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Gilead and Novo Nordisk’s NASH trial meets primary endpoint

Gilead and Novo Nordisk have announced that a phase II proof-of-concept trial evaluating combination treatments for non-alcoholic steatohepatitis (NASH) met its primary endpoint.

The five-arm trial evaluated combinations of Novo’s semaglutide – a GLP-1 receptor agonist – with Gilead’s investigational FXR agonist cilofexor and/or Gilead’s investigational ACC inhibitor firsocostat over 24 weeks.

The results, which were presented at The Liver Meeting Digital Experience 2020, showed that the trial met the primary endpoint by demonstrating that all regimens were well tolerated in people with NASH and mild to moderate fibrosis.

In addition, exploratory efficacy endpoints, which assessed biomarkers of liver health at 24 weeks, showed ‘statistically significant improvements’ in hepatic steatosis and liver injury in the combination arms compared to semaglutide alone.

Semaglutide is used in Novo’s once-weekly injection for type 2 diabetes Ozempic, as well as its once-daily type 2 diabetes pill Rybelsus.

The companies also said that although semaglutide significantly improved NASH and fibrosis-related endpoints in the trial, the addition of either cilofexor or the firsocostat analog improved liver reduction further.

NASH is a chronic liver disease characterised by fat accumulation and inflammation in the liver, which can cause scarring – fibrosis – that negatively impacts liver function.

“This trial brings together Gilead and Novo Nordisk’s respective expertise and science to provide important insights into potential new combination therapies involving semaglutide to help people living with NASH,” said Martin Holst Lange, senior vice president, global development at Novo Nordisk.

“We are now carefully evaluating next steps together based on a thorough assessment of data,” he added.