Novo Nordisk's CagriSema Shows Top Weight Loss Results in Obesity Trial

Bagsværd, Denmark, 20 December 2024 – Novo Nordisk has unveiled the primary results from its REDEFINE 1 phase 3 clinical trial. This trial is part of the broader REDEFINE programme, aimed at assessing the efficacy and safety of CagriSema, a once-weekly subcutaneous treatment combining cagrilintide 2.4 mg and semaglutide 2.4 mg. It compares this combination with each component individually and with a placebo. The trial enrolled 3,417 individuals who were either obese or overweight, with at least one comorbid condition and started with an average body weight of 106.9 kg.

The trial successfully met its primary objective by showcasing a statistically significant and superior weight reduction with CagriSema compared to placebo by the end of the 68-week period. The study followed a flexible protocol, allowing participants to adjust their dosing as needed throughout the duration. By the end of the trial, 57.3% of participants on CagriSema were on the highest dosage, in contrast to 82.5% for those on cagrilintide 2.4 mg and 70.2% for semaglutide 2.4 mg.

In examining patients' adherence to the treatment, those on CagriSema experienced an average weight reduction of 22.7% after 68 weeks. This is compared to an 11.8% reduction for those on cagrilintide, 16.1% for semaglutide, and 2.3% for placebo recipients. Furthermore, 40.4% of CagriSema users achieved a weight loss of 25% or more, while only 6.0% of cagrilintide users, 16.2% of semaglutide users, and 0.9% of placebo users reached this mark.

Employing the treatment policy estimand, which evaluates treatment effects regardless of adherence, CagriSema users achieved a 20.4% weight reduction compared to 11.5% for cagrilintide, 14.9% for semaglutide, and 3.0% for the placebo group.

Safety and tolerability were key focuses of the trial, with CagriSema, cagrilintide, and semaglutide displaying a favorable safety profile. The most frequent side effects for CagriSema were gastrointestinal in nature, predominantly mild to moderate, and subsided over time, aligning with the characteristics of the GLP-1 receptor agonist class.

Martin Holst Lange, Novo Nordisk's Executive Vice President for Development, highlighted the promising weight loss results of CagriSema, noting its superiority over the individual components even with only 57% of patients reaching the highest dosage. He emphasized the potential for further exploration of CagriSema’s weight loss capabilities.

Looking ahead, results from REDEFINE 2, another pivotal phase 3 trial involving adults with type 2 diabetes and obesity or overweight, are anticipated in the first half of 2025.

CagriSema is being explored as a treatment for adults dealing with overweight or obesity, and for those with type 2 diabetes, under separate programs. It is a fixed-dose combination of cagrilintide and semaglutide, designed to facilitate weight loss by curbing hunger and enhancing feelings of satiety, thus reducing caloric intake.

The REDEFINE programme is a comprehensive phase 3 clinical development endeavour featuring multiple trials, including REDEFINE 1 and others exploring various populations and conditions. Novo Nordisk, a leading global healthcare company based in Denmark, continues to innovate in addressing serious chronic diseases. Established in 1923, the company employs around 72,000 people across 80 countries and markets its products worldwide.