Rezolute, Inc. (Nasdaq: RZLT) announced on October 14, 2026, that the open-label Phase 3 study of ersodetug in tumor hyperinsulinism (HI), known as the upLIFT study, has reached full enrollment. The registrational trial is designed to evaluate the drug's ability to treat refractory hypoglycemia caused by insulinoma or non-islet cell tumors.
The upLIFT study is a single-arm, open-label trial involving approximately 16 participants. These individuals suffer from uncontrolled hypoglycemia due to tumor HI and require continuous intravenous (IV) glucose. Participants receive ersodetug at a dose of 9 mg/kg per week for an 8-week pivotal treatment period, added to standard care. Following this initial phase, all participants may continue treatment in a long-term extension.
The primary endpoint of the study is the percentage of participants who achieve at least a 50 percent reduction from baseline in their glucose infusion rate (GIR). For the study to meet statistical significance, the lower bound of the 95% confidence interval for the responder rate must be greater than or equal to 30 percent. With 16 participants, this equates to a required response rate of at least 56 percent.
Earlier in the year, Rezolute reported that 7 of the first 8 participants enrolled in the study met the responder criterion for the primary endpoint. Each of these participants also achieved complete discontinuation of IV glucose. The eighth participant elected to pursue hospice care shortly after enrollment and died one week later due to cancer progression; the company considers this participant a non-responder.
Rezolute expects to release topline data from the upLIFT study in mid-December 2026. The company also stated its intention to continue an expanded access program to provide ersodetug on a compassionate use basis to patients with serious and refractory hypoglycemia due to tumor HI.
