RecruitingPhase 3NCT06881992

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)


Sponsor

Rezolute

Enrollment

16 participants

Start Date

Apr 16, 2025

Study Type

INTERVENTIONAL

Conditions

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).


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.

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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

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NCT06881992