Rezolute Announces Completion of Enrollment in Phase 3 upLIFT Study of Ersodetug in Tumor Hyperinsulinism
Key Highlights
- ➤upLIFT Phase 3 enrollment complete; topline results expected mid-December 2026
- ➤Trial enrolls 16 participants with tumor hyperinsulinism and uncontrolled hypoglycemia
- ➤Seven of eight initial participants met the primary responder criterion
- ➤Each initial responder discontinued intravenous glucose with ersodetug treatment
- ➤No drug-related safety findings reported among participants treated thus far
Expert Statements
Brian Roberts, Chief Medical Officer of Rezolute
“Completing enrollment in the upLIFT study marks an important milestone as we advance a potentially transformative treatment option for patients living with tumor hyperinsulinism.”
Brian Roberts, Chief Medical Officer of Rezolute
“Now that we have a path forward for congenital hyperinsulinism, we look forward to announcing topline data from upLIFT and to the extent the study outcomes are favorable, the potential to advance both indications in 2027.”
Brian Roberts, Chief Medical Officer of Rezolute
“We are deeply grateful to the patients, families, investigators and advocacy groups whose dedication and partnership have enabled us to reach this point.”
REDWOOD CITY, Calif., Oct. 14, 2026 (GLOBE NEWSWIRE) -- Rezolute, Inc. (Nasdaq: RZLT) (Rezolute or Company), a late-stage ultra-rare disease company focused on treating refractory hypoglycemia caused by any form of hyperinsulinism (HI), today announced that the open-label Phase 3 study of ersodetug in tumor HI (upLIFT) is now fully enrolled and topline data are expected mid-December 2026. The Company plans to continue its expanded access program for purposes of providing ersodetug on a compassionate use basis to individuals living with serious and refractory hypoglycemia due to tumor HI.
The upLIFT study is a single-arm, open-label, registrational study in 16 participants with insulinoma or non-islet cell tumors who have uncontrolled hypoglycemia caused by tumor HI. The study’s primary endpoint is the percent of participants who require intravenous glucose for refractory hypoglycemia that achieve at least a 50 percent reduction from baseline in glucose infusion rate (GIR) within the 8-week pivotal treatment phase. For statistical significance, the lower bound of the 95% confidence interval (CI) for the percent responder rate must be ≥30%, equating to a response rate of at least 56% (95% CI of 30-80%) for 16 participants.
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