Gilead Expands its Collaboration with Novo Nordisk to Evaluate Triple Combination Regimen for Compensated Cirrhosis (F4) due to NASH

March 19, 2021 Auto Bot Clinical Trials, collaboration, Expands, Gilead, NASH, Novo Nordisk 0

Shots:

  • The companies plan to initiate a P-IIb study assessing NovoNordisk’s semaglutide and FD combination of Gilead’s cilofexor + firsocostat vs PBO in ~440 patients with compensated cirrhosis (F4) due to NASH
  • The trial will evaluate the therapeutic effect on liver fibrosis improvement and NASH resolution and expected to initiate recruitment in H2’21 The new P-IIb study results built on the P-IIa POC study which met its 1EPs demonstrated that all regimens were well tolerated @24wks.
  • Additionally, post-hoc analyses evaluating biomarkers of liver health @24wks. showed significant improvements in hepatic steatosis and liver injury. Liver stiffness and ELF score declined in all groups

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