The Liver Meeting
The Liver Meeting
Source:

Newsome PN, et al. Abstract 0010. Presented at: The Liver Meeting Digital Experience; Nov. 13-16, 2020.

Disclosures: Newsome reports financial ties to BMS, Boehringer Ingelheim, Echosens, Gilead, Novo Nordisk, Pfizer, Pharmaxis and Poxel on behalf of the University of Birmingham.
December 01, 2020
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Semaglutide produces NASH resolution without worsening fibrosis

Source:

Newsome PN, et al. Abstract 0010. Presented at: The Liver Meeting Digital Experience; Nov. 13-16, 2020.

Disclosures: Newsome reports financial ties to BMS, Boehringer Ingelheim, Echosens, Gilead, Novo Nordisk, Pfizer, Pharmaxis and Poxel on behalf of the University of Birmingham.
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Patients treated with subcutaneous semaglutide experienced better resolution of non-alcoholic steatohepatitis without worsening fibrosis, according to the results of a placebo-controlled study presented at The Liver Meeting Digital Experience.

In his presentation, Phillip N. Newsome, PhD, from the Birmingham Biomedical Research Centre in the United Kingdom, said a glucagon-like peptide-1 analog, like semaglutide (Novo Nordisk), can impact appetite suppression, gastric emptying and glycemic control.

“Semaglutide is the latest example of long-lasting GLP-1 analogs with a half-life of 165 hours and which is licensed in the management of patients with diabetes,” he said. “In this study, it is being tested for its efficacy in patients with NASH.”

Researchers recruited 320 patients with biopsy-confirmed NASH to investigate the effects of semaglutide. Patients had fibrosis stage F1 (28%), F2 (23%) or F3 (49%), a NAFLD activity score (NAS) of at least 4 and a BMI of more than 25 kg/m2.

Investigators randomly assigned patients to receive either 0.1, 0.2 or 0.4 mg of subcutaneous semaglutide or placebo once daily for 72 weeks. The primary outcome, tested in patients with F2 or F3 (n = 230), was resolution of NASH with no worsening of fibrosis. Researchers also assessed improvement in fibrosis with no worsening of NASH as a confirmatory secondary endpoint.

A greater proportion of patients in all three semaglutide dose groups achieved the primary endpoint (40.4%, 35.6% and 58.9%) compared with placebo (17.2%). There was no significant difference between the treatment groups and the placebo group in the secondary endpoint of fibrosis improvement.

However, Newsome said a pre-specified analysis of changes in fibrosis stage over treatment showed that there was a dose-dependent difference between patients who received semaglutide compared with placebo. Among patients who received placebo, 18.8% of patients experienced a worsening in liver fibrosis, compared with just 4.9% in the 0.4 mg semaglutide group.

Investigators also observed dose-dependent improvements in alanine aminotransferase, aspartate aminotransferase, gamma-glutamyl transferase and fibrosis biomarkers, as well as better induction of weight loss among patients who received semaglutide.

“Fewer patients had progression of fibrosis, and there were significant improvements in fibrosis biomarkers,” Newsome said. “In addition, there were improvements in multiple metabolic characteristics, and the safety profile was very much consistent with that seen in patients treated with semaglutide with type 2 diabetes.”