Multiple Endocrine Neoplasia

Results of part 1 of the ESSENCE phase 3 trial, published in The New England Journal of Medicine, demonstrated that a greater proportion of patients with MASH achieved resolution of steatohepatitis with no worsening of liver fibrosis compared to placebo. Patients with MASH also saw statistically significant and superior improvement in liver fibrosis with no worsening of steatohepatitis compared to placebo1 Approximately one in 20 people in the US are living with MASH.2 Left untreated, MASH can progress to serious and even fatal outcomes, such as cirrhosis, liver cancer, and the need for liver transplant3 Additionally, Novo Nordisk's application for Wegovy® (semaglutide) injection 2.4 mg for the treatment of metabolic dysfunction-associated steatohepatitis (MASH) was recently accepted by FDA and granted Priority Review PLAINSBORO, N.J., April 30, 2025 /PRNewswire/ -- Today, The New England Journal of Medicine (NEJM) published results from part 1 of the ongoing phase 3 ESSENCE trial which investigated the effects of once-weekly subcutaneous semaglutide 2.4 mg on liver histology compared to placebo at 72 weeks in adults with MASH and moderate to advanced liver fibrosis (stage 2 or 3). At Week 72, the first primary endpoint showed 62.9% of people treated with semaglutide 2.4 mg achieved resolution of steatohepatitis with no worsening of liver fibrosis compared to 34.3% on placebo with estimated difference in responder proportions (EDP) of 28.7% (95% CI, 21.1 to 36.2; P<0.001). For the second primary endpoint at Week 72, 36.8% of people treated with semaglutide 2.4 mg achieved improvement in liver fibrosis with no worsening of steatohepatitis compared to 22.4% on placebo (EDP, 14.4%; 95% CI, 7.5 to 21.3; P<0.001).1 "ESSENCE part 1 demonstrates the effects of semaglutide 2.4 mg on the key histological elements, which may reduce disease progression to cirrhosis and end-stage liver disease," said Arun Sanyal, MD, lead author, principal investigator, and Director, Stravitz-Sanyal Institute for Liver Disease and Metabolic Health, Virginia Commonwealth University. "This is crucial, given the strong link between MASH and other cardiometabolic conditions." A confirmatory secondary endpoint at Week 72 showed 32.7% of patients treated with semaglutide 2.4 mg achieved both resolution of steatohepatitis and improvement in liver fibrosis compared to 16.1% of patients on placebo (EDP, 16.5%; 95% CI, 10.2 to 22.8; P<0.001).1 Furthermore, Novo Nordisk also announced that the US Food and Drug Administration has accepted the supplemental New Drug Application (sNDA) and granted Priority Review for Wegovy® (semaglutide) injection 2.4 mg to treat noncirrhotic MASH in adults with moderate to advanced liver scarring (fibrosis). Priority review designation means that FDA will review the application in six months, rather than the standard nine-month review period. "Novo Nordisk continues to explore semaglutide across metabolic and cardiovascular health including MASH, a condition with limited treatment options for patients and healthcare professionals," said Anna Windle, PhD, senior vice president of Clinical Development, Medical & Regulatory Affairs at Novo Nordisk. "We are encouraged by these published findings in the NEJM and what this could mean for patients. Based on these data, we look forward to working with regulatory authorities to bring this potential new treatment option to patients." Non-invasive tests (NITs) are valuable in supporting the screening of people at risk of developing MASH and may address early MASH detection. Implementing NITs may allow for fibrosis risk stratification earlier in the disease progression journey.4,5 The expanded analysis of ESSENCE showed apparent improvements of pre-specified NITs, including vibration-controlled transient elastography (VCTE), the Enhanced Liver Fibrosis (ELF)™ test, and PRO-C3, in adults treated with semaglutide 2.4 mg compared to placebo. These were supportive secondary endpoints, not controlled for multiplicity.1 Safety endpoints in the ESSENCE trial included adverse events and laboratory assessments. By Week 72, 88% of participants received and maintained the full target dose of semaglutide 2.4 mg. No new safety signals emerged, and the safety profile was consistent with the vast body of evidence for semaglutide. The most common adverse events were gastrointestinal-related, including nausea (36.3% semaglutide; 13.2% placebo), diarrhea (26.9% semaglutide; 12.2% placebo), constipation (22.3% semaglutide; 8.4% placebo), and vomiting (18.6% semaglutide; 5.6% placebo). Adverse events leading to trial discontinuation were 2.6% for the semaglutide group and 3.3% for the placebo group.1 Semaglutide 2.4 mg is not approved in the US for the treatment of MASH. 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 an estimated 1,200 planned participants are 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 objective was to demonstrate that treatment with semaglutide 2.4 mg improves liver histology compared with placebo at 72 weeks based on biopsy sampling from the first 800 randomized patients. In part 2, which is ongoing, the 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.1,6 About semaglutide 2.4 mg Semaglutide injection 2.4 mg is previously approved along with a reduced calorie diet and increased physical activity, 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 off and to reduce the risk of major CV events such as death, heart attack, or stroke in adults with known heart disease and either obesity or overweight.7 It is important to note that semaglutide injection 2.4 mg contains a Boxed Warning for possible thyroid tumors, including cancer and should not be used in those with a personal or family history of medullary thyroid carcinoma (MTC) or Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).7 Semaglutide is not approved for the treatment of adults with MASH. Safety and efficacy are not established, and there is no guarantee that semaglutide will become commercially available for this use under clinical investigation. About Metabolic Dysfunction-Associated Steatohepatitis (MASH) MASH is a chronic, progressive metabolic disease affecting the liver, which can be potentially life-threatening if not properly managed.8,9 Among people who are living with overweight or obesity, approximately one in three also have MASH.10 Excess fat can build up in the liver, which, over time, can lead to inflammation and severe scarring of the liver.11 People living with MASH often experience few or no specific symptoms in the early stages of the disease, which often results in a delayed diagnosis.12 Approximately, one in 20 people in the United States are living with MASH.2 The disease progresses to cirrhosis in an estimated 20% of cases.13 MASH is a leading cause of cirrhosis in adults in the US, and MASH-related cirrhosis is the second indication for liver transplants in the country.14 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. Contacts for further information References Sanyal AJ, Newsome PN, Kliers I, et al. Phase 3 trial of semaglutide in metabolic dysfunction-associated steatohepatitis. New Eng J Med. 2025;392(17). doi:10.1056/NEJMoa2413258 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:e0488. doi:10.1097/HC9.0000000 000000488 Fichez J, Mouillot T, Vonghia L, et al. Non-invasive tests for fibrotic MASH for reducing screen failure in therapeutic trials. JHEP Reports. 2025;7(4);101351. doi:10.1016/j.jhepr.2025.10135 Wattacheril JJ, Abdelmalek MF, Lim JK, et al. AGA clinical practice update on the role of noninvasive biomarkers in the evaluation and management of nonalcoholic fatty liver disease: expert review. Gastroenterology. 2023;165:1080-1088. doi:10.1053/j.ga stro.2023.06.013 Rinella ME, Neuschwander-Tetri BA, Siddiqui MS, et al. AASLD practice guidance on the clinical assessment and management of nonalcoholic fatty liver disease. Hepatology. 2023;77:1797-1835. doi:10.1097/HEP.0000000000000323 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;10:18331. doi:10.1111/apt.18331 Wegovy® (semaglutide) injection [package insert]. Plainsboro, NJ: Novo Nordisk Inc. Ilan Y. Analogy between non-alcoholic steatohepatitis (NASH) and hypertension: a stepwise patient-tailored approach for NASH treatment. Ann Gastroenterol. 2018; 31:296-304. doi:10.20524/aog.2018.0248 Tesfay M, Goldkamp JW, Neuschwander-Tetri BA. NASH: the emerging most common form of chronic liver disease. Mo Med. 2018;115:225-229. 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;8:20-30. doi: 10.1016/S2468-1253(22)00317-X National Institute of Diabetes and Digestive and Kidney Diseases. Definition & facts of NAFLD & NASH. Accessed November 7, 2024. Available at: 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;136:229-245. doi:10.1080/00325481.2024.2325332 Sheka AC, Adeyi O, Thompson J, et al. Nonalcoholic steatohepatitis: a review. JAMA. 2020;323:1619. doi:10.1001/jama.2020.5249 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 SOURCE NOVO NORDISK INC. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Building on results of the landmark SELECT trial, SCORE shows cardiovascular (CV) risk reduction with use of semaglutide 2.4 mg in a real-world environment1 SCORE is a retrospective, observational analysis of 27,963 patients with obesity or overweight and established cardiovascular disease1 PLAINSBORO, N.J., March 30, 2025 /PRNewswire/ -- Today, Novo Nordisk presented new data from the retrospective, observational SCORE study that assessed treatment with semaglutide 2.4 mg and the risk of major adverse cardiovascular events (MACE) in adults with overweight or obesity and established cardiovascular disease (CVD).1 The real-world analysis was presented at the American College of Cardiology Annual Scientific Session and Expo (ACC.25).1 Compared with non-users, semaglutide 2.4 mg use was associated with a significantly lower risk of revised MACE-3 composite endpoint (heart attack, stroke, or all-cause death) by 57% (HR: 0.43; 95% CI: 0.31-0.61; p < 0.001).1 Revised MACE-3 occurred in 42 (0.45%) of the 9,321 patients in the semaglutide 2.4 mg group and 175 (0.94%) of the 18,642 patients in the non-user group.1 The mean follow-up duration was 7.1 months for semaglutide users and 6.4 months for non-users.1 "Real-world analyses such as SCORE complement randomized controlled trials by offering healthcare professionals additional information about how therapies perform in routine clinical practice as they partner with patients on individualized treatment decisions," said Jason Brett, MD, Acting Principal Medical Head at Novo Nordisk Inc. "Our mission is to drive change in how obesity is seen and treated, and the real-world evidence from SCORE provides actionable insights that can ultimately help improve patient care for people living with obesity at risk for CV events." Compared with non-users, semaglutide 2.4 mg use was associated with a significantly lower risk of revised MACE-5 composite endpoint (heart attack, stroke, hospitalization for heart failure (HF), evidence of a coronary revascularization procedure, or all-cause death) by 45% (HR: 0.55; 95% CI: 0.43-0.70; p < 0.001).1 Revised MACE-5 occurred in 88 (0.94%) of the 9,321 patients in the semaglutide 2.4 mg group and 288 (1.54%) of 18,642 patients in the non-user group.1 SCORE results were consistent across a variety of CV endpoints, including death. Compared with non-users, semaglutide 2.4 mg use was also associated with significantly lower risk of hospitalization for HF, CV-related death, and all-cause death.1 Real-world study data can provide valuable insights into how treatments work outside of controlled clinical trial settings. Real-world data analyses also have several limitations; results may reflect residual unmeasured confounding; while associations can be demonstrated, causal relationships cannot be definitively established. The relatively recent approval of semaglutide 2.4 mg limited follow-up duration, restricting the assessment of long-term benefits.1 Additionally, use of retrospective claims data may exclude patients with intermittent coverage or underserved populations, potentially limiting generalizability.1 About semaglutide 2.4 mg Semaglutide injection 2.4 mg is previously approved along with a reduced calorie diet and increased physical activity, 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 off and to reduce the risk of major CV events such as death, heart attack, or stroke in adults with known heart disease and either obesity or overweight.2 It is important to note that semaglutide injection 2.4 mg contains a Boxed Warning for possible thyroid tumors, including cancer and should not be used in those with a personal or family history of medullary thyroid carcinoma (MTC) or Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).2 Semaglutide is not approved in the U.S. to reduce heart failure outcomes, coronary revascularization, or all-cause death.2 About real-world evidence (RWE) SCORE study Real-world studies are conducted to complement randomized controlled trials, which are the gold standard for evaluating the safety and efficacy of a treatment.3 The SCORE study analyzed MACE outcomes among semaglutide 2.4 mg users and non-users in real-world clinical practice.1 Analysis was based on a database with administrative medical and pharmacy claims linked to clinical and laboratory measurements that is nationally representative of the U.S. population and a sample of patients who met similar inclusion criteria as in the SELECT trial.1,2 Patients aged ≥ 45 years with overweight or obesity (diagnosis or BMI ≥ 27 kg/m2) and established CVD (prior heart attack, ischemic stroke, or peripheral arterial disease (PAD)) but no diabetes were placed into two study groups, including patients who initiated semaglutide 2.4 mg (n=9,321), and non-users who did not initiate semaglutide 2.4 mg (n=18,642).1 Each semaglutide 2.4 mg user was matched using propensity scoring to two non-users to balance baseline characteristics including: demographics, overweight/obesity status, BMI, comorbidities, procedures, medication use, and HRU. Patient characteristics among matched patients were well-balanced.1 About SELECT cardiovascular outcomes trial SELECT was a multicenter, randomized, double-blind, placebo-controlled, event-driven superiority trial designed to evaluate the efficacy of semaglutide 2.4 mg versus placebo as an adjunct to cardiovascular standard of care for reducing the risk of major adverse cardiovascular events (cardiovascular death, non-fatal heart attack, or non-fatal stroke) in adults with established CVD with overweight or obesity with no prior history of diabetes.4 In SELECT, established CVD was defined as a prior heart attack, prior stroke, or symptomatic PAD.4 The trial, initiated in 2018, enrolled 17,604 adults and was conducted in 41 countries at more than 800 investigator sites.4 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 U.S. headquarters in New Jersey and commercial, production, and research facilities in seven states plus Washington DC, Novo Nordisk employs approximately 8,000 people throughout the country. For more information, visit novonordisk-us.com, Facebook, Instagram, X, LinkedIn, and YouTube. ______________________ References: Zhao Z, Song J, Faurby M, et al. Lower Risk of MACE and All-Cause Death in Patients Initiated on Semaglutide 2.4 mg in Routine Clinical Care: Results from the SCORE Study (Semaglutide Effects on Cardiovascular Outcomes in People with Overweight or Obesity in the Real World). Moderated poster presentation presented at the American College of Cardiology Scientific Session & Expo 2025; 29-31 March 2025; McCormick Place Convention Center, Chicago, US. Presentation 947-13. Wegovy® (semaglutide) injection 2.4 mg Prescribing Information. Plainsboro, NJ: Novo Nordisk Inc.; 2025. Blonde L, Khunti K, Harris SB, et al. Interpretation and Impact of Real-World Clinical Data for the Practicing Clinician. Adv Ther. 2018;35(11):1763-1774. doi:10.1007/s12325-018-0805-y. Lincoff MA, Brown-Frandson K, Colhoun HM, et al. Semaglutide and cardiovascular outcomes in obesity without diabetes. N Engl J Med. 2023;389:2221-2232. © 2025 Novo Nordisk All rights reserved. US25SEMO00448 March 2025 SOURCE NOVO NORDISK INC. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Ozempic® is now indicated to reduce the risk of kidney disease worsening, kidney failure, and death from cardiovascular disease in adults with type 2 diabetes and chronic kidney disease The approval is based on the results of the pivotal FLOW phase 3b kidney outcomes trial and addresses a critical need for adults with type 2 diabetes living with this common comorbidity of chronic kidney disease PLAINSBORO, N.J., Jan. 28, 2025 /PRNewswire/ -- Novo Nordisk today announced that the U.S. Food and Drug Administration (FDA) has approved Ozempic® to reduce the risk of kidney disease worsening, kidney failure (end-stage kidney disease), and death due to cardiovascular disease in adults with type 2 diabetes and chronic kidney disease (CKD).1 This approval, along with its existing indications for adults with type 2 diabetes to improve glycemic control and to reduce the risk of major cardiovascular events in adults also with known heart disease, establishes Ozempic® (semaglutide) injection 0.5 mg, 1 mg, or 2 mg as the most broadly indicated glucagon-like peptide-1 receptor agonist (GLP-1 RA) in its class. Experience the full interactive Multichannel News Release here: "Chronic kidney disease is very serious and common in patients living with type 2 diabetes and represents a critical need for adults living with these comorbidities. This approval for Ozempic® allows us to more broadly address conditions within cardiovascular-kidney-metabolic syndrome, which affects millions of adults and could have serious consequences if left untreated," said Anna Windle, PhD, Senior Vice President Clinical Development, Medical & Regulatory Affairs at Novo Nordisk. "With this new indication, Ozempic® stands out uniquely as the most broadly indicated GLP-1 RA in its class. We are proud to continue advancing innovations that will have a meaningful impact for this patient population, underscoring Novo Nordisk's commitment to cardiometabolic care." CKD affects approximately 37 million adults in the U.S. and is expected to rise with an aging demographic and increasing prevalence of diabetes, the leading cause of CKD and kidney failure.2,3 CKD is a common complication of type 2 diabetes, with approximately 40% of people with type 2 diabetes also experiencing CKD.2,4 For people with type 2 diabetes, CKD can be a significant burden and can cause additional sickness, including increased risk of cardiovascular problems and death.4,5 This FDA approval is based on results from the FLOW phase 3b kidney outcomes trial investigating the effects of once-weekly Ozempic® injection on major kidney and cardiovascular outcomes in adults with type 2 diabetes and CKD.1 The FLOW trial achieved its primary endpoint with Ozempic® 1 mg, demonstrating a statistically significant and superior 24% relative risk reduction of kidney disease worsening, kidney failure (end-stage kidney disease), and death due to cardiovascular disease (4.9% absolute risk reduction at 3 years) compared to placebo, when added to standard of care.1 "Type 2 diabetes can be challenging enough to manage without the added risk of chronic kidney disease, and I have seen in my own practice that patients with type 2 diabetes and chronic kidney disease need extra support from medications that may have a profound clinical impact by lowering the risk of major kidney and cardiovascular outcomes," said Richard E. Pratley, MD, Medical Director at the AdventHealth Diabetes Institute Orlando, FL, and Co-Chair of the FLOW Trial. "A large portion of patients I treat experience serious kidney complications and comorbidities, with some even requiring dialysis. Today's decision by the FDA offers hope for the millions of adults living with both conditions and provides an additional treatment option, representing a significant advancement for my patients." The FDA initially approved Ozempic® in 2017 to improve blood sugar (glucose), along with diet and exercise, in adults with type 2 diabetes. In 2020, Ozempic® was granted an additional indication to reduce the risk of major cardiovascular events such as heart attack, stroke, or death in adults with type 2 diabetes with known heart disease. Today, the FDA has expanded the benefits of Ozempic® to a new patient population that needs critical treatment options to reduce the risk of kidney disease worsening, kidney failure (end-stage kidney disease), and death due to cardiovascular disease in adults with type 2 diabetes and chronic kidney disease. Only Novo Nordisk manufactures FDA-approved semaglutide medicines, like Ozempic®. About FLOW FLOW was an international, randomized, double-blind, parallel-group, placebo-controlled, event-driven superiority trial comparing once-weekly Ozempic® 1 mg with placebo as an adjunct to standard of care on kidney outcomes for reducing the incidence of the primary composite endpoint of a sustained decline in eGFR of ≥50%, sustained eGFR < 15 mL/min/1.73 m2, chronic renal replacement therapy, renal death, and CV death in adults with type 2 diabetes and CKD. 3,533 adults (1,767 in the Ozempic® group and 1,766 in the placebo group) were enrolled in the trial conducted in 28 countries at approximately 400 investigator sites. The FLOW trial was initiated in 2019. At the recommendation from an Independent Data Monitoring Committee, the FLOW study was stopped early due to meeting pre-specified efficacy criteria after a median follow-up of 3.4 years.6 What is Ozempic® Ozempic® (semaglutide) injection 0.5 mg, 1 mg, or 2 mg is an injectable prescription medicine used: along with diet and exercise to improve blood sugar (glucose) in adults with type 2 diabetes to reduce the risk of major cardiovascular events such as heart attack, stroke, or death in adults with type 2 diabetes with known heart disease to reduce the risk of kidney disease worsening, kidney failure (end-stage kidney disease), and death due to cardiovascular disease in adults with type 2 diabetes and chronic kidney disease It is not known if Ozempic® is safe and effective for use in children. Important Safety Information Do not share your Ozempic® pen with other people, even if the needle has been changed. You may give other people a serious infection or get a serious infection from them. What is the most important information I should know about Ozempic®? Ozempic® may cause serious side effects, including: Possible thyroid tumors, including cancer. Tell your health care 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, Ozempic® and medicines that work like Ozempic® caused thyroid tumors, including thyroid cancer. It is not known if Ozempic® will cause thyroid tumors or a type of thyroid cancer called medullary thyroid carcinoma (MTC) in people Do not use Ozempic® if you or any of your family have ever had MTC, or if you have an endocrine system condition called Multiple Endocrine Neoplasia syndrome type 2 (MEN 2) Do not use Ozempic® if: you or any of your family have ever had MTC or if you have MEN 2 you are allergic to semaglutide or any of the ingredients in Ozempic®. See symptoms of serious allergic reaction in "What are the possible side effects of Ozempic®?" Before using Ozempic®, tell your health care provider if you have any other medical conditions, including if you: have or have had problems with your pancreas have a history of diabetic retinopathy have severe problems with your stomach, such as slowed emptying of your stomach (gastroparesis) or problems with digesting food are scheduled to have surgery or other procedures that use anesthesia or deep sleepiness (deep sedation) are pregnant or breastfeeding or plan to become pregnant or breastfeed. It is not known if Ozempic® will harm your unborn baby or pass into your breast milk. You should stop using Ozempic® at least 2 months before you plan to become pregnant Tell your health care provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, herbal supplements, and other medicines to treat diabetes, including insulin or sulfonylureas. What are the possible side effects of Ozempic®? Ozempic® may cause serious side effects, including: inflammation of your pancreas (pancreatitis). Stop using Ozempic® and call your health care provider right away if you have severe pain in your stomach area (abdomen) that will not go away, with or without vomiting. You may feel the pain from your abdomen to your back changes in vision. Tell your health care provider if you have changes in vision during treatment with Ozempic® low blood sugar (hypoglycemia). Your risk for getting low blood sugar may be higher if you use Ozempic® with another medicine that can cause low blood sugar, such as a sulfonylurea or insulin. Signs and symptoms of low blood sugar may include: dizziness or lightheadedness, blurred vision, anxiety, irritability or mood changes, sweating, slurred speech, hunger, confusion or drowsiness, shakiness, weakness, headache, fast heartbeat, and 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 health care 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 Ozempic®. Tell your health care provider if you have stomach problems that are severe or will not go away serious allergic reactions. Stop using Ozempic® 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 gallbladder problems. Gallbladder problems have happened in some people who take Ozempic®. Tell your health care provider right away if you get symptoms which may include: pain in your upper stomach (abdomen), fever, yellowing of the skin or eyes (jaundice), or clay-colored stools food or liquid getting into the lungs during surgery or other procedures that use anesthesia or deep sleepiness (deep sedation). Ozempic® may increase the chance of food getting into your lungs during surgery or other procedures. Tell all your health care providers that you are taking Ozempic® before you are scheduled to have surgery or other procedures The most common side effects of Ozempic® may include nausea, vomiting, diarrhea, stomach (abdominal) pain, and constipation. 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 U.S. headquarters in New Jersey and commercial, production, and research facilities in seven states plus Washington DC, Novo Nordisk employs approximately 8,000 people throughout the country. 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. This information is intended for US media audiences only. Contact for further information Media: Liz Skrbkova (US) +1 609 917 0632 (Mobile) [email protected] Jamie Bennett (US) +1 640 250 1881 (Mobile) [email protected] References Ozempic® (semaglutide) injection [package insert]. Plainsboro, NJ: Novo Nordisk Inc; 2024. Feng X (Snow), Farej R, Dean BB, et al. CKD prevalence among patients with and without type 2 diabetes: regional differences in the United States. Kidney Medicine. 2022;4(1):100385. doi:. National Kidney Foundation. Diabetes and chronic kidney disease. Last accessed: January 2025. Available at: Von Scholten BJ, Kreiner FF, Rasmussen S, Rossing P, Idorn T. (2022). The potential of GLP-1 receptor agonists in type 2 diabetes and chronic kidney disease: from randomised trials to clinical practice. Ther Adv Endocrinol Metab. 2022; 13, 20420188221112490. . Afkarian M, Sachs MC, Kestenbaum B, Hirsch IB, Tuttle KR, Himmelfarb J, de Boer IH. Kidney disease and increased mortality risk in type 2 diabetes. J Am Soc Nephrol. 2013 Feb;24(2):302-8. doi: 10.1681/ASN.2012070718. Epub 2013 Jan 29. PMID: 23362314; PMCID: PMC3559486. Perkovic V, Tuttle KR, Rossing P, et al. Effects of semaglutide on chronic kidney disease in patients with type 2 diabetes. NEJM. 2024. . Novo Nordisk is a registered trademark of Novo Nordisk A/S. © 2025 Novo Nordisk All rights reserved. US24OZM00639 January 2025 SOURCE Novo Nordisk, Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED