US-based biopharmaceutical company Ligand Pharmaceuticals Incorporated has begun a Phase ll clinical trial of its glucagon receptor antagonist LGD-6972 to treat type 2 diabetes mellitus (T2DM).
The randomised, double-blind, placebo-controlled trial will assess the safety and efficacy of LGD-6972 as an adjunct to diet and exercise in patients with T2DM whose blood glucose levels are ineffectively controlled with metformin.
A total of 148 patients with T2DM are to be enrolled in the trial, which will be conducted at up to 30 clinical sites situated across the US.
During the trial, patients will be treated with one of three doses of LGD-6972 or placebo once daily for 12 weeks.
The primary endpoint of the trial includes the change from baseline in hemoglobin A1c, while secondary endpoints include the change from baseline in fasting plasma glucose, insulin, glucagon and GLP-1.
The secondary endpoint also includes changes in lipids, blood pressure and body weight.
The trial is expected to be completed by late next year.
Ligand Pharmaceuticals Incorporated CEO John Higgins said: “Glucagon antagonism has continued to emerge as a leading non-insulin mechanism for type 2 diabetes.
“We look forward to obtaining data next year, and to potential future partnering of this asset, consistent with our shots-on-goal business model.”
The company said that the Phase l trial results of LGD-6972 have showed that the solution could help in reducing plasma glucose in patients with T2DM.
Diabetes is currently estimated to affect more than 415 million people worldwide.
Studies have shown that around 44 million people have diabetes in North America and if the current trend continues, by 2050 approximately 33% of the US population will be affected by the disease.