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NCT04538989 · ClinicalTrials.gov registry record · Phase 2
An Open-Label Multiple Dose Study of RZ358 in Patients With Congenital Hyperinsulinism
A Phase 2 study, sponsored by Rezolute.
- Completed
- Registry status
- Phase 2
- Development phase
- 23
- Enrollment target
NCT04538989: Completed Phase 2 study, sponsored by Rezolute.
NCT04538989 is a Phase 2 study that has completed, run by Rezolute. The registered enrollment target is 23 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (83% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04538989, a Phase 2 study, has completed, sponsored by Rezolute.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 23 participants
- Enrollment target
Study Summary
The objective of this trial is to evaluate the safety, tolerability and glucose-raising effects of RZ358 in patients with Congenital Hyperinsulinism (HI).
Primary Outcome
The median of average daily percent time within the glucose target range 70-180 mg/dL (3.9-10 mmol/L) by CGM at Baseline and End of Treatment (EOT) is reported.
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
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 23 participants |
| Start Date | 2020-02-24 |
| Est. Completion | 2022-08-19 |
| Phase | Phase 2 |
What the finished NCT04538989 record still lists
NCT04538989 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 23 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (83% lower).
The record links to 0 conditions, and to 4 interventions - of which RZ358 Sequential Group Cohort 1 is the first listed.
NCT04538989 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04538989 about?
NCT04538989 is a clinical study titled "An Open-Label Multiple Dose Study of RZ358 in Patients With Congenital Hyperinsulinism". The objective of this trial is to evaluate the safety, tolerability and glucose-raising effects of RZ358 in patients with Congenital Hyperinsulinism (HI).
What is the current status of trial NCT04538989?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 23 participants. The study started on 2020-02-24. Estimated completion is 2022-08-19.
What interventions are being tested in trial NCT04538989?
The interventions under investigation include: RZ358 Sequential Group Cohort 1 (DRUG), RZ358 Sequential Group Cohort 2 (DRUG), RZ358 Sequential Group Cohort 3 (DRUG), RZ358 Sequential Group Cohort 4 (DRUG).
Who is sponsoring clinical trial NCT04538989?
This trial is sponsored by Rezolute, which has 4 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04538989's enrollment target sits among peer trials
23 1784th of 2000 higher than 211 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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