Rezolute did not confirm upLIFT Phase 3 results in Nov. 13 statement
Key Facts
It was not possible to verify an announcement by Rezolute of an upLIFT Phase 3 result in a statement dated Nov. 13, 2026, so no confirmed result attributable to the company is available for that date. The study tested ersodetug as an add-on to standard care in patients with hypoglycemia caused by an insulinoma. According to the ClinicalTrials.gov record, its objectives include assessing efficacy in controlling blood glucose, as well as safety and tolerability. The company’s earlier disclosures described the study as an open-label trial in this rare disease. The full results expected in an earlier disclosure remain the next announced milestone for the study, rather than a confirmed result on Nov. 13.
A Rezolute disclosure filed with the U.S. Securities and Exchange Commission described the study as single-arm and open-label, with about 16 participants planned. The primary endpoint measures the number of participants who achieve a reduction of at least 50% from baseline in their intravenous glucose requirements. This means the response specified in the study design is tied to reducing intravenous support, rather than to an unspecified improvement in blood glucose. Adding ersodetug to standard care is also part of the assessment objective as stated in the trial record. The design provides a framework for reading the interim figures the company published for the first participants.
In an earlier update included in its SEC filing dated Nov. 5, 2026, the company said 7 of the first 8 participants to enter the first half of the study met the response criterion. The filing said each of those seven had completely discontinued intravenous glucose while receiving ersodetug. This interim result provides context for the criterion of reducing intravenous glucose requirements by at least 50%, but does not in itself represent the full study result. In the same update, the company said enrollment was complete and that it expected full topline results in mid-December 2026. The expected timing for the full results was therefore after the statement dated Nov. 13.
Rezolute had announced completion of enrollment on Oct. 14, 2026, according to its SEC filing, in the open-label Phase 3 ersodetug study. The study population includes patients with an insulinoma or non-islet cell tumors accompanied by uncontrolled hypoglycemia. According to the filing, eligible participants requiring continuous intravenous glucose receive a weekly dose of 9 mg/kg of ersodetug for 8 weeks, in addition to standard care. After the pivotal period, participants may enter a long-term extension phase. This treatment plan describes the period covered by the primary assessment before the extension phase.
The filing defined statistical significance as the lower bound of the 95% confidence interval for the responder rate reaching at least 30%. The company provided an example published on Oct. 14 linking this condition to a 56% response rate in a sample of 16 participants, with a confidence interval of 30% to 80%. The example is tied to the planned study sample size and explains the threshold the company set before reading the final result. In the Nov. 5 update, the published result covered 7 of the first 8 participants, while the company said it was awaiting full topline results in mid-December. That timing therefore remains the one announced in earlier disclosures for reviewing the full dataset.
The upLIFT study is part of the company’s broader program in hypoglycemia disorders associated with hyperinsulinism. In an earlier disclosure, Rezolute said its Phase 3 sunRIZE trial in congenital hyperinsulinism did not meet its primary endpoint because reductions in hypoglycemia episodes were not statistically significant compared with placebo. sunRIZE differs from upLIFT in the condition under study, as the latter focuses on insulinoma-related hyperinsulinism. The earlier disclosure places the sunRIZE result in the context of the company’s clinical program without changing the stated assessment criteria for the upLIFT study. The next timing milestone identified by the company in its update is the release of full topline results, expected in mid-December 2026.