The Phase Ia study was a randomized, placebo-controlled, double-blind, ascending-dose clinical trial in 60 healthy male and female volunteers examining doses of MBX-2982 in the 10-1000mg range. All doses of the drug were well tolerated and no dose-related adverse events were observed.
According to the company, MBX-2982 was rapidly absorbed, demonstrated excellent exposure and exhibited a half- life consistent with once-daily dosing. As observed in preclinical studies in animals, MBX-2982 showed dose-dependent reductions in glucose and increases in GLP-1 following a mixed meal. These results provide initial clinical validation of the unique mechanism of action of MBX-2982, the company said.
MBX-2982 is a potential treatment for type 2 diabetes that targets G protein-coupled receptor 119, a receptor that interacts with bioactive lipids known to stimulate glucose-dependent insulin secretion.
Harold Wart, CEO of Metabolex, said: “The results of this Phase Ia clinical trial are very encouraging and support the continued development of MBX-2982 as an important new therapy for treating type 2 diabetes. Based on the excellent safety profile and encouraging effects on glucose levels observed in our Phase Ia trial, we have advanced MBX-2982 into a Phase Ib study in which we are evaluating the multiple-dose pharmacokinetics and pharmacodynamics.”