India, April 23 -- Rezolute, Inc. (RZLT) on Wednesday announced that an independent Data Monitoring Committee or DMC has issued a positive recommendation for the ongoing Phase 3 sunRIZE study of ersodetug, supporting continued enrollment without the need for a sample size increase.
The sunRIZE study is a randomized, double-blind, placebo-controlled Phase 3 trial evaluating Ersodetug in patients with congenital hyperinsulinism, a rare pediatric condition marked by life-threatening, persistent hypoglycemia.
The interim analysis was based on predefined criteria evaluating the study's primary endpoint - hypoglycemia events - after approximately half of the participants had completed their primary assessments.
The DMC found no signs of futili...