US biotech Gilead Sciences (Nasdaq: GILD) and Danish diabetes specialist Novo Nordisk (NOV: N) have announced that the companies have expanded their clinical collaboration in non-alcoholic steatohepatitis (NASH).
They will conduct a Phase IIb double-blind, placebo-controlled study to investigate the safety and efficacy of Novo Nordisk’s semaglutide, a GLP-1 receptor agonist, and a fixed-dose combination of Gilead’s investigational FXR agonist cilofexor and investigational ACC inhibitor firsocostat, alone and in combination in people with compensated cirrhosis due to NASH.
The four-arm study in approximately 440 patients will evaluate the treatments’ impact on liver fibrosis improvement and NASH resolution and will begin recruitment in the second half of 2021.
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