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.
Gilead Sciences recently signed an agreement with Merck to develop and commercialise long-acting treatments for HIV.