10:33 AM EDT, 11/01/2024 (MT Newswires) -- Novo Nordisk ( NVO ) said Friday that the first part of an ongoing phase 3 trial in people with liver fibrosis and metabolic dysfunction-associated steatohepatitis, or MASH, reached its primary endpoints.

The first part of the trial assessed the effect of 2.4 milligrams of semaglutide given once a week on liver tissue compared with placebo for 800 people at 72 weeks, the company said.

The study reached its primary endpoints by showing a "statistically significant and superior improvement in liver fibrosis with no worsening of steatohepatitis, as well as resolution of steatohepatitis with no worsening of liver fibrosis with semaglutide 2.4 mg compared to placebo," the company said.

At week 72 of the trial, 37% of the people given semaglutide reached an improvement in liver fibrosis with no worsening of steatohepatitis compared with 22.5% on placebo, the company said.

Also, 62.9% of people administered semaglutide reached resolution of steatohepatitis with no worsening of liver fibrosis compared to 34.1% on placebo, Novo said.

The drug also showed a "safe and well-tolerated profile," the company said.

Novo said it plans to file for regulatory clearance in the US and EU in H1 2025.

The second part of the trial will go on with an expected readout in 2029, it said.

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