Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as RZ358 Sequential Group Cohort 1
RZ358 Sequential Group · 1 trial · 1 indication
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.
The average daily percent time within the glucose target range (70-180 mg/dL) is compared from baseline to end of treatment (EOT) and the median percent change of that difference is reported.
All patients who received RZ358 and for whom the primary PK data was considered to be sufficient and interpretable were to be included in the PK analyses. Individual and mean plasma concentration data is summarized descriptively at the specified timepoints. The results of this study may be combined with those of other studies for analysis and modeling (e.g., population PK and PK-PD), and therefore the PK parameters are reported separately, as part of an iterative population PK approach.
| Arm | Type | Description |
|---|---|---|
| RZ358 Cohort 1 | EXPERIMENTAL | - |
| RZ358 Cohort 2 | EXPERIMENTAL | - |
| RZ358 Cohort 3 | EXPERIMENTAL | - |
| RZ358 Cohort 4 | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| RZ358 Sequential Group Cohort 1 | DRUG | IV infusion for 8 weeks (3 mg/kg bi-weekly for 8 weeks) |
| RZ358 Sequential Group Cohort 2 | DRUG | IV infusion for 8 weeks (6 mg/kg bi-weekly for 8 weeks) |
| RZ358 Sequential Group Cohort 3 | DRUG | IV infusion for 8 weeks (9 mg/kg bi-weekly for 8 weeks) |
| RZ358 Sequential Group Cohort 4 | DRUG | IV infusion for 8 weeks (bi-weekly fixed dose-titration from 3 to 9 mg/kg for the first 4 weeks, followed by a fixed 9 mg/kg dose amount thereafter for the remaining 4 weeks) |
Inclusion Criteria: * Male or female age 2-45 years old (except age 12-45 in US) with an established clinical diagnosis of congenital hyperinsulinism * Able to provide written informed consent or, as applicable, assent * Confirmed hypoglycemia as assessed by CGM, SMBG, and clinical evaluation, duri...
RZ358 Sequential Group is a Phase 2 clinical study cohort evaluating RZ358 in patients with congenital hyperinsulinism. It is being developed by Rezolute, Inc. (ticker RZLT). The study was an open-label, multiple-dose trial conducted across multiple countries and has been completed.
RZ358 Sequential Group is used to evaluate RZ358 as a treatment for congenital hyperinsulinism, a rare endocrine disorder. The Phase 2 study assessed multiple doses of RZ358 in patients with this condition. The trial has been completed.
RZ358 Sequential Group is developed by Rezolute, Inc., which trades under the ticker RZLT. Rezolute is the sponsor of the Phase 2 clinical study of RZ358 in congenital hyperinsulinism.
RZ358 Sequential Group is in Phase 2 clinical development. The Phase 2 trial has been completed. RZ358 is an investigational small molecule and has not been approved for any indication.
RZ358 Sequential Group was evaluated in one completed Phase 2 trial, NCT04538989, titled An Open-Label Multiple Dose Study of RZ358 in Patients With Congenital Hyperinsulinism. The trial enrolled 23 patients across the United States, Bulgaria, Canada, Denmark, Georgia, Germany, Israel, Russia, Spain, Turkey, and the United Kingdom.
Yes, RZ358 Sequential Group is also known as RZ358 Sequential Group Cohort 1. Both names refer to the same Phase 2 study cohort of RZ358 in congenital hyperinsulinism, developed by Rezolute, Inc. (RZLT).