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NCT06208215 · ClinicalTrials.gov registry record · Phase 3
RZ358 Treatment for Congenital Hyperinsulinism
A Phase 3 study of Congenital Hyperinsulinism, sponsored by Rezolute.
- Active
- Registry status
- Phase 3
- Development phase
- 56
- Enrollment target
- 18
- Study locations
NCT06208215 is a Phase 3 study of Congenital Hyperinsulinism that is active but no longer recruiting, run by Rezolute. The registered enrollment target is 56 participants, below the 70-participant average among 7 other Congenital Hyperinsulinism trials with a reported enrollment target (20% lower). The trial reports 18 study locations across 3 states.
The verdict
NCT06208215, a Phase 3 study of Congenital Hyperinsulinism, is active but no longer recruiting, sponsored by Rezolute.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 56 participants
- Enrollment target
- 18
- Study locations
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 Studied
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
Study Locations (18)
Other
- Rezolute Investigative Site, Varna, Bulgaria - Varna
- Rezolute Investigative Site, Odense, Denmark - Odense
- Rezolute Investigative Site, Bron, France - Bron
- Rezolute Investigative Site, Paris, France - Paris
- Rezolute Investigative Site, Tbilisi, Georgia - Tbilisi
- Rezolute Investigative Site, Berlin, Germany - Berlin
- Rezolute Investigative Site, Dusseldorf, Germany - Düsseldorf
- Rezolute Investigative Site, Athens, Greece - Athens
- Rezolute Investigative Site, Seeb, Oman - Seeb
- Rezolute Investigative Site, Al Rayyan, Qatar - Al Rayyan
- Rezolute Investigative Site, Barcelona, Spain - Barcelona
- Rezolute Investigative Site, Sevilla, Spain - Seville
- Rezolute Investigative Site, Ankara, Turkey - Ankara
- Rezolute Investigative Site, London, United Kingdom - London
- Rezolute Investigative Site, Manchester, United Kingdom - Manchester
- Rezolute Investigative Site, Hà Nội, Vietnam - Hà Nội
Pennsylvania
- Children's Hospital of Philadelphia - Philadelphia
Texas
- Cook Children's Medical Center - Fort Worth
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 56 participants |
| Start Date | 2024-01-11 |
| Est. Completion | 2027-11-14 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06208215
The ClinicalTrials.gov registry entry for NCT06208215 describes a study currently listed as active not recruiting, categorized as Phase 3. The registered enrollment target is 56 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 70-participant average among 7 other Congenital Hyperinsulinism trials with a reported enrollment target (20% lower). The listed sponsor is Rezolute, which has 4 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Congenital Hyperinsulinism appearing as the primary indexed condition, and to 3 interventions - of which RZ358 (5 mg/kg) + SOC (Standard-of-Care) or Placebo + SOC is the first listed.
NCT06208215 reports 18 study locations spanning 3 distinct geographic areas - top geographies include Other, Pennsylvania, Texas.
Frequently Asked Questions
What is clinical trial NCT06208215 about?
NCT06208215 is a clinical study titled "RZ358 Treatment for Congenital Hyperinsulinism". 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 ope...
What is the current status of trial NCT06208215?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 56 participants. The study started on 2024-01-11. Estimated completion is 2027-11-14.
What conditions does trial NCT06208215 study?
This clinical trial studies the following conditions: Congenital Hyperinsulinism.
What interventions are being tested in trial NCT06208215?
The interventions under investigation include: 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 (DRUG).
Who is sponsoring clinical trial NCT06208215?
This trial is sponsored by Rezolute, which has 4 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06208215 being conducted?
This trial has 18 study locations across Pennsylvania, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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