CagriSema 2.4 mg / 2.4 mg demonstrated 22.7% mean weight reduction in adults with overweight or obesity in REDEFINE 1, published in NEJM
PLAINSBORO, N.J., June 22, 2025 /PRNewswire/ — 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 (estimated difference [95% CI] -20.4 [-21.1 to -19.7]; p<0.001) 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 (estimated difference [95% CI] -17.3 [-18.1 to -16.6]; p<0.001).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% ([95% CI] 39.5 (37.1 to 41.9); p<0.001).* Additionally, 23.1% lost ≥30% of their body weight ([95% CI] 22.7 (20.7 to 24.7); p<0.001).1* When applying the treatment policy estimand, 34.7% of participants treated with CagriSema achieved ≥25% body-weight reduction ([95% CI] 33.7 (31.5 to 35.9); p<0.001) and 19.3% achieved ≥30% body-weight reduction ([95% CI] 18.9 (17.1 to 20.7); p<0.001).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.
'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 was 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 (estimated difference [95% CI] -12.6% [-13.4 to -11.7]; p<0.001).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 (estimated difference [95% CI] -10.4% [-11.2 to -9.5]; p<0.001).3** A greater proportion of participants receiving CagriSema, compared with placebo, reduced their body weight by >5% (83.6% vs 30.8% of participants; p<0.001), ≥10% (65.6% vs 10.3%), ≥15% (43.9% vs 2.4%), and ≥20% (22.9% vs 0.5%; p<0.001).3 The safety results from CagriSema in REDEFINE 2 were similar to those reported in REDEFINE 1.3
The REDEFINE clinical program 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 program) and as a treatment for adults with type 2 diabetes (REIMAGINE program). CagriSema is a fixed-dose combination of a long-acting amylin analogue, cagrilintide 2.4 mg and semaglutide 2.4 mg.
CagriSema is not approved in the US for weight loss.
About the REDEFINE clinical trial programREDEFINE is a phase 3 clinical development program 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 68-week, double-blind, placebo- and active-controlled 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-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 obesityObesity 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
The prevalence of overweight and obesity is a public health issue that has severe cost implications to healthcare systems.9,10 In the US, about 40% of adults live with obesity.11
About Novo Nordisk Novo Nordisk is a leading global healthcare company that's been making innovative medicines to help people with diabetes lead longer, healthier lives for more than 100 years. This heritage has given us experience and capabilities that also enable us to drive change to help people defeat other serious chronic diseases such as obesity, rare blood, and endocrine disorders. We remain steadfast in our conviction that the formula for lasting success is to stay focused, think long-term, and do business in a financially, socially, and environmentally responsible way. With a US presence spanning 40 years, Novo Nordisk US is headquartered in New Jersey and employs over 10,000 people throughout the country across 12 manufacturing, R&D and corporate locations in eight states plus Washington DC. For more information, visit novonordisk-us.com, Facebook, Instagram, and X.
Novo Nordisk is committed to the responsible use of our semaglutide-containing medicines which represent distinct products with different indications, dosages, prescribing information, titration schedules, and delivery forms. These products are not interchangeable and should not be used outside of their approved indications. Learn more at semaglutide.com.
Contacts for further information
Media:
Liz Skrbkova (US)+1 609 917 0632USMediaRelations@novonordisk.com
Ambre James-Brown (Global)+45 3079 9289Globalmedia@novonordisk.com
Investors:
Frederik Taylor Pitter (US)+1 609 613 0568fptr@novonordisk.com
Jacob Martin Wiborg Rode (Global)+45 3075 5956jrde@novonordisk.com
Sina Meyer (Global)+45 3079 6656 azey@novonordisk.com
Ida Schaap Melvold (Global)+45 3077 5649 idmg@novonordisk.com
Max Ung (Global)+45 3077 6414mxun@novonordisk.comz
References:
Garvey T, Blüher M, Contreras C, et al. Coadministered Cagrilintide and Semaglutide in Adults with Overweight or Obesity. N Engl J Med. 2025;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 M, Bajaj H, Broholm C, et al. Cagrilintide–Semaglutide in Adults with Overweight or Obesity and Type 2 Diabetes. N Engl J Med. 2025;10.1056/NEJMoa2502082. 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. Centers for Disease Control and Prevention. Risk Factors for Obesity. Last accessed: June 2025. Available at: https://www.cdc.gov/obesity/risk-factors/risk-factors.html. Centers for Disease Control and Prevention. Why it matters. Last accessed: June 2025. Available at: https://www.cdc.gov/obesity/php/about/?CDC_AAref_Val=https://www.cdc.gov/obesity/about-obesity/why-it-matters.html. Centers for Disease Control and Prevention. Obesity and Severe Obesity Prevalence in Adults: United States, August 2021–August 2023. Last accessed June 2025. Available at: https://www.cdc.gov/nchs/products/databriefs/db508.htm.
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This heritage has given us experience and capabilities that also enable us to drive change to help people defeat other serious chronic diseases such as obesity, rare blood, and endocrine disorders. We remain steadfast in our conviction that the formula for lasting success is to stay focused, think long-term, and do business in a financially, socially, and environmentally responsible way. With a US presence spanning 40 years, Novo Nordisk US is headquartered in New Jersey and employs over 10,000 people throughout the country across 12 manufacturing, R&D, and corporate locations in eight states plus Washington DC. For more information, visit Facebook, Instagram, and X. References Alhemo® (concizumab-mtci) injection, for subcutaneous use [package insert]. Plainsboro, NJ: Novo Nordisk Inc. Chowdary P., et al. Concizumab prophylaxis in people with haemophilia A or haemophilia B without inhibitors (explorer8): a prospective, multicentre, open-label, randomised, phase 3a trial. Lancet Hematology. 2024;11:e891-904. Novo Nordisk. FDA approves drug to prevent or reduce the frequency of bleeding episodes for patients with hemophilia A with inhibitors or hemophilia B with inhibitors. Accessed May 2025. Available at Shapiro AD. Concizumab: a novel anti-TFPI therapeutic for hemophilia. Blood Adv. 2021;5(1):279. Matsushita T, Shapiro A, Abraham A, et al. Phase 3 trial of concizumab in hemophilia with inhibitors. N Engl J Med. 2023; 389(9): 783-794. Research Study to Look at How Well the Drug Concizumab Works in Your Body if You Have Haemophilia Without Inhibitors (explorer8). Accessed May 2025. Available at MedlinePlus. Hemophilia. Accessed May 2025. Available at World Federation of Hemophilia. Annual Global Survey 2023. Accessed July 2025. Further information Liz Skrbkova (US)+1 609 917 0632 (Mobile)USMediaRelations@ Ambre James-Brown (Global)+45 3079 9289Globalmedia@ Alhemo® is a registered trademark of Novo Nordisk Health Care AG. Novo Nordisk is a registered trademark of Novo Nordisk A/S.© 2025 Novo Nordisk All rights reserved. US25AHM00187 July 2025
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Novogene Certified for Olink® Services Across Multiple Labs; Expands Proteomics Portfolio with Olink® Reveal 'With Olink® Reveal offering deep insights into inflammatory biology, we empower researchers to accelerate biomarker discovery, translational research, and precision medicine. This recognition further enhances Novogene's leadership in comprehensive multi-omics solutions,' said Justin Lee, Novogene VP of Global Marketing. Mosanna Therapeutics Launches with $80 Million to Advance Novel Nighttime Nasal Spray for Obstructive Sleep Apnea Mosanna is pioneering a pharmaceutical solution for sleep apnea patients with MOS118, a nasal spray administered at bedtime that helps restore the body's natural airway reflex. Research has shown that, for reasons yet unknown, the natural airway reflex in OSA patients exhibits decreased activity during sleep resulting in loss of airway patency and apnea. Grady Launches Emergency Medical Helicopter in Partnership with Air Methods This cutting-edge air ambulance will be staffed entirely by Grady medical personnel – highly trained nurses, paramedics, and critical care specialists – while experienced pilots from Air Methods will operate the aircraft. The partnership brings together top-tier medical care and aviation expertise to deliver life-saving interventions to patients faster than ever before. Visby Medical™ Raises up to $65 Million in New Financing Round to Accelerate Launch of Groundbreaking At-Home Sexually Transmitted Infections (STI) Test 'Visby Medical has delivered the first and only laboratory-grade STI testing solution that can be made directly accessible to individuals. We were eager to invest in Visby ahead of their FDA clearance, knowing this would represent a breakthrough moment for the diagnostics industry,' said Isaac Ro, Catalio Capital Management Partner. For more news like this, check out all of the latest health-related releases from PR Newswire. Trending Topics Among the health news that was distributed in June, the PR Newswire team was able spot several larger stories that highlight the trends shaping the industry. Men's Mental Health: Men's Mental Health Month aims to break the stigma and explore the factors that play into to the often less talked about issue. Studies released in June point looked into several contributing factors. According to Postpartum Support International, at least one in ten fathers experience postpartum depression during the perinatal period with as many as 50% of fathers suffering at the same time as their partners. On the financial side of things, Beyond Finance revealed financial distress is fueling a silent mental health crisis among men, driven by secrecy, shame and isolation. Men have reported feeling frustrated, anxious, overwhelmed and embarrassed because of their financial situation — yet nearly a quarter (22%) don't feel comfortable seeking out financial advice from anyone. Sleep Health: The Associated Professional Sleep Societies (APSS) hosted its annual meeting, SLEEP 2025, in Seattle from June 8-11. The event showcased several advances shaping the future of sleep medicine. Researchers from Huxley Medical shared data highlighting the capabilities of the SANSA home sleep apnea test. Another study, this one from Rest and SleepScore Labs, showed significant perceived improvements in sleep comfort, temperature regulation and overall sleep quality when using Rest's Evercool® products like pillowcases and sheets. Do you have a health press release to distribute? Sign up with PR Newswire to share your story with the audiences who matter most. 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