ESSENCE trial data showed 63% of participants receiving semaglutide achieved steatohepatitis resolution without worsening of liver fibrosis, compared with 34% receiving placebo, at Week 72.

• Singapore's Health Sciences Authority (HSA) has approved Wegovy® (once-weekly injectable semaglutide 2.4 mg) as the first approved treatment in Singapore for adults with noncirrhotic metabolic dysfunction-associated steatohepatitis (MASH, formerly known as NASH) and moderate to advanced liver fibrosis (F2–F3), as an adjunct to a reduced-calorie diet and increased physical activity.^[1]
• At Week 72 in the ESSENCE phase 3 trial, semaglutide outperformed placebo on both primary endpoints: 63% vs 34% achieved resolution of steatohepatitis without worsening of liver fibrosis; 37% vs 22% achieved at least a one-stage improvement in liver fibrosis without worsening of steatohepatitis; and 33% vs 16% achieved both endpoints.^[1]
• In 2024, MASH accounted for 39.8% of cirrhosis cases in SingHealth's Chronic Liver Disease Registry, compared with 23.5% for hepatitis B, based on data from nearly 1,200 people.^[3]

Novo Nordisk announced that Singapore's Health Sciences Authority (HSA) has approved Wegovy® (once-weekly injectable semaglutide 2.4 mg) as the first approved treatment in Singapore for adults with noncirrhotic metabolic dysfunction-associated steatohepatitis (MASH, formerly known as NASH) and moderate to advanced liver fibrosis (F2–F3), as an adjunct to a reduced-calorie diet and increased physical activity.^[1]

Clinical evidence supporting approval

The approval is based on the planned interim Week 72 efficacy analysis of Novo's ESSENCE trial, a randomised, double-blind, placebo-controlled phase 3 study.^[1]

At Week 72, semaglutide demonstrated statistically significant improvements compared with placebo on both primary endpoints:^[1]

• 63% of participants receiving semaglutide achieved resolution of steatohepatitis without worsening of liver fibrosis, compared with 34% receiving placebo.^[1]
• 37% achieved at least a one-stage improvement in liver fibrosis without worsening of steatohepatitis, compared with 22% receiving placebo.^[1]
• 33% achieved both resolution of steatohepatitis and improvement in liver fibrosis, compared with 16% receiving placebo.^[1]

These results are from a planned interim analysis; ESSENCE trial is continuing to evaluate long-term outcomes over 240 weeks, including whether semaglutide lowers the risk of liver-related clinical events in adults with MASH and moderate to advanced liver fibrosis.^[1]

Metabolic dysfunction-associated steatotic liver disease (MASLD), commonly referred to as fatty liver disease, is associated with metabolic risk factors including obesity.^[2] MASH is the more serious, progressive form of MASLD, in which excess liver fat is accompanied by inflammation and liver-cell injury that can cause progressive scarring, or fibrosis. MASH often develops without noticeable symptoms and, if untreated, can progress to cirrhosis or liver cancer. Globally, the age-standardised prevalence of MASLD increased by 11.2% between 2010 and 2021.^[5]

In Singapore, the pattern of advanced liver disease is changing. Data from nearly 1,200 people with cirrhosis in SingHealth's Chronic Liver Disease Registry showed that MASH accounted for 39.8% of cirrhosis cases in 2024, surpassing hepatitis B at 23.5%.^[3]

Dr Stephanie Ambrose, Head of Medical & Regulatory Affairs, Novo Singapore: "MASH is an increasingly recognised metabolic liver disease that can progress without obvious symptoms, placing patients at risk of serious liver-related complications. This new indication expands treatment options for appropriate adults with MASH and F2-F3 fibrosis in Singapore, alongside lifestyle interventions including a reduced-calorie diet and increased physical activity. Novo is dedicated to working with the healthcare community to support early identification, appropriate treatment and improved outcomes for people living with MASH."

Dr Kieron Lim, Senior Consultant Gastroenterologist & President of Gastroenterological Society of Singapore (GESS): "MASH can progress quietly. People with obesity, type 2 diabetes or other metabolic risk factors may need a more complete liver assessment even if they feel well. The key clinical question is not only whether fat is present in the liver, but whether inflammation and fibrosis have developed. Earlier recognition allows clinicians to address both the liver disease and the metabolic factors driving it."

Safety

The safety profile observed in adults with MASH was consistent with that seen across the other approved indications for once-weekly injectable semaglutide 2.4 mg. The most frequently reported adverse reactions are gastrointestinal (e.g., nausea). The Singapore prescribing information should be consulted for the full indications, contraindications, warnings, precautions and adverse reactions.