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).
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).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
16
Ersodetug (9 mg/kg) + SOC
Investigative Site
Chicago, Illinois, United States
NOT_YET_RECRUITINGInvestigative Site
Bethesda, Maryland, United States
NOT_YET_RECRUITINGProportion of participants with clinically meaningful reduction in IV glucose infusion rate from baseline.
Time frame: 8 weeks
Change from baseline in average daily IV glucose/dextrose infusion rate (GIR).
Time frame: 8 weeks
Change from baseline in average daily total IV glucose delivery (g)
Time frame: 8 weeks
Time to complete weaning off IV glucose administration after initiating ersodetug.
Time frame: 8 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Investigative Site
Boston, Massachusetts, United States
RECRUITINGInvestigative Site
Rochester, Minnesota, United States
RECRUITINGInvestigative Site
New York, New York, United States
NOT_YET_RECRUITINGInvestigative Site
Canton, Ohio, United States
RECRUITINGInvestigative Site
Portland, Oregon, United States
RECRUITINGInvestigative Site
Houston, Texas, United States
NOT_YET_RECRUITINGInvestigative Site
Clichy, Île-de-France Region, France
NOT_YET_RECRUITINGInvestigative Site
Rotterdam, South Holland, Netherlands
NOT_YET_RECRUITING...and 3 more locations