Novo Nordisk has reported positive outcomes from part one of the ESSENCE trial of semaglutide 2.4mg in treating metabolic dysfunction-associated steatohepatitis (MASH) and moderate to advanced liver fibrosis.
The trial met its primary endpoints, showing a significant improvement in liver fibrosis compared to placebo.
The ongoing, pivotal Phase III, double-blinded, 240-week study involves 1,200 adults with MASH and stage two or three liver fibrosis.
Semaglutide 2.4mg, a glucagon-like peptide 1 (GLP-1) receptor agonist known as Wegovy, was subcutaneously administered once weekly.
During the first part, the trial assessed semaglutide's effects on liver tissue in 800 participants at 72 weeks.
In this trial, 37% of participants showed improvement in liver fibrosis with no steatohepatitis worsening at 72 weeks against 22.5% on placebo.
Additionally, 62.9% attained resolution of steatohepatitis with no liver fibrosis worsening, versus 34.1% on placebo.
The safety and tolerability profile of semaglutide 2.4mg was consistent with previous trials.
In the first half of next year, the company plans to seek regulatory approvals in the US and European Union (EU). The second part of the ESSENCE trial will continue and readout is expected in 2029.
Novo Nordisk executive vice-president and development head Martin Holst Lange said: “We are very pleased about the ESSENCE clinical trial results and the potential of semaglutide to help people living with MASH.
“Among people with overweight or obesity, one in three live with MASH. This has a serious impact on their health and represents a significant unmet need.”
MASH is a severe and progressive liver disease linked to metabolic disorders.
Wegovy is approved for use with a reduced-calorie diet and increased physical activity to cut the risk of major adverse cardiovascular events (MACE) in adults with cardiovascular disease and obesity or deemed overweight in the US.
Following the positive outcomes of the Phase III SOUL trial, Novo Nordisk expressed its plans to file for a label expansion for its oral semaglutide, Rybelsus in the US and EU, last month.
