A Phase 3 Study of Ersodetug in Patients With Tumor Hyperinsulinism
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)
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).
Eligibility
Min Age: 18 Years
Plain Language Summary
Simplified for easier understanding
This Phase 3 study tests ersodetug, a new drug designed to block excess insulin production in people with a rare condition called tumor hyperinsulinism — where a neuroendocrine tumor (a slow-growing cancer of hormone-producing cells) causes the body to overproduce insulin, leading to dangerously low blood sugar levels that cannot be controlled by standard means.
**You may be eligible if:**
- You are 18 or older
- You have a confirmed neuroendocrine tumor that is causing dangerously low blood sugar (hypoglycemia) due to excess insulin or insulin-like factors
- Standard treatments to control your blood sugar have not worked
- You are currently requiring intravenous glucose or nutrition support for at least 7 days to manage your blood sugar
- Your case has been reviewed by a multidisciplinary team including an oncologist
**You may NOT be eligible if:**
- Your hypoglycemia is caused by something other than a neuroendocrine tumor
- You have not yet tried standard anti-hypoglycemic therapies
- You are not currently dependent on IV glucose or nutritional support
- You are pregnant or breastfeeding
- You have serious other conditions that make participation unsafe
Talk to your doctor to see if this trial is right for you.
This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
DRUGErsodetug
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
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.