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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 is a Phase 2 study that has completed, run by Rezolute. The registered enrollment target is 23 participants.

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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).

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

FieldValue
Enrollment Target 23 participants
Start Date 2020-02-24
Est. Completion 2022-08-19
Phase Phase 2

Sponsor

Rezolute

4 total trials

What the Registry Record Tells You About NCT04538989

The ClinicalTrials.gov registry entry for NCT04538989 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 23 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Rezolute, which has 4 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 4 interventions - of which RZ358 Sequential Group Cohort 1 is the first listed.

NCT04538989 reports 0 study locations.

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.