US-based biopharmaceutical firm Zafgen has started a Phase II clinical trial of its second-generation MetAP2 inhibitor ZGN-1061 to treat patients with type 2 diabetes.
ZGN-1061 is a fumagillin-class, injectable small molecule with the ability to maximise impact on metabolic parameters associated with the treatment of type 2 diabetes and related metabolic disorders.
The randomised, placebo-controlled Phase II trial is designed to investigate three ZGN-1061 doses over a period of 12 weeks in around 120 overweight or obese patients at 23 centres in Australia and New Zealand.
Patients will be subcutaneously administered with either 0.05mg, 0.3mg, 0.9mg of ZGN-1061 or placebo every three days.
Zafgen president and CEO Thomas Hughes said: “ZGN-1061 has the potential to drive improvements across a number of metabolic endpoints which are not fully addressed by current diabetes treatments, and we look forward to sharing progress on enrolment of the clinical trial and reporting interim data in the first half of next year.”
While the primary objectives are glycemic control, safety and tolerability, the trial will also assess the effects of ZGN-1061 on various metabolic measures and cardiovascular risk factors such as body weight, plasma lipid fractions and inflammation.
The firm’s chief medical officer Dennis Kim said that the trial will also aim to determine an optimal dose range for use in later-stage trials.
A previous Phase I trial demonstrated that ZGN-1061 improved metabolic measures with rapid drug absorption and clearance.
The trial further indicated favourable safety and tolerability without any prothrombotic effects or serious adverse events (SAEs).