Rezolute’s Ersodetug Study Sees 75% Response Rate with No Safety Issues
RZLT•Rezolute’s Phase 3 upLIFT study of ersodetug in tumor hyperinsulinism is 50% enrolled with six of eight participants meeting the primary endpoint of ≥50% reduction in IV glucose infusion rate and complete discontinuation of IV glucose. No drug-related adverse events were reported, with topline data expected in H2 2026.
1. Interim Efficacy Results
Rezolute’s ongoing Phase 3 upLIFT study of ersodetug in tumor hyperinsulinism has enrolled eight of a planned 16 participants. Six of these achieved at least a 50% reduction in IV glucose infusion rate and complete discontinuation of IV glucose, meeting the study’s primary endpoint.
2. Safety and Tolerability
Ersodetug was well tolerated in both the pivotal eight-week treatment phase and extension period, with no drug-related adverse events or safety concerns reported to date.
3. Next Steps and Regulatory Path
All participants who completed the pivotal phase have entered long-term extension treatment, and topline results for the fully enrolled study are expected in the second half of 2026. Rezolute plans to engage FDA to define the path forward for the congenital hyperinsulinism indication based on these findings.
