Rezolute has completed enrollment in its Phase 3 upLIFT study of ersodetug for tumor hyperinsulinism, with topline results expected in mid-December 2026.
The single-arm, open-label trial enrolled 16 participants with insulinoma or non-islet cell tumors whose hypoglycemia remains uncontrolled. Participants requiring continuous intravenous glucose receive ersodetug at 9 milligrams per kilogram weekly for eight weeks, alongside standard care.
The primary endpoint measures the proportion achieving at least a 50% reduction from baseline in their glucose infusion rate during the pivotal treatment period. The study requires a response rate of at least 56%, with the lower bound of the 95% confidence interval reaching 30%, to meet its statistical threshold.
Earlier this year, Rezolute reported that seven of the first eight participants met the response criterion. All seven also discontinued intravenous glucose. The company reported no drug-related safety findings at that stage.
The eighth participant entered home hospice shortly after enrollment and died a week later from cancer progression. Rezolute counted that participant as a nonresponder.
Additional endpoints include discontinuation of glucose infusions, time to hospital discharge, hypoglycemia frequency and duration, and patient-reported quality of life. Participants may continue receiving treatment in a long-term extension.
Ersodetug is an investigational monoclonal antibody designed to reduce insulin receptor overactivation caused by insulin and related substances, including those produced by tumors. Its safety and efficacy have not been established by regulatory authorities.
Rezolute will continue its expanded access program for patients with serious, treatment-resistant hypoglycemia caused by tumor hyperinsulinism while awaiting the completed trial’s results.
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