Pharma Focus Asia

Ligand Announces Top-Line Results from Phase 2 Study of LGD-6972 in Patients with Type 2 Diabetes

Wednesday, September 06, 2017

Ligand Pharmaceuticals Incorporated announced positive top-line results from a Phase 2 clinical study evaluating the efficacy and safety of LGD-6972, as an adjunct to diet and exercise, in subjects with type 2 diabetes mellitus (T2DM) inadequately controlled on metformin monotherapy. LGD-6972 is Ligand’s novel, oral, small molecule, glucagon receptor antagonist (GRA). The study achieved statistical significance (p < 0.0001) in the primary endpoint of change from baseline in hemoglobin A1c (HbA1c) after 12 weeks of treatment at all doses tested, demonstrating a robust, dose-dependent reduction in HbA1c of 0.90%, 0.92% and 1.20% with 5 mg, 10 mg and 15 mg of LGD-6972, respectively, compared to a 0.15% reduction with placebo.

LGD-6972 was safe and well tolerated, with no drug-related serious adverse events and no dose dependent changes in lipids (including total cholesterol, LDL cholesterol, HDL cholesterol, and triglycerides), body weight or blood pressure after 12 weeks of treatment.

Additional details from the Phase 2 study will be submitted for presentation at future scientific conferences and for publication.

“Diabetes is a growing and global medical epidemic and despite many approved therapies, there is need for new mechanisms to treat the disease,” said John Higgins, Chief Executive Officer. “Based on these trial results and previous data, we believe LGD-6972 has best-in-class type properties given its potency and effectiveness in patients with type 2 diabetes and given its potential applicability to type 1 diabetes as well. We look forward to presenting the full data set at an upcoming conference and to exploring potential partnership opportunities for this program.”

“A safe and effective small molecule glucagon receptor antagonist would be a major advancement in the treatment of type 2 diabetes, providing a novel and unique mechanism to manage the disease and potentially a way to influence the natural progression of the disease”, said Robert Henry, M.D., Professor of Medicine, Division of Endocrinology and Metabolism, University of California, San Diego School of Medicine; Chief, Section of Endocrinology and Metabolism and Director, Center for Metabolic Research, VA; and Past-President Medicine and Science, American Diabetes Association. "The clinical data set, lack of adverse events, and strong and clinically-relevant reduction of HbA1c shows promise for patients with type 2 diabetes and clearly warrants further clinical evaluation and advancement.”

“Inhibition of glucagon action is a novel approach to improve glycemic control in both type 1 and type 2 diabetes mellitus,” said Jeremy Pettus, M.D., Assistant Professor of Medicine Division of Endocrinology, University of California, San Diego and a Principal Investigator on the study. “In Type 1 diabetes, a safe and effective glucagon receptor antagonist may provide a means to reduce daily insulin requirements and improve glucose control throughout the day. LGD-6972 may provide these benefits along with the convenience of oral administration.”

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