Trial intelligence / Profile preview

Phase 3 Study of RZ358 in Congenital Hyperinsulinism

2023-503240-13-00Phase 3Authorised

Sponsor
Rezolute, Inc.
Start
Dec 2023
Modality
Monoclonal Antibodies → Antibody-Based Therapeutics
Countries
17
01

Overview

Phase 3, randomised, double-blind trial in congenital hyperinsulinism (HI) comparing RZ358 with Placebo (2 arms). Primary endpoint: Change in average weekly incidence of hypoglycemia events by SMBG after 24 weeks. Planned start Dec 2023; status: authorised.

02

Drugs

ersodetug
03

Conditions

congenital hyperinsulinism (HI)

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