Rezolute reports positive phase 3 results in tumor hyperinsulinism study
Key points
- Rezolute (NASDAQ:RZLT) reported preliminary Phase 3 results showing that ersodetug met the primary efficacy endpoint in its upLIFT study for tumor hyperinsulinism.
- 13 of 16 participants achieved at least a 50% reduction in intravenous glucose infusion requirements, while 12 discontinued intravenous glucose completely.
- The company expects complete study results and statistical analysis by mid-December 2026, followed by planned FDA discussions in the first quarter of 2027.
Rezolute (NASDAQ:RZLT) reported preliminary Phase 3 upLIFT results showing that 13 of 16 participants achieved at least a 50% reduction in intravenous glucose infusion requirements while receiving experimental drug ersodetug.
Of the 13 participants who met the response criterion, 12 also discontinued intravenous glucose completely, while three participants remained in the pivotal treatment period, including two who had not yet achieved the required response.
The upLIFT study is a single-arm, open-label Phase 3 trial involving patients with tumor hyperinsulinism, meaning it has no placebo or comparison group against which to measure treatment outcomes.
One participant discontinued treatment early, entered hospice and subsequently died from cancer progression, and Rezolute counted the participant as a non-responder, while no drug-related safety findings have been reported to date.
Rezolute expects completed-study results, including statistical analysis, by mid-December 2026 and plans to engage with the U.S. Food and Drug Administration in the first quarter of 2027.
Ersodetug remains investigational and is being developed to treat severe, persistent low blood sugar caused by hyperinsulinism, with the upLIFT study evaluating patients with insulinoma and non-islet cell tumors.
