Eli Lilly and Maryland-based MacroGenics have declared that the Protege trial has achieved its targeted patient enrollment.
The Protege trial is a randomized, double-blind, multi-center, multi-national, 4-arm, controlled study. It is designed to evaluate the safety and efficacy of teplizumab in individuals with recent-onset type 1 diabetes, aged 8 to 35, who are within 12 weeks of their diagnosis.
More than 530 individuals are enrolled in the study across 14 countries.
Both the companies have also initiated the Protege Encore trial, another Phase-III global study of teplizumab, in individuals with recent-onset type 1 diabetes. It is designed to capture patient-reported outcome measures, in addition to safety and efficacy data.
Scott Koenig, President and CEO of MacroGenics, said: The completion of enrollment of the Protege study is an important milestone for MacroGenics and for the type 1 diabetes research community.
We appreciate the dedication of the patients, their caregivers and clinical investigators who helped advance this important late-stage clinical trial, he added.