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Open Label Arm, SoC + RZ358 (start 5mg/kg and increase to 10 mg/kg per protocol schedule for Congenital Hyperinsulinism (sunRIZE Trial)

Phase 3
Recruiting
Research Sponsored by Rezolute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
An established clinical diagnosis of congenital HI (hyperinsulinism), with or without identification of a known monogenic variant by genetic testing
Aged ≥ 3 months and ≤ 45 years old at screening
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 weeks, plus up to two years of open-label extension (ole) period
Awards & highlights

sunRIZE Trial Summary

This trial is testing the effectiveness and safety of a drug called RZ358 for treating congenital hyperinsulinism. The study will compare how well RZ358 works when added to standard treatment compared

Who is the study for?
This trial is for individuals with congenital hyperinsulinism, a condition causing excessive insulin production. Participants should be currently receiving standard treatments without sufficient control of their condition.Check my eligibility
What is being tested?
The study tests RZ358 at different doses (5 mg/kg and 10 mg/kg) added to the usual care versus a placebo plus usual care over six months. It also looks at how safe and effective RZ358 is over a longer period.See study design
What are the potential side effects?
Specific side effects of RZ358 are not listed, but they may include reactions similar to other medications in its class or issues related to blood sugar management.

sunRIZE Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have been diagnosed with congenital hyperinsulinism, with or without a known genetic cause.
Select...
I am between 3 months and 45 years old.
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I have low blood sugar levels 3 or more times a week.

sunRIZE Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 weeks, plus up to two years of open-label extension (ole) period
This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 weeks, plus up to two years of open-label extension (ole) period for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Glycemic efficacy: Target glucose control
Secondary outcome measures
Glycemic efficacy: Occurrence of hypoglycemia
Other Glycemic efficacy: Continuous Glucose Monitor (CGM) Daily Assessment
Other Glycemic efficacy: Continuous Glucose Monitor (CGM) Overnight Assessment
+4 more

sunRIZE Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: Open Label Arm, SoC + RZ358 (start 5mg/kg and increase to 10 mg/kg per protocol scheduleExperimental Treatment1 Intervention
Infant participants from ≥3 months to <1 year old who receive SOC therapy + RZ358 starting at 5 mg/kg and increasing to 10 mg/kg of RZ358, as needed, per the protocol schedule
Group II: SoC (Standard-of-Care) + RZ358 (5 mg/kg) or PlaceboPlacebo Group1 Intervention
Participants ≥1 year old who receive SOC therapy and 5 mg/kg of RZ358 or placebo
Group III: SoC + RZ358 (10 mg/kg) or PlaceboPlacebo Group1 Intervention
Participants ≥1 year old who receive SOC therapy and 10 mg/kg of RZ358 or placebo

Find a Location

Who is running the clinical trial?

RezoluteLead Sponsor
2 Previous Clinical Trials
123 Total Patients Enrolled
1 Trials studying Congenital Hyperinsulinism
23 Patients Enrolled for Congenital Hyperinsulinism
Gopal Saha, MDStudy DirectorRezolute

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the Open Label Arm, SoC + RZ358 (with a starting dose of 5mg/kg and an increase to 10 mg/kg according to FDA guidelines) received official approval?

"Considering that this trial is in Phase 3 and has accumulated substantial safety data, our team at Power rates the safety of Open Label Arm with SoC + RZ358 (starting at 5mg/kg and increasing to 10 mg/kg per protocol schedule) as a score of 3."

Answered by AI

What are the eligibility criteria for individuals to participate in this clinical study?

"To be considered eligible for participation in this clinical trial, patients must have a diagnosis of congenital hyperinsulinism and fall within the age range of 3 months to 45 years. The study has a total capacity for enrolling 56 participants."

Answered by AI

Are there any available positions for participants in this research study?

"According to the information available on clinicaltrials.gov, this specific clinical trial is no longer actively seeking participants. The trial was initially posted and last updated on January 11th, 2024. However, I am pleased to inform you that there are currently 19 other ongoing trials that are actively enrolling patients at this time."

Answered by AI

In how many diverse venues is this experimental examination currently being conducted?

"This clinical trial is taking place in various locations worldwide. Some of the participating sites include Rezolute Investigative Site in Bron, France; Rezolute Investigative Site in Barcelona, Spain; and Rezolute Investigative Site in Hà Nội, Vietnam. Additionally, there are 17 other locations involved in this study."

Answered by AI

Does this clinical trial include individuals who are above the age of 50?

"Potential participants eligible for this research must be at least 3 months old and no older than 45 years."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
RZ358 Treatment for Congenital Hyperinsulinism
2024. "RZ358 Treatment for Congenital Hyperinsulinism". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06208215.
~37 spots leftby Apr 2025
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