Novo Nordisk announced phase II clinical data of semaglutide in the treatment of nonalcoholic steatohepatitis (NASH) at the European Association for the Study of the Liver (EASL) in 2022. The results showed that the study did not meet the primary endpoint, with placebo being more effective than semaglutide.
This is a placebo-controlled Phase II clinical trial (NCT03987451) to evaluate the efficacy and safety of semaglutide injection in NASH patients (F4) with compensated cirrhosis. A total of 71 subjects were included in the study and were randomized to receive 2.4 mg of semaglutide and placebo once a week for 48 weeks.
The results showed that only 10.6% of patients in the semaglutide treatment group improved liver fibrosis, while NASH did not worsen. The proportion of patients in the placebo group was 29.2%. For secondary endpoints, 34% of patients in the semaglutide group saw resolution of NASH, meaning improvement in liver inflammation and hepatocyte ballooning, compared with 20.8% in the placebo group.
A Novo Nordisk spokesperson said that the development of semaglutide for NASH indications is still in progress and is actually in Phase III clinical stage. In August 2020, the FDA granted the product breakthrough therapy designation for the treatment of NASH. In April 2021, Novo Nordisk launched an international multicenter Phase III clinical trial of semaglutide in the treatment of NASH, including in China.
Earlier in 2020, Novo Nordisk announced the efficacy and safety of semaglutide at three dose levels subcutaneously administered once daily in NASH subjects versus placebo. 58.9% of patients in the semaglutide group achieved NASH resolution without worsening fibrosis, compared with 17.2% of patients in the placebo group.
It is worth mentioning that another phase II trial of semaglutide also met the primary endpoint, which aims to evaluate semaglutide and Gilead’s FXR agonist cilofexor and ACC inhibition in 108 NASH patients. Efficacy and safety of combined use of firsocostat for 24 weeks. The results showed that the combination of semaglutide was well tolerated in NASH patients with mild to moderate fibrosis.
Semaglutide, a long-acting glucagon-like peptide-1 receptor (GLP-1R) agonist, is currently approved in the United States for the treatment of type 2 diabetes and obesity. In April 2021, the product entered the Chinese market as a supplement to diet and exercise to improve glycemic control in patients with type 2 diabetes (T2DM).