As reported on the Manila Times, Singapore’s Health Sciences Authority (HSA) has approved once-weekly injectable semaglutide 2.4 mg (Wegovy) for adults with noncirrhotic metabolic dysfunction-associated steatohepatitis (MASH) and moderate to advanced liver fibrosis.

According to information supplied by Novo Nordisk, the new indication makes Wegovy the first treatment approved in Singapore specifically for adults with MASH and F2-F3 fibrosis. Treatment is intended to be used alongside dietary calorie reduction and increased physical activity.

Phase 3 ESSENCE Data Support Approval

The regulatory decision was supported by a planned 72-week interim efficacy analysis of the phase 3 ESSENCE trial, a randomized, double-blind, placebo-controlled study evaluating semaglutide in people with MASH.

At week 72, 63% of participants assigned to semaglutide experienced resolution of steatohepatitis without deterioration of liver fibrosis, versus 34% of those receiving placebo.

Semaglutide also demonstrated an effect on fibrosis. A reduction in fibrosis of at least one stage, without worsening of steatohepatitis, occurred in 37% of semaglutide-treated participants compared with 22% of the placebo group.

In addition, 33% of patients receiving semaglutide met both histologic outcomes, compared with 16% receiving placebo.

ESSENCE remains ongoing, with follow-up planned through 240 weeks to assess longer-term outcomes, including whether treatment reduces liver-related clinical events in patients with MASH and moderate to advanced fibrosis.

Growing Burden of Metabolic Liver Disease

MASH is a progressive form of metabolic dysfunction-associated steatotic liver disease (MASLD), a condition associated with metabolic risk factors such as obesity. In MASH, liver fat accumulation is accompanied by inflammation and cellular injury, which can lead to fibrosis and eventually more advanced liver disease.

An important challenge is that MASH may progress without readily apparent symptoms, potentially delaying diagnosis until significant liver damage has developed.

The condition is increasingly relevant in Singapore. According to figures provided from SingHealth’s Chronic Liver Disease Registry, MASH was associated with 39.8% of cirrhosis cases recorded in 2024 among a population of nearly 1,200 people. Hepatitis B accounted for 23.5%.

The data underscore the changing profile of chronic liver disease as metabolic conditions become increasingly important contributors to advanced liver disease.

Focus on Earlier Identification

The approval also highlights the importance of assessing fibrosis and inflammation among patients with metabolic risk factors, rather than focusing solely on the presence of excess liver fat.

People with obesity, type 2 diabetes and other metabolic risks may warrant more comprehensive liver assessment even in the absence of symptoms, according to clinical commentary accompanying Novo Nordisk’s announcement. Detecting progressive disease earlier may provide an opportunity to address both liver injury and the metabolic factors contributing to it.

Novo Nordisk said it intends to work with healthcare professionals in Singapore to support earlier identification and appropriate management of patients with MASH.

Safety Profile

According to the company, the safety findings for semaglutide 2.4 mg in adults with MASH were consistent with its established safety profile in other approved indications. Gastrointestinal adverse reactions, including nausea, were among the most commonly reported events.

Clinicians should consult the Singapore prescribing information for complete information regarding Wegovy’s approved indication, contraindications, warnings, precautions and adverse reactions.

Key Takeaway

The Singapore authorization introduces the country’s first approved pharmacologic treatment specifically for adults with noncirrhotic MASH and F2-F3 fibrosis. In the interim ESSENCE analysis, semaglutide produced higher rates of both steatohepatitis resolution and fibrosis improvement than placebo at 72 weeks, while longer-term evaluation of clinical outcomes remains underway.