Semaglutide (Novo Nordisk)

Bagsværd, Denmark, 17 January 2025 – Novo Nordisk today announced headline results from STEP UP, a phase 3b trial in the global STEP programme. STEP UP is a 72-week efficacy and safety trial investigating subcutaneous semaglutide 7.2 mg compared to semaglutide 2.4 mg and placebo, all administered once weekly. The trial included 1,407 randomised adults with obesity. All treatment arms were in conjunction with lifestyle intervention. The trial achieved its primary endpoint by demonstrating a statistically significant and superior weight loss at week 72 with semaglutide 7.2 mg versus placebo. When evaluating the effects of treatment if all people adhered to treatment 1 from a mean baseline body weight of 113 kg, people treated with semaglutide 7.2 mg achieved a superior weight loss of 20.7% after 72 weeks compared to a reduction of 17.5% with semaglutide 2.4 mg and 2.4% with placebo. In addition, 33.2% of those who received semaglutide 7.2 mg achieved a weight loss of 25% or more after 72 weeks, compared to 16.7% with semaglutide 2.4 mg and 0.0% with placebo. When applying the treatment policy estimand 2 , people treated with semaglutide 7.2 mg achieved a superior weight loss of 18.7% compared to a reduction of 15.6% with semaglutide 2.4 mg and 3.9% with placebo. In the trial, semaglutide 7.2 mg appeared to have a safe and well-tolerated profile. The most common adverse events were gastrointestinal, and the vast majority were mild to moderate and diminished over time, consistent with the GLP-1 receptor agonist class. “We are very pleased to demonstrate 20.7% weight loss and to see that 33% of patients achieved more than 25% weight loss with semaglutide 7.2 mg, with a safety and tolerability profile comparable to semaglutide 2.4 mg,” said Martin Holst Lange, executive vice president for Development at Novo Nordisk. “Results from STEP UP further strengthen the clinical profile of semaglutide for the treatment of obesity, in addition to the health benefits already established with Wegovy ® , including cardiovascular risk reduction as seen in SELECT”. The results from the second semaglutide 7.2 mg phase 3 trial, STEP UP T2D, in adults with type 2 diabetes and obesity are expected within the next few months. Detailed results from the STEP UP trial are expected to be presented at a scientific conference in 2025. About the STEP UP trials Novo Nordisk has initiated two trials investigating the efficacy of semaglutide 7.2mg, STEP UP and STEP UP T2D. The 72-week STEP UP trial was a randomised, double-blinded, parallel-group, placebo-controlled, superiority trial designed to evaluate the efficacy of semaglutide 7.2 mg with semaglutide 2.4 mg and placebo as an adjunct to lifestyle intervention. 1,407 adults with BMI ≥30 kg/m 2 and without diabetes were included in the trial. The primary objective was to demonstrate superiority of semaglutide 7.2 mg against placebo on weight loss. Key secondary endpoints included number of participants achieving 10%, 15%, 20% and 25% weight loss, respectively. The ongoing 72-week STEP UP T2D trial will investigate semaglutide 7.2 mg in 512 adults with obesity and type 2 diabetes, with the primary objective to demonstrate superiority of semaglutide 7.2 mg against placebo on weight loss. About Wegovy ® (semaglutide 2.4 mg) 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/m 2 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 showing the benefits of Wegovy ® in reducing the risk of MACE, improving HFpEF-related symptoms and physical function, as well as reducing pain related to knee osteoarthritis. 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, as well as to reduce excess body weight and maintain weight reduction long term in adults and paediatric patients aged 12 years and older with obesity and in adults with overweight in the presence of at least one weight-related comorbid condition. 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 72,000 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 Company announcement No 2 / 2025 1 Based on the trial product estimand: treatment effect if all people adhered to treatment 2 Based on the treatment policy estimand: treatment effect regardless of treatment adherence

Novo Nordisk’s blockbuster GLP-1 products Ozempic and Wegovy are among the next 15 drugs subject to the government’s Medicare negotiation program under the Inflation Reduction Act, following repeated calls from lawmakers to make the treatments more affordable. The list came weeks before the government’s deadline, kicking off a new cycle that’s slated to take place under the incoming Trump administration. Together, the 15 drugs cost Medicare Part D about $41 billion from November 2023 through October 2024. Combined with the first 10 drugs subject to Medicare negotiations, the 25 drugs accounted for 36% of Medicare Part D spending during the same period. While only drugs that have been approved for at least seven years are eligible for negotiations under the IRA, Wegovy made the list because CMS’ current guidance allows it to group drugs with the same active molecule . Popular GLP-1 drugs like Ozempic and Wegovy are currently covered by Medicare only in certain circumstances, but not when solely prescribed for obesity. The Biden administration proposed a new rule in November that would expand coverage, but it would need to be finalized by the Trump administration. Novo Nordisk told Endpoints via email on Friday that it “remains opposed to government price setting through the IRA and has significant concerns about how the law is being implemented by this administration, including aggregating multiple products that individually would not meet the requirements of the statute.” Industry group PhRMA similarly expressed reservations about how the majority of the drugs in this second round are small molecule pills, and how pills in general are put at a disadvantage under the IRA when compared to large molecule drugs or biologics that have two extra years of monopoly protection before price negotiation. When it comes to selecting drugs for negotiation, senior administration officials said the process is “data-driven” and “carefully circumscribed in statute.””Any team following the process that is required by the statute would end up with the same list,” the officials told reporters ahead of the announcement. The changeover adds to the uncertainty of Medicare negotiations, a process that has, for the most part, occurred behind closed doors and is still being debated in multiple lawsuits across the country. It remains unclear whether the negotiation process — or the law itself — will see changes under the Trump administration. Negotiated prices for the next 15 drugs would take effect on Jan. 1, 2027, according to current guidance by the Centers for Medicare and Medicaid Services. The latest guidance calls for earlier and more flexible communication with drugmakers, though it’s unclear if the next administration will take a different approach. The Biden administration has touted the first round of Medicare negotiations as a win over the pharma industry. CMS expects lower list prices for the first 10 drugs to save Medicare $6 billion in 2026, the first year they are in effect. Anna Kaltenboeck, who co-authored the IRA’s drug-negotiation section, said that while the next administration will not have “blanket authority to change the core parts of the law,” certain aspects of the process can be changed without legislative action. For example, CMS could alter its guidance or how it interprets parts of the law, such as how many times it meets with drugmakers, or how many listening sessions it holds. “The degree to which they play hardball with manufacturers in the process could change,” she said. Kaltenboeck added that a misinterpretation of the process is that it is formulaic when in reality being at the negotiating table is “much more nuanced.” CMS’ negotiating style may change with the next administration, she said. In response to the new round of negotiations, AARP executive VP and chief advocacy and engagement officer Nancy LeaMond said the nonprofit will “continue fighting to protect Medicare negotiation from any efforts to weaken or undo it, ensuring older Americans can afford the lifesaving medicines they rely on.” Meanwhile, drugmakers have argued the negotiation process lacks transparency and is akin to price setting. Their legal challenges have largely fallen flat, with six of seven drugmaker lawsuits argued during the first round of negotiations rejected by federal district courts and now in appeals. The seventh case, brought by Merck, has yet to be decided. Barring a court win, Kaltenboeck said she still expects the first round of negotiations to take effect in 2026.