Biopharmaceutical company Gilead Sciences Inc (Nasdaq:GILD) and Novo Nordisk A/S (NASDAQ Copenhagen:NOVO B) on Monday announced an update of the results of a Phase 2 proof-of-concept trial at The Liver Meeting Digital Experience (TLMdX) from 13-16 November 2020.
Under the five-arm trial, Novo Nordisk evaluated the combinations of its semaglutide, a GLP-1 receptor agonist, with Gilead's investigational FXR agonist cilofexor and/or Gilead's investigational ACC inhibitor firsocostat over 24 weeks in 108 people with non-alcoholic steatohepatitis (NASH).
The companies added that the trial met its primary endpoint by demonstrating that in people with NASH and mild to moderate fibrosis all regimens were well tolerated. The results demonstrated that while semaglutide significantly improved NASH and fibrosis-related endpoints, the addition of either cilofexor or the firsocostat analog further improved liver fat reduction. The combination of all three agents had the greatest impact on changes in the NAFLD Activity Score (NAS).
NASH is a chronic and progressive liver disease characterized by fat accumulation and inflammation in the liver, which can lead to scarring, or fibrosis, that impairs liver function. The risk of progression to advanced liver disease, liver decompensation and liver cancer, is higher in people with NASH than in the general population and NASH could become the leading reason for liver transplants in most countries.
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