NCT06881992 · Rezolute
A Phase 3 Study of Ersodetug in Patients With Tumor-Associated Hyperinsulinism
(tHI)
What this study is about
The objectives of this study are to evaluate the glycemic effectiveness, safety, and tolerability of ersodetug for treatment of hypoglycemia in patients with Tumor-Associated Hyperinsulinism (tHI).
View original scientific description
The objectives of this study are to evaluate the glycemic efficacy, safety, and tolerability of ersodetug for treatment of hypoglycemia in patients with Tumor-Associated Hyperinsulinism (tHI).
Interventions
DRUG
Ersodetug
Ersodetug (9 mg/kg) + SOC
Primary outcome measures
Proportion of participants with clinically meaningful reduction in IV glucose infusion rate from baseline.
Time frame: 8 weeks
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- The eligibility criteria of all participants must be evaluated by a multidisciplinary team led by the PI which must include an oncologist
- Male or female participants of ≥18 years of age who provide written informed consent
- Participants with a clinical diagnosis and laboratory confirmation of ICT or NICT, with associated hypoglycemia that is considered refractory to surgery and to usual SOC anti-hypoglycemia therapies, per investigator judgement.
- Experiencing an average of ≥ 3 hypoglycemia events per week that meet Level 2 criteria and/or Level 3 criteria during the two weeks before randomization
Exclusion criteria
- Participants who have not previously received tumor-directed therapy (including at least one course/trial of systemic tumor-directed therapy, as appropriate) but are considered appropriate for tumor-directed therapies by the investigator and/or a multi-disciplinary oncology
Where
- Chicago, Illinois
- Bethesda, Maryland
- Boston, Massachusetts
- Rochester, Minnesota
- New York, New York
- Canton, Ohio
- Portland, Oregon
- Houston, Texas
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced May 18, 2026 · Source of record for eligibility and locations