NOVO NORDISK INC.: Wegovy approved by FDA for the treatment of adults with noncirrhotic MASH with moderate to advanced liver fibrosis

• Wegovy^® (semaglutide) injection 2.4 mg is now indicated to treat adults with metabolic dysfunction-associated steatohepatitis (MASH) with moderate to advanced liver scarring (fibrosis), but not with cirrhosis of the liver, in conjunction with a reduced calorie diet and increased physical activity¹
• The accelerated approval is based on Part 1 of the ESSENCE trial, in which Wegovy^® demonstrated a statistically significant improvement in liver fibrosis (liver scarring) with no worsening of steatohepatitis, as well as resolution of steatohepatitis with no worsening of liver fibrosis compared to placebo^1,2
• Wegovy^® is also indicated, along with a reduced calorie diet and increased physical activity, to reduce the risk of major cardiovascular events such as death, heart attack, or stroke in adults with known heart disease and with either obesity or overweight, and for adults and children aged 12 years and older with obesity, or some adults with overweight who also have weight-related medical problems, to help them lose excess body weight and keep the weight off¹

PLAINSBORO, N.J., Aug. 15, 2025 /PRNewswire/ -- Novo Nordisk today announced that the US Food and Drug Administration (FDA) has approved a new indication for Wegovy^® (semaglutide) injection 2.4 mg, making it the first and only glucagon-like peptide-1 receptor agonist (GLP-1 RA) FDA-approved to treat adults with MASH with moderate to advanced liver scarring (fibrosis), but not with cirrhosis of the liver, in conjunction with a reduced calorie diet and increased physical activity.¹ This indication is approved based on improvement of MASH and liver scarring (fibrosis). There is an ongoing study to confirm the clinical benefit of Wegovy^® in adults with MASH.¹

This FDA approval is based on results from the phase 3 ESSENCE trial investigating the effects of once-weekly Wegovy^® 2.4 mg injection on liver histology in adults with MASH and moderate to advanced liver fibrosis (stage F2 to F3) at Week 72. The first primary endpoint showed 63% of people treated with Wegovy^® 2.4 mg injection (n=534) achieved resolution of steatohepatitis and no worsening of liver fibrosis compared to 34% on placebo (n=266) with a statistically significant difference in response rate vs placebo of 29 (95% CI, 21;36). Additionally, the second primary endpoint showed 37% of people treated with Wegovy^® 2.4 mg achieved improvement in liver fibrosis and no worsening of steatohepatitis compared to 22% on placebo with a statistically significant difference in response rate vs placebo of 14 (95% CI, 8;21). A confirmatory secondary endpoint at Week 72 showed 33% of patients treated with Wegovy^® 2.4 mg achieved both resolution of steatohepatitis and improvement in liver fibrosis compared to 16% on placebo with a statistically significant difference in response rate vs placebo of 17 (95% CI, 10;23). A total of 83.5% of the patients in the semaglutide group maintained the target dose of 2.4 mg until Week 72.^1,2

"Today's decision by the FDA reflects the continued progress in how we understand and treat patients with MASH, bringing us closer to care that meets the needs of people living with this disease," said Arun Sanyal, MD, Director, Stravitz-Sanyal Institute for Liver Disease and Metabolic Health, Virginia Commonwealth University. "If left untreated, MASH can lead to serious and potentially fatal outcomes. The clinical evidence seen in ESSENCE underscores the promise of this approach to treating adults with MASH with moderate to advanced liver fibrosis."

MASH represents a significant health burden in the US, affecting approximately one in 20 people.³ People living with MASH are often asymptomatic or present with nonspecific symptoms in the early stages of the disease, which may result in a delayed diagnosis.⁴ Left untreated, MASH can progress to serious and even fatal outcomes, such as cirrhosis, liver cancer, and the need for liver transplant.⁵ Among people who are living with overweight or obesity worldwide, one in three also have MASH.⁶

"For far too long, this disease has remained unrecognized, undiagnosed, and often untreated, despite impacting so many people," said Dave Moore, executive vice president of US Operations, at Novo Nordisk. "The FDA's conditional approval of Wegovy^® for the treatment of adults with noncirrhotic MASH marks a truly pivotal milestone and a significant step forward for the MASH community and those seeking new options. This builds on the expanding body of evidence demonstrating the clinical benefits of semaglutide across a range of chronic conditions including diabetes, obesity, cardiovascular and chronic kidney disease."

The FDA initially approved Wegovy^® in 2021 with a reduced calorie meal plan and increased physical activity to help adults with obesity, or some adults with excess weight (overweight) who also have weight-related medical problems to lose weight and keep the weight off. The indication was expanded in 2022 to include children aged 12 years and older with obesity. In 2024, Wegovy^® was approved to reduce the risk of major cardiovascular events such as death, heart attack, or stroke in adults with known heart disease and either obesity or overweight.¹ Today, the FDA has granted accelerated approval for Wegovy^® for a new patient population to treat adults with MASH with moderate to advanced liver scarring (fibrosis), but not with cirrhosis of the liver.

In February 2025, Novo Nordisk also filed for regulatory approval in the EU, followed by regulatory submission in Japan in May 2025.

About ESSENCE
ESSENCE is a phase 3 trial evaluating the effect of once-weekly subcutaneous semaglutide 2.4 mg in adults with metabolic dysfunction-associated steatohepatitis with moderate to advanced liver fibrosis (stage 2 or 3). It is a two-part trial where 1,197 participants were randomized 2:1 to receive semaglutide 2.4 mg or placebo, on top of standard of care for 240 weeks. Lifestyle counseling and management of coexisting diseases were recommended in alignment with guidelines. In Part 1, the primary objective was to demonstrate that treatment with semaglutide 2.4 mg improves liver histology compared with placebo in patients with MASH and fibrosis stage 2 or 3. In Part 2, which is ongoing, the primary objective is to demonstrate that treatment with semaglutide 2.4 mg lowers the risk of liver-related clinical events compared to placebo in adults with MASH and moderate to advanced liver fibrosis at 240 weeks.^2,7

About Metabolic Dysfunction-Associated Steatohepatitis (MASH)
MASH is a serious form of fatty liver disease, which can be potentially life-threatening if not properly managed.⁴ Among people who are living with overweight or obesity worldwide, approximately one in three also have MASH.⁶ Excess fat can build up in the liver, which, over time, can lead to inflammation and significant scarring of the liver.⁸ People living with MASH are often asymptomatic or present with nonspecific symptoms in the early stages of the disease, which may result in a delayed diagnosis.⁴ Approximately one in 20 people in the United States are living with MASH.³ The disease progresses to cirrhosis in an estimated 20% of cases.⁹ MASH is a leading cause of cirrhosis in adults in the US, and MASH-related cirrhosis is the second most common indication for liver transplants in the country.¹⁰

What is Wegovy^®?
WEGOVY^® (semaglutide) injection 2.4 mg is an injectable prescription medicine used with a reduced calorie diet and increased physical activity.

• to treat adults with metabolic dysfunction-associated steatohepatitis (MASH) with moderate to advanced liver scarring (fibrosis), but not with cirrhosis of the liver
  • This indication is approved based on improvement of MASH and liver scarring (fibrosis). There is an ongoing study to confirm the clinical benefit of Wegovy^® in adults with MASH.
• to reduce the risk of major cardiovascular events such as death, heart attack, or stroke in adults with known heart disease and with either obesity or overweight
• that may help adults and children aged 12 years and older with obesity, or some adults with excess weight (overweight) who also have weight-related medical problems to lose excess body weight and keep the weight off

Wegovy^® contains semaglutide and should not be used with other semaglutide-containing products or other GLP-1 receptor agonist medicines.

It is not known if Wegovy^® is safe and effective:

• for the treatment of MASH in children under 18 years
• to reduce the risk of major cardiovascular events (death, heart attack, or stroke) in children under 18 years
• for the treatment of long-term weight loss in children under 12 years

Important Safety Information

What is the most important information I should know about Wegovy^®?
Wegovy^® may cause serious side effects, including:

• Possible thyroid tumors, including cancer. Tell your healthcare provider if you get a lump or swelling in your neck, hoarseness, trouble swallowing, or shortness of breath. These may be symptoms of thyroid cancer. In studies with rodents, Wegovy^® and medicines that work like Wegovy^® caused thyroid tumors, including thyroid cancer. It is not known if Wegovy^® will cause thyroid tumors or a type of thyroid cancer called medullary thyroid carcinoma (MTC) in people
• Do not use Wegovy^® if you or any of your family have ever had a type of thyroid cancer called medullary thyroid carcinoma (MTC) or if you have an endocrine system condition called Multiple Endocrine Neoplasia syndrome type 2 (MEN 2)

Do not use Wegovy^® if:

• you or any of your family have ever had a type of thyroid cancer called medullary thyroid carcinoma (MTC) or if you have an endocrine system condition called Multiple Endocrine Neoplasia syndrome type 2 (MEN 2)
• you have had a serious allergic reaction to semaglutide or any of the ingredients in Wegovy^®

Before using Wegovy^®, tell your healthcare provider if you have any other medical conditions, including if you:

• have or have had problems with your pancreas or kidneys
• have type 2 diabetes and a history of diabetic retinopathy
• have or have had depression, suicidal thoughts, or mental health issues
• are scheduled to have surgery or other procedures that use anesthesia or deep sleepiness (deep sedation)
• are pregnant or plan to become pregnant. Wegovy^® may harm your unborn baby. You should stop using Wegovy^® 2 months before you plan to become pregnant
• are breastfeeding or plan to breastfeed. It is not known if Wegovy^® passes into your breast milk

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Wegovy^® may affect the way some medicines work and some medicines may affect the way Wegovy^® works. Tell your healthcare provider if you are taking other medicines to treat diabetes, including sulfonylureas or insulin. Wegovy^® slows stomach emptying and can affect medicines that need to pass through the stomach quickly.

What are the possible side effects of Wegovy^®?
Wegovy^® may cause serious side effects, including:

• inflammation of your pancreas (pancreatitis). Stop using Wegovy^® and call your healthcare provider right away if you have severe pain in your stomach area (abdomen) that will not go away, nausea or vomiting. Sometimes you may feel the pain from your abdomen to your back
• gallbladder problems. Wegovy^® may cause gallbladder problems, including gallstones. Some gallstones may need surgery. Call your healthcare provider if you have symptoms, such as pain in your upper stomach (abdomen), fever, yellowing of the skin or eyes (jaundice), or clay-colored stools
• increased risk of low blood sugar (hypoglycemia), especially those who also take medicines for diabetes such as insulin or sulfonylureas. This can be a serious side effect. Talk to your healthcare provider about how to recognize and treat low blood sugar and check your blood sugar before you start and while you take Wegovy^®. Signs and symptoms of low blood sugar may include dizziness or light-headedness, blurred vision, anxiety, irritability or mood changes, sweating, slurred speech, hunger, confusion or drowsiness, shakiness, weakness, headache, fast heartbeat, or feeling jittery
• dehydration leading to kidney problems. Diarrhea, nausea, and vomiting may cause a loss of fluids (dehydration) which may cause kidney problems. It is important for you to drink fluids to help reduce your chance of dehydration. Tell your healthcare provider right away if you have nausea, vomiting, or diarrhea that does not go away
• severe stomach problems. Stomach problems, sometimes severe, have been reported in people who use Wegovy^®. Tell your healthcare provider if you have stomach problems that are severe or will not go away
• serious allergic reactions. Stop using Wegovy^® and get medical help right away, if you have any symptoms of a serious allergic reaction, including swelling of your face, lips, tongue, or throat, problems breathing or swallowing, severe rash or itching, fainting or feeling dizzy, or very rapid heartbeat
• change in vision in people with type 2 diabetes. Tell your healthcare provider if you have changes in vision during treatment with Wegovy^®
• increased heart rate. Wegovy^® can increase your heart rate while you are at rest. Tell your healthcare provider if you feel your heart racing or pounding in your chest and it lasts for several minutes
• depression or thoughts of suicide. You should pay attention to any mental changes, especially sudden changes in your mood, behaviors, thoughts, or feelings. Call your healthcare provider right away if you have any mental changes that are new, worse, or worry you
• food or liquid getting into the lungs during surgery or other procedures that use anesthesia or deep sleepiness (deep sedation). Wegovy^® may increase the chance of food getting into your lungs during surgery or other procedures. Tell all your healthcare providers that you are taking Wegovy^® before you are scheduled to have surgery or other procedures

The most common side effects of Wegovy^® may include: nausea, diarrhea, vomiting, constipation, stomach (abdomen) pain, headache, tiredness (fatigue), upset stomach, dizziness, feeling bloated, belching, low blood sugar in people with type 2 diabetes, gas, stomach flu, heartburn, and runny nose or sore throat.

Please click HERE for Wegovy^® Prescribing Information and Medication Guide.

About Novo Nordisk
Novo Nordisk is a leading global healthcare company that's been making innovative medicines to help people with diabetes lead longer, healthier lives for more than 100 years. This heritage has given us experience and capabilities that also enable us to drive change to help people defeat other serious chronic diseases such as obesity, rare blood, and endocrine disorders. We remain steadfast in our conviction that the formula for lasting success is to stay focused, think long-term, and do business in a financially, socially, and environmentally responsible way. With a US presence spanning 40 years, Novo Nordisk US is headquartered in New Jersey and employs over 10,000 people throughout the country across 12 manufacturing, R&D and corporate locations in eight states plus Washington DC. For more information, visit novonordisk-us.com, Facebook, Instagram, and X.

Novo Nordisk is committed to the responsible use of our semaglutide-containing medicines which represent distinct products with different indications, dosages, prescribing information, titration schedules, and delivery forms. These products are not interchangeable and should not be used outside of their approved indications. Learn more at semaglutide.com.

References

1. Wegovy^® (semaglutide) injection [package insert]. Plainsboro, NJ: Novo Nordisk Inc.
2. Sanyal AJ, Newsome PN, Kliers I, et al. Phase 3 Trial of Semaglutide in Metabolic Dysfunction-Associated Steatohepatitis. N Engl J Med. 2025;392(21):2089-2099. doi:10.1056/NEJMoa2 413258
3. Younossi ZM, Mangla KK, Chandramouli AS, et al. Estimating the economic impact of comorbidities in patients with MASH and defining high-cost burden in patients with noncirrhotic MASH. Hepatol Commun. 2024;8(8):e0488. doi:10.1097/HC9.00000 00000000488
4. Allen AM, Charlton M, Cusi K, et al. Guideline-based management of metabolic dysfunction-associated steatotic liver disease in the primary care setting. Postgrad Med. 2024;136(3):229-245. doi:10.1080/00325481.2024.2325332
5. Kugelmas M, Noureddin M, Gunn N, et al. The use of current knowledge and non-invasive testing modalities for predicting at-risk non-alcoholic steatohepatitis and assessing fibrosis. Liver Int. 2023;43(5):964-974. doi:10.1111/liv.15555
6. Quek J, Chan KE, Wong ZY, et al. Global prevalence of non-alcoholic fatty liver disease and non-alcoholic steatohepatitis in the overweight and obese population: a systematic review and meta-analysis. Lancet Gastroenterol Hepatol. 2023;8(1):20-30. doi:10.1016/S2468-1253(22)00317-X
7. Newsome PN, Sanyal AJ, Engebretsen KA, et al. Semaglutide 2.4 mg in participants with metabolic dysfunction-associated steatohepatitis: baseline characteristics and design of the phase 3 ESSENCE trial. Aliment Pharmacol Ther. 2024;60(11-12):1525-1533. doi:10.1111/apt.18331
8. National Institute of Diabetes and Digestive and Kidney Diseases. Definition & facts of NAFLD & NASH. Accessed June 13, 2025. https://www.niddk.nih.gov/health-information/liver-disease/nafld-nash/definition-facts
9. Sheka AC, Adeyi O, Thompson J, et al. Nonalcoholic steatohepatitis: a review. JAMA. 2020;323(16):1619. doi:10.1001/jama.2020.5249
10. Younossi ZM, Koenig AB, Abdelatif D, et al. Global epidemiology of nonalcoholic fatty liver disease-Meta-analytic assessment of prevalence, incidence, and outcomes. Hepatology. 2016;64(1):73-84. doi:10.1002/hep.28431

Wegovy^® is a registered trademark of Novo Nordisk A/S. Novo Nordisk is a registered trademark of Novo Nordisk A/S. All other trademarks, registered or unregistered, are the property of their respective owners.

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