deltatrials
Completed PHASE2 INTERVENTIONAL 4-arm NCT04538989

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

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

Sponsor: Rezolute

Conditions Congenital Hyperinsulinism
Interventions RZ358 Sequential Group Cohort 1 RZ358 Sequential Group Cohort 2 RZ358 Sequential Group Cohort 3 RZ358 Sequential Group Cohort 4
Updated 16 times since 2020 Last updated: May 9, 2025 Started: Feb 24, 2020 Primary completion: Apr 5, 2022 Completion: Aug 19, 2022
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

A PHASE2 clinical study on Congenital Hyperinsulinism, this trial is completed. The trial is conducted by Rezolute and has accumulated 16 data snapshots since 2020. Longitudinal tracking of this trial contributes to a broader understanding of treatment development timelines.

Status Flow

~Oct 2020 – ~Nov 2020 · 31 days · monthly snapshot~Nov 2020 – ~Dec 2020 · 30 days · monthly snapshot~Dec 2020 – ~Jan 2021 · 31 days · monthly snapshot~Jan 2021 – ~Mar 2021 · 59 days · monthly snapshot~Mar 2021 – ~Apr 2021 · 31 days · monthly snapshot~Apr 2021 – ~Jun 2021 · 2 months · monthly snapshot~Jun 2021 – ~Sep 2021 · 3 months · monthly snapshot~Sep 2021 – ~Nov 2021 · 2 months · monthly snapshot~Nov 2021 – ~Jan 2022 · 2 months · monthly snapshot~Jan 2022 – ~Feb 2022 · 31 days · monthly snapshot~Feb 2022 – ~Sep 2022 · 7 months · monthly snapshot~Sep 2022 – ~Jul 2024 · 22 months · monthly snapshot~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshot~Sep 2024 – ~Jun 2025 · 9 months · monthly snapshot~Jun 2025 – ~Sep 2025 · 3 months · monthly snapshot~Sep 2025 – present · 10 months · monthly snapshot

Change History

16 versions recorded

  1. Sep 2025 — Present [monthly]

    Completed PHASE2

  2. Jun 2025 — Sep 2025 [monthly]

    Completed PHASE2

  3. Sep 2024 — Jun 2025 [monthly]

    Completed PHASE2

  4. Jul 2024 — Sep 2024 [monthly]

    Completed PHASE2

  5. Sep 2022 — Jul 2024 [monthly]

    Completed PHASE2

    Status: Active Not Recruiting → Completed

▶ Show 11 earlier versions

  1. Feb 2022 — Sep 2022 [monthly]

    Active Not Recruiting PHASE2

    Status: Recruiting → Active Not Recruiting

  2. Jan 2022 — Feb 2022 [monthly]

    Recruiting PHASE2

  3. Nov 2021 — Jan 2022 [monthly]

    Recruiting PHASE2

  4. Sep 2021 — Nov 2021 [monthly]

    Recruiting PHASE2

  5. Jun 2021 — Sep 2021 [monthly]

    Recruiting PHASE2

  6. Apr 2021 — Jun 2021 [monthly]

    Recruiting PHASE2

  7. Mar 2021 — Apr 2021 [monthly]

    Recruiting PHASE2

  8. Jan 2021 — Mar 2021 [monthly]

    Recruiting PHASE2

  9. Dec 2020 — Jan 2021 [monthly]

    Recruiting PHASE2

  10. Nov 2020 — Dec 2020 [monthly]

    Recruiting PHASE2

  11. Oct 2020 — Nov 2020 [monthly]

    Recruiting PHASE2

    First recorded

Feb 2020

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Rezolute
Data source: Rezolute

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

Barcelona, Spain , Fort Worth, United States , Jerusalem, Israel , Kayapınar, Turkey (Türkiye) , London, United Kingdom , Magdeburg, Germany , Monteral, Canada , Moscow, Russia , Odense, Denmark , Philadelphia, United States and 7 more locations