Sanofi said it would begin global phase-3 clinical trials to compare Hanmi Pharmaceutical’s new obesity and diabetes treatment Efpeglenatide with a rival drug by Lilly.
Sanofi, the partner firm for Hanmi, announced on Wednesday that it officially registered the comparison study on online registry disclosure site clinicaltrials.gov. The trials will assess Efpeglenatide’s noninferiority to Trulicity (dulaglutide) in 900 patients with type-2 diabetes inadequately controlled with metformin, a widely used oral medicine for diabetes.
By administering Efpeglenatide and Trulicity once a week for 56 weeks, the study will compare the drug safety, blood glucose control and weight control effect, changes in blood sugar in empty stomach, and hypoglycemia symptoms.
The French pharmaceutical company is conducting two other types of phase-3 trials globally. The studies aim to compare Efpeglenatide with placebo and to verify the drug’s cardiovascular risk.
Efpeglenatide is a long-acting glucagon-like peptide-1 (GLP-1) biological treatment for diabetes. In 2015, Sanofi obtained its license from Hanmi and had since been conducting multiple phase-3 trials simultaneously around the world.
“Various trials are swiftly undergoing to prove Efpeglenatide’s global competitiveness. We will closely work with our partner company to accelerate commercialization of the drug,” Hanmi Pharmaceutical CEO Kwon Se-chang said.
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