Bagsværd, Denmark, December 20, 2024 – Novo Nordisk today announced topline results from REDEFINE 1, a phase 3 trial of the global REDEFINE program. REDEFINE 1 is a 68-week efficacy and safety trial evaluating subcutaneous CagriSema (a fixed-dose combination of cagrilintide 2.4 mg and semaglutide 2.4 mg) versus individual components cagrilintide 2.4 mg , semaglutide 2.4 mg and placebo, all administered once weekly. The trial included 3,417 randomized individuals with obesity or overweight with one or more comorbidities and a mean baseline body weight of 106.9 kg.

The trial met its primary endpoint by demonstrating statistically significant and superior weight loss at week 68 with CagriSema compared to placebo.

The REDEFINE 1 trial relied on a flexible protocol, allowing patients to change their dosage throughout the trial. After 68 weeks, 57.3% of patients treated with CagriSema were receiving the highest dose, compared to 82.5% with cagrilintide 2.4 mg and 70.2% with semaglutide 2.4 mg.

When evaluating the effects of the treatment whether all people adhered to the treatment¹people treated with CagriSema achieved 22.7% greater weight loss after 68 weeks, compared to an 11.8% reduction with cagrilintide 2.4 mg, 16.1% with semaglutide 2.4 mg and 2 .3% with placebo alone. Additionally, 40.4% of patients who received CagriSema achieved weight loss of 25% or more after 68 weeks, compared to 6.0% with cagrilintide 2.4 mg, 16.2% with semaglutide 2.4 mg and 0.9% with the placebo.

When applying the processing policy estimate²people treated with CagriSema achieved a 20.4% greater weight loss, compared to a reduction of 11.5% with cagrilintide 2.4 mg, 14.9% with semaglutide 2.4 mg, and 3.0%. with the placebo.

In the trial, CagriSema, cagrilintide 2.4 mg and semaglutide 2.4 mg appeared to have a safe and well-tolerated profile. The most common adverse events with CagriSema were gastrointestinal, and the vast majority were mild to moderate and decreased over time, consistent with the GLP-1 receptor agonist class.

“We are encouraged by the weight loss profile of CagriSema demonstrating superiority over semaglutide and cagrilintide monotherapy in the REDEFINE 1 trial. This goal was achieved even though only 57% of patients reached the highest dose of CagriSema,” said Martin Holst Lange, vice president. President of Development at Novo Nordisk. “With the information obtained from the REDEFINE 1 trial, we plan to further explore the additional weight loss potential of CagriSema. »

Results from the second pivotal phase 3 trial, REDEFINE 2, in adults with type 2 diabetes and obesity or overweight are expected during the first half of 2025.

About CagriSema
CagriSema subcutaneous once a week is being studied by Novo Nordisk as a treatment for adults who are overweight or obese (REDEFINE program) and as a treatment for adults with type 2 diabetes (REIMAGINE program). CagriSema is a fixed-dose combination of a long-acting amylin analogue, cagrilintide 2.4 mg and semaglutide 2.4 mg. Both molecules induce weight loss by reducing hunger, increasing the feeling of fullness and thus helping people to eat less and reduce their calorie intake.

About the REDEFINE clinical trial program
REDEFINE is a Phase 3 clinical development program with once-weekly subcutaneous CagriSema in the treatment of obesity. The global clinical trial program includes two pivotal Phase 3 trials, which enrolled approximately 4,600 overweight or obese adults. Additional phase 3 trials are underway.

REDEFINE 1 – a 68-week phase 3 efficacy and safety trial of CagriSema, cagrilintide 2.4 mg and semaglutide 2.4 mg once weekly versus placebo in 3,400 obese or overweight adults with one or more comorbidities and without type 2 diabetes.

REDEFINE 2 – a 68-week phase 3 efficacy and safety trial of once-weekly CagriSema versus placebo in 1,200 adults with type 2 diabetes and obesity or overweight.

REDEFINE 3 – a Phase 3, event-based cardiovascular outcomes trial comparing once-weekly CagriSema to placebo in 7,000 adults with established cardiovascular disease with or without type 2 diabetes.

REDEFINE 4 – a 72-week phase 3 efficacy and safety trial comparing CagriSema once weekly versus tirzepatide 15 mg once weekly in 800 obese adults.

About Novo Nordisk
Novo Nordisk is a leading global healthcare company, founded in 1923 and headquartered in Denmark. Our goal is to drive change to defeat serious chronic diseases, building on our diabetes heritage. We do this by pioneering scientific breakthroughs, expanding access to our medicines, and working to prevent and ultimately cure disease. Novo Nordisk employs approximately 72,000 people in 80 countries and markets its products in approximately 170 countries. Novo Nordisk B shares are listed on Nasdaq Copenhagen (Novo-B). Its ADRs are listed on the New York Stock Exchange (NVO). For more information, visit novonordisk.com,
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Company Announcement No. 99 / 2024

¹ Based on the estimation of the test product according to the test protocol, regardless of dose.
² Based on treatment policy estimation: treatment effect regardless of treatment compliance.

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  PR241220-CagriSema-Obesity