Trial · NCT06208215
RZ358 Treatment for Congenital Hyperinsulinism
NCT06208215, Phase 3, Active not recruiting, Rezolute
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. RZ358 Treatment for Congenital Hyperinsulinism. Trials, record NCT06208215. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06208215
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- RZ358 Treatment for Congenital Hyperinsulinism
- NCT number
- NCT06208215
- Status
- Active not recruiting
- Phases
- Phase 3
- Enrollment
- 56 participants, estimated
- Lead sponsor
- Rezolute
- Conditions
- Congenital Hyperinsulinism
- Interventions
- RZ358 (5 mg/kg) + SOC (Standard-of-Care) or Placebo + SOC, RZ358 (10 mg/kg) or Placebo + SOC, RZ358 (5-10 mg/kg) + SOC
- First posted
- 2024-01-17
- Last updated
- 2026-01-08
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Glycemic efficacy: Target glucose control | 24 weeks | Change in average weekly hypoglycemia events from baseline by point-of-care Self-Monitoring Blood Glucose (SMBG) |
| Secondary | Glycemic efficacy: Occurrence of hypoglycemia | 24 weeks | Change in average daily percent time in hypoglycemia from baseline by Continuous Glucose Monitor (CGM) |
| Secondary | Safety Assessments: safety and tolerability of RZ358 in patients with congenital hyperinsulinism | 24 weeks, plus up to two years of Open-Label Extension (OLE) period | Treatment emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) captured per Common Terminology Criteria for Adverse Events (CTCAE) guidelines and coadded per Medical Dictionary for Regulatory Activities (MedDRA) will be summarized by system organ class, preferred term, and analyzed by number and percentage of events by treatment groups. Hepatic ultrasound: evaluated for significant structural changes (e.g. peliosis Hepatitis) Immunogenicity assessments: Blood samples for anti-drug antibody to RZ358 will be evaluated based on the titer, and potential neutralization effects. Hyperglycemia events: Will be evaluated by SMBG at thresholds of \>250 mg/dL and \>300 mg/dL and summarized by the treatment groups. |
| Secondary | Safety Assessments: safety and tolerability of RZ358 in patients with congenital hyperinsulinism, Laboratory tests evaluated for significant changes from baseline by treated groups | Time Frame: 24 weeks, plus up to two years of Open-Label Extension (OLE) period | Laboratory parameters: ALT (U/L), AST (U/L), and ALP (U/L) will be evaluated for any significant changes from baseline (\>3x ULN) by treatment groups. Vital Signs: blood pressure (mm of Hg), heart rate (beats/minute), and respiration (rate/minute) will be evaluated for any significant changes from baseline by treatment groups. ECG: heart rate (beats/minute), PR (milliseconds), QTcF intervals (milliseconds) will be evaluated for any significant changes from baseline by treatment groups. |
| Secondary | Other Glycemic efficacy: Self-Monitoring Blood Glucose (SMBG) | 24 weeks | Proportion of participants experiencing no potentially serious hypoglycemia events by SMBG. |
| Secondary | Other Glycemic efficacy: Self-Monitoring Blood Glucose (SMBG) Weekly Assessment | 24 weeks | Change in average weekly incidence of potentially serious hypoglycemia events by Self-Monitoring Blood Glucose (SMBG). |
| Secondary | Other Glycemic efficacy: Continuous Glucose Monitor (CGM) Daily Assessment | 24 weeks | Change in average daily percent time with potentially serious hypoglycemia by Continuous Glucose Monitor (CGM). |
| Secondary | Other Glycemic efficacy: Continuous Glucose Monitor (CGM) Overnight Assessment | 24 weeks | Change in average 8-hour overnight percent time with hypoglycemia by CGM. Change in average daily duration (min) with hypoglycemia by CGM. Proportion of participants achieving \<4% average daily time in by CGM |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT06208215
GET https://conductscience.org/api/trials/v1/NCT06208215/registered