REDWOOD CITY, Calif., October 14, 2026
Rezolute, Inc. (NASDAQ: RZLT), a late-stage biotechnology company focused on treatments for refractory hypoglycemia caused by hyperinsulinism (HI), announced the completion of enrollment in its Phase 3 upLIFT clinical trial evaluating ersodetug in patients with tumor hyperinsulinism. The company expects to report topline results in mid-December 2026. The open-label, single-arm registrational study evaluates the investigational antibody in patients with insulinoma or non-islet cell tumors who experience uncontrolled hypoglycemia. The trial’s completion marks an important milestone in Rezolute’s development program targeting severe, difficult-to-manage low blood glucose associated with excessive insulin receptor activation. The company also plans to continue its expanded access program, providing ersodetug on a compassionate-use basis to eligible individuals living with serious, refractory hypoglycemia caused by tumor hyperinsulinism. Rezolute stated that favorable study outcomes could support further development of ersodetug for tumor and congenital hyperinsulinism in 2027.
upLIFT Trial Evaluates Reduction in Intravenous Glucose Requirements
The upLIFT Phase 3 trial enrolled approximately 16 participants with uncontrolled hypoglycemia associated with insulinomas or non-islet cell tumors. Eligible participants requiring continuous intravenous (IV) glucose receive ersodetug at 9 mg/kg once weekly for eight weeks, in addition to standard of care. After the pivotal treatment period, participants may enter a long-term extension. The primary endpoint measures the proportion of participants who achieve at least a 50% reduction from baseline in glucose infusion rate (GIR) during the eight-week treatment phase. For the primary endpoint to meet the study’s specified statistical success criterion, the lower bound of the 95% confidence interval for the responder rate must be at least 30%. For the planned 16 participants, this corresponds to a response rate of at least 56%, with a cited confidence interval of 30% to 80%. Additional endpoints include complete discontinuation of IV glucose and the time required to discontinue it, time to hospital discharge, hypoglycemia events, outpatient glucose measurements and patient-reported quality of life. These measures are intended to assess whether treatment can reduce dependence on glucose infusions and improve aspects of patients’ clinical course.
Earlier Participants Showed Reduced Glucose Requirements
Rezolute previously reported that seven of the first eight participants enrolled in the study met the responder criterion for the primary endpoint. According to the company, all seven responders also achieved complete discontinuation of IV glucose following administration of ersodetug. The treatment was reported to have been well tolerated in the study to that point, with no drug-related safety findings reported. The eighth participant elected to receive hospice care at home shortly after enrollment and died one week later because of cancer progression. Rezolute considers this participant a non-responder for the primary endpoint. These interim observations provide an early view of treatment outcomes, but the final analysis will include the completed study population and determine whether the trial meets its prespecified endpoint. Chief Medical Officer Brian Roberts said completing enrollment represents an important development milestone and that the company looks forward to reporting topline results. He also noted that, depending on the study outcomes, Rezolute could advance development in both tumor and congenital hyperinsulinism in 2027. The upcoming results will be important in assessing whether the early response pattern is maintained across the full trial population.
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Ersodetug Targets Insulin Receptor Overactivation
Ersodetug is a fully human monoclonal antibody designed to bind allosterically to the insulin receptor and reduce its overactivation by insulin and related substances, including insulin-like growth factor 2 (IGF-2). In tumor hyperinsulinism, excessive insulin production by insulinomas or the release of insulin-like substances by certain non-islet cell tumors can activate insulin receptors and cause severe hypoglycemia. The condition is associated with substantial morbidity and mortality, and new approaches to controlling refractory hypoglycemia remain an unmet medical need. By acting downstream of insulin or IGF-2 secretion, ersodetug is being investigated for its potential to address hypoglycemia across different forms of hyperinsulinism. Rezolute is also developing the candidate for congenital hyperinsulinism and hypoglycemia associated with gastrointestinal surgery. The company has reported real-world experience with ersodetug in patients with insulinomas and non-islet cell tumors. However, ersodetug remains investigational, and its safety and efficacy have not been approved by any health authority. The anticipated December topline results from upLIFT will provide the next major clinical milestone for its tumor hyperinsulinism program.
Source::Rezolute press release
