A Phase 3 Study of Ersodetug in Patients With Tumor Hyperinsulinism (Tumor HI)
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)
Sponsor: Rezolute
A observational or N/A phase clinical study on Tumor Hyperinsulinism (Tumor HI), this trial is actively recruiting participants. The trial is conducted by Rezolute and has accumulated 8 data snapshots since 2025. Oncology trials at this stage typically focus on safety, tolerability, and early efficacy signals.
Study Description(click to expand)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).
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).
Status Flow
Change History
8 versions recorded-
Apr 18, 2026 — Present [daily]
Recruiting
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Apr 16, 2026 — Apr 18, 2026 [daily]
Recruiting
Phase: PHASE3 → None
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Jan 2026 — Apr 2026 [monthly]
Recruiting PHASE3
-
Nov 2025 — Jan 2026 [monthly]
Recruiting PHASE3
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Oct 2025 — Nov 2025 [monthly]
Recruiting PHASE3
▶ Show 3 earlier versions
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Sep 2025 — Oct 2025 [monthly]
Recruiting PHASE3
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Jun 2025 — Sep 2025 [monthly]
Recruiting PHASE3
Status: Not Yet Recruiting → Recruiting
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Apr 2025 — Jun 2025 [monthly]
Not Yet Recruiting PHASE3
First recorded
Eligibility 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).
Contact Information
- Rezolute
For direct contact, visit the study record on ClinicalTrials.gov .