A Phase 3 Study of Ersodetug in Patients With Tumor Hyperinsulinism
Recruiting
Phase 3
Interventional Study
Tumor Hyperinsulinism (Tumor HI)
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 16 (estimated)
- Sponsor
- Rezolute · Other
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About This Trial
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).
Trial Locations
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Eligibility Criteria
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.
* Clinical diagnosis of neuroendocrine tumor (NET)…
Contacts