Amylin Pharmaceuticals and Takeda Pharmaceutical have suspended clinical activities in an ongoing phase II study examining the safety and effectiveness of the investigational combination therapy pramlintide/metreleptin for the treatment of obesity. The clinical study was voluntarily halted to investigate a new antibody-related laboratory finding with metreleptin treatment in two patients who participated in a previously completed clinical study of obesity.
"The safety of patients in our clinical programs is of paramount concern to the companies. We have taken this precaution so that we can thoroughly investigate this finding," said Orville Kolterman, M.D., senior vice president and chief medical officer of Amylin Pharmaceuticals. "Together with our partner, Takeda, we are committed to working closely with clinical investigators, regulators and outside experts to determine the best path forward."