Novo Nordisk's CagriSema was associated with significant reduction in blood pressure and showed anti-inflammatory effects while reducing the proportion of patients at risk of developing heart disease over time in new analyses at ObesityWeek®

Rhea-AI Summary

Novo Nordisk (NVO) presented post hoc REDEFINE 1 analyses at ObesityWeek (Nov 6, 2025) showing investigational CagriSema (2.4 mg/2.4 mg) reduced systolic blood pressure by 10.9 mmHg versus 8.8 mmHg for semaglutide 2.4 mg and 2.1 mmHg for placebo over 68 weeks.

CagriSema allowed ~40% of participants on antihypertensives to reduce or stop medication and lowered hsCRP by 68.9% (versus 55.4% semaglutide, 16.0% placebo). Safety was consistent with the GLP-1 RA class; gastrointestinal adverse events were more frequent with CagriSema.

Positive

• Systolic BP reduction of 10.9 mmHg over 68 weeks
• ~40% of patients on BP meds reduced or stopped medication
• hsCRP reduced by 68.9% at week 68 versus 55.4% with semaglutide

Negative

• Overall discontinuation due to adverse events 6% (vs 3.7% placebo)
• Gastrointestinal adverse events in 79.6% of CagriSema patients (vs 39.9% placebo)
• Nausea reported in 55% of CagriSema patients (vs 12.6% placebo)

Insights

Cardiometabolic Clinical Analyst

Post hoc REDEFINE 1 analyses show sizable systolic blood pressure and inflammation reductions with CagriSema, but findings are hypothesis‑generating.

Combined cagrilintide/semaglutide (CagriSema) produced a −10.9 mmHg reduction in systolic blood pressure over 68 weeks, greater than semaglutide −8.8 mmHg and placebo −2.1 mmHg, and allowed about 40% of people on antihypertensives to reduce or stop medication. The treatment also cut hsCRP by −68.9%, larger than semaglutide (−55.4%) and placebo (−16.0%), and reduced the proportion at intermediate‑to‑high 10‑year ASCVD risk. These are direct, measurable changes in established cardiovascular risk markers.

Results are post hoc and therefore exploratory; causal claims about clinical outcomes would require confirmation. Safety signals were class‑typical gastrointestinal events (nausea, constipation, vomiting) with discontinuation at 6% versus 3.7% for placebo. A dedicated outcomes trial (REDEFINE 3) is ongoing, which is the appropriate next step to test whether biomarker improvements translate into fewer cardiovascular events.

• A post hoc analysis of REDEFINE 1 demonstrated a 10.9 mmHg reduction in systolic blood pressure with investigational CagriSema (2.4 mg/2.4 mg), allowing 40% of people on blood pressure medications to reduce or stop their medication¹
• CagriSema treatment demonstrated a nearly 70% reduction in a key inflammatory marker associated with increased cardiovascular risk²
• Data showed that fewer people on CagriSema were at intermediate-to-high risk of developing atherosclerotic cardiovascular disease (ASCVD) within the next 10 years³

PLAINSBORO, N.J. and BAGSVÆRD, Denmark, Nov. 6, 2025 /PRNewswire/ -- At ObesityWeek^® (November 4-7 in Atlanta, GA), Novo Nordisk presented new post hoc analyses from the phase 3 REDEFINE 1 trial evaluating CagriSema, an investigational injectable combination treatment for adults with overweight or obesity, and its effects on well-known cardiovascular (CV) risk factors, including hypertension and systemic inflammation.^1-3 The results from the post hoc analysis of REDEFINE 1, exploring the CV risk reduction potential of investigational CagriSema, were also simultaneously published in Hypertension.¹

With CagriSema treatment, systolic blood pressure was reduced by -10.9 mmHg over 68 weeks (versus -8.8 mmHg with semaglutide 2.4 mg and -2.1 mmHg with placebo).^* This reduction was seen regardless of BMI (less than versus greater than or equal to 35 kg/m²). In the CagriSema group, nearly 4 out of 10 people who had been on blood pressure-lowering medication were able to cut down or stop this medication during the trial.¹ Exploratory post hoc analyses are hypothesis generating, and further work investigating the clinical validity of these results would be of value.

"We're very excited by the results of these analyses of CagriSema, which show promising results of combining cagrilintide with the proven significant effects of semaglutide on CV health," said Martin Holst Lange, chief scientific officer and executive vice president of Research & Development at Novo Nordisk. "People living with obesity have treatment goals that often include both losing weight and improving overall health. That's why we continue to explore new therapies that we hope will deliver on weight loss needs while reducing the risk of obesity-related health issues like cardiovascular disease."

CagriSema was also associated with a reduction in a key marker of body-wide inflammation – high-sensitivity C-reactive protein (hsCRP) – at week 68, regardless of baseline hsCRP levels. The reduction with CagriSema (–68.9%) was greater than with semaglutide 2.4 mg alone (–55.4%) or placebo (–16.0%).^*2 In a mediation analysis, the hsCRP reduction with CagriSema was only partially explained by weight loss, suggesting that the inflammatory effects of CagriSema are not fully weight loss dependent.

"The CagriSema data presented at ObesityWeek^® are very encouraging regarding the effects on well-known CV risk factors like high blood pressure – a strong signal that warrants further investigation. High blood pressure has a significant impact on the heart, increasing the risk of heart attacks and strokes and, alongside inflammation, is a key driver of cardiovascular disease," said Professor Subodh Verma, Cardiac Surgeon and Canada Research Chair Division of Cardiac Surgery, Li Ka Shing Knowledge Institute of St. Michael's Hospital, University of Toronto, Canada. "If we can lower inflammation, bring blood pressure to more normal levels, and help people lose weight at the same time, there's potential for holistic improvement in overall health."

High blood pressure and chronic inflammation are critical in the development of atherosclerotic cardiovascular disease (ASCVD). CagriSema reduced the proportion of people who were at intermediate-to-high risk of developing ASCVD within the next 10 years.^*3 A dedicated trial (REDEFINE 3) is ongoing to investigate the effect of CagriSema on CV outcomes in patients with established cardiovascular disease, with or without type 2 diabetes. 

Safety data generated in the REDEFINE 1 trial 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, adverse events were mainly gastrointestinal (79.6% in the CagriSema group versus 39.9% with placebo), including nausea (55% versus 12.6%), constipation (30.7% versus 11.6%), and vomiting (26.1% versus 4.1%), and were mostly transient and mild-to-moderate in severity.⁴

^* Based on the trial product estimand; estimated treatment effect if all participants adhered to treatment.

About CagriSema
CagriSema 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 the GLP-1 receptor agonist, semaglutide 2.4 mg.⁴ 

CagriSema is not approved in the US or EU.

About the REDEFINE 1 trial
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), cagrilintide 2.4 mg monotherapy and semaglutide 2.4 mg monotherapy versus placebo in 3,417 adults with obesity (BMI ≥30 kg/m²), or overweight (BMI ≥27 kg/m²) with one or more obesity-related comorbidities, and without type 2 diabetes.⁴

About obesity 
Obesity is a serious chronic, progressive and complex disease that requires long-term management.^5-7 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.^5,7 Obesity is influenced by a variety of factors, including genetics, social determinants of health, and the environment.^8,9

About Novo Nordisk
Novo Nordisk is a leading global healthcare company with a heritage of more than 100 years in diabetes care. Building on this foundation, our purpose is to drive change to defeat serious chronic diseases — from diabetes and obesity to rare blood and endocrine disorders — by pioneering scientific breakthroughs, expanding access to medicines, and working to prevent and ultimately cure disease. We are committed to long‑term, responsible business practices that deliver financial, social and environmental value. Headquartered in Denmark and operating in around 80 countries, Novo Nordisk employs approximately 78,500 people and markets products in roughly 170 countries. In the United States, Novo Nordisk has a 40‑year presence, is headquartered in New Jersey and employs over 10,000 people across more than 10 manufacturing, R&D and corporate locations in eight states plus Washington, D.C. For more information, visit novonordisk.com and novonordisk‑us.com, and follow us on 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 (US) +1 609 613 0568 fptr@novonordisk.com

_______________________

References

1. Verma S, Böttcher M, Brown P, et al. CagriSema Reduces Blood Pressure in Adults with Overweight or Obesity: The REDEFINE 1 Trial. Oral presentation at ObesityWeek^® 2025; 4–7 November 2025; Georgia World Congress Center, Atlanta, USA.
2. Taub PR, Blüher M, Böttcher M, et al. CagriSema Reduces hsCRP in Adults with Overweight or Obesity: The REDEFINE 1 Trial. Poster presentation at ObesityWeek^® 2025; 4–7 November 2025; Georgia World Congress Center, Atlanta, USA.
3. Verma S, Böttcher M, Brown P, et al. CagriSema Reduces Predicted ASCVD Risk in Adults with Overweight or Obesity: The REDEFINE 1 Trial. Poster presentation at ObesityWeek^® 2025; 4–7 November 2025; Georgia World Congress Center, Atlanta, USA.
4. Garvey WT, Blüher M, Osorto Contreras CK, et al. Coadministered Cagrilintide and Semaglutide in Adults with Overweight or Obesity. N Engl J Med. 2025;393:635–647. 
5. 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.  
6. 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.  
7. 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. 
8. 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. 
9. World Obesity Federation. World Obesity Atlas 2023. Last accessed: June 2025. Available at: https://www.worldobesity.org/resources/resource-library/world-obesity-atlas-2023. 

© 2025 Novo Nordisk    All rights reserved.    US25SEMO03075   October 2025

 

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FAQ

What did Novo Nordisk announce about CagriSema (NVO) at ObesityWeek on Nov 6, 2025?

Novo Nordisk presented REDEFINE 1 post hoc analyses showing CagriSema reduced systolic BP by 10.9 mmHg and hsCRP by 68.9% at 68 weeks.

How many patients on blood pressure medication could reduce or stop meds with CagriSema in REDEFINE 1 (NVO)?

About 40% of participants on antihypertensive therapy were able to reduce or stop their blood pressure medication.

What were the main safety findings for CagriSema in REDEFINE 1 (NVO)?

Safety aligned with the GLP-1 RA class; discontinuations were 6% and gastrointestinal events occurred in 79.6% of CagriSema patients.

How did CagriSema affect inflammation markers compared with semaglutide 2.4 mg (NVO)?

CagriSema reduced high-sensitivity C-reactive protein by 68.9% versus 55.4% for semaglutide 2.4 mg at week 68.

Will CagriSema have cardiovascular outcome data for investors to watch (NVO)?

A dedicated outcomes trial, REDEFINE 3, is ongoing to investigate CagriSema's effect on cardiovascular outcomes in patients with established CV disease.