Novo Nordisk A/S: CagriSema 2.4 mg / 2.4 mg demonstrated 22.7% mean weight reduction in adults with overweight or obesity in REDEFINE 1, published in New England Journal of Medicine
Data presented simultaneously at the American Diabetes Association's® 85th Scientific Sessions, showed mean weight reduction in the highest range of efficacy observed with existing weight loss interventions1
When adhering to treatment, weight loss of ≥5%, ≥20%, ≥25%, and ≥30% was observed in 97.6%, 60.2%, 40.4% and 23.1% of patients respectively at 68 weeks1*
The REDEFINE clinical programme is ongoing to further investigate efficacy and safety of CagriSema, including recently initiated REDEFINE 112
Bagsværd, Denmark, 22 June – Today, The New England Journal of Medicine (NEJM) published results from Novo Nordisk's phase 3 REDEFINE 1 trial evaluating the efficacy and safety of investigational CagriSema plus lifestyle interventions for weight loss in adults with obesity or overweight who have a weight-related medical complication and without diabetes.1 REDEFINE 1 met its co-primary endpoints and achieved statistically significant and clinically meaningful weight loss at 68 weeks in patients taking CagriSema versus placebo.1 These data, along with the related phase 3 REDEFINE 2 study conducted in adults with overweight or obesity and type 2 diabetes, were presented today during a scientific symposium at the American Diabetes Association's (ADA) 85th Scientific Sessions and published in NEJM.
'In REDEFINE 1, participants saw significant and clinically meaningful weight loss under a protocol that allowed investigators to maintain patients on a submaximal dose if deemed best for the patient. We also witnessed low, single-digit discontinuation rates due to adverse events in both REDEFINE 1 and 2,' said Martin Holst Lange, executive vice president and head of Development at Novo Nordisk. 'These results reinforce our confidence in CagriSema, and we continue to study the potential of this combination through the REDEFINE trials.'
CagriSema is an investigational product that combines the GLP-1 RA, semaglutide, with an amylin analogue, cagrilintide. The REDEFINE 1 trial found that treatment with CagriSema resulted in greater weight loss of 22.7% at 68 weeks versus 2.3% in the placebo group if all patients adhered to treatment.1* When evaluating the treatment effect regardless of adherence, those treated with CagriSema achieved statistically significant weight loss of 20.4% at 68 weeks versus 3.0% for the placebo group.1** In addition, a supportive secondary analysis showed that half (50.7%) of trial participants with obesity treated with CagriSema reached the threshold for non-obesity (BMI < 30 kg/m2) at the end of treatment, from a mean BMI of 38 kg/m2 at the start of treatment. In the placebo group,10.2% reached that threshold at 68 weeks.1
Select confirmatory secondary endpoints showed that if all participants adhered to treatment 40.4% of those receiving CagriSema achieved a body weight reduction of ≥25%.* Additionally, 23.1% lost ≥30% of their body weight.1* When applying the treatment policy estimand, 34.7% of participants treated with CagriSema achieved ≥25% body-weight reduction and 19.3% achieved ≥30% body-weight reduction.1** In a prespecified analysis of 252 participants, the relative reduction in fat and lean soft-tissue mass from baseline to week 68 was -35.7% (fat mass) and -14.4% (lean soft-tissue mass) for those treated with CagriSema versus –5.7% and –4.3% for the placebo group, respectively.1
"In REDEFINE 1, CagriSema provided weight loss in the highest range of efficacy observed with existing weight loss interventions,' said lead investigator Timothy Garvey, MD, professor of medicine and director of the Diabetes Research Center at the University of Alabama at Birmingham. 'Investigators were allowed some flexibility in dose adjustments to balance efficacy and safety, but regardless of dose adjustments participants lost significant weight. These findings are relatable to clinical practice, where dosing is often adjusted based on individual needs and clinical judgement.'
Safety data generated in the REDEFINE 1 and 2 trials were comparable with the GLP-1 RA class. Overall, discontinuation rates due to adverse events were low, with 6% for CagriSema versus 3.7% for placebo in REDEFINE 1 and 8.4% with CagriSema versus 3% with placebo in REDEFINE 2.1,3 In REDEFINE 1, adverse events were mainly gastrointestinal (79.6% in the CagriSema group vs. 39.9% with placebo), including nausea (55% vs. 12.6 %), constipation (30.7% vs. 11.6%), vomiting (26.1% vs. 4.1%) and were mostly transient and mild-to-moderate in severity.1
Results from REDEFINE 2, a phase 3 study that evaluated the efficacy and safety of CagriSema plus lifestyle interventions in adults with obesity and type 2 diabetes (T2D), were also simultaneously presented during a scientific symposium at the ADA's Scientific Sessions and published in NEJM.3 In REDEFINE 2, if all participants adhered to treatment, the estimated mean change in body weight from baseline to week 68 was –15.7% with CagriSema versus –3.1% with placebo.3* When applying the treatment policy estimand, the estimated mean change in body weight from baseline to week 68 was –13.7% with CagriSema versus –3.4% with placebo.3** A greater proportion of participants receiving CagriSema, compared with placebo, reduced their body weight by >5% (83.6% vs. 30.8% of participants), ≥10% (65.6% vs. 10.3%), ≥15% (43.9% vs. 2.4%), and ≥20% (22.9% vs. 0.5%;).3 The safety results from CagriSema in REDEFINE 2 were similar to those reported in REDEFINE 1.3
The REDEFINE clinical programme will continue to assess the efficacy and safety of CagriSema. Most recently, Novo Nordisk initiated the REDEFINE 11 trial with the first patient visit occurring in early June 2025. REDEFINE 11 will explore further weight loss potential and safety of CagriSema 2.4 mg / 2.4 mg through a longer trial duration and other protocol changes compared to REDEFINE 1 and 2. * Based on the trial product estimand; this estimand estimates what the effect would be if all participants adhered to treatment ** Based on the treatment policy estimand: treatment effect regardless of treatment adherence
About CagriSemaCagriSema is being investigated by Novo Nordisk as a once-weekly subcutaneous injectable 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.
About the REDEFINE clinical trial programmeREDEFINE is a phase 3 clinical development programme with once-weekly subcutaneous CagriSema in obesity. REDEFINE 1 and REDEFINE 2 have enrolled approximately 4,600 adults with overweight or obesity. REDEFINE 1 was a double-blind, placebo-and active-controlled 68-week efficacy and safety phase 3 trial of once-weekly CagriSema, cagrilintide 2.4 mg and semaglutide 2.4 mg versus placebo in 3,417 adults with obesity or overweight with one or more comorbidities and without type 2 diabetes. REDEFINE 2 was a double-blind, randomized, placebo- and controlled 68-week efficacy and safety phase 3 trial of once-weekly CagriSema versus placebo in 1,206 adults with type 2 diabetes and either obesity or overweight.
Multiple REDEFINE clinical trials are currently underway including: REDEFINE 3, an event-driven cardiovascular outcomes phase 3 trial; REDEFINE 4 an 84-week head-to-head efficacy and safety phase 3 trial of once-weekly CagriSema versus once-weekly tirzepatide; and REDEFINE 11, a phase 3 trial with longer duration and other protocol changes compared to REDEFINE 1 and 2.
About obesity Obesity is a serious chronic, progressive, and complex disease that requires long-term management.4-6 One key misunderstanding is that this is a disease of just lack of willpower, when in fact there is underlying biology that may impede people with obesity from losing weight and keeping it off.4,6 Obesity is influenced by a variety of factors, including genetics, social determinants of health, and the environment.7,8
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 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 9289 abmo@novonordisk.com
Liz Skrbkova (US) +1 609 917 0632 lzsk@novonordisk.com
Investors:
Jacob Martin Wiborg Rode +45 3075 5956 jrde@novonordisk.com
Ida Schaap Melvold +45 3077 5649 idmg@novonordisk.com
Sina Meyer +45 3079 6656 azey@novonordisk.com
Max Ung +45 3077 6414 mxun@novonordisk.com
Frederik Taylor Pitter +1 609 613 0568 fptr@novonordisk.com
References:
Garvey WT, Blüher MD, Contreras CKO, et al. CagriSema in Adults with Overweight or Obesity. New England Journal of Medicine 2025. doi: 10.1056/NEJMoa2502081
ClinicalTrials.gov. A Research Study to Look at How Well CagriSema Helps People Living With Obesity Lose Weight and Maintain Weight Loss in the Long-term. Last Accessed: June 2025. Available at: https://clinicaltrials.gov/study/NCT07011667.
Davies MJ, Harpreet S, Bajaj MD, et al. CagriSema in Adults with Overweight or Obesity and Type 2 Diabetes. New England Journal of Medicine 2025.
Kaplan LM, Golden A, Jinnett K, et al. Perceptions of barriers to effective obesity care: results from the national action study. Obesity. 2018;26(1):61-69.
Bray GA, Kim KK, Wilding JPH; World Obesity Federation. Obesity: a chronic relapsing progressive disease process. A position statement of the World Obesity Federation. Rev. 2017;18(7):715-723.
Garvey WT, Mechanick JI, Brett EM, et al. American association of clinical endocrinologists and American College of Endocrinology comprehensive clinical practice guidelines for medical care of patients with obesity. Endocr Pract. 2016;22 (Suppl 3):1-203.
Centers for Disease Control and Prevention. Adult obesity facts. Last accessed: June 2025. Available at: https://www.cdc.gov/obesity/adult-obesity-facts/index.html.
World Obesity Federation. World Obesity Atlas 2023. Last accessed: June 2025. Available at: https://www.worldobesity.org/resources/resource-library/world-obesity-atlas-2023.
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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 U.S. presence spanning 40 years, Novo Nordisk U.S. 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 Facebook, Instagram, and X. Contacts for further information: Media: Liz Skrbkova (US)+1 609 917 0632NNIMediaTeam@ James-Brown (Global)+45 3079 9289Globalmedia@ Investors: Frederik Taylor Pitter (US) +1 609 613 0568fptr@ Martin Wiborg Rode (Global)+45 3075 5956jrde@ Meyer (Global) +45 3079 6656 azey@ Schaap Melvold (Global) +45 3077 5649 idmg@ Ung (Global)+45 3077 6414mxun@ References Oldenberg J, Benson G, Chowdaryet P, et al. FRONTIER5 direct switch study: safety of initiating Mim8 prophylaxis without washout of emicizumab. Oral presentation presented at the Congress of the International Society on Thrombosis and Haemostasis 2025; June 21-25 2025; Walter E. Washington Convention Center, Washington D.C., US. Session code 13686. Mahlangu J, Ahuja S, Cockrell E, et al. FRONTIER5 device handling and patient-reported outcomes. Oral presentation presented at the Congress of the International Society on Thrombosis and Haemostasis 2025; June 21–25 2025; Walter E. Washington Convention Center, Washington D.C., US. Session code 13786. A Research Study Looking at How Safe it is to Switch From Emicizumab to Mim8 in People With Haemophilia A (FRONTIER5). Last accessed May 2025. Available at MedlinePlus. Hemophilia. Last accessed May 2025. Available at Iorio A, Stonebraker JS, Chambost H, et al. Establishing the Prevalence and Prevalence at Birth of Hemophilia in Males: A Meta-analytic Approach Using National Registries. Ann Intern Med. 2019;171:540-546. Kim JY, You CW. The prevalence and risk factors of inhibitor development of FVIII in previously treated patients with hemophilia A. Blood Res. 2019;54:204-209. Ostergaard H, Lund J, Greisen PJ, et al. A factor VIIIa-mimetic bispecific antibody, Mim8, ameliorates bleeding upon severe vascular challenge in hemophilia A mice. Blood. 2021;138:1258-1268. A Research Study Looking at Long-term Treatment With Mim8 in People With Haemophilia A (FRONTIER4). Last accessed May 2025. Available at U.S. National Library of Medicine. F8 gene. MedlinePlus Genetics. Last accessed May 2025. Available at A Research Study Investigating Mim8 in People With Haemophilia A. Last accessed June 2025. Available at A Research Study Investigating Mim8 in Adults and Adolescents With Haemophilia A With or Without Inhibitors. Last accessed May 2025. Available at A Research Study Looking at Mim8 in Children With Haemophilia A With or Without Inhibitors. Last accessed May 2025. Available at Novo Nordisk is a registered trademark of Novo Nordisk A/S. © 2025 Novo Nordisk All rights reserved. US25HRBD00174 June 2025 View original content to download multimedia: SOURCE Novo Nordisk Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
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Your AI use could have a hidden environmental cost
Sign up for CNN's Life, But Greener newsletter. Our limited newsletter series guides you on how to minimize your personal role in the climate crisis — and reduce your eco-anxiety. Whether it's answering work emails or drafting wedding vows, generative artificial intelligence tools have become a trusty copilot in many people's lives. But a growing body of research shows that for every problem AI solves, hidden environmental costs are racking up. Each word in an AI prompt is broken down into clusters of numbers called 'token IDs' and sent to massive data centers — some larger than football fields — powered by coal or natural gas plants. There, stacks of large computers generate responses through dozens of rapid calculations. The whole process can take up to 10 times more energy to complete than a regular Google search, according to a frequently cited estimation by the Electric Power Research Institute. So, for each prompt you give AI, what's the damage? To find out, researchers in Germany tested 14 large language model (LLM) AI systems by asking them both free-response and multiple-choice questions. Complex questions produced up to six times more carbon dioxide emissions than questions with concise answers. In addition, 'smarter' LLMs with more reasoning abilities produced up to 50 times more carbon emissions than simpler systems to answer the same question, the study reported. 'This shows us the tradeoff between energy consumption and the accuracy of model performance,' said Maximilian Dauner, a doctoral student at Hochschule München University of Applied Sciences and first author of the Frontiers in Communication study published Wednesday. Typically, these smarter, more energy intensive LLMs have tens of billions more parameters — the biases used for processing token IDs — than smaller, more concise models. 'You can think of it like a neural network in the brain. The more neuron connections, the more thinking you can do to answer a question,' Dauner said. Complex questions require more energy in part because of the lengthy explanations many AI models are trained to provide, Dauner said. If you ask an AI chatbot to solve an algebra question for you, it may take you through the steps it took to find the answer, he said. 'AI expends a lot of energy being polite, especially if the user is polite, saying 'please' and 'thank you,'' Dauner explained. 'But this just makes their responses even longer, expending more energy to generate each word.' For this reason, Dauner suggests users be more straightforward when communicating with AI models. Specify the length of the answer you want and limit it to one or two sentences, or say you don't need an explanation at all. Most important, Dauner's study highlights that not all AI models are created equally, said Sasha Luccioni, the climate lead at AI company Hugging Face, in an email. Users looking to reduce their carbon footprint can be more intentional about which model they chose for which task. 'Task-specific models are often much smaller and more efficient, and just as good at any context-specific task,' Luccioni explained. If you are a software engineer who solves complex coding problems every day, an AI model suited for coding may be necessary. But for the average high school student who wants help with homework, relying on powerful AI tools is like using a nuclear-powered digital calculator. Even within the same AI company, different model offerings can vary in their reasoning power, so research what capabilities best suit your needs, Dauner said. When possible, Luccioni recommends going back to basic sources — online encyclopedias and phone calculators — to accomplish simple tasks. Putting a number on the environmental impact of AI has proved challenging. The study noted that energy consumption can vary based on the user's proximity to local energy grids and the hardware used to run AI partly why the researchers chose to represent carbon emissions within a range, Dauner said. Furthermore, many AI companies don't share information about their energy consumption — or details like server size or optimization techniques that could help researchers estimate energy consumption, said Shaolei Ren, an associate professor of electrical and computer engineering at the University of California, Riverside who studies AI's water consumption. 'You can't really say AI consumes this much energy or water on average — that's just not meaningful. We need to look at each individual model and then (examine what it uses) for each task,' Ren said. One way AI companies could be more transparent is by disclosing the amount of carbon emissions associated with each prompt, Dauner suggested. 'Generally, if people were more informed about the average (environmental) cost of generating a response, people would maybe start thinking, 'Is it really necessary to turn myself into an action figure just because I'm bored?' Or 'do I have to tell ChatGPT jokes because I have nothing to do?'' Dauner said. Additionally, as more companies push to add generative AI tools to their systems, people may not have much choice how or when they use the technology, Luccioni said. 'We don't need generative AI in web search. Nobody asked for AI chatbots in (messaging apps) or on social media,' Luccioni said. 'This race to stuff them into every single existing technology is truly infuriating, since it comes with real consequences to our planet.' With less available information about AI's resource usage, consumers have less choice, Ren said, adding that regulatory pressures for more transparency are unlikely to the United States anytime soon. Instead, the best hope for more energy-efficient AI may lie in the cost efficacy of using less energy. 'Overall, I'm still positive about (the future). There are many software engineers working hard to improve resource efficiency,' Ren said. 'Other industries consume a lot of energy too, but it's not a reason to suggest AI's environmental impact is not a problem. We should definitely pay attention.'
