US drug developer Genaera has started dosing subjects in study MSI-1436C-102, a multiple ascending-dose Phase Ib trial of trodusquemine (MSI-1436) in overweight and obese type 2 diabetics.
The agent works centrally and peripherally to regulate insulin and leptin pathways through the highly selective inhibition of its novel target enzyme, PTP-1B. Data from the double-blind, randomized, placebo-controlled, 21-patient study is expected in the first half of next year.
Study 102 will establish multiple-dose pharmacokinetics and expand the safety database for MSI-1436 in a population of overweight and obese adult type 2 diabetics who are poorly controlled on metformin. The study will also evaluate key secondary outcomes in this population, including oral glucose tolerance and insulin sensitivity, satiety and weight loss.
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