Merck's efinopegdutide bests Ozempic in tease of phase 2 NASH data

Merck & Co. says its dual GLP-1/glucagon receptor co-agonist efinopegdutide beat out Novo Nordisk's Ozempic in the tricky indication of nonalcoholic fatty liver disease (NAFLD).

While NAFLD may be a road less frequently traveled in the budding GLP-1 space, which is better known for Type 2 diabetes and, more recently, obesity, efinopegdutide posted a 72.7% mean reduction in liver fat content (LFC) at week 24 compared to 42.3% for Novo Nordisk’s diabetes drug, which is also known as semaglutide or Wegovy when marketed for weight loss.

The phase 2a trial randomized 145 people to receive either efinopegdutide or Ozempic with nearly a third of participants having Type 2 diabetes. The average LFC among recruited patients before treatment was 20.3%, according to abstract data published earlier this week.

In addition to besting Ozempic on mean LFC reductions, Merck reported that 66.7% of patients given efinopegdutide achieved LFC levels below 5%, compared to 17.8% for Ozempic. The company is set to present a closer look at the data at the upcoming annual meeting of the European Association for the Study of the Liver. 

Evercore ISI analyst Umer Raffat cautioned that Merck used 1 mg of Ozempic in the trial, as opposed to the more common 2.4-mg dosing, though a second study is underway testing the higher dose comparator. Nonetheless, he said the data suggest validation of GLPs in the NASH setting, though it may ultimately be a bigger boost to a company like Lilly, which has been testing Mounjaro in NASH. 

“Thus, the real winner out of [Merck’s] NASH update may remain the big incumbents, [Lilly] and Novo,” Raffat wrote. He added that he’s hoping for more tolerability data in Merck’s full look under the hood. The company said in the abstract that there were no “meaningful differences” in side effects, including side effects leading to discontinuation. 

The data are a boost to Merck’s dealmaking acumen, after the company licensed efinopegdutide from Hanmi Pharmaceutical in August 2020. Merck coughed up only $10 million upfront for the asset, with $860 million in biobucks on the table. Hanmi also retained rights to commercialize the drug in Korea. Efinopegdutide was originally licensed to J&J but was discarded after failing to impress as a weight loss treatment.