Novo Nordisk shared promising findings from the first part of its clinical trial evaluating semaglutide 2.4 mg (this dose commercially branded as Wegovy) for the treatment of metabolic dysfunction-associated steatohepatitis (MASH), previously known as non-alcoholic steatohepatitis (NASH).
This marks the third major indication that Novo is pursuing for semaglutide. Marketed as Ozempic for the treatment of type 2 diabetes and Wegovy for obesity, the blockbuster GLP-1 drug has transformed the landscape of weight management in particular.
In the Phase III double-blinded 240-week ESSENCE trial involving 1,200 patients with MASH, a weekly 2.4 mg dose of semaglutide was shown to improve liver fibrosis without exacerbating steatohepatitis and to resolve steatohepatitis without worsening liver fibrosis in patients who had stage 2 or stage 3 fibrosis.
In the trial, 37 percent of patients receiving semaglutide experienced improved liver fibrosis without a worsening of their steatohepatitis after 72 weeks, compared to only 22.5 percent in the placebo group.
Additionally, 62.9 percent of patients treated with semaglutide saw their steatohepatitis resolve without any worsening of liver fibrosis, versus 34.1 percent in the control group.
Novo Nordisk also noted that semaglutide’s safety profile in the ESSENCE trial was consistent with results from previous studies of the GLP-1 agonist.
The trial is structured in multiple parts, with the first part focusing on assessing key efficacy and safety endpoints, particularly liver histology improvement and reduction of fibrosis.
Novo said part two of the trial is ongoing, with an expected readout to come in 2029.
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MASH is a severe form of non-alcoholic fatty liver disease (NAFLD) that affects over 115 million people globally.
It is characterized by liver inflammation, cell damage and fibrosis. MASH is closely associated with metabolic syndrome and poses risks of liver-related complications, including cirrhosis and liver cancer.
Wegovy is approved in the US for use alongside a reduced-calorie diet and increased physical activity to lower the risk of major adverse cardiovascular events (MACE) in adults with cardiovascular disease who are either obese or considered overweight.
Semaglutide’s ability to reduce body weight and improve glucose metabolism has led to the exploration of its potential in managing MASH, given the disease’s metabolic underpinnings.
Novo’s positive semaglutide trial results were reported just one day after Madrigal reported that the third-quarter sales of its commercial MASH product, Rezdiffra (resmetirom), exceeded Wall Street’s expectations, hitting $62 million.
According to Fierce Pharma, during an analyst call last week, Madrigal shared that it ended the third quarter with over 6,800 patients on Rezdiffra, up from just over 2,000 at the beginning of the period.
William Blair analyst Andy Hsieh noted that Novo’s semaglutide results show a level of fibrosis improvement similar to that achieved with Rezdiffra, saying the findings have “practice-changing potential.”
Related: Eli Lilly’s Mounjaro Outperforms Novo Nordisk’s Ozempic in New Weight Loss Study
Following the positive data, Novo said it plans to submit approval applications to regulators in the US and Europe in the first half of 2025.
The company also said detailed findings from its MASH study will be presented at a scientific conference later this year.
Another MASH hopeful will be entering late-stage trials this year. Sagimet Biosciences that its investigational drug denifanstat will be heading into Phase III trials for MASH, with backing from the US Food and Drug Administration (FDA) after the drug yielded positive Phase II data. In early October, the FDA granted Breakthrough Therapy designation to denifanstat for non-cirrhotic MASH.
In a press release, 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.”
After positive results from the Phase III SOUL trial, Novo Nordisk announced last month it plans to seek a label expansion for its oral semaglutide, Rybelsus, in both the US and the European Union (EU).
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