Melior begins Phase IIb trial for Type II diabetes candidate MLR-1023

Melior Discovery Inc. (Exton, Pa.) spinout Melior Pharmaceuticals I Inc. began a Phase IIb trial of MLR-1023 to treat adults with Type II diabetes uncontrolled on metformin.

The 12-week, double-blind trial will enroll 400 patients in the U.S. and South Korea to receive placebo or once-daily 25, 50 or 100 mg oral MLR-1023 plus metformin. The primary endpoint is the change from baseline to week 12 in HbA1c. Secondary endpoints include the proportion of patients with an HbA1c of <7% and <6.5% at week 12 and changes from baseline to week 12 in fasting plasma glucose (FPG), fasting insulin, insulin sensitivities, lipid profile and body weight...