Gilead Sciences and Novo Nordisk are expanding their clinical collaboration in non-alcoholic steatohepatitis (NASH) to conduct a larger trial later this year.
The move comes after a previous study, investigating Novo Nordisk’s semaglutide alone and in combination with Gilead’s cilofexor and/or firsocostat in patients suffering from NASH with mild to moderate fibrosis, reported positive data.
The larger Phase IIb study will assess the safety and efficacy of semaglutide and a fixed-dose combination of cilofexor and firsocostat, alone and in combination in patients with compensated cirrhosis (F4) due to NASH.
The four-arm double-blind, placebo-controlled study aims to enrol around 440 patients, with recruitment expected to begin in the second half of this year.
Post-hoc analyses of the previous study identified statistically significant improvements in hepatic steatosis and liver injury in the combination treatment arms compared with semaglutide alone.
Around 5% to 14% of the subjects across all groups withdrew from the study due to adverse events.
Novo Nordisk executive vice-president and development head Martin Holst Lange said: “NASH is a disease with a high unmet medical need, as no drugs are currently approved to treat this potentially life-threatening condition.
“Building on the positive results from our proof-of-concept trial, we hope together with Gilead to demonstrate the potential for semaglutide with cilofexor and firsocostat to help people living with NASH.”
Semaglutide, a GLP-1 receptor agonist, has been approved for the treatment of type 2 diabetes but is yet to receive the green light from a regulatory authority for treating patients with NASH.
Gilead’s investigational FXR agonist cilofexor and investigational ACC inhibitor firsocostat are also not approved.
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