- CagriSema achieved 23% weight loss after 84 weeks of treatment
- Kaglisema 2.4/2.4 mg did not meet the primary endpoint of non-inferiority in weight loss compared to tirzepatide 15 mg at 84 weeks.1
- Additional trials are investigating Kaglisema’s potential for complete weight loss, including higher dose combinations.
Bagsvaer, Denmark, February 23, 2026 – Novo Nordisk today announced topline results from REDEFINE 4, an open-label Phase 3 study in the global REDEFINE clinical trial program.
REDEFINE 4 is an 84-week trial investigating CagriSema (a fixed-dose combination of 2.4 mg of cagrilintide and 2.4 mg of semaglutide) compared to 15 mg of tirzepatide, both administered once weekly subcutaneously. The trial enrolled 809 randomized participants with obesity and one or more comorbidities, with a mean baseline weight of 114.2 kg. The study had an open-label design, and all investigators and participants were aware of the specific drugs administered throughout the study.
When evaluating the effectiveness of treatment, if everyone complies with treatment.1Patients treated with Kaglisema 2.4 mg/2.4 mg achieved a weight loss of 23.0% after 84 weeks compared to 25.5% with Tirzepatide 15 mg. When to apply treatment regimen estimand2patients treated with CagriSema 2.4 mg/2.4 mg achieved 20.2% weight loss at 84 weeks compared to 23.6% weight loss with tirzepatide. The trial failed to meet its primary endpoint of demonstrating non-inferiority of Kaglisema in weight loss compared to tirzepatide after 84 weeks.
In trials, CagriSema appeared to have a safe and well-tolerated profile. The most common adverse events with Kagrisema were gastrointestinal, with the majority being mild to mild.
It is moderate and decreases over time, consistent with the class of GLP-1 receptor agonists.
“We are pleased with the 23% weight loss with Kaglisema in this open-label study. Kaglisema has the potential to be the first GLP-1/Amylin combination product to hit the market for people with obesity, and Kagrilintide is the first to replace semaglutide. “Based on the findings from the completed studies, we are excited about the future.” Martin Horst Lange, Executive Vice President, Research and Development and Chief Scientific Officer at Nordisk, said: “The results of the REDEFINE program strengthen our commitment to transforming obesity care through novel products such as CagriSema and zenagamtide, which have the potential to provide even greater health benefits to patients living with obesity.”
CagriSema for weight management will be submitted to the US FDA in December 2025 based on the pivotal trials REDEFINE 1 and REDEFINE 2, with an FDA decision expected by the end of 2026. The REDEFINE 11 Phase 3 study investigating the complete weight loss potential of CagriSema 2.4/2.4 mg in obesity is expected to report data in the first half of 2027, coinciding with the start of Phase 2. 3 A high-dose trial of Kagrisema is planned for the second half of 2026.
conference call
Novo Nordisk will hold an investor conference call on February 23, 2026 at 11:30 a.m. Central European Time (equivalent to 5:30 a.m. EDT). A dial-in link to the conference call will be published in the Investor section of novonordisk.com.
About Kagrisema
Novo Nordisk is investigating once-weekly subcutaneous CagriSema as a treatment for adults who are overweight or obese (REDEFINE program) and adults with type 2 diabetes (REIMAGINE program). CagriSema is a fixed-dose combination of the long-acting amylin analogs cagrilintide 2.4 mg and semaglutide 2.4 mg. These two molecules cause weight loss by reducing hunger and increasing satiety, thereby helping people eat less and reduce their calorie intake.
About the REDEFINE program
REDEFINE is a Phase 3 clinical development program that administers CagriSema subcutaneously once a week to obese patients. The global clinical trial program includes two pivotal Phase 3 trials involving approximately 4,600 overweight or obese adults. The Phase 3 testing program includes:
REDEFINE 1 – A 68-week phase 3 efficacy and safety study of once-weekly Kaglisema 2.4mg/2.4mg, Cagrilintide 2.4mg, Semaglutide 2.4mg plus placebo in 3,417 obese or overweight adults with one or more comorbidities and no type 2 diabetes.
REDEFINE 2 – A 68-week phase 3 efficacy and safety study of once-weekly CagriSema 2.4 mg/2.4 mg versus placebo in 1,206 obese or overweight adults with type 2 diabetes.
REDEFINE 3 – A phase 3 event-driven cardiovascular outcomes trial of once-weekly CagriSema 2.4 mg/2.4 mg versus placebo in 7,000 adults with established cardiovascular disease with and without type 2 diabetes.
REDEFINE 8 – A 104-week efficacy and safety Phase 3 study of weekly CagriSema 2.4 mg/2.4 mg versus placebo in 400 obese adults, including assessment of body composition. The study includes a 52-week extension phase investigating maintenance of weight loss with CagriSema 2.4 mg/2.4 mg or a dose-escalation algorithm.
REDEFINE 9 – A 68-week efficacy and safety phase 3 study of weekly CagriSema 1.7 mg/1.7 mg and CagriSema 1.0 mg/1.0 mg plus placebo in 300 overweight or obese adults.
REDEFINE 11 – Phase 3 study of the efficacy and safety of weekly CagriSema 2.4 mg/2.4 mg versus placebo in 600 obese adults over 80 weeks. The trial includes an 80-week extension phase investigating maintenance of weight loss.
A Phase 3 efficacy and safety trial of high-dose Kaglisema 2.4 mg/7.2 mg is expected to begin in the second half of 2026 in obese adults.
Novo Nordisk is a global healthcare company founded in 1923 and headquartered in Denmark. Our purpose is to build on our heritage in diabetes to drive change to overcome this serious chronic disease. We do this by pioneering scientific advances, expanding access to medicines, and working to prevent and ultimately cure disease. Novo Nordisk has approximately 68,800 employees in 80 countries and sells products in approximately 170 countries. For more information, please visit: novonordisk.com, facebook, Instagram, ×, linkedin and YouTube.
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Company Announcement No.13/2026
1 Based on efficacy estimates according to study protocol, regardless of dose changes
2 Based on treatment plan estimates: treatment efficacy independent of treatment adherence