Rezolute said Oct. 14 that it has completed enrollment in its Phase 3 Uplift study of ersodetug in tumor hyperinsulinism, putting the company on track to report topline data in mid-December 2026.
The study is enrolling 16 participants with insulinoma or non-islet cell tumors and uncontrolled hypoglycemia. Rezolute said the primary endpoint is the share of participants who need intravenous glucose and achieve at least a 50% reduction from baseline in glucose infusion rate over the 8-week treatment period. For the trial to show statistical significance, at least 56% of participants must respond, which would produce a 95% confidence interval lower bound of 30%.
Rezolute previously said 7 of the first 8 participants met that responder threshold. All 7 also discontinued intravenous glucose entirely after receiving ersodetug. The eighth participant was counted as a non-responder after choosing hospice care and dying one week later from cancer progression.
The company said ersodetug has been well tolerated in the study so far, with no drug-related safety findings reported.
Rezolute said it will continue its expanded access program for patients with serious, refractory hypoglycemia from tumor hyperinsulinism while it awaits the December data. It also said that if the Uplift results are favorable, it could move both tumor hyperinsulinism and congenital hyperinsulinism programs forward in 2027. Following these announcements, the company's shares moved -5.34%, and are now trading at a price of $4.61. Check out the company's full 8-K submission here.
