Tag: Novo Nordisk

Akero Therapeutics to be Acquired by Novo Nordisk for up to $5.2 Billion

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Shareholders to Receive $54 Per Share in Cash and CVR of $6 Per Share  Advances Akero’s Mission of Bringing Novel Therapies to Patients with High Unmet Medical Needs SOUTH SAN FRANCISCO, Calif., Oct. 09, 2025 (GLOBE NEWSWIRE) — Akero Therapeutics, Inc. (“Akero”) (Nasdaq: AKRO), a clinical-stage company developing transformational treatments for patients with serious metabolic diseases marked by high unmet medical need, today announced that it has entered into a definitive agreement to be acquired by Novo Nordisk A/S (“Novo Nordisk”) for up to $5.2 billion in cash. Under the terms of the agreement, Akero shareholders will receive $54.00 per share in cash at closing and a non-transferable Contingent Value Right (“CVR”). Each CVR will entitle its holder to receive a cash payment of $6.00 per share upon full U.S. regulatory approval of efruxifermin (“EFX”) for treatment of compensated cirrhosis due to MASH by June 30, 2031. The upfront cash portion of the consideration represents an equity value of approximately $4.7 billion, a 19% premium to Akero’s 30-day Volume Weighted Average Price (VWAP), and a 42% premium to Akero’s closing price on May 19, 2025 prior to market speculation. Combined, the upfront and potential contingent value payment represent, if achieved, an equity value of approximately $5.2 billion, a 32% premium to Akero’s 30-day VWAP, and a 57% premium to Akero’s closing price on May 19, 2025 prior to market speculation. Akero’s innovative EFX program – focused on developing a best-in-class treatment for metabolic dysfunction-associated steatohepatitis (“MASH”) – will complement Novo Nordisk’s leadership in GLP-1 based metabolic treatments. Novo Nordisk’s world leading capabilities in cardio-metabolic disease will enhance and accelerate evaluation of EFX in the Phase 3 SYNCHRONY program, preparation for a successful commercial launch, and delivery of EFX to patients in need around the globe. “We are excited to enter into this transaction with Novo Nordisk, which follows a comprehensive review undertaken by our Board of Directors, delivers meaningful value to Akero shareholders, and positions us to expand treatment options for people around the globe through Novo Nordisk’s industry-leading development capabilities and commercial infrastructure,” said Andrew Cheng, M.D., Ph.D, President and CEO of Akero Therapeutics. “I want to thank Akero’s talented employees for their tireless commitment to advancing EFX and meeting a critical global unmet need. We look forward to joining the Novo Nordisk family and accelerating the momentum of EFX to deliver a transformational impact on patients’ lives.” The transaction has been unanimously approved by Akero’s Board of Directors and is expected to close around year-end, subject to approval by Akero shareholders and upon satisfaction of customary closing conditions including approvals by regulatory authorities. Morgan Stanley & Co. LLC and J.P. Morgan Securities LLC are serving as financial advisors to Akero Therapeutics, and Kirkland & Ellis LLP as its legal advisor. About Akero TherapeuticsAkero Therapeutics is a clinical-stage company developing transformational treatments for patients with serious metabolic diseases marked by high unmet medical need, including metabolic dysfunction-associated steatohepatitis (MASH). Akero’s lead product candidate, efruxifermin (EFX), is currently being evaluated in three ongoing Phase 3 clinical studies: SYNCHRONY Histology in patients with pre-cirrhotic (F2-F3 fibrosis) MASH, SYNCHRONY Outcomes in patients with compensated cirrhosis (F4) due to MASH, and SYNCHRONY Real-World in patients with MASH or MASLD (metabolic dysfunction-associated steatotic liver disease). The Phase 3 SYNCHRONY program builds on the results of two Phase 2b clinical trials, the HARMONY study in patients with pre-cirrhotic MASH and the SYMMETRY study in patients with compensated cirrhosis due to MASH. Akero is headquartered in South San Francisco. Visit us at Akerotx.com and follow us on LinkedIn and X for more information. About Novo NordiskNovo Nordisk is a leading global healthcare company founded in 1923 and headquartered in Denmark. Our purpose is to drive change to defeat serious chronic diseases built upon our heritage in diabetes. We do so by pioneering scientific breakthroughs, expanding access to our medicines and working to prevent and ultimately cure disease. As of August 2025, Novo Nordisk employed about 78,400 people in 80 countries and markets its products in around 170 countries. Novo Nordisk’s B shares are listed on Nasdaq Copenhagen (NOVO-B). Its ADRs are listed on the New York Stock Exchange (NVO). For more information, visit novonordisk.com, Facebook, Instagram, X, LinkedIn and YouTube. About EFX and the SYNCHRONY programEFX, Akero’s lead product candidate, is currently being evaluated in three ongoing phase 3 trials. In multiple phase 2 trials, EFX has been observed to reverse fibrosis (including compensated cirrhosis), resolve MASH, reduce non-invasive markers of fibrosis and liver injury, and improve insulin sensitivity and lipoprotein profile. This holistic profile offers the potential to address the complex, multi-system disease state of all stages of MASH, including improvements in risk factors linked to cardiovascular disease – the leading cause of death among MASH patients. Engineered to mimic the biological activity profile of native FGF21, EFX is designed to offer once-weekly subcutaneous dosing and has been generally well-tolerated in clinical trials to date. The ongoing global phase 3 SYNCHRONY program (total ~3,500 participants) is comprised of three, randomized, placebo-controlled trials evaluating the efficacy and safety of EFX in both compensated cirrhosis (F4) due to MASH and pre-cirrhotic (F2-F3) MASH. SYNCHRONY Real-World, assessing the safety and tolerability of EFX (50 mg) in patients with noninvasively diagnosed MASH or metabolic dysfunction-associated steatotic liver disease (MASLD) (F1-F4).SYNCHRONY Histology, evaluating the efficacy and safety of EFX (28 mg and 50 mg) in patients with biopsy-confirmed pre-cirrhotic (F2-F3) MASH.SYNCHRONY Outcomes, evaluating the efficacy and safety of EFX (50 mg) for the treatment of compensated cirrhosis (F4) due to MASH. Important Information and Where to Find ItIn connection with the proposed transaction between Akero Therapeutics, Inc. (“Akero”) and Novo Nordisk A/S (“Parent”), Akero intends to file with the Securities and Exchange Commission (“SEC”) a proxy statement (the “Proxy Statement”), the definitive version of which will be sent or provided to Akero stockholders. Akero may also file other documents with the SEC regarding the proposed transaction. This document is not a substitute for the Proxy Statement or any other document which Akero may file with the SEC. INVESTORS AND SECURITY HOLDERS ARE URGED TO READ THE PROXY STATEMENT AND ANY OTHER RELEVANT DOCUMENTS THAT ARE FILED OR WILL BE FILED WITH THE SEC, AS WELL AS ANY AMENDMENTS OR SUPPLEMENTS TO THESE DOCUMENTS, CAREFULLY AND IN THEIR ENTIRETY BECAUSE THEY CONTAIN OR WILL CONTAIN IMPORTANT INFORMATION ABOUT THE PROPOSED TRANSACTION AND RELATED MATTERS. Investors and security holders may obtain free copies of the Proxy Statement (when it is available) and other documents that are filed or will be filed with the SEC by Akero through the website maintained by the SEC at www.sec.gov, Akero’s website at https://ir.akerotx.com/financial-information/sec-filings or by contacting the Akero investor relations department at the following: Christina Tartaglia (212) 362-1200 IR@akerotx.com Participants in the SolicitationThis communication does not constitute a solicitation of a proxy, an offer to purchase or a solicitation of an offer to sell any securities. Akero and certain of its directors and executive officers may be deemed to be participants in the solicitation of proxies in respect of the proposed transaction. Information regarding Akero’s directors and executive officers, including a description of their direct interests, by security holdings or otherwise, is contained in (i) the “Directors, Executive Officers and Corporate Governance,” “Executive Compensation” and “Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters” sections of the Annual Report on Form 10-K for the fiscal year ended December 31, 2024 of Akero, which was filed with the SEC on February 28, 2025 and (ii) the “Proposal 1 – Election of Class III Directors,” “Executive Compensation,” and “Principal Stockholders” sections of Akero’s proxy statement for its 2025 annual meeting of stockholders, which was filed with the SEC on April 28, 2025, and will be contained in the proxy statement to be filed by Akero in connection with the proposed transaction. Any change of the holdings of Akero’s securities by its directors or executive officers from the amounts set forth in the proxy statement for its 2025 annual meeting of stockholders have been reflected in the following Statements of Changes in Beneficial Ownership on Form 4 filed with the SEC: by Jonathan Young, filed on October 3, 2025, September 12, 2025, September 4, 2025, August 13, 2025, July 2, 2025, June 20, 2025 and June 12, 2025; by Catriona Yale, dated September 12, 2025, July 18, 2025, July 2, 2025, June 20, 2025, June 20, 2025, June 12, 2025 and May 19, 2025; by Richard William White, dated September 12, 2025, July 2, 2025, June 20, 2025 and June 12, 2025; by Timothy Rolph, dated September 12, 2025, September 10, 2025, August 7, 2025, July 9, 2025, July 2, 2025, June 20, 2025, June 12, 2025, June 9, 2025, May 8, 2025 and April 28, 2025; by Andrew Cheng, dated September 12, 2025, August 13, 2025, July 11, 2025, July 2, 2025, June 20, 2025, June 12, 2025 and May 13, 2025; by Scott Gangloff, dated August 19, 2025, July 2, 2025 and June 20, 2025; by Jane Henderson, dated August 12, 2025 and June 5, 2025; by Patrick Lamy, dated July 3, 2025, July 2, 2025, June 20, 2025, June 20, 2025, June 12, 2025, June 4, 2025, May 23, 2025 and May 9, 2025; by Mark T. Iwicki, dated June 5, 2025; by Seth Loring Harrison, dated June 5, 2025; by Yuan Xu, dated June 5, 2025; by Tomas J. Heyman, dated June 5, 2025; by Judy Chou, dated June 5, 2025; and by Graham G. Walmsley, dated June 5, 2025. Akero stockholders may obtain additional information regarding the direct and indirect interests of the participants in the solicitation of proxies in connection with the proposed transaction, including the interests of Akero directors and executive officers in the transaction, which may be different than those of Akero stockholders generally, by reading the Proxy Statement and any other relevant documents that are filed or will be filed with the SEC relating to the transaction. These documents (when available) may be obtained free of charge from the website maintained by the SEC at www.sec.gov and Akero’s website at https://ir.akerotx.com/financial-information/sec-filings. Forward-Looking Statements DisclaimerThis communication contains forward-looking statements related to Akero, Parent and the proposed acquisition of Akero by Parent (the “Transaction”) that involve substantial risks and uncertainties. Forward-looking statements include any statements containing the words “anticipate,” “believe,” “estimate,” “expect,” “intend,” “goal,” “may,” “might,” “plan,” “predict,” “project,” “seek,” “target,” “potential,” “will,” “would,” “could,” “should,” “continue” and similar expressions. In this communication, Akero’s forward-looking statements include statements about the parties’ ability to satisfy the conditions to the consummation of the Transaction; statements about the expected timetable for completing the transaction; Akero’s plans, objectives, expectations and intentions, the financial condition, results of operations and business of Akero, the U.S. Food and Drug Administration’s approval of Akero’s new drug application for efruxifermin for the treatment of metabolic dysfunction-associated steatohepatitis, Akero’s ability to commercialize current and future product candidates, and the anticipated timing of closing of the Transaction. Forward-looking statements are subject to certain risks, uncertainties, or other factors that are difficult to predict and could cause actual events or results to differ materially from those indicated in any such statements due to a number of risks and uncertainties. Those risks and uncertainties that could cause the actual results to differ from expectations contemplated by forward-looking statements include, among other things: uncertainties as to the ability to obtain shareholder approval; risks related to non-achievement of the CVR milestones and that holders of the CVRs will not receive any payments in respect of those CVRs; the possibility that competing offers will be made; the possibility that various closing conditions for the Transaction may not be satisfied or waived, including that a governmental entity may prohibit, delay or refuse to grant approval for the consummation of the Transaction; the effects of the Transaction on relationships with employees, other business partners or governmental entities; the difficulty of predicting the timing or outcome of FDA approvals or actions, if any; the impact of competitive products and pricing; that Parent may not realize the potential benefits of the Transaction; other business effects, including the effects of industry, economic or political conditions outside of the companies’ control; transaction costs; actual or contingent liabilities; and other risks listed under the heading “Risk Factors” in Akero’s periodic reports filed with the U.S. Securities and Exchange Commission, including quarterly reports on Form 10-Q and annual reports on Form 10-K. These risks, as well as other risks associated with the proposed transaction, are more fully discussed in the Proxy Statement to be filed with the U.S. Securities and Exchange Commission in connection with the proposed transaction. While the list of factors presented here is, and the list of factors presented in the Proxy Statement will be, considered representative, no such list should be considered to be a complete statement of all potential risks and uncertainties. You should not place undue reliance on these statements. All forward-looking statements are based on information currently available to Akero and Parent, and Akero and Parent disclaim any obligation to update the information contained in this communication as new information becomes available. Investor Contact:Christina TartagliaPrecision AQ(212) 362-1200IR@akerotx.com Media Contact:Jamie Moser / Andrew SiegelJoele Frank, Wilkinson Brimmer Katcher(212) 355-4449

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Novo Nordisk A/S: Ozempic® reduces the risk of heart attack, stroke and death by 23% compared to dulaglutide in the first head-to-head real-world study

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Ozempic® (once-weekly injectable semaglutide) was associated with a 23% reduced risk of heart attack, stroke and death in people with type 2 diabetes and cardiovascular disease on Medicare versus dulaglutide1Data also highlighted Ozempic® was associated with a 26% lower risk of death versus dulaglutide1This study is the first to directly compare these glucagon-like peptide 1 receptor agonist (GLP-1 RA) medications in everyday real-life use. It fills a significant gap in understanding their effects on heart health in older people at high risk, which could help support informed treatment decisions and health policies.1 Bagsværd, Denmark, 18 September 2025 – Novo Nordisk today announced results from the REACH real-world study, which demonstrated that compared to dulaglutide, Ozempic® (once-weekly injectable semaglutide) was associated with a reduced risk of major adverse cardiovascular events such as a heart attack or stroke by 23%1. The data span nearly 60,000 US Medicare patients (aged ≥66 years) living with type 2 diabetes, atherosclerotic cardiovascular disease (ASCVD) – a condition where fatty deposits build up in blood vessels, reducing blood flow and increasing the risk of heart attacks, strokes and related problems – and multiple health conditions2. The results were presented at the European Association for the Study of Diabetes (EASD) 2025 Annual Meeting on 15–19 September in Vienna, Austria1. “As we age, the risk of experiencing a heart attack, stroke or dying from a cardiovascular event increases. At the same time, there are limited clinical data for people living with diabetes and cardiovascular disease aged 66 years or older. These data, showing a 23% risk reduction of a heart attack, stroke and death, fill an important gap and reinforce the well-established clinical evidence of semaglutide,” said Filip Krag Knop, senior vice president and incoming chief medical officer at Novo Nordisk. “This is great news for older patients as well as healthcare professionals, as these results build on the importance of our randomised clinical trial data assessing the effectiveness of treatments in a real-life setting. This also supports what we already know from our clinical development programmes that not all GLP-1 RAs are the same.”Beyond these essential benefits, once-weekly semaglutide was also associated with a 25% risk reduction of heart attack, stroke, hospitalisation for unstable angina or heart failure, and death from any cause (five-point MACE)1. Ozempic® is the only GLP-1 RA that has proven risk reduction of cardiovascular and kidney events in people with type 2 diabetes3-6. These results provide the first direct comparison of cardiovascular outcomes between Ozempic® and dulaglutide in US Medicare beneficiaries and add to the body of evidence for Ozempic®. About REACH REACH is a comprehensive series of studies assessing the cardiovascular disease-related outcomes of the once-weekly GLP-1 RA class, including semaglutide, compared to glucose-lowering therapies such as DPP4 inhibitors, SGLT2 inhibitors and others. It also includes within-class comparisons of GLP-1 RAs from multiple administrative claims and electronic health record databases. The study presented at the European Association for the Study of Diabetes (EASD) 2025 Annual Meeting is a real-world evidence analysis evaluating cardiovascular risk reduction with GLP-1 RAs – semaglutide and dulaglutide – in people with type 2 diabetes and atherosclerotic cardiovascular disease (ASCVD). This study draws from Medicare fee-for-service claims data, using a target-trial emulation framework, including 58,336 matched patients (29,168 patients in each treatment group) aged ≥66 years with type 2 diabetes and ASCVD who initiated once-weekly semaglutide or dulaglutide. Direct cardiovascular outcome comparisons between GLP-1 RAs are lacking. These results address a critical gap for insights, particularly in an older Medicare population with multiple comorbidities underrepresented in randomised clinical trials. About Ozempic®Ozempic® (semaglutide) injection 0.25 mg, 0.5 mg, 1.0 mg or 2.0 mg is a once-weekly GLP-1 RA indicated, along with diet and exercise, to improve blood sugar (glucose) in adults with type 2 diabetes and to reduce the risk of major cardiovascular events such as heart attack, stroke or death in adults with type 2 diabetes mellitus with known heart disease. Ozempic® is the only GLP-1 RA indicated to reduce the risk of worsening kidney disease and risk of death from cardiovascular events in adults with type 2 diabetes and chronic kidney disease. Ozempic® is currently marketed in 72 countries, and 7 million people with type 2 diabetes are currently being treated with Ozempic® worldwide. Novo Nordisk is a leading global healthcare company founded in 1923 and headquartered in Denmark. Our purpose is to drive change to defeat serious chronic diseases built upon our heritage in diabetes. We do so by pioneering scientific breakthroughs, expanding access to our medicines, and working to prevent and ultimately cure disease. Novo Nordisk employs about 78,400 people in 80 countries and markets its products in around 170 countries. For more information, visit novonordisk.com, Facebook, Instagram, X, LinkedIn and YouTube. Contacts for further information Media:   Ambre James-Brown  +45 3079 9289 globalmedia@novonordisk.com   Liz Skrbkova (US) +1 609 917 0632 lzsk@novonordisk.com   Investors:   Jacob Martin Wiborg Rode +45 3075 5956 jrde@novonordisk.com   Sina Meyer  +45 3079 6656 azey@novonordisk.com   Max Ung +45 3077 6414  mxun@novonordisk.com    Christoffer Sho Togo Tullin +45 3079 1471 cftu@novonordisk.com   Alex Bruce  +45 34 44 26 13 axeu@novonordisk.com   Frederik Taylor Pitter  +1 609 613 0568 fptr@novonordisk.com   _______________________References1.      Tan M, et al. Late-breaking oral presentation presented at the European Association for the Study of Diabetes (EASD) 2025; Sep 15-19 2025; Vienna, Austria.2.      Dai D, et al. Cancer Control. 2022;29:10732748221140691.3.      Marso SP, et al. N Engl J Med. 2016;375:1834-1844.4.      Perkovic V, et al. N Engl J Med. 2024;391:109-121.5.      Ozempic® (once-weekly semaglutide): US Prescribing Information. 2025 [online]. Available at: https://www.novo-pi.com/ozempic.pdf Last accessed: September 2025.6.      EMA. Ozempic® (once-weekly semaglutide) Summary of Product Characteristics. 2025 [online]. Available at: https://www.ema.europa.eu/en/medicines/human/EPAR/ozempic. Last accessed: September 2025.
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PR250918-EASD-REACH

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EU approval makes Novo Nordisk’s oral semaglutide the first and only oral GLP-1 RA to reduce cardiovascular death, heart attack and stroke

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Oral semaglutide (Rybelsus®) is now the first and only oral GLP-1 RA approved for type 2 diabetes, with proven cardiovascular benefits1This approval is based on results from the SOUL clinical trial, where oral semaglutide (Rybelsus®) reduced cardiovascular death, heart attack and stroke by 14% versus placebo, when added to standard of care, in adults with type 2 diabetes at high cardiovascular risk1In addition, new results from SOUL will be presented at one of the largest diabetes conferences (EASD) later this week, showing that oral semaglutide significantly reduced hospitalisations compared with placebo2 Bagsværd, Denmark, 15 September 2025 – Novo Nordisk today announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has approved an update to the Rybelsus® (oral semaglutide) label to reflect the cardiovascular benefits seen in the SOUL trial. SOUL was a phase 3b trial carried out to evaluate the effect of Rybelsus® on cardiovascular outcomes in people with type 2 diabetes and atherosclerotic cardiovascular disease (ASCVD) and/or chronic kidney disease (CKD)1. Rybelsus® is now the first and only oral glucagon-like peptide 1 receptor agonist (GLP-1 RA) – mimicking a natural hormone in your body that helps regulate blood sugar, appetite, and digestion – available in the EU for type 2 diabetes with a proven cardiovascular benefit1. “Heart problems are the leading cause of disability and death for people living with type 2 diabetes. Therefore, treatments that also address heart problems are key to improving not only health outcomes, but also quality of life – and this approval will help do just that,” said Emil Kongshøj Larsen, executive vice president, International Operations at Novo Nordisk. “This milestone makes semaglutide the only oral GLP-1 RA with proven blood glucose and body weight reduction, as well as cardiovascular benefits.” New results from the SOUL trial will be shared later this week at the European Association for the Study of Diabetes (EASD) 2025 Annual Meeting, 15–19 September. These include findings that treatment with oral semaglutide significantly reduced hospitalisations related to serious adverse events compared with placebo2. Additional SOUL results will be presented at the same meeting, which highlight that the cardiovascular benefits of oral semaglutide were consistent regardless of body mass index (BMI) and body weight of participants3. In the US, a decision is expected later this year for a label extension for the cardiovascular indication for Rybelsus®. Novo Nordisk has also submitted an application in the US for a once-daily 25 mg oral formulation of semaglutide (Wegovy® in a pill) in adults living with obesity or overweight and cardiovascular disease. A decision is expected at the turn of this year, and if approved, Wegovy® would become the first oral GLP-1 RA indicated for chronic weight management. Rybelsus® is the first and only oral GLP-1 RA approved for the treatment of type 2 diabetes, following its launch in 2019. It is supported by a strong clinical and real-world evidence base, demonstrating superior blood glucose reduction and body weight reduction versus multiple comparators, as well as an established safety profile in people with type 2 diabetes4-8. About SOUL SOUL was a multicentre, international, randomised, double-blind, parallel-group, placebo-controlled, phase 3 cardiovascular outcomes trial, with 9,650 participants enrolled. It was conducted to assess the effect of oral semaglutide versus placebo, when added to standard of care, on cardiovascular outcomes in people with type 2 diabetes and established cardiovascular disease and/or chronic kidney disease (CKD). The SOUL trial was initiated in 2019. The primary outcome was time-to-first occurrence of major adverse cardiovascular events (MACE; a composite objective consisting of cardiovascular death, heart attack and stroke) 1. The SOUL trial demonstrated a superior reduction in MACE of 14% for people treated with oral semaglutide compared to placebo in people with type 2 diabetes and cardiovascular disease and/or CKD, making Rybelsus® (oral semaglutide) the first and only oral GLP-1 RA with a proven cardiovascular benefit1. About Rybelsus® Rybelsus® (oral semaglutide) is a glucagon-like peptide 1 receptor agonist (GLP-1 RA) indicated for the treatment of adults with insufficiently controlled type 2 diabetes mellitus to improve glycaemic control as an adjunct to diet and exercise7, 9. Rybelsus® is administered once daily and is approved for use in the following therapeutic dosages: 1.5 mg, 3 mg, 4 mg, 7 mg, 9 mg, 14 mg, 25 mg and 50 mg4, 5. Rybelsus® offers superior blood glucose lowering versus multiple comparators4, 5, together with consistent weight reduction4, 5, 10, reduction in cardiometabolic risk factors10 and reduction in major adverse cardiovascular events (MACE) 1. Rybelsus® is now the first and only oral GLP-1 RA available in the EU for type 2 diabetes with a proven cardiovascular benefit1. It is currently available in 48 countries11, and more than 2.4 million people with type 2 diabetes are currently being treated with Rybelsus® worldwide12. About Wegovy®Semaglutide 2.4 mg is marketed under the brand name Wegovy®. In the EU, Wegovy® is indicated as an adjunct to a reduced-calorie diet and increased physical activity for weight management in adults with a BMI of 30 kg/m2 or greater (obesity) or adults with a BMI of 27 kg/m2 or greater (overweight) in the presence of at least one weight-related comorbid condition. In the EU, Wegovy® is also indicated for paediatric patients aged 12 years and older with an initial BMI at the 95th percentile or greater for age and gender (obesity) and body weight above 60 kg. The clinical section of the label also includes data on Wegovy® major adverse cardiovascular events (MACE) risk reduction, improvements in heart failure with preserved ejection fraction (HFpEF)-related symptoms and physical function, as well as pain reduction related to knee osteoarthritis13. In the US, Wegovy® is indicated in combination with a reduced calorie diet and increased physical activity to reduce the risk of MACE in adults with established cardiovascular disease and either obesity or overweight, to reduce excess body weight and maintain weight reduction long term in paediatric patients aged 12 years and older with obesity and in adults with obesity or with overweight in the presence of at least one weight-related comorbid condition, as well as for the treatment of noncirrhotic metabolic dysfunction-associated steatohepatitis (MASH) in adults with moderate to advanced liver scarring (fibrosis), but not with cirrhosis of the liver, in combination with a reduced calorie diet and increased physical activity14. Novo Nordisk is a leading global healthcare company founded in 1923 and headquartered in Denmark. Our purpose is to drive change to defeat serious chronic diseases built upon our heritage in diabetes. We do so by pioneering scientific breakthroughs, expanding access to our medicines, and working to prevent and ultimately cure disease. Novo Nordisk employs about 78,400 people in 80 countries and markets its products in around 170 countries. For more information, visit novonordisk.com, Facebook, Instagram, X, LinkedIn and YouTube. Contacts for further information Media: Ambre James-Brown +45 3079 9289globalmedia@novonordisk.comLiz Skrbkova (US)+1 609 917 0632lzsk@novonordisk.comInvestors: Jacob Martin Wiborg Rode+45 3075 5956jrde@novonordisk.comSina Meyer +45 3079 6656azey@novonordisk.comMax Ung+45 3077 6414 mxun@novonordisk.com Christoffer Sho Togo Tullin+45 3079 1471cftu@novonordisk.comAlex Bruce +45 34 44 26 13axeu@novonordisk.comFrederik Taylor Pitter +1 609 613 0568fptr@novonordisk.com _______________________References1.      McGuire DK, et al. N Engl J Med. 2025;392(20):2001-2012.2.      Buse JB, et al. Oral presentation presented at the European Association for the Study of Diabetes (EASD) 2025; 15-19 Sep 2025; Vienna, Austria.3.      Inzucchi SE, et al. Oral presentation presented at the European Association for the Study of Diabetes (EASD) 2025; 15–19 Sep 2025; Vienna, Austria. 4.      Rosenstock J, et al. JAMA. 2019;321(15):1466-1480.5.      Rodbard HW, et al. Diabetes Care. 2019;42(12):2272-2281.6.      Pratley R, et al. Lancet. 2019;394(10192):39-50.7.      Rybelsus® (oral semaglutide): US Prescribing Information. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/213051s023lbl.pdf. Last accessed: September 2025.8.      Aroda VR, et al. Lancet. 2023;402(10403):693-704.9.      Rybelsus® (oral semaglutide): Summary of Product Characteristics. Available at: https://www.ema.europa.eu/en/medicines/human/EPAR/rybelsus. Last accessed: September 2025.10.      Husain M, et al. N Engl J Med. 2019;381(9):841-851.11.      Novo Nordisk Data on File. LEA portal Product Planning, 25th Aug 2025.12.      Novo Nordisk Data on File. IQVIA Jun’25 Patients R3M Vol. data. 2025.13.      Wegovy® (semaglutide): Summary of Product Characteristics. Available at: https://www.ema.europa.eu/en/documents/product-information/wegovy-epar-product-information_en.pdf. Last accessed: September 2025.14.      Wegovy® (semaglutide): US Prescribing Information. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/215256s015lbl.pdf. Last accessed: September 2025.
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PR250915-Rybelsus-label-update-SOUL

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Novonesis and Novo Nordisk will explore new solutions to improve metabolic health

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Novonesis and Novo Nordisk join forces in a new research collaboration to explore solutions that seek to preserve and optimize metabolic health and well-being for people. COPENHAGEN, Denmark – September 8, 2025. Novonesis and Novo Nordisk has entered a research partnership to explore the role of the gut microbiome in the maintenance of metabolic health. The gut microbiome is the collection of microorganisms, such as bacteria, fungi, and viruses, that naturally live in the human gut. The science surrounding the microbiome, and how it contributes to human health in many ways, has grown tremendously over the last years1. Novonesis and Novo Nordisk will work closely to explore solutions that seek to preserve and optimize metabolic health and improve people’s well-being mediated through the gut microbiome. Synbiotic food supplements, composed of probiotics and prebiotics, will be developed and tested for their ability to affect health parameters linked to metabolic health such as blood glucose and cholesterol levels. Probiotics are living microorganisms, while prebiotics are the “fuel” that helps sustain these beneficial microorganisms.2 The partnership will investigate how the gut microbiome may be used to monitor and predict metabolic and overall health trajectories in individuals. Additionally, it will explore novel biomarkers with the aim of measuring the effectiveness of gut microbiome solutions. “At Novonesis, we are committed to advancing our understanding of the human microbiome and the crucial role it plays in digestion, immunity, mood, well-being, and much more. This new collaboration with Novo Nordisk enables us to deepen our understanding of the gut microbiome’s role in maintaining metabolic health and to identify innovative products that support it. Together, we will conduct research on the gut microbiome for predictive purposes and strive to create impactful biosolutions that enhance health and well-being throughout life stages”, says Henrik Joerck Nielsen, Executive Vice President, Human Health Biosolutions & Strategy. Obesity is recognized as a chronic, progressive disease by the World Health Organization (WHO).3 It is a multifactorial disease that is associated with more than 200 possible health complications, including type 2 diabetes and cardiovascular disease.4 “Obesity is a complex disease driven by multiple factors, including our hormones and genetics, and we are becoming increasingly aware of the role the gut plays in maintaining metabolic health and thereby minimizing the risk of developing obesity,5” says Professor Nadeem Sarwar, Corporate Vice President and Head of the Transformational Prevention Unit in Obesity at Novo Nordisk. “Prevention is an integral part of Novo Nordisk’s sustainable and holistic approach to stop the global rise of obesity. The Transformational Prevention Unit’s mission is to deliver science-based and scalable commercial solutions to predict and pre-empt obesity and its consequences for people at greatest risk. We can’t do this alone – building novel, multi-sector partnerships is crucial to deliver impactful solutions. We are excited to work with Novonesis to explore strategies for promoting long-term health that may support us on our mission.” About Novonesis Novonesis is leading the era of biosolutions. By leveraging the power of microbiology with science, we transform the way the world produces, consumes and lives. In more than 30 industries, our biosolutions are already creating value for thousands of customers and benefiting the planet. Our 10,000 people worldwide work closely with our partners and customers to transform business with biology. About Novo Nordisk Novo Nordisk is a leading global healthcare company, founded in 1923 and headquartered in Denmark. Our purpose is to drive change to defeat serious chronic diseases, built upon our heritage in diabetes. We do so by pioneering scientific breakthroughs, expanding access to our medicines, and working to prevent and ultimately cure disease. Novo Nordisk employs about 78,400 people in 80 countries and markets its products in around 170 countries. For more information, visit novonordisk.com, Facebook, Instagram, X, LinkedIn and YouTube. Media Relations – Novonesis Media Relations – Novo NordiskJens GamborgInterim Head of External Communication Phone: +45 30 77 71 82jgam@novonesis.com  Martin Havtorn PetersenGlobal Media & Stakeholder Comms LeadPhone: +45 30 75 52 46mhpz@novonordisk.com 1 Marco ML. Defining how microorganisms benefit human health. Microbial Biotechnology (2020). Available at: https://doi.org/10.1111/1751-7915.13685. 2 Science Direct, Chapter 12 – The Role of Prebiotics in Disease Prevention and Health Promotion (2019). Available at: https://doi.org/10.1016/B978-0-12-814468-8.00012-0 3 World Health Organization. Obesity and Overweight (2025). Available at: https://www.who.int/news-room/fact-sheets/detail/obesity-and-overweight. 4 Horn, D.B., Almandoz, J. P., & Look, M. What is clinically relevant weight loss for your patients and how can it be achieved? A narrative review. Postgraduate medicine (2022), 134(4), 359–375. 5 Delzenne, N.M., Bindels, L.B., Neyrinck, A.M. et al. The gut microbiome and dietary fibres: implications in obesity, cardiometabolic diseases and cancer. Nat Rev Microbiol (2024). Available at: https://doi.org/10.1038/s41579-024-01108-z.

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Novo Nordisk to present new semaglutide data on ‘food noise’, body composition and cardiovascular benefits, as well as pipeline data at the EASD diabetes congress

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The INFORM real-world evidence study shows impact of semaglutide on reducing ‘food noise’, and the STEP UP clinical trial highlights semaglutide’s effect on control of eating and body composition after losing weightNext-generation obesity treatment cagrilintide demonstrates promise as standalone therapy (REDEFINE 1); data also being presented on amycretinThe first head-to-head real-world study, REACH shows superiority of Ozempic® versus dulaglutide on cardiovascular events such as heart attack and stroke Bagsværd, Denmark, 5 September 2025 – Novo Nordisk today announced the presentation of 35 abstracts from across its diabetes and obesity portfolio at the upcoming European Association for the Study of Diabetes (EASD) congress 2025 from 15 to 19 September in Vienna, Austria. The presentations include clinical and real-world data reinforcing semaglutide’s broad health benefits, widest approved indications, and its well-established weight loss effect. Novo Nordisk will also present data on new obesity pipeline therapies, including CagriSema, cagrilintide and amycretin. On 17 September, Novo Nordisk will also host an R&D investor event to cover the science and abstracts presented at the congress. The event will be accessible via a live webcast on the Novo Nordisk investor website. “With the broadest approved indications in both obesity and type 2 diabetes, semaglutide is today making a real difference in helping people lose weight while also protecting them from cardiovascular events such as heart attacks,” said Martin Holst Lange, chief scientific officer and executive vice president, Research & Development at Novo Nordisk. “We are now leading the way in developing next-generation treatments – such as combining cagrilintide with semaglutide or using it as a monotherapy – to better meet the needs of people living with diabetes and obesity, and we are excited to present these data at EASD.” Summary of presentationsAccepted data at the 61st annual meeting of the EASD include the following poster and oral presentations. Accepted abstracts include preliminary data that may be subject to change in the final published manuscripts. Dates and times of the presentations can be found on the EASD website. EASD scientific symposia SOUL Trial: Effects of oral semaglutide on cardiovascular outcomes in people with type 2 diabetes at high cardiovascular risk – Wednesday 17 September; 08:30 – 09:30 CEST EASD poster and oral sessionsWegovy® (once-weekly semaglutide 2.4 mg) Impact on food noise after initiating semaglutide treatment: results from a US survey (INFORM). Short oral presentation (45-SO) – Tuesday 16 September; 12:00 – 13:00 CESTImpact of once-weekly semaglutide on cardiovascular events in adults with overweight or obesity in a real-world Danish population. Oral presentation (148-OR) – 18 September; 11:30 – 11:45 CEST Once-weekly semaglutide 7.2 mg Effect of semaglutide 7.2 mg on anthropometric measures of obesity: the STEP UP trial Oral presentation (145-OR) – Thursday 18 September; 10:45 – 11:00 CESTControl of eating with semaglutide 7.2 mg in adults with obesity: the STEP UP trial. Oral presentation (146-OR) – Thursday 18 September; 11:00 – 11:15 CESTEffect of semaglutide on body composition and proximal muscle strength: the STEP UP trial. Oral presentation (147-OR) – Thursday 18 September: 11:15 – 11:20 CEST Ozempic® (once-weekly semaglutide 1.0 mg) Comparative effectiveness of once-weekly semaglutide vs dulaglutide on cardiovascular outcomes in US Medicare beneficiaries with type 2 diabetes and atherosclerotic cardiovascular disease. Late breaking presentation (LBA-19) – Thursday 18 September; 10:45 – 11:00 CEST Rybelsus® (once-daily oral semaglutide) Oral semaglutide and cardiovascular outcomes by baseline A1c and BMI in people with type 2 diabetes in the SOUL trial. Oral presentation (2-OR) – Tuesday 16 September; 10:15 – 10:30 CESTEffects of oral semaglutide on hospitalisation rates in people with type 2 diabetes and atherosclerotic cardiovascular disease and/or chronic kidney disease: SOUL trial results. Oral presentation (127-OR) – Wednesday 17 September; 14:30 – 14:45 CEST Semaglutide for MASH Impact of semaglutide on liver-related responses in people with metabolic dysfunction-associated steatohepatitis with/without type 2 diabetes: post hoc analysis of the ESSENCE trial. Short oral presentation (555-SO) – Tuesday 16 September; 13:15 – 14:15 CEST CagriSema REDEFINE 2: a randomised trial of combined semaglutide 2.4 mg and cagrilintide 2.4 mg for the treatment of adults with BMI ≥27kg/m2 and type 2 diabetes. Oral presentation (73-OR) – Wednesday 17 September; 09:45 – 10:00 CESTCagriSema improves glycaemic outcomes across weight loss categories in adults with BMI ≥27 kg/m2 and type 2 diabetes in the blinded continuous glucose monitoring subgroup in REDEFINE 2. Oral presentation (13-OP) – Wednesday 17 September; 14:30 – 14:45 CESTREDEFINE1: a randomised study of combined semaglutide 2.4 mg and cagrilintide 2.4 mg for the treatment of overweight or obesity in adults. Oral presentation (190-OR) – Thursday 18 September; 16:15 – 16:30 CEST Cagrilintide Efficacy and safety of cagrilintide 2.4 mg in adults with overweight/obesity: data from REDEFINE 1. Short oral presentation (43-SO) – Tuesday 16 September; 12:00 – 13:00 CEST Amycretin Amycretin, a novel, unimolecular glucagon-like peptide-1 and amylin receptor agonist: results of a phase 1b/2a clinical trial. Oral presentation (63-OR) – Tuesday 16 September; 15:15 – 15:30 CESTPharmacokinetics, safety and tolerability of amycretin in people with renal impairment. Oral presentation (15-OR) – Wednesday 17 September; 15:00 – 15:15 CESTThe effect of amycretin, a unimolecular glucagon-like peptide-1 and amylin receptor agonist, on body weight and metabolic dysfunction in mice and rats. Oral presentation (188-OR) – Thursday 18 September; 15:45 – 16:00 CEST About semaglutideSemaglutide is a glucagon-like peptide 1 receptor agonist (GLP-1 RA) that mimics the effects of the naturally occurring hormone GLP-1, which regulates weight and blood sugar. It has been tested in several robust clinical development programmes and outcome studies in cardiometabolic diseases, including type 2 diabetes, obesity, cardiovascular disease, heart failure, chronic kidney disease, liver disease, and other related cardiometabolic diseases1-5. Semaglutide has a well-established safety and tolerability profile supported by over 33 million patient-years of exposure since its launch in 20186. Semaglutide is marketed under the brand names Wegovy® (once-weekly semaglutide 2.4 mg injection), Ozempic® (once-weekly semaglutide 1.0 mg injection), and Rybelsus® (once-daily oral semaglutide 14 mg). Novo Nordisk is a leading global healthcare company founded in 1923 and headquartered in Denmark. Our purpose is to drive change to defeat serious chronic diseases built upon our heritage in diabetes. We do so by pioneering scientific breakthroughs, expanding access to our medicines and working to prevent and ultimately cure disease. Novo Nordisk employs about 78,400 people in 80 countries and markets its products in around 170 countries. Novo Nordisk’s B shares are listed on Nasdaq Copenhagen (Novo-B). Its ADRs are listed on the New York Stock Exchange (NVO). For more information, visit novonordisk.com, Facebook, Instagram, X, LinkedIn and YouTube. Contacts for further information Media: Ambre James-Brown +45 3079 9289abmo@novonordisk.comLiz Skrbkova (US)+1 609 917 0632lzsk@novonordisk.comInvestors: Jacob Martin Wiborg Rode+45 3075 5956jrde@novonordisk.comSina Meyer +45 3079 6656azey@novonordisk.comMax Ung+45 3077 6414 mxun@novonordisk.com Christoffer Sho Togo Tullin+45 3079 1471cftu@novonordisk.comAlex Bruce +45 34 44 26 13axeu@novonordisk.comFrederik Taylor Pitter +1 609 613 0568fptr@novonordisk.com _______________________References1.      Perkovic V, Tuttle KR, Rossing P, et al. Effects of Semaglutide on Chronic Kidney Disease in Patients with Type 2 Diabetes. N Engl J Med. 2024;391:109-121.2.      Marso SP, Bain SC, Consoli A, et al. Semaglutide and Cardiovascular Outcomes in Patients with Type 2 Diabetes. N Engl J Med. 2016;375:1834-1844.3.      McGuire DK, Marx N, Mulvagh SL, et al. Oral Semaglutide and Cardiovascular Outcomes in High-Risk Type 2 Diabetes. N Engl J Med. 2025.4.      Lincoff AM, Brown-Frandsen K, Colhoun HM, et al. Semaglutide and Cardiovascular Outcomes in Obesity without Diabetes. N Engl J Med. 2023;389:2221-2232.5.      Pratley RE, Aroda VR, Lingvay I, et al. Semaglutide versus dulaglutide once weekly in patients with type 2 diabetes (SUSTAIN 7): a randomised, open-label, phase 3b trial. Lancet Diabetes Endocrinol. 2018;6:275-286.6.      Novo Nordisk data on file (IQVIA MIDAS® monthly volume sales data for the time period Jan 2018 to July 2024 [40 countries]). Novo Nordisk A/S, Bagsværd, Denmark.
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ADA 2025: Novo Nordisk highlights strong portfolio data with new semaglutide and CagriSema results, redefining possibilities in obesity and diabetes care

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Novo Nordisk to present data from STEP UP trial on a higher dose of Wegovy® (semaglutide 7.2 mg) for those in need of greater weight loss Data will expand semaglutide evidence in both a clinical and real-world setting, including cardiometabolic and kidney health benefits for those with obesity and diabetesNovo Nordisk continues to pioneer obesity innovation, including presentation of full Phase 3 REDEFINE 1 and 2 trial results, providing insights into the transformational potential of CagriSema Bagsværd, Denmark, 10 June – Novo Nordisk today announced that new data from its industry-leading portfolio in metabolic and cardiovascular health will be showcased at the upcoming American Diabetes Association (ADA) 85th Scientific Sessions taking place in Chicago US, 20 – 23 June 2025. A total of 29 abstracts will be presented, including trials investigating the weight loss efficacy of higher dose Wegovy® (semaglutide 7.2 mg) in people with obesity (STEP UP) and those with obesity and type 2 diabetes (STEP UP T2D) as a new option for those in need of greater weight loss. New data will offer additional evidence of the broader cardiovascular and kidney health benefits of semaglutide for people with type 2 diabetes through analyses of the SOUL, STRIDE and FLOW trials, as well as insights from further real-world studies of semaglutide 2.4 mg. The presentation of the CagriSema REDEFINE 1 and 2 trials are the first ever Phase 3 data presented on a GLP-1 and amylin receptor agonist combination, offering insights into the transformational potential of this investigational medicine. Data will also be presented on pipeline candidate amycretin, demonstrating Novo Nordisk’s commitment to obesity innovation and individualised healthcare solutions. On 22 June, Novo Nordisk will also host an R&D investor event on their metabolic and cardiovascular health portfolio to cover the science and abstracts presented at the congress. The event will be accessible via a live webcast on the Novo Nordisk investor website. “Aiming to address individual needs and preferences for better health, we look forward to providing a higher dose of Wegovy® (semaglutide 7.2 mg) for people with obesity in need of more significant weight loss, alongside the broader health benefits seen with semaglutide,“ said Ludovic Helfgott, executive vice president of Product & Portfolio Strategy at Novo Nordisk. “Semaglutide has shown comprehensive and disease-modifying effects across the metabolic and cardiovascular health spectrum, and the data presented at ADA 2025 for Wegovy®, Rybelsus®, and Ozempic® will add to this evidence base as we aspire to a future where semaglutide is a foundational therapy that can provide people with comprehensive protection, early enough to make a difference.” “We recognise the complex interplay between cardiovascular and metabolic diseases, including type 2 diabetes and obesity, which require a personalised treatment approach,” said Martin Holst Lange, executive vice president for Development at Novo Nordisk. “As we look to further build an impactful portfolio of medicines to address patient needs, our data presented at ADA 2025 demonstrates not only how we are already delivering for a wide range of these needs with semaglutide, but that we are continuing to invest in innovation to support people living with serious chronic disease.” Novo Nordisk data overview at ADA 2025: ADA Scientific Sessions: Diabetes and peripheral artery disease—evolving role of GLP-1 RA and new insights from the STRIDE trial – Saturday 21 June; 13:30–15:00 CDTEfficacy and Safety of CagriSema 2.4 mg/2.4 mg in Adults with Overweight/Obesity—The REDEFINE 1 and REDEFINE 2 clinical trials – Sunday 22 June; 8:00–9:30 CDTSOUL trial—effects of oral semaglutide on cardiovascular (and other) outcomes in people with type 2 diabetes at high CV risk – Sunday 22 June; 16:30–18:00 CDT Novo Nordisk poster and oral presentations: Ozempic® (once-weekly semaglutide 1.0 mg) Impact of semaglutide on kidney, cardiovascular, and mortality outcomes by baseline BMI and weight loss in people with T2D and CKD: data from the FLOW Trial. Poster presentation (1971-LB poster) – Sunday 22 June; 12:30–13:30 CDTOnce-weekly semaglutide versus placebo for the treatment of type 2 diabetes and chronic kidney disease in Denmark: a long-term cost effectiveness analysis based on FLOW. Poster presentation (782-P) – Sunday 22 June; 12:30–13:30 CDTChanges in clinical measures in US adults with type 2 diabetes (T2D) and chronic kidney disease (CKD) who received once-weekly (OW) semaglutide. Poster presentation (838-P) – Sunday 22 June; 12:30–13:30 CDTChanges in clinical measures among US adults with type 2 diabetes (T2D) and chronic kidney disease (CKD) receiving once-weekly semaglutide (sema OW) vs. oral antidiabetic medications (ADMs). Poster presentation (2005-LB poster) – Sunday 22 June; 12:30–13:30 CDTEffect of type 2 diabetes characteristics on semaglutide treatment in people with type 2 diabetes and peripheral artery disease: a post-hoc analysis of the STRIDE Trial. Oral presentation (291-OR) – Monday 23 June; 13:30–13:45 CDT Rybelsus® (once-daily oral semaglutide) Real-world impact of oral semaglutide (sema) alone and vs DPP-4is on weight, BMI and HbA1c outcomes in type 2 diabetes (T2D): an observational study (PAUSE). Poster presentation (732-P) – Sunday 22 June; 12:30–13:30 CDTOral semaglutide and cardiovascular outcomes by baseline A1c and BMI in people with type 2 diabetes in the SOUL trial. Oral presentation (292-OR) – Monday 23 June; 13:45–14:00 CDT Wegovy® (once-weekly semaglutide 2.4 mg) Demographic and clinical characteristics associated with real-world persistence on semaglutide for weight management in the USA. Poster presentation (786-P) – Sunday 22 June; 12:30–13:30 CDTTwo-year real-world effectiveness of semaglutide in patients with obesity or overweight. Poster presentation (1733-P) – Monday 23 June; 12:30–13:30 CDTReduction of the 10-Year ASCVD risk in patients with overweight or obesity treated with semaglutide 2.4 mg in routine clinical care: a real-world study. Poster presentation (1734-P) – Monday 23 June; 12:30–13:30 CDT Once-weekly semaglutide 7.2 mg Efficacy and safety of semaglutide 7.2 mg in obesity: STEP UP trial. Poster presentation (1966-LB ePoster) – Saturday 21 June; 13:30–15:00 CDT Efficacy and safety of semaglutide 7.2 mg in obesity: STEP UP trial. Poster presentation (1966-LB poster) – Sunday 22 June; 12:30–13:30 CDT Efficacy and safety of semaglutide 7.2 mg in obesity and type 2 diabetes: STEP UP T2D trial. Poster presentation (1978-LB poster) – Sunday 22 June; 12:30–13:30 CDT CagriSema Effect of combined therapy with once-weekly subcutaneous cagrilintide 2.4 mg and semaglutide 2.4 mg (CagriSema) on energy intake, gastric emptying, and appetite in adults with overweight or obesity. Poster presentation (1969-LB poster) – Sunday 22 June; 12:30–13:30 CDTDiabetes, cagrisema-induced weight loss in diet-induced obese rats relies on preserved mitochondrial leak respiration in skeletal muscle. Poster presentation (1693-P) – Monday 23 June; 12:30–13:30 CDT Amycretin/amylin The amylin receptor selective agonist NN1213 reduces food intake and body weight in rats without decreasing calcium plasma levels. Oral presentation (86-OR) – Friday 20 June; 14:45–15:00 CDTAmycretin, a novel, unimolecular GLP-1 and amylin receptor agonist: results of a phase 1b/2a clinical trial. Poster presentation (2002-LB poster) – Sunday 22 June; 12:30–13:30 CDT Once-weekly insulin icodec Efficacy and hypoglycemia outcomes with once-weekly insulin icodec vs once-daily basal insulin in T2D by diabetes duration: ONWARDS 1–5. Poster presentation (816-P) – Saturday 21 June; 12:30– 13:30 CDTEfficacy and hypoglycemia outcomes with once-weekly insulin icodec vs once-daily basal insulin in T2D by baseline A1C: ONWARDS 1–5. Poster presentation (822-P) – Saturday 21 June; 12:30–13:30 CDTEfficacy and hypoglycemia outcomes with once-weekly insulin icodec vs once-daily basal insulin in T2D by baseline BMI: ONWARDS 1–5. Poster presentation (819-P) – Saturday 21 June; 12:30–13:30 CDT Once-weekly IcoSema CGM-derived model-based postprandial glucose with IcoSema vs other insulin regimens: a post hoc analysis of COMBINE 1 and 3. Poster presentation (815-P) – Saturday 21 June; 12:30–13:30 CDTA1C and hypoglycemia outcomes with once-weekly IcoSema vs comparators in T2D by kidney function. Poster presentation (804-P) – Saturday 21 June; 12:30–13:30 CDTCGM-based outcomes in adults with T2D receiving IcoSema vs comparators: post hoc analysis of COMBINE 1 and 3. Poster presentation (830-P) – Saturday 21 June; 12:30–13:30 CDTComparison of characteristics among individuals with established vs newly diagnosed type 2 diabetes during ischemic stroke hospitalization – a retrospective cohort study. Poster presentation (1373-P) – Saturday 21 June; 12:30–13:30 CDT Digital Health Effect of telemonitoring using connected devices on insulin injection adherence in people living with T2D. Oral presentation (315-OR) – Monday 23 June; 13:30–13:45 CDTTracking treatment outcomes using the semaglutide patient support solution app. Poster presentation (1098-P) – Sunday 22 June; 12:30–13:30 CDT General diabetes Prevalence and factors for treatment failure with sodium-glucose co-transporter 2 inhibitor (SGLT2i) in US adults with type 2 diabetes (T2D). Poster presentation (909-P) – Sunday 22 June; 12:30–13:30 CDTMacrovascular and microvascular complications in Medicare patients with type 2 diabetes and atherosclerotic cardiovascular disease from 2006-2021: incidence stratified by sex, age, and race/ethnicity. Poster presentation (1870-LB poster) – Sunday 22 June; 12:30–13:30 CDTElevated body mass index at type 2 diabetes diagnosis is associated with increased risk of cardiovascular disease and kidney outcomes. Poster presentation (427-P) – Monday 23 June; 12:30–13:30 CDT General obesity Health utilities of people with obesity in Taiwan: a nationwide representative analysis. Publication Only (63-PUB) About semaglutideSemaglutide is a glucagon-like peptide 1 receptor agonist (GLP-1 RA), which mimics the effects of the naturally occurring hormone GLP-1. Semaglutide has been tested in several robust clinical development programmes and outcome studies in cardiometabolic diseases, including type 2 diabetes, obesity, cardiovascular disease, heart failure, chronic kidney disease, liver disease and other related cardiometabolic diseases. It has a cumulative exposure of over 33 million patient-years since 2018.1 Semaglutide is marketed under the brand names Wegovy® (once-weekly semaglutide 2.4 mg injection), Ozempic® (once-weekly semaglutide 1.0 mg injection), and Rybelsus® (once-daily oral semaglutide 14 mg). About CagriSemaOnce-weekly subcutaneous CagriSema is being investigated by Novo Nordisk as a treatment for adults with overweight or obesity (REDEFINE programme) and as a treatment for adults with type 2 diabetes (REIMAGINE programme). CagriSema is a fixed-dose combination of a long-acting amylin analogue, cagrilintide 2.4 mg and semaglutide 2.4 mg. The two molecules induce weight loss by reducing hunger, increasing feelings of fullness, thereby helping people eat less and reduce their calorie intake. About amycretinAmycretin is a unimolecular long-acting GLP-1 and amylin receptor agonist under development by Novo Nordisk, to provide an efficacious and convenient treatment for adults with overweight or obesity and as a treatment for adults with type 2 diabetes. Amycretin is developed for oral and subcutaneous administration. About once-weekly basal insulin icodec Insulin icodec is a once-weekly basal insulin analogue designed to cover the basal insulin requirements for a full week with a single subcutaneous injection. About once-weekly IcoSema Once-weekly IcoSema is a fixed-ratio combination of a once-weekly basal insulin icodec and once-weekly semaglutide (700U/2 mg per millilitre). IcoSema is titrated in the same way as insulin, with a maximum weekly dose of 350 dose steps (ie 350 U insulin icodec/1mg semaglutide). About Novo NordiskNovo Nordisk is a leading global healthcare company founded in 1923 and headquartered in Denmark. Our purpose is to drive change to defeat serious chronic diseases built upon our heritage in diabetes. We do so by pioneering scientific breakthroughs, expanding access to our medicines, and working to prevent and ultimately cure disease. Novo Nordisk employs about 77,400 people in 80 countries and markets its products in around 170 countries. For more information, visit novonordisk.com, Facebook, Instagram, X, LinkedIn and YouTube. Contacts for further information Media: Ambre James-Brown +45 3079 9289abmo@novonordisk.comLiz Skrbkova (US)+1 609 917 0632lzsk@novonordisk.comInvestors: Jacob Martin Wiborg Rode+45 3075 5956jrde@novonordisk.comIda Schaap Melvold +45 3077 5649 idmg@novonordisk.comSina Meyer +45 3079 6656 azey@novonordisk.comMax Ung+45 3077 6414mxun@novonordisk.comFrederik Taylor Pitter +1 609 613 0568fptr@novonordisk.com  1 Novo Nordisk data on file.
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Novo Nordisk A/S: Oral semaglutide demonstrates a 14% reduction in risk of major adverse cardiovascular events in adults with type 2 diabetes in the SOUL trial

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Bagsværd, Denmark, 21 October 2024 — Novo Nordisk today announced the headline results from the SOUL cardiovascular outcomes trial. The double-blinded, randomised trial compared oral semaglutide to placebo as an adjunct to standard of care for the prevention of major adverse cardiovascular events (MACE). The trial enrolled 9,650 people with type 2 diabetes and established cardiovascular disease (CVD) and/or chronic kidney disease (CKD). As part of standard of care, 49% of patients received SGLT2i at some point during the trial.

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Novo Nordisk Foundation and Technical University of Denmark press release: Bacteria in our gut could play a role in cardiometabolic disease: A new initiative aims to find out

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A new Denmark-based research initiative aims to establish a potential causal link between the gut microbiome – the combined genetic material of the communities of bacteria and other microbes in the human gut – and the development of cardiometabolic diseases (CMD) such as obesity, type 2 diabetes, and cardiovascular disease. The goal is to generate knowledge that can lead to new prevention or treatment options for people living with, or at risk of, CMD.
COPENHAGEN, Denmark, May 22, 2024 /PRNewswire/ — The Novo Nordisk Foundation has committed DKK 150 million (USD 22 million) for the first phase of the Microbiome Health Initiative, a virtual research centre anchored at the Technical University of Denmark (DTU), north of Copenhagen. Professor Fredrik Bäckhed from the University of Gothenburg will be employed part-time at DTU to lead the initiative, with Professor Tine Rask Licht from DTU National Food Institute as co-Director.
Research has already shown associations between several gut bacteria or metabolites – substances produced by microbes – and CMD. In Phase 1, the initiative will therefore focus on collaborative research projects that investigate the specific effects of these bacteria or metabolites and advance understanding on how microbiome interventions could reduce the risk of CMD or help manage it. This phase will run from 2024-2028.
“Our task is to verify a causal connection between the intestinal microbiome and diseases such as cardiovascular disease and diabetes,” says Professor Licht.
“These links have been partially elucidated in laboratory trials and animal experiments, but there is yet no solid evidence of causal relationships in humans. Once we have this knowledge, the next step in the project will be to find and develop new strategies to treat or prevent these major diseases. Such new strategies will rely on modification of our gut microbiome, for example by adding new microbes, or new dietary components.”
The initiative also involves leading scientists at the University of Copenhagen, Amsterdam University Medical Centre, and the Weizmann Institute of Science in Israel, and clinicians at Odense University Hospital and Steno Diabetes Centre Copenhagen. Together, they cover a broad range of disciplines, including microbial physiology, bioinformatics, aetiology of CMD, and human interventions.
While DTU’s strength in the project is research into the impact of diet on the structure and activity of the human microbiome, the other research centres in the initiative have extensive expertise in CMD research, microbiome research, and translation into clinical settings.
“The interdisciplinary approach of the project makes it possible to coordinate research between the strongest international environments,” says Professor Bäckhed. “It is unique that we can coordinate efforts between universities and hospitals to develop the most promising treatment concepts.”
‘A whole new set of tools’Despite major advances in research and treatment, the prevalence of CMD has doubled in the last 30 years. This group of conditions – including obesity and type 2 diabetes – and associated complications such as heart attack and stroke are now the leading cause of death worldwide.
Also in the last years, advances in microbiome research have led to new understanding regarding the impact of microbes and their metabolic output on human physiology, immunity, and disease processes. In the case of CMD, evidence strongly suggests that the gut microbiome – partly due to the metabolites the microbes produce – plays a critical role, and that by making small changes, individuals could reduce their risk of, for example, developing diabetes or suffering a heart attack. This initiative aims to generate significant new knowledge that, in the future, could lead to approved microbiome-based solutions such as supplements or improved dietary guidance to prevent or treat CMD.
“The Danish microbiome research field is strong but, in order to take the critical next steps, we need an ambitious, interdisciplinary approach that also includes leading international experts,” says Birgitte Holst, Scientific Director in Medical Science at the Novo Nordisk Foundation.
“If this initiative succeeds in establishing a causal link between the microbiome and CMD, it could lead to a whole new set of tools for managing these devastating diseases and help resolve a major global health challenge.”
Phase 2, which is subject to approval following a mid-term evaluation of Phase 1, would run from 2026-2030. In this phase, the initiative would support human intervention studies and invest in infrastructure to support the development of microbes, microbial compounds, or targeted supplements for therapeutic purposes.
Editor’s Notes
About DTU National Food Institute
DTU National Food Institute conducts research into and disseminates – through advice, innovation and teaching – sustainable and value-creating solutions in the area of food and health for the benefit of society. The DTU National Food institute’s vision is to make a difference by generating future prosperity through research into food and health. The institute prevents disease and promotes health, develops new and better food products for a growing population and creates sustainable technological solutions. The institute’s tasks are carried out in a unique interdisciplinary cooperation in e.g. nutrition, chemistry, toxicology, microbiology, epidemiology, modelling and technology.
About the Novo Nordisk Foundation
Established in Denmark in 1924, the Novo Nordisk Foundation is an enterprise foundation with philanthropic objectives. The vision of the Foundation is to improve people’s health and the sustainability of society and the planet. The Foundation’s mission is to progress research and innovation in the prevention and treatment of cardiometabolic and infectious diseases as well as to advance knowledge and solutions to support a green transformation of society.
www.novonordiskfonden.dk/en
SOURCE Novo Nordisk Foundation

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