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Novo Nordisk
Novo Nordisk (NOVO) investor relations material
Novo Nordisk Study result summary
Complete event summary combining all related documents: earnings call transcript, report, and slide presentation.Study result summary23 Feb, 2026
Study design and objectives
REDEFINE 4 was an open-label, phase III trial with 809 adults with obesity and comorbidities, comparing CagriSema 2.4 mg/2.4 mg to tirzepatide 15 mg over 84 weeks, primarily in the U.S.
The primary endpoint was to confirm non-inferiority of CagriSema versus tirzepatide in percentage body weight change over 84 weeks.
Both drugs were administered once weekly via subcutaneous injection, with dose modifications allowed and regimens consistent with prior REDEFINE trials.
All participants and investigators were aware of treatment assignments.
Key efficacy and safety results
CagriSema achieved a 23% mean weight reduction, while tirzepatide achieved 25.5% after 84 weeks, starting from a mean baseline weight of 140.2 kg.
The primary endpoint of non-inferiority was not met, as CagriSema did not match tirzepatide's weight loss efficacy.
Using the treatment-regimen estimand, CagriSema achieved 20.2% weight loss versus 23.6% for tirzepatide.
Both treatments showed similar safety and tolerability profiles, with gastrointestinal events being the most common and generally mild to moderate, diminishing over time.
Interpretation and trial limitations
Tirzepatide's efficacy in this trial exceeded typical results from previous studies, possibly due to open-label design and investigator familiarity.
More patients in the tirzepatide arm reached the highest dose, likely influenced by the open-label format and investigator experience.
Not all CagriSema patients reached the full target dose, suggesting further weight loss potential remains untapped.
CagriSema's competitive strategy post-REDEFINE 4
What is the full weight-loss potential of CagriSema?
Basis for FDA submission given REDEFINE 4 results
Did CagriSema meet non-inferiority vs Tirzepatide?
What are key next-gen AOM pipeline assets?
When is US FDA decision for CagriSema expected?
Open-label bias impact on future trial design
CagriSema launch strategy post-REDEFINE 4
REDEFINE learnings applied to AMAZE program
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Next Novo Nordisk earnings date
AGM 202626 Mar, 2026
Novo Nordisk
Next Novo Nordisk earnings date
AGM 202626 Mar, 2026
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Frequently asked questions
Experts in treatment of chronic illnesses
Novo Nordisk is a Danish global healthcare company focused on treatment of serious chronic conditions. They specialize in developing and manufacturing innovative pharmaceutical products, including insulin, GLP-1 analogs, and other treatments. With a strong commitment to R&D within the field of medical science and through a focus on helping chronically ill patients, Novo Nordisk aims to improve the lives of people living with serious diseases.
A Scandinavian giant
Novo Nordisk, a Danish company founded in 1923, is one of the global leaders in healthcare dedicated to addressing diabetes and chronic diseases. Headquartered just outside of Copenhagen, Novo Nordisk operates around 80 offices in over 160 countries, serving patients and healthcare professionals with the help of over 50.000 staff. The company has a rich history of pioneering research and innovation in the field of diabetes care, providing a range of pharmaceutical products and treatment solutions. Novo Nordisk is one of the largest companies in Denmark, and acts as a key player in the Danish economy together with companies such as Carlsberg and Maersk.
Known for their work with diabetes
Novo Nordisk is renowned for its significant contributions in the field of diabetes treatment. With a strong focus on research and innovation, the company develops and provides a wide range of pharmaceutical products and therapies to help manage diabetes and improve patients' quality of life. Novo Nordisk's range of products for diabetes care includes insulin products, injectable and oral glucose-lowering medications, as well as devices for insulin administration. The company is committed to advancing diabetes care through ongoing research, development of new treatments, and educational initiatives for healthcare professionals and patients. Diabetes treatment is in huge demand worldwide, and other companies providing insulin for patients across the globe include companies like Eli Lilly and Sanofi.
A strong focus on medical innovation
Experts in chronic illness, Novo Nordisk is dedicated to addressing a range of health conditions beyond just diabetes. Their portfolio of products includes treatments for obesity, hemophilia, growth disorders, and rare diseases. By focusing on patient needs and utilizing their experience and scientific expertise, Novo Nordisk strives to provide the best possible solutions and care for patients who rely on medication in their day-to-day lives.
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