Rezolute, Inc. RZLT on Wednesday announced the Independent Data Monitoring Committee’s (DMC) recommendation to continue the Phase 3 sunRIZE study as planned in patients with congenital hyperinsulinism (HI) without increasing the study sample size.
HI is a genetic disorder in which the insulin cells of the pancreas, called beta cells, secrete too much insulin.
“We are thrilled with the DMC’s favorable recommendation, which appears to validate our initial assumptions for the design and powering of the Phase 3 sunRIZE study,” Rezolute Chief Medical Officer Brian Roberts said. “While we remain blinded to the partial study data and are not privy to any of the statistical outputs from the DMC, we are nevertheless encouraged…
