HQ Team
November 2, 2024: Danish multinational pharmaceutical company Novo Nordisk’s end-stage trial in patients with fatty liver disease saw reduced liver scarring (fibrosis) and its resolution without worsening the condition.
According to a statement from the Bagsværd, Denmark-headquartered company, 37% of people treated with semaglutide, a drug for weight loss and type 2 diabetes, had improved their liver scarring after 72 weeks without worsening the conditions.
That compared to 22.5% in the placebo or fake treatment.
Data from the trial showed that 63% of the participants on semaglutide had their fatty liver conditions resolved without making their liver scarring worse.
Participants on the placebo or the dummy drug had only 34% resolution in the scars.
Regulatory approvals
Eight hundred participants were involved in the trial. They were given a 2.4-milligram dose of semaglutide to treat a liver condition called metabolic dysfunction-associated steatohepatitis, or MASH.
Novo Nordisk expects to file for regulatory approvals in the US and the European Union in the first half of 2025, according to the company statement.
The only Food and Drug Administration-approved medicine for treating fatty liver is Madrigal Pharmaceuticals, Inc.’s Rezdiffra. It is indicated in conjunction with diet and exercise for the treatment of adults with noncirrhotic MASH with moderate to advanced liver fibrosis.
The FDA’s continued approval for this indication may be contingent upon verification and description of clinical benefit in ongoing confirmatory trials.
Inflammation of liver
MASH is a serious, progressive metabolic disease affecting the liver, which can be fatal if not properly managed. More than 250 million people live with MASH, and the number of individuals in advanced stages of the disease is expected to double by 2030.
Of those who are currently overweight or living with obesity, more than one in three are also living with MASH.
People living with MASH often experience few or no specific symptoms in the early stages of the disease, which results in delayed diagnosis. In rare cases, people may experience fatigue, pain or weight loss.
Over time, inflammation and scarring of the liver (cirrhosis) can occur. The risk of progression to advanced liver disease, including liver cancer, is higher in people living with MASH than in the general population.
Type 2 diabetes
The cause of MASH or non-alcoholic fatty liver disease is unknown. Risk factors include obesity, gastric bypass surgery, high cholesterol and type 2 diabetes. No standard treatment exists. Instead, doctors will treat the underlying condition, such as obesity.
“We are very pleased about the…trial results and the potential of semaglutide to help people living with MASH,” said Martin Holst Lange, executive vice president and head of Development at Novo Nordisk.
“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,” he said.
