Rezolute Presents Phase 3 sunRIZE Data and Post-Hoc Analyses at Pediatric Endocrine Society Annual Meeting
Rezolute announced that its Phase 3 sunRIZE study results for ersodetug in congenital hyperinsulinism were accepted for an oral presentation at the Pediatric Endocrine Society Annual Meeting on May 1, 2026. The presentation will feature previously reported topline outcomes plus pre-specified and post-hoc analyses indicating sustained target engagement and therapeutic benefit.
1. Presentation Details
Rezolute will deliver an oral presentation of its Phase 3 sunRIZE trial results at the Pediatric Endocrine Society Annual Meeting on May 1, 2026, from 8:15 to 9:15 a.m. PT. Dr. Diva D. De León-Crutchlow, MD, MSCE, will discuss the study’s key findings during Oral Abstracts Session #1.
2. sunRIZE Phase 3 Study Design
The sunRIZE trial (RZ358-301) is a multicenter, randomized, double-blind, placebo-controlled, parallel-arm study evaluating ersodetug (5 or 10 mg/kg) versus placebo in 63 congenital hyperinsulinism patients aged 3 months to 45 years. Primary and key secondary endpoints assess change from baseline in weekly hypoglycemia events and percent time in hypoglycemia over six months.
3. Data Inclusion and Findings
In addition to previously disclosed topline results, Rezolute will present both pre-specified and post-hoc analyses that continue to demonstrate target engagement at the insulin receptor and show therapeutic benefit in reducing hypoglycemia events.