NCT06881992

A Phase 3 Study of Ersodetug in Patients With Tumor Hyperinsulinism

A Phase 3, Single-Arm, Open-label, Pivotal Study to Evaluate the Efficacy and Safety of Ersodetug Compared to Baseline in Patients With Inadequately Controlled Hypoglycemia Due to Tumor Hyperinsulinism (Tumor HI)

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 16 (estimated)
• Sponsor: Rezolute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The objectives of this study are to evaluate the glycemic efficacy, safety, and tolerability of ersodetug as add-on to standard of care (SOC) therapy for treatment of hypoglycemia in patients with Tumor Hyperinsulinism (Tumor HI).

Detailed description

This study will include participants who are suffering from low blood sugar related symptoms (hypoglycemia) due to over-production of hormones (e.g. insulin or similar substances) by certain non-removable tumors that cannot be treated satisfactorily with available treatment. Every study participant will receive ersodetug doses weekly for 8 weeks alongside their usual treatments for hypoglycemia at a dose of 9 mg/kg. The study is divided into 3 periods: Screening (up to 4 weeks), Treatment (8 weeks) and either End of Study Follow-up (approximately up to 20 weeks after the last dose) or optional Open Label Extension (OLE) phase (up to 3 years). This study is being conducted at approximately 10-15 study sites in approximately 5 countries. The study will enroll approximately 16 participants, all with a diagnosis of tumor HI (insulin- or IGF producing tumors).

Conditions

• Tumor Hyperinsulinism (Tumor HI)

Interventions

Type	Name	Description
DRUG	Ersodetug	Ersodetug (9 mg/kg) + SOC

Timeline

• Start date: 2025-04-16
• Primary completion: 2027-09-01
• Completion: 2027-09-01
• First posted: 2025-03-18
• Last updated: 2026-04-17

Locations

13 sites across 5 countries: United States, France, Netherlands, Switzerland, United Kingdom

Regulatory

• FDA-regulated drug study