A Phase 3 Study of Ersodetug in Patients With Tumor Hyperinsulinism
NCT06881992 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 16
Last updated 2026-05-18
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).
Conditions
- Tumor Hyperinsulinism (Tumor HI)
Interventions
- DRUG
-
Ersodetug
Ersodetug (9 mg/kg) + SOC
Sponsors & Collaborators
-
Rezolute
lead OTHER
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-04-16
- Primary Completion
- 2027-09-30
- Completion
- 2027-09-30
- FDA Drug
- Yes
Countries
- United States
- France
- Netherlands
- Switzerland
- United Kingdom
Study Locations
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