A Phase 3 Study of Ersodetug in Patients With Tumor Hyperinsulinism
Start Date
4/16/2025
Completion Date
9/1/2027
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).
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
Ersodetug
Conditions
Locations
Investigative Site
Chicago, Illinois 60637
United States
Investigative Site
Bethesda, Maryland 20892
United States
Investigative Site
Boston, Massachusetts 02114
United States
Investigative Site
Rochester, Minnesota 55905
United States
Investigative Site
New York, New York 10021
United States
Investigative Site
Canton, Ohio 44718
United States
Investigative Site
Portland, Oregon 97239
United States
Investigative Site
Houston, Texas 77030
United States
Investigative Site
Clichy, Île-de-France Region 92110
France
Investigative Site
Rotterdam, South Holland 3015
Netherlands
Investigative Site
Basel, Canton Basel-Stadt CH-4001
Switzerland
Investigative Site
Saint Johns Wood, London NW3 2QG
United Kingdom
Investigative Site
Withington, Manchester M20 4BX
United Kingdom