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RECRUITING
NCT06881992
PHASE3

A Phase 3 Study of Ersodetug in Patients With Tumor Hyperinsulinism

Sponsor: Rezolute

View on ClinicalTrials.gov

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).

Official title: 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)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

16

Start Date

2025-04-16

Completion Date

2027-09

Last Updated

2025-12-30

Healthy Volunteers

No

Interventions

DRUG

Ersodetug

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