GLP-1 drugs enter the field of fatty liver treatment for the first time
YaoRong Circle learned:Novo Nordisk recently announced that the U.S. Food and Drug Administration (FDA) has approved Wegovy based on a supplemental new drug application (sNDA).®(Novo Nordisk's product name in China is NovoYing)®, semaglutide 2.4 mg) for the new indication: for the treatment of adult patients with non-cirrhotic metabolic dysfunction-associated steatohepatitis (MASH) with moderate to severe liver fibrosis (consistent with stage F2-F3 fibrosis), in conjunction with diet control and increased physical activity.
This accelerated approval is based on Stage 1 of the ESSENCE trial: Wegovy compared to placebo®Can improve liver fibrosis (without worsening steatohepatitis), with statistically significant and superior efficacy; additionally, it can also improve steatohepatitis (without worsening liver fibrosis).
Clinical data from ESSENCE showed that at week 72, 36.8% of subjects receiving Wegovy® achieved improvement in liver fibrosis without worsening of steatohepatitis, compared with 22.4% in the placebo group. 62.9% of subjects receiving Wegovy®Subjects receiving treatment showed improvement in steatohepatitis without worsening of liver fibrosis, compared to 34.3% in the placebo group.
Novo Nordisk's Executive Vice President and Chief Scientific Officer (CSO) Martin Holst Lange said: "Wegovy®now holds a unique position: becoming the first and only GLP-1 drug approved for the treatment of MASH. This further strengthens the evidence of semaglutide's benefits beyond the extensive clinical data confirming its weight loss and cardiovascular advantages. MASH is a significant health burden, affecting one in three overweight or obese individuals worldwide. It is estimated that approximately 22 million people in the United States alone have MASH. With Wegovy®Approved for the treatment of MASH, we are offering a new therapeutic option for MASH patients that not only halts disease progression but also helps reverse liver damage.
From the date of approval, Wegovy®Already available in the United States for the treatment of MASH.
Metabolic dysfunction-associated steatohepatitis (MASH) is a serious progressive metabolic liver disease that can be life-threatening if not properly managed. There are over 250 million people with MASH, and the number of patients with advanced-stage disease is expected to double by 2030. More than one-third of individuals who are currently overweight or obese also have MASH. MASH patients often do not exhibit specific symptoms or only mild symptoms in the early stages, frequently leading to delayed diagnosis. Compared to the general population, MASH patients have a higher risk of progressing to advanced liver diseases, including liver cancer.
ESSENCE is a phase 3 trial evaluating the efficacy of once-weekly subcutaneous semaglutide 2.4 mg in adult patients with metabolic dysfunction-associated steatohepatitis (MASH) and moderate-to-severe liver fibrosis (stage F2–F3). The ESSENCE trial consists of two stages and plans to enroll 1,200 participants, who will be randomized in a 2:1 ratio to receive either semaglutide 2.4 mg or placebo in addition to standard of care for 240 weeks. The objective of Stage 1 is to demonstrate, based on liver biopsy samples from the first 800 randomized patients, that treatment with semaglutide 2.4 mg improves liver histology at week 72. The objective of Stage 2 is to demonstrate that, in adult patients with MASH and moderate-to-severe fibrosis, semaglutide 2.4 mg reduces the risk of liver-related clinical events at week 240 compared with placebo.
Based on Phase 1 of the ESSENCE trial, Novo Nordisk also submitted a marketing authorization application in the European Union in February 2025, followed by a submission in Japan in May 2025. Results from Phase 2 of the ESSENCE trial are expected to be released in 2029.
FDA initially approved Wegovy in 2021.®registration application, based on controlled diet and increased physical activity, for use in obese adults or overweight adults with weight-related health issues to help them lose weight and maintain weight loss. In 2022, this indication was expanded to include obese children aged 12 and older. In 2024, Wegovy®FDA today approved Wegovy for reducing the risk of major cardiovascular adverse events (such as death, heart attack, or stroke) in obese or overweight adults with heart disease.®Accelerated approval for the treatment of adult patients with MASH and moderate to severe liver fibrosis, but without cirrhosis.
Novo Nordisk was founded in 1923 and is a global leader in biopharmaceuticals, headquartered in Denmark. Building on a century-long heritage in diabetes care, our mission is to drive change and defeat serious chronic diseases. To achieve this, we lead scientific breakthroughs, expand access to our medicines, and are committed to preventing and ultimately curing diseases. Novo Nordisk has approximately 78,400 employees across 80 countries and serves customers in around 170 countries and regions worldwide.