This trial has completed recruitment on this platform, and is no longer accepting new referrals.
This study is evaluating the safety, tolerability, and glucose-raising effects of RZ358 in patients with congenital hyperinsulinism (HI).
Trial ID: NCT04538989
Rezolute is committed to ensuring the safety of all study participants and has taken steps to reduce the burden that comes with study participation as much as possible. The study is open to anyone that meets the entry criteria and is willing to travel to a clinical trial site location that is participating in the RIZE study. The RIZE study provides participants and a family member with travel, lodging and food support during the study and follow up visits.
We want to learn if RZ358 can be used to prevent severe, persistent low blood sugar in patients with congenital hyperinsulinism (HI). There is a significant need to develop safer, better tolerated and more effective therapies aimed at preventing chronic and recurrent hypoglycemia (low blood sugar) in HI.
Congenital HI is a rare genetic condition, which most commonly presents at birth, and causes excessive and unregulated insulin release from the pancreas. This can leave patients vulnerable to frequent, potentially dangerous episodes of low blood sugar. In the developing child, the brain is particularly vulnerable to these low blood sugar episodes, requiring intensive monitoring and intervention to minimize potential neurologic damage. There is no cure for HI and current therapies are either ineffective or are not well tolerated from a safety perspective. If removal of the pancreas is required, this may be associated with short and long-term complications, and often results in insulin-dependent diabetes.
This clinical trial is designed to evaluate the safety and effectiveness of RZ358 in patients with congenital HI whose hypoglycemia is inadequately controlled on existing therapies. To determine if you can take part in the study, you will need to visit a study center to undergo medical tests and assessments. The eligibility visit and screening period is up to 5 weeks before the start of the study.
Once a participant is enrolled, RZ358 will be administered via a 30-minute infusion weekly or bi-weekly for a total treatment period of 8 weeks and a post-treatment follow-up period of 13 weeks.
By taking part in the study, you will receive the following at no charge:
If you choose to participate and you or your child is eligible, you will be directed to one of the study centers taking part in this clinical trial. Travel assistance and lodging is provided for patients/families that require support to and from the specific centers during study participation.
You will need to travel to one of the study clinics taking part in this clinical trial.
Sites are located in the cities/states identified with the red pin: