Phase 3 Study to Assess Safety and Effectiveness of Weekly Ersodetug for Treating Low Blood Sugar Caused by Tumor Hyperinsulinism

What this Trial Is About

Researchers are evaluating the effects of ersodetug as an additional treatment to standard care for patients who have Tumor Hyperinsulinism Tumor HI, a condition causing low blood sugar due to hormone overproduction by certain tumors that cannot be removed or treated satisfactorily with current therapies. This Phase 3 study aims to assess the blood sugar control, safety, and tolerability of ersodetug in this patient group. Participants will receive weekly doses of ersodetug at 9 mgkg for 8 weeks alongside their usual hypoglycemia treatments. The study is organized into three parts a screening period lasting up to 4 weeks, an 8-week treatment phase, and either an end-of-study follow-up period of up to 20 weeks or an optional open-label extension lasting up to 3 years. Approximately 16 participants diagnosed with tumor HI will take part across several international study sites. During the study, participants will be monitored for changes in their need for intravenous glucose, including the main outcome of whether their glucose infusion rate decreases meaningfully after 8 weeks. Researchers will also track other measures such as total daily glucose delivery and the time needed to stop IV glucose after starting ersodetug. Safety assessments and follow-up visits will continue after treatment for up to 20 weeks or longer if participants choose the extension phase.

A Phase 3 Study of Ersodetug in Patients With Tumor Hyperinsulinism