The Phase 3 pivotal study is designed to evaluate the efficacy and safety of RZ358 for the treatment of congenital hyperinsulinism (HI) as add-on to standard-of-care (SOC) therapy compared to SOC alone over 24 weeks and to evaluate the longer-term safety and efficacy of RZ358 during a subsequent open-label extension (OLE) period.
Congenital Hyperinsulinism
The Phase 3 pivotal study is designed to evaluate the efficacy and safety of RZ358 for the treatment of congenital hyperinsulinism (HI) as add-on to standard-of-care (SOC) therapy compared to SOC alone over 24 weeks and to evaluate the longer-term safety and efficacy of RZ358 during a subsequent open-label extension (OLE) period.
RZ358 Treatment for Congenital Hyperinsulinism
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Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, United States, 19104
Cook Children's Medical Center, Fort Worth, Texas, United States, 76104
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
For general information about clinical research, read Learn About Studies.
3 Months to 45 Years
ALL
No
Rezolute,
Gopal Saha, MD, STUDY_DIRECTOR, Rezolute
2026-09-28