At a glance
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An Open-Label Multiple-Dose Study of RZ358 in Patients With Congenital Hyperinsulinism
In Brief
A Phase 2 clinical trial evaluating RZ358 Sequential Group Cohort 1, RZ358 Sequential Group Cohort 2, and 2 other interventions for Congenital Hyperinsulinism. Completed, enrolled 23 participants across 17 sites in 11 countries.
Detailed Summary
The objective of this trial is to evaluate the safety, tolerability and glucose-raising effects of RZ358 in patients with Congenital Hyperinsulinism (HI).
Study Details
Timeline
Interventions
IV infusion for 8 weeks (3 mg/kg bi-weekly for 8 weeks)
IV infusion for 8 weeks (6 mg/kg bi-weekly for 8 weeks)
IV infusion for 8 weeks (9 mg/kg bi-weekly for 8 weeks)
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)