Tumor-associated hyperinsulinism
Conditions
Brief summary
Percent change from baseline in average weekly count of aggregate Level 2 (<54 mg/dL [<3 mmol/L] by SMBG) and adjudicated Level 3 hypoglycemia events during the entire pivotal treatment period, OL: Number of participants with clinically meaningful reduction (≥50%) in glucose infusion rate from baseline, OLE: Long-term glycemic efficacy (by SMBG) of ersodetug will be assessed similar to Pivotal Phase endpoints; additionally, changes in background SOC medications for hypoglycemia will be evaluated, such as the occurrence of overall use, de-escalation, and escalation of SOC regimen., OLE: Long-term safety and tolerability of ersodetug based on assessments of AEs, SAEs, clinical laboratory measurements, immunogenicity assessments, ECG, hepatic ultrasound, vital signs, and physical examination
Detailed description
Change from baseline in average weekly count of aggregate Level 2 (<54 mg/dL [<3 mmol/L] by SMBG) and adjudicated Level 3 hypoglycemia events during the entire pivotal treatment period, Percent change from baseline in average weekly count of Level 2 hypoglycemia (glucose <54 mg/dL [<3 mmol/L] by SMBG) events., Percent change from baseline in average weekly count of Level 3 (adjudicated) hypoglycemia events, Percent change from baseline in average daily percent time with Level 2 hypoglycemia (glucose <54 mg/dL [<3 mmol/L]) by CGM during Weeks 1-8 of the pivotal treatment period, Percent change from baseline in average weekly count of overall hypoglycemia events (<70 mg/dL [<3.9 mmol/L]) by SMBG during Weeks 1-8 of the pivotal treatment period., OL: Change from baseline in average daily IV glucose/dextrose infusion rate (GIR), OL: Change from baseline in average daily total IV glucose delivery (mg) during the entire pivotal treatment period, OL: Time to complete weaning off IV glucose administration after initiating ersodetug
Interventions
DRUGRZ358 placebo is a sterile solution for parenteral administration with a minimum extractable volume of 1.0 mL in an ISO
2R
DRUGand an aluminum seal with plastic
flip-off cap. The buffered vehicle nominal composition is as follows: 10mM L-histidine
DRUG270mM
sorbitol
DRUGpH 5.8
Sponsors
Rezolute Inc.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percent change from baseline in average weekly count of aggregate Level 2 (<54 mg/dL [<3 mmol/L] by SMBG) and adjudicated Level 3 hypoglycemia events during the entire pivotal treatment period, OL: Number of participants with clinically meaningful reduction (≥50%) in glucose infusion rate from baseline, OLE: Long-term glycemic efficacy (by SMBG) of ersodetug will be assessed similar to Pivotal Phase endpoints; additionally, changes in background SOC medications for hypoglycemia will be evaluated, such as the occurrence of overall use, de-escalation, and escalation of SOC regimen., OLE: Long-term safety and tolerability of ersodetug based on assessments of AEs, SAEs, clinical laboratory measurements, immunogenicity assessments, ECG, hepatic ultrasound, vital signs, and physical examination | — |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline in average weekly count of aggregate Level 2 (<54 mg/dL [<3 mmol/L] by SMBG) and adjudicated Level 3 hypoglycemia events during the entire pivotal treatment period, Percent change from baseline in average weekly count of Level 2 hypoglycemia (glucose <54 mg/dL [<3 mmol/L] by SMBG) events., Percent change from baseline in average weekly count of Level 3 (adjudicated) hypoglycemia events, Percent change from baseline in average daily percent time with Level 2 hypoglycemia (glucose <54 mg/dL [<3 mmol/L]) by CGM during Weeks 1-8 of the pivotal treatment period, Percent change from baseline in average weekly count of overall hypoglycemia events (<70 mg/dL [<3.9 mmol/L]) by SMBG during Weeks 1-8 of the pivotal treatment period., OL: Change from baseline in average daily IV glucose/dextrose infusion rate (GIR), OL: Change from baseline in average daily total IV glucose delivery (mg) during the entire pivotal treatment period, OL: Time to complete weaning off IV glucose ad | — |
Countries
France, Netherlands
Outcome results
None listed