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Rezolute Completes Phase 3 upLIFT Trial Enrollment for Tumor Hyperinsulinism Drug

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RZLT$4.23 −8.24%

Rezolute, Inc. (RZLT) has fully enrolled its Phase 3 upLIFT clinical trial evaluating ersodetug for the treatment of tumor hyperinsulinism, a rare condition that causes severe low blood sugar. The single-arm study includes 16 patients with uncontrolled hypoglycemia driven by insulinoma or non-islet cell tumors.

The trial is designed to measure whether ersodetug can significantly reduce a patient's dependence on continuous intravenous glucose. Earlier data from the first eight patients showed seven achieved a full discontinuation of IV glucose alongside meeting the trial's primary endpoint, while one participant entered hospice care due to cancer progression. No drug-related safety concerns have been reported.

Topline data from the study are expected in mid-December 2026. If the trial yields favorable outcomes, the company aims to advance regulatory progress across both tumor and congenital hyperinsulinism indications in 2027. Following the announcement, Rezolute stock declined 8.24% to close at $4.23.

Key points

  • Rezolute, Inc. fully enrolled all 16 participants in its Phase 3 upLIFT study testing ersodetug for tumor hyperinsulinism.
  • Topline clinical data from the registrational trial are anticipated in mid-December 2026.
  • Seven of the first eight patients in the study met the primary endpoint and completely stopped intravenous glucose treatment.
  • No drug-related safety issues have been identified in the study to date.
  • Shares of Rezolute (NASDAQ:RZLT) fell 8.24% to $4.23 following the update.

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Questions and answers

What is the main goal of Rezolute's Phase 3 upLIFT study?

The study tests whether ersodetug reduces intravenous glucose needs by at least 50 percent in patients with tumor hyperinsulinism over eight weeks.

When will Rezolute release topline results for ersodetug?

Topline clinical results from the Phase 3 upLIFT trial are expected in mid-December 2026.

What were the early results from the upLIFT trial?

Seven of the first eight participants met the primary endpoint and completely eliminated their need for intravenous glucose infusion.