Novo's investigational CagriSema, a GLP-1 and amylin analog, demonstrated ~21% average weight loss with lower doses in the REDEFINE 9 trial, presented at ObesityWeek® 2026 and published in The Lancet Diabetes & Endocrinology

• REDEFINE 9 trial showed CagriSema 1.7 mg / 1.7 mg and 1.0 mg / 1.0 mg produced estimated average weight loss of 20.7% and 21.0%, respectively, at 68 weeks, compared with 2.0% with placebo, in adults with overweight or obesity, if all patients stayed on treatment¹
• REDEFINE 9 is the first phase 3 trial to evaluate CagriSema, an investigational amylin analog and GLP-1 receptor agonist combination, at doses lower than 2.4 mg / 2.4 mg^1,2

PLAINSBORO, N.J. and BAGSVÆRD, Denmark, Nov. 14, 2026 /PRNewswire/ -- Today, Novo Nordisk announced primary results from the phase 3 REDEFINE 9 trial of investigational CagriSema, a fixed-dose combination of the long-acting amylin analog cagrilintide and the GLP-1 receptor agonist semaglutide, in adults with overweight or obesity. REDEFINE 9 is the first phase 3 trial for weight management to evaluate CagriSema at doses lower than the maximum dose that has been evaluated in the REDEFINE clinical program, 2.4 mg / 2.4 mg.¹ The results were presented at ObesityWeek^® 2026 in Washington, DC, US, and simultaneously published in The Lancet Diabetes & Endocrinology.^1,2

"Understanding how people respond to treatment across different doses is an important part of obesity research," said Martin Holst Lange, executive vice president, chief scientific officer and head of Research & Development at Novo. "REDEFINE 9 studied each dose against its own placebo comparison over 68 weeks. The results add to our understanding of CagriSema across doses and, together with the broader REDEFINE program, inform how we continue to develop the combination of cagrilintide and semaglutide. We look forward to sharing these data with the scientific community at ObesityWeek^®."

In REDEFINE 9, both doses of CagriSema produced significantly greater estimated average weight loss than placebo at week 68: 20.7% and 21.0%, respectively, compared with 2.0% with placebo (estimated treatment difference −18.8 and −19.0 percentage points; p<0.0001 for both), based on the efficacy estimand,* which reflects the treatment effect if all participants adhered to treatment.¹ At both doses, a significantly higher proportion of adults achieved body weight reductions of at least 5%, 10%, 15% and 20% compared with placebo.¹ Both CagriSema 1.7 mg / 1.7 mg and 1.0 mg / 1.0 mg also produced significantly greater reductions in abdominal fat, as measured by waist circumference, a confirmatory secondary endpoint (17.2 cm and 17.5 cm, respectively, compared with 3.6 cm with placebo; p<0.0001 for both).¹

Based on the treatment regimen estimand,^† estimated average weight loss at week 68 was 19.4% and 18.6% with CagriSema 1.7 mg / 1.7 mg and 1.0 mg / 1.0 mg, respectively, compared with 4.6% with placebo (estimated treatment difference −14.7 and −13.9 percentage points; p<0.0001 for both), and 92.8% and 87.7%, respectively, achieved at least 5% body weight reduction, compared with 41.1% with placebo.¹

Change in body weight with CagriSema 1.7 mg / 1.7 mg and 1.0 mg / 1.0 mg at week 68 in REDEFINE 9 (efficacy estimand*)¹

^a Statistically significant compared with placebo, p<0.0001.

The trial was not powered to detect differences between the two CagriSema doses.

Change in body weight with CagriSema 1.7 mg / 1.7 mg and 1.0 mg / 1.0 mg at week 68 in REDEFINE 9 (treatment regimen estimand^†)¹

^a Statistically significant compared with placebo, p<0.0001.

The trial was not powered to detect differences between the two CagriSema doses.

"In REDEFINE 9, we evaluated the efficacy and safety of CagriSema 1.7 mg / 1.7 mg and 1.0 mg / 1.0 mg, and participants at both doses lost significantly more weight than those who received placebo," said Dr. Sean Wharton, Department of Medicine, Temerty Faculty of Medicine, University of Toronto, and lead author of the REDEFINE 9 publication. "These findings add to the evidence from the REDEFINE program and have potential to inform clinical practice, where dosing is often adjusted based on individual needs and clinical judgment."

In REDEFINE 9, the safety profile at both doses was consistent with previous CagriSema trials.¹ The most frequently reported adverse events were gastrointestinal and mild to moderate in severity, and adverse events leading to permanent treatment discontinuation occurred in 2.9% and 4.9% of adults receiving CagriSema 1.7 mg / 1.7 mg and 1.0 mg / 1.0 mg, respectively, compared with 4.9% with placebo.¹

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.

*Efficacy estimand: treatment effect if all participants adhered to treatment.

^†Treatment regimen estimand: treatment effect regardless of treatment discontinuation or use of weight management rescue intervention.

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 9 trial?
REDEFINE 9 was a 68-week phase 3, placebo-controlled trial, double-blind within dose levels, evaluating the efficacy and safety of once-weekly CagriSema 1.7 mg / 1.7 mg and 1.0 mg / 1.0 mg in 309 adults with obesity (BMI ≥30 kg/m²), or overweight (BMI ≥27 kg/m²) with one or more obesity-related complication, and without diabetes. Participants were randomized 2:1:2:1 to CagriSema 1.7 mg / 1.7 mg or placebo, or CagriSema 1.0 mg / 1.0 mg or placebo. All participants received lifestyle intervention, and each CagriSema dose was compared with pooled placebo.¹

What is obesity?
Obesity is a serious, chronic, progressive, and complex disease that requires long-term management.^3-5 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.^3,5 Obesity is influenced by a variety of factors, including genetics, social determinants of health, and the environment.^6,7

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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References

1. Wharton S, Broholm C, Horn D, et al. Efficacy and safety of coadministered cagrilintide-semaglutide (CagriSema) 1.7 mg/1.7 mg and 1.0 mg/1.0 mg in adults with overweight or obesity (REDEFINE 9): a multicentre, randomised, double-blind, phase 3b trial. Lancet Diabetes Endocrinol. Published online November 14, 2026.
2. Wharton S, Broholm C, Horn D, et al. REDEFINE 9: effect of CagriSema 1.7 mg/1.7 mg and 1.0 mg/1.0 mg in adults with overweight or obesity. Presented at: ObesityWeek^® 2026; November 14-17, 2026; Washington, DC.
3. 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.
4. 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.
5. 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.
6. 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.
7. World Obesity Federation. World Obesity Atlas 2025. Last accessed: November 2026. Available at: https://www.worldobesity.org/resources/resource-library/world-obesity-atlas-2025.

SOURCE NOVO NORDISK INC.