Novo's CagriSema was associated with 25% mean weight loss among early responders in a post hoc analysis of REDEFINE 1 presented at ObesityWeek® 2026

• In a post hoc analysis of the phase 3 REDEFINE 1 trial, 67.8% of adults treated with investigational CagriSema 2.4 mg / 2.4 mg were early responders, achieving at least 5% weight loss by week 8¹
• Women were more likely to be early responders than delayed responders (71.8% vs 59.5%)¹
• In a separate post hoc analysis of REDEFINE 1, significantly more adults with overweight or obesity treated with investigational CagriSema 2.4 mg / 2.4 mg reported a meaningful improvement in physical function at 68 weeks compared with placebo (73.1% vs 49.1%; efficacy estimand*)²

PLAINSBORO, N.J. and BAGSVÆRD, Denmark, Nov. 15, 2026 /PRNewswire/ -- Today, Novo Nordisk announced results from two post hoc analyses of the phase 3 REDEFINE 1 trial of investigational CagriSema 2.4 mg / 2.4 mg, a fixed-dose combination of the long-acting amylin analog cagrilintide and the GLP-1 receptor agonist semaglutide, in adults with overweight or obesity. The analyses provide further insight into differences in individual patterns of weight loss, including early treatment response, as well as participants' reported physical and psychosocial effects of weight. Results were presented at ObesityWeek^® 2026 in Washington, DC, US.^1,2

"Obesity is a chronic disease, and people respond to treatment differently and over different timeframes," said Martin Holst Lange, executive vice president, chief scientific officer and head of Research & Development at Novo. "That is why we continue to study the REDEFINE 1 data in greater depth. In this post hoc analysis, most people treated with CagriSema 2.4 mg / 2.4 mg were early responders, meaning they lost at least 5% of their body weight within the first 8 weeks of treatment. Together with the patient-reported physical function results, this research adds to the growing evidence base from the REDEFINE clinical program."

Early response and weight loss trajectories (post hoc analysis)
In this post hoc analysis, 67.8% of CagriSema-treated participants were early responders (at least 5% weight loss at week 8). Observed mean weight loss at week 68 was 25.4% among early responders. Among delayed responders, observed mean weight loss at week 68 was 17.8%.^‡ Women were more likely to be early responders than delayed responders (71.8% vs 59.5%).¹

Weight loss by early response status with CagriSema 2.4 mg / 2.4 mg in REDEFINE 1 (post hoc analysis; observed data‡)¹

"In clinical practice, it can be hard to know early on how an individual patient will respond to treatment," said Dr. W. Timothy Garvey, Department of Nutrition Sciences, University of Alabama at Birmingham, and author of the REDEFINE 1 early response analysis. "This post hoc analysis shows that people treated with CagriSema 2.4 mg / 2.4 mg experienced different weight loss trajectories, including onset of response to treatment. These values are hypothesis-generating, and they are not the basis for changing clinical decision-making."

Patient-reported physical and psychosocial function
The Impact of Weight on Quality of Life-Lite Clinical Trials Version (IWQOL-Lite-CT), used in the REDEFINE 1 analysis, is a validated questionnaire used to assess how weight affects physical function, such as the ability to carry out everyday physical activities, and psychosocial function, such as self-esteem and comfort in social situations, including whether changes are meaningful to the individual.²

At week 68, 73.1% of adults treated with CagriSema 2.4 mg / 2.4 mg reported a meaningful within-person change in physical function vs 49.1% with placebo (post hoc analysis; efficacy estimand,* which assumes all participants adhered to treatment).² In these post hoc analyses, 69.0% vs 42.1% reported a meaningful within-person change in psychosocial function, and the proportion reporting meaningful within-person change in physical function was significantly greater with CagriSema than with placebo from week 8 through week 68.²

Proportion of adults achieving a meaningful within-person change in IWQOL-Lite-CT scores at week 68 in REDEFINE 1 (post hoc analyses; efficacy estimand*)²

"Obesity goes far beyond the scale; my patients are more concerned with how weight affects their ability to move comfortably and participate confidently in everyday life," said Dr. Domenica Rubino, Washington Center for Weight Management and Research, co-author of the REDEFINE 1 physical and psychosocial function analysis. "In this post hoc analysis of REDEFINE 1, 73.1% of people treated with CagriSema 2.4 mg / 2.4 mg reported a meaningful improvement in physical function at week 68, compared with 49.1% of those receiving placebo. Additional post hoc analyses suggest these improvements may begin early in treatment, which warrants further study."

In the REDEFINE 1 trial, discontinuation due to adverse events occurred in 5.9% of participants receiving CagriSema versus 3.5% with placebo.³ 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.³

Novo filed a New Drug Application with the U.S. Food and Drug Administration in December 2025 for CagriSema 2.4 mg / 2.4 mg for weight management. A decision is expected in Q4 2026. CagriSema is not approved for use in the United States. Safety and efficacy are not established. There is no guarantee that this investigational medicine will become commercially available for the uses under clinical investigation.

What is CagriSema?
Once-weekly subcutaneous CagriSema is being investigated by Novo as a treatment for adults with overweight or obesity (REDEFINE program) and as a treatment for adults with type 2 diabetes (REIMAGINE program). CagriSema is an investigational fixed-dose combination of a long-acting amylin analog, cagrilintide, and the GLP-1 receptor agonist, semaglutide.

What is the REDEFINE program?
REDEFINE is a phase 3 clinical development program with once-weekly subcutaneous CagriSema in obesity. The global clinical trial program includes two pivotal phase 3 trials, which included approximately 4,600 adults with overweight or obesity.

What is the REDEFINE 1 trial?
REDEFINE 1 was a 68-week, double-blind, placebo- and active-controlled efficacy and safety phase 3 trial of once-weekly CagriSema 2.4 mg / 2.4 mg, semaglutide 2.4 mg and cagrilintide 2.4 mg versus placebo in 3,417 adults with obesity or overweight with one or more comorbidities and without type 2 diabetes.³

What is 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 is the global healthcare company that believes lasting health starts now. For over a century, we've combined leading scientific expertise with a deep understanding of people's lives. We develop treatments and support that help millions of people make progress they can see, feel, and sustain now and in the future. Every day, over 66,500 employees around the world advance our purpose to drive change for lasting health. Through our partnerships, programs, and investments, we're working to prevent disease, expand access to treatments and reduce our environmental impact to help even more people live healthier lives. In the United States, Novo has a 40-year presence, is headquartered in New Jersey and employs approximately 10,000 people. For more information, visit novonordisk.com and novonordisk-us.com and follow us on Instagram, LinkedIn, TikTok, Facebook, X and YouTube.

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© 2026 Novo Nordisk All rights reserved. US26CSOB00483 November 2026

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References

1. Pietiläinen KH, Almandoz J, Christensen MH, et al. Early response and weight loss trajectories with CagriSema in overweight or obesity: REDEFINE 1. Presented at: ObesityWeek^® 2026; November 14-17, 2026; Washington, DC.
2. Rubino D, Pietiläinen KH, Sharma AM, et al. Effects of CagriSema on physical and psychosocial function in overweight or obesity: REDEFINE 1. Presented at: ObesityWeek^® 2026; November 14-17, 2026; Washington, DC.
3. 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.
4. 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.
5. Bray GA, Kim KK, Wilding JPH; World Obesity Federation. Obesity: a chronic relapsing progressive disease process. A position statement of the World Obesity Federation. Obes Rev. 2017;18(7):715-723.
6. 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.
7. Centers for Disease Control and Prevention. Adult obesity facts. Last accessed: November 2026. Available at: https://www.cdc.gov/obesity/adult-obesity-facts/index.html.
8. World Obesity Federation. World Obesity Atlas 2025. Last accessed: November 2026. Available at: https://www.worldobesity.org/resources/resource-library/world-obesity-atlas-2025.

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