A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Ersodetug in Patients With Inadequately Controlled Hypoglycemia Due to Tumor-Associated Hyperinsulinism (tHI)
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).
• 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
• 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 tHI confirmed via laboratory assessment who have failed to achieve adequate control of hypoglycemia with usual SOC anti-hypoglycemic therapies, per investigator judgement.
• Requiring IV glucose infusion and/or parenteral nutrition for ≥3 days for management of uncontrolled hypoglycemia