CagriSema FDA Approval Status
Last updated by Judith Stewart, BPharm on March 11, 2025.
FDA Approved: No
Brand name: CagriSema
Generic name: cagrilintide and semaglutide
Company: Novo Nordisk
Treatment for: Weight Loss (Obesity/Overweight), Type 2 Diabetes
CagriSema is a fixed-dose combination of cagrilintide (an investigational long-acting amylin analogue) and semaglutide (an approved glucagon-like peptide receptor agonist) in development for the treatment of people with overweight or obesity and type 2 diabetes.
- CagriSema contains a fixed dose combination of cagrilintide 2.4 mg and semaglutide 2.4 mg that is administered as a once-weekly subcutaneous injection.
- Cagrilintide and semaglutide work together to induce weight loss by reducing hunger, increasing feelings of fullness, and thereby helping people eat less and reduce their calorie intake.
- CagriSema is being studied as a treatment for adults with overweight or obesity in the REDEFINE phase 3 clinical development programme that consists of two pivotal phase 3 trials, which have enrolled approximately 4,600 adults with overweight or obesity. The phase 3 trial programme includes:
- REDEFINE 1 - a 68-week efficacy and safety phase 3 trial of once-weekly CagriSema, cagrilintide 2.4 mg, and semaglutide 2.4 mg versus placebo in 3,417 adults with obesity or overweight with one or more comorbidities and without type 2 diabetes. On December 20, 2024, it was announced that the REDEFINE 1 trial achieved its primary endpoint by demonstrating a statistically significant and superior weight loss of 22.7% at week 68 with CagriSema, compared to a reduction of 11.8% with cagrilintide 2.4 mg, 16.1% with semaglutide 2.4 mg and 2.3% with placebo alone.
- REDEFINE 2 - a 68-week efficacy and safety phase 3 trial of once-weekly CagriSema versus placebo in 1,200 adults with type 2 diabetes and either obesity or overweight. On March 10, 2025, it was announced that REDEFINE 2 achieved its primary endpoint by demonstrating a statistically significant and superior weight loss of 15.7% at week 68 with CagriSema compared to 3.1% with placebo. Weight loss of 5% or more after 68 weeks was a co-primary endpoint and was achieved by 89.7% of patients on CagriSema, compared to 30.3% on placebo.
- REDEFINE 3 – an event-driven cardiovascular outcomes phase 3 trial of once-weekly CagriSema versus placebo in 7,000 adults with established cardiovascular disease with or without type 2 diabetes (in progress).
- REDEFINE 4 – an 84-week efficacy and safety phase 3 trial of once-weekly CagriSema versus once-weekly tirzepatide 15 mg in 800 adults with obesity (in progess). - CagriSema is being studied as a treatment for adults with type 2 diabetes in the REIMAGINE programme, a 32 week efficacy and safety phase 2 clinical trial of once weekly CagriSema compared to the individual components semaglutide 2.4 mg and cagrilintide 2.4 mg, all administered once weekly, in 92 people with type 2 diabetes and overweight. On August 22, 2022, it was announced that people treated with CagriSema achieved a numerically higher HbA1c reduction of 2.18%-points compared to a reduction of 1.79%-points for people treated with semaglutide and 0.93%-points with cagrilintide alone. People treated with CagriSema achieved a numerically higher body weight reduction of 15.6% compared to a reduction of 5.1% for people treated with semaglutide and 8.1% with cagrilintide alone.
- The most common adverse events with CagriSema were gastrointestinal, and the vast majority were mild to moderate and diminished over time, consistent with the GLP-1 receptor agonist class.
Development timeline for CagriSema
Further information
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