Merck's GLP-1R/GCGR Dual Agonist Efinopegdutide (MK-6024) Receives CDE Acceptance for Clinical Trial Application in China

Source: PharmaCube Info

Author: info

On January 24, the CDE website showed that the clinical application of Merck Sharp & Dohme's Efinopegdutide (MK-6024) in China was accepted.

Efinopegdutide is a once-weekly glucagon-like peptide-1 (GLP-1)/glucagon receptor (GCGR) dual agonist discovered by Hanmi Pharmaceutical. In August last year, MSD agreed to pay Hanmi Pharmaceutical an upfront fee of $10 million, milestone payments of up to $860 million, and double-digit royalties for the development, manufacturing, and commercialization rights of the product for the treatment of non-alcoholic steatohepatitis (NASH). Meanwhile, Hanmi retains the option for the commercialization rights of efinopegdutide in Korea.

In July last year, MSD registered a head-to-head Phase IIa clinical trial of Efinopegdutide (MK-6024) vs Semaglutide for the treatment of Non-Alcoholic Fatty Liver Disease (NAFLD) on the U.S. Clinical Trials Registry (clinicaltrials).

This study plans to recruit 130 subjects, who will receive either weekly injections of Efinopegdutide or weekly injections of semaglutide. The study hypothesis is that Efinopegdutide is superior to semaglutide, or that after 24 weeks, the mean reduction in liver fat content (LFC) from baseline in the Efinopegdutide group will be at least 10% greater than that in the semaglutide group.

Note: The original text has been abridged.