Rezolute Finished Enrollment for Phase 3 Trial

The clinical study tests the effectiveness of ersodetug in patients suffering from tumor hyperinsulinism.

Updated on Oct. 14, 2026 in Diabetes

Rezolute Finished Enrollment for Phase 3 Trial

Rezolute has successfully completed participant enrollment for its Phase 3 upLIFT study evaluating the drug candidate ersodetug. The trial aims to address the life-threatening hypoglycemia caused by tumor hyperinsulinism through insulin receptor inhibition.

Why it matters

Tumor hyperinsulinism results in severe hypoglycemia due to insulin receptor over-activation, a condition for which effective treatments are currently limited. This study tests whether the monoclonal antibody can significantly reduce the intravenous glucose requirements of affected individuals.

The upLIFT study includes 16 participants who receive a 9 mg/kg weekly dose of ersodetug over an 8-week period. Success is defined as a 50 percent reduction in the glucose infusion rate required to maintain patient stability.

The players

Rezolute

This biopharmaceutical company is based in Redwood City, California, and focuses on developing therapies for metabolic and rare diseases.

Ersodetug

This monoclonal antibody is an experimental drug designed to inhibit the insulin receptor to treat hyperinsulinism.

The details

Participants in the trial receive ersodetug, a monoclonal antibody designed to target the insulin receptor. Researchers are closely monitoring how effectively the drug reduces the need for intravenous glucose among those struggling with tumor hyperinsulinism.

The company announced the completion of enrollment on October 14, 2026.
Topline data from the study is expected to be released by mid-December 2026.
Potential advancement of two clinical indications is planned for 2027.

The Big Picture

The clinical progression of ersodetug follows a pattern set by the FDA's expanded access program, which provides pathways for patients to access investigational therapies outside of clinical trials.

This development brings researchers closer to determining if ersodetug can provide a viable treatment for life-threatening hyperinsulinism. Patients currently reliant on intravenous glucose may eventually see new options for managing insulin receptor over-activation.

The takeaway

The successful enrollment of this study marks a critical step toward validating a new monoclonal antibody treatment for rare metabolic disorders. These clinical efforts offer potential long-term hope for individuals who currently lack standard pharmaceutical interventions for their hypoglycemia.