Gilead Sciences Inc. and Novo Nordisk A/S on Thursday said they are expanding their clinical collaboration in nonalcoholic steatohepatitis, a chronic liver condition commonly known as NASH.
The companies said they plan to conduct a Phase 2b study to investigate the safety and efficacy of Novo's semaglutide paired with a fixed-dose combination of Gilead's investigational compounds cilofexor and firsocostat, alone and in combination in people with compensated cirrhosis due to NASH.
Semaglutide is the active ingredient in Novo's Ozempic injection and Rybelsus pills, which are both approved to treat type 2 diabetes.
Gilead and Novo said the four-arm study in roughly 440 patients will evaluate the impact on liver fibrosis improvement and NASH resolution, with recruitment starting in the second half of 2021.
Gilead, a Foster City, Calif., biopharmaceutical company, and Danish pharmaceutical company Novo announced plans in 2019 to collaborate in NASH.
The companies in November said a Phase 2a proof-of-concept study investigating semaglutide alone and in combination with cilofexor and/or firsocostat in people with NASH and mild to moderate fibrosis met its primary endpoint, showing that all regimens were well tolerated over 24 weeks.
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