Tests ersodetug for low blood sugar caused by insulin-producing tumors
Tests ersodetug, added to usual care, in adults with tumor-caused low blood sugar.
Plain-language title generated from the registry record
Registry title: A Phase 3 Study of Ersodetug in Patients With Tumor Hyperinsulinism
Key facts
- Where
- Basel, SwitzerlandSee the site
- Phase
- Phase 3
Where in Switzerland
- BaselBasel, SwitzerlandTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Rezolute
- Trial code
- NCT06881992
- Record updated
- 28 September 2026
- Original description
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).Read full original descriptionShow less
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)
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).
Inclusion: 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) (ICT or NICT) with biochemical evidence of tumor hyperinsulinism (hypoglycemia with inappropriately elevated insulin or insulin-like growth factor (IGF)/variant suppression) confirmed via laboratory assessment who have failed to achieve adequate control of hypoglycemia with usual SOC anti-hypoglycemic therapies, per investigator judgement; Currently requiring IV glucose infusion and/or parenteral nutrition for ≥7 days for the management of refractory hypoglycemia (prior to administration of the 1st dose of ersodetug).
Exclusion: Treatment with an investigational drug or device within 30 days or 5 half-lives of the investigational drug (whichever is longer), however, if the treating physician and Medical Monitor consider no significant risk of drug-drug interaction and potential benefit outweighs the risk then the participant may be allowed to participate. Participation in registries and purely diagnostic studies is allowed; Any organ condition, concomitant disease (e.g., psychiatric illness, severe alcoholism, or drug abuse, cardiac, hepatic, or kidney disease), or other abnormality that itself, or the treatment of which in the opinion of the investigator and/or Sponsor's Medical Monitor would pose an unacceptable risk to the participant in the study; Evidence of active infection including human immunodeficiency virus, hepatitis B, or hepatitis C (excluding immunization patterns); Known allergy or sensitivity to ersodetug or any component of the drug; Estimated life expectancy (additional lifespan) due to underlying disease (tumor) is <8 weeks; Any out-of-range laboratory value at screening (other than glucose) that is assessed as clinically significant by the investigator. Laboratory or radiographic abnormalities that are considered related to the underlying disease (tumor) or associated therapies and do not pose additional safety risk for study participation per investigator and Medical Monitor may be allowed.