Actively Recruiting
A Phase 3 Study of Ersodetug in Patients With Tumor Hyperinsulinism
Led by Rezolute · Updated on 2026-05-08
16
Participants Needed
13
Research Sites
124 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
A Phase 3 Study of Ersodetug in Patients With Tumor Hyperinsulinism
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female participants aged 18 years or older who provide written informed consent
- Clinical diagnosis of neuroendocrine tumor with biochemical evidence of tumor hyperinsulinism confirmed by laboratory tests
- Failure to achieve adequate control of hypoglycemia with standard anti-hypoglycemic therapies
- Currently requiring intravenous glucose infusion and/or parenteral nutrition for at least 7 days to manage refractory hypoglycemia
- Eligibility evaluation by a multidisciplinary team led by the principal investigator including an oncologist
You will not qualify if you...
- Active infection including HIV, hepatitis B, or hepatitis C (excluding immunization patterns)
- Treatment with an investigational drug or device within 30 days or 5 half-lives unless deemed safe by investigator and Medical Monitor
- Clinically significant abnormal laboratory values at screening excluding glucose unless related to tumor or therapy and approved by investigator
- Known allergy or sensitivity to ersodetug or any component of the drug
- Any organ condition, concomitant disease, or abnormality posing unacceptable risk as judged by investigator or Medical Monitor
- Estimated life expectancy less than 8 weeks due to underlying disease
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 13 locations
1
Investigative Site
Chicago, Illinois, United States, 60637
Actively Recruiting
2
Investigative Site
Bethesda, Maryland, United States, 20892
Not Yet Recruiting
3
Investigative Site
Boston, Massachusetts, United States, 02114
Actively Recruiting
4
Investigative Site
Rochester, Minnesota, United States, 55905
Actively Recruiting
5
Investigative Site
New York, New York, United States, 10021
Actively Recruiting
6
Investigative Site
Canton, Ohio, United States, 44718
Actively Recruiting
7
Investigative Site
Portland, Oregon, United States, 97239
Actively Recruiting
8
Investigative Site
Houston, Texas, United States, 77030
Not Yet Recruiting
9
Investigative Site
Clichy, Île-de-France Region, France, 92110
Actively Recruiting
10
Investigative Site
Rotterdam, South Holland, Netherlands, 3015
Not Yet Recruiting
11
Investigative Site
Basel, Canton Basel-Stadt, Switzerland, CH-4001
Actively Recruiting
12
Investigative Site
Saint Johns Wood, London, United Kingdom, NW3 2QG
Not Yet Recruiting
13
Investigative Site
Withington, Manchester, United Kingdom, M20 4BX
Actively Recruiting
Research Team
R
Rezolute Clinical Trial
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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