Rezolute, Inc. announced on November 13, 2026, that its ongoing open-label Phase 3 upLIFT study of ersodetug has achieved its primary efficacy endpoint based on preliminary results from a data evaluation conducted on November 5, 2026. The primary endpoint measures the proportion of patients able to achieve at least a 50% reduction from baseline in glucose infusion rate (GIR), a metric indicating intravenous glucose dependency. To achieve statistical significance, the lower bound of the 95% confidence interval for the responder rate must exceed 30%.
As of the preliminary evaluation, 13 out of 16 enrolled participants met the responder criterion. Of these, 12 participants achieved a complete discontinuation of intravenous glucose. The remaining three participants are still in the pivotal period of the study, with two not yet meeting the responder criterion. One participant discontinued the study early and entered home hospice care, later dying due to cancer progression; this participant was classified as a non-responder for the primary endpoint.
The 16 participants included four with non-islet cell tumors and 12 with insulin-secreting malignant islet cell tumors (insulinomas). Ersodetug was well-tolerated throughout the pivotal and extension phases, with no drug-related safety findings attributed to the therapy. Rezolute expects to announce full topline results, including statistical analysis of the primary endpoint, by mid-December 2026.
The company stated it is positioned to advance both congenital hyperinsulinism and tumor HI into the approval process next year and looks forward to discussions with the FDA in the first quarter of 2027.
