Germany
  • Greece
  • Oman
  • Qatar
  • Spain
  • Turkey (Türkiye)
  • United Kingdom
  • Vietnam

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 NCT06208215 on ClinicalTrials.gov