Rezolute, Inc. (NASDAQ:RZLT) reported an interim update from its ongoing Phase 3 upLIFT study evaluating ersodetug in patients with tumor hyperinsulinism (HI), saying six of the eight participants enrolled so far achieved the study’s primary endpoint.
Tumor hyperinsulinism is a rare condition caused by certain islet cell and non-islet cell tumors that trigger hypoglycemia through overactivation of the insulin receptor.
Insulinomas, the most common type of islet cell tumor, cause hypoglycemia by stimulating excessive insulin production.
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Six Of Eight Enrolled Participants Meet Primary Endpoint
The late-stage ultra-rare disease company said the trial has enrolled eight participants to date, placing it halfway toward its planned enrollment target of 16 patients. The study includes individuals with both insulinoma and non-islet cell tumor hypoglycemia.
According to the company, six participants achieved at least a 50% reduction from baseline in intravenous glucose requirements, measured by glucose infusion rate (GIR), during the trial’s eight-week pivotal treatment phase.
Rezolute added that each of those six participants was also able to completely discontinue intravenous glucose therapy while receiving ersodetug.
One Participant Counted As Non-Responder Following Hospice Transition
One enrolled participant withdrew consent before completing the pivotal treatment phase and discontinued ersodetug along with all non-palliative therapies.
The patient had Stage 4 metastatic colon cancer and an Eastern Cooperative Oncology Group performance status of 4. The individual chose to leave the hospital for hospice care at home and died one week later due to cancer progression.
Rezolute said the reduction and eventual discontinuation of intravenous glucose occurred during the transition to hospice care. As a result, the participant was classified as a non-responder for purposes of evaluating the study’s primary endpoint.
The eighth participant was recently enrolled and remains in the pivotal treatment phase.
Safety Profile Remains Favorable
All participants who completed the eight-week treatment period elected to continue into the study’s open-label extension phase, with cumulative treatment durations reaching up to six months.
The company reported that ersodetug has been well tolerated across both the pivotal and extension phases of the study. No drug-related adverse events or other safety findings have been reported so far.
In December 2025, the company’s Phase 3 sunRIZE study evaluating ersodetug in patients with congenital hyperinsulinism (HI), did not meet its primary endpoint, which assessed the change in the average weekly hypoglycemia events by self-monitored blood glucose.
RZLT Stock Price Activity: Rezolute shares were up 15.65% at $4.18 at the time of publication on Tuesday, according to Benzinga Pro.
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