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A Phase 3 Study of Ersodetug in Patients With Tumor Hyperinsulinism
Sponsor: Rezolute
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).
Official title: 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)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
16
Start Date
2025-04-16
Completion Date
2027-09
Last Updated
2025-12-30
Healthy Volunteers
No
Conditions
Interventions
Ersodetug
Ersodetug (9 mg/kg) + SOC
Locations (13)
Investigative Site
Chicago, Illinois, United States
Investigative Site
Bethesda, Maryland, United States
Investigative Site
Boston, Massachusetts, United States
Investigative Site
Rochester, Minnesota, United States
Investigative Site
New York, New York, United States
Investigative Site
Canton, Ohio, United States
Investigative Site
Portland, Oregon, United States
Investigative Site
Houston, Texas, United States
Investigative Site
Clichy, Île-de-France Region, France
Investigative Site
Rotterdam, South Holland, Netherlands
Investigative Site
Basel, Canton Basel-Stadt, Switzerland
Investigative Site
Saint Johns Wood, London, United Kingdom
Investigative Site
Withington, Manchester, United Kingdom