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NCT06208215 (RZ358 in Congenital Hyperinsulinism): BVCT ex-ante prediction vs. reported outcome

On 1 Aug 2025, BioinvestGPT's BVCT predicted technical success and commercial success for this trial. The 11 Dec 2025 readout is classified on the dashboard as False Positive (FP), a missed prediction. Recorded clinical-benefit conclusion: statistically insignificant and commercially insufficient.

Clinical Trial

NCTID
NCT06208215
Acronym
sunRIZE
Drug Name
RZ358 (ersodetug)
Drug MoA
allosteric anti-INSR inhibitor
Drug Modality
monoclonal antibody
Drug Class
First-In-Class
Therapeutic Area
Nutritional and Metabolic Diseases
Indication
Congenital Hyperinsulinism
Human Patients
56
Sponsor
Rezolute
Phase
Phase 3

Prediction of , index 2059

Prospective Prediction
Prediction Index
2059
Prediction Date
Commercial Prediction
SUCCESS (commercially sufficient additive clinical benefit in average weekly hypoglycemia events count)
Technical Prediction
SUCCESS (statistically significant additive clinical benefit in average weekly hypoglycemia events count compared with placebo)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
132 days in advance
Readout Data Interpretation
ersodetug failed to meet any primary or secondary endpoints
Press Release
Prediction Result
Prediction Accuracy
Missed Prediction
Due to
due to suboptimal causal modeling of INSR in the exact clinical setting of congenital hyperinsulinism that has been permanently improved
Clinical Benefit Conclusion
statistically insignificant and commercially insufficient
Prediction Classification
False Positive (FP)

ClinicalTrials.gov record

ClinicalTrials.gov record, retrieved 2026-09-24. Third-party data.

Official title
A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Parallel-Arm Study to Evaluate the Efficacy and Safety of RZ358 in Patients With Congenital Hyperinsulinism
Phase
Phase 3
Status
Active not recruiting
Enrollment
56
Lead sponsor
Rezolute
Conditions
Congenital Hyperinsulinism
Interventions
DRUG: RZ358 (5 mg/kg) + SOC (Standard-of-Care) or Placebo + SOC; DRUG: RZ358 (10 mg/kg) or Placebo + SOC; DRUG: RZ358 (5-10 mg/kg) + SOC
Design
Randomized · Parallel · Triple
Primary purpose
Treatment
Start
2024-01-11
Primary completion
2025-11-14
Completion
2027-11-14
Primary outcomes
  • Glycemic efficacy: Target glucose control (24 weeks)

NCT06208215 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

How to read these records: evidence · methodology · all trials