Merck's GLP-1/GCGR Dual Agonist Efinopegdutide Challenges Semaglutide in NAFLD Head-to-Head Phase IIa Trial

Recently, the U.S. clinical trial registry (ClinicalTrials.gov) showed that MSD has registered a head-to-head Phase IIa clinical trial of Efinopepdutide (MK-6024) vs. semaglutide for the treatment of non-alcoholic fatty liver disease (NAFLD).Clinical Trial。

Efinopegdutide is a once-weekly injectable glucagon-like peptide-1 (GLP-1)/glucagon receptor (GCGR) dual agonist discovered by Hanmi Pharmaceuticals. Last August, MSD entered into an agreement with Hanmi Pharmaceuticals, featuring a $10 million upfront payment, up to $860 million in milestone payments, and double-digit sales royalties, to secure the rights to develop, manufacture, and commercialize the product for the treatment of non-alcoholic steatohepatitis (NASH). Additionally, Hanmi retains an option for the commercialization rights of efinopegdutide in South Korea.

This study plans to enroll 130 subjects to receive once-weekly injections of efinopegdutide or semaglutide. The study hypothesis is that efinopegdutide is superior to semaglutide, with the mean reduction from baseline in liver fat content (LFC) at Week 24 being at least 10% greater in the efinopegdutide group than in the semaglutide group.

Semaglutide is a long-acting GLP-1RA developed by Novo Nordisk. In May 2020, the Phase II trial of semaglutide for the treatment of NASHClinical trialPositive results were achieved. Compared with placebo, semaglutide significantly resolved NASH histological features without worsening liver fibrosis. Among patients receiving the highest dose of semaglutide, 58.9% achieved NASH resolution, compared to 17.2% in the placebo group. Meanwhile, patients treated with semaglutide also demonstrated improvement in liver fibrosis parameters, and liver function indicators such as transaminases were significantly improved.(BioonBioon.com）