Wegovy can work in adults with moderate to advanced liver fibrosis -- stages F2 to F3 -- along with a reduced calorie diet and increased physical activity. (File photo)
The Central Drugs Standard Control Organisation (CDSCO) has approved Novo Nordisk’s Wegovy (semaglutide 2.4 mg) for the treatment of fatty liver disease, now called MASH (Metabolic Dysfunction-Associated Steatohepatitis). This is a serious, progressive form of fatty liver disease that causes chronic inflammation and liver damage.
This is the first time an injectable GLP-1 therapy has been approved in India for this specific liver condition, in addition to its use for obesity. GLP-1 drugs mimic a natural gut hormone to regulate blood sugar, reduce appetite and slow digestion.
The approval is based on the global ESSENCE trial, in which Wegovy demonstrated resolution of steatohepatitis in 63% of patients and reduction in liver fibrosis in 37% of patients. Importantly, the liver benefits appear not to be solely explained by weight loss, suggesting an independent therapeutic impact on liver health. Semaglutide was found to directly reduce liver fat, inflammation and scarring. The approved dose for this indication is 2.4 mg, administered through a once-weekly injection.
The approval is significant given the growing burden of fatty liver disease in India. MASH develops due to excess fat buildup in the liver, leading to chronic inflammation and progressive liver damage. It is often called a “silent disease” because many people remain symptom-free until the disease reaches an advanced stage. Wegovy has been approved for adults with moderate to advanced liver fibrosis (stages F2 to F3), alongside a reduced-calorie diet and increased physical activity.
According to Dr Arvinder Singh Soin, Chairman, Liver Transplant, Medanta, Gurugram, the burden of fatty liver is enormous. “Nearly 38-40% of Indians have fatty liver disease. About one-third of them develop MASH, which essentially means fatty liver with inflammation. Of those with MASH, around one-third may eventually progress to cirrhosis, and nearly a quarter of patients with cirrhosis can develop liver cancer. Some patients may even develop liver cancer without progressing to cirrhosis. Given India’s population, this translates into an enormous disease burden,” he says. Which is why the use of GLP-1 therapy could be a gamechanger.
MASH is part of the broader metabolic dysfunction story, closely linked to obesity, insulin resistance and high blood sugar. GLP-1 drugs are proving capable of reversing many aspects of this metabolic disease process. “They can improve and even reverse Grade 1 and Grade 2 liver fibrosis. This is a major development for India because millions of people with fatty liver disease stand to benefit,” says Dr Soin.
Dr Soin says the benefits seen in clinical trials are also being reflected in real-world practice. He has been using semaglutide and tirzepatide in overweight patients with MASH and has seen excellent results. “More than 300 patients have benefited from these therapies in our practice, and nearly 60% have shown improvement in their liver disease. The overall response has been very encouraging,” he says.
In the ESSENCE trial, 63% of patients receiving Wegovy achieved resolution of MASH without worsening of liver scarring, compared with 34% of those receiving placebo. Around 37% of patients also showed improvement in liver fibrosis.
However, he cautions that the medication is not a substitute for healthier living. “Patients must continue with lifestyle modifications because stopping these changes can result in weight regain, worsening diabetes and recurrence of liver disease,” Dr Soin warns.
He recommends sustained calorie reduction, avoiding ultra-processed foods and excess fructose, cutting down unnecessary fats, and increasing protein intake to around 1.2-1.3 grams per kilogram of body weight daily. “It’s not about following a rigid diet. People should understand the nutritional composition of food — carbohydrates, proteins and fats — and choose foods they enjoy while staying within those nutritional principles,” he adds.
Vikrant Shrotriya, Managing Director, Novo Nordisk India, says, “The burden of MASH continues to rise in India, but treatment options are still severely limited. People with MASH face a higher risk of serious liver complications and heart-related disease. That is why we need treatment options that can address these connected health risks. This approval is an important milestone, giving doctors and patients a new option for people at risk of MASH while also helping to address obesity and related heart and metabolic diseases.”