Novo Nordisk’s CagriSema demonstrates superior weight loss results in REDEFINE 1 trial

Novo Nordisk A/S has unveiled significant findings from its REDEFINE 1 trial, marking a major advancement in the treatment of obesity and overweight conditions. Conducted as part of the company’s phase 3 clinical programme, this trial highlights the efficacy of CagriSema, a fixed-dose combination of cagrilintide 2.4 mg and semaglutide 2.4 mg, in promoting substantial weight loss.

The study, which spanned 68 weeks, involved 3,417 participants with a mean baseline body weight of 106.9 kg and at least one obesity-related comorbidity. By achieving statistically significant and superior weight loss compared to its individual components and placebo, CagriSema surpassed expectations, offering a glimpse into the future of obesity management.

How Effective Is CagriSema in Treating Obesity?

CagriSema demonstrated remarkable results in the REDEFINE 1 trial, particularly when evaluating patients who adhered to treatment protocols. Those treated with CagriSema achieved an average weight loss of 22.7%, significantly higher than the reductions observed with semaglutide alone (16.1%) or cagrilintide alone (11.8%). In contrast, participants in the placebo group experienced a modest weight loss of just 2.3%.

Approximately 40.4% of patients receiving CagriSema achieved a weight loss of 25% or more, far exceeding the outcomes seen with semaglutide (16.2%) or cagrilintide (6.0%). These results reflect CagriSema’s superior efficacy, even though only 57% of patients reached the highest dose during the trial.

Novo Nordisk also applied the treatment policy estimand, which accounts for real-world challenges such as dose adjustments and discontinuations. Using this measure, patients treated with CagriSema achieved an average weight loss of 20.4%, still outperforming semaglutide (14.9%) and cagrilintide (11.5%), with placebo showing minimal impact (3.0%).

What Makes CagriSema Unique?

CagriSema combines two powerful molecules: cagrilintide, a long-acting amylin analogue, and semaglutide, a GLP-1 receptor agonist. Together, these agents target appetite regulation by reducing hunger and increasing feelings of fullness, which helps patients lower their calorie intake effectively.

Martin Holst Lange, Executive Vice President for Development at Novo Nordisk, emphasised the significance of the findings. He noted that the trial’s outcomes validate the potential of combination therapies like CagriSema in achieving superior weight loss compared to monotherapies, even when dose limitations occur.

Is CagriSema Safe?

The REDEFINE 1 trial also provided reassuring data on CagriSema’s safety profile. The treatment was well-tolerated, with side effects largely limited to mild-to-moderate gastrointestinal symptoms such as nausea and vomiting, which diminished over time. These findings are consistent with the safety profile of GLP-1 receptor agonists, a class of drugs widely used for obesity and diabetes management.

What’s Next for Novo Nordisk?

Building on the success of REDEFINE 1, Novo Nordisk is advancing its broader REDEFINE programme. The upcoming REDEFINE 2 trial, focused on adults with type 2 diabetes and obesity or overweight, is expected to report results in the first half of 2025. Other trials in the programme include:

REDEFINE 3, a cardiovascular outcomes study involving adults with or without type 2 diabetes.

REDEFINE 4, a comparative study evaluating CagriSema against tirzepatide in obesity treatment.

These trials aim to solidify Novo Nordisk’s position as a leader in obesity management and expand its portfolio of evidence-based therapies.

Scaling Up Manufacturing Capacity

In a strategic move to meet growing demand, Novo Nordisk recently completed its acquisition of three manufacturing sites from Novo Holdings A/S. This expansion follows Novo Holdings’ acquisition of Catalent, Inc., a global leader in contract development and manufacturing.

Lars Fruergaard Jørgensen, Novo Nordisk’s CEO, expressed optimism about the acquisition, stating that the new facilities would enhance the company’s ability to supply treatments for chronic conditions at scale. This manufacturing boost aligns with Novo Nordisk’s goal of addressing the unmet needs of patients with obesity and other serious conditions.

A Turning Point in Obesity Treatment

The REDEFINE 1 trial underscores Novo Nordisk’s commitment to innovation in obesity treatment. With CagriSema demonstrating unparalleled efficacy and a promising safety profile, the therapy represents a significant step forward for patients struggling with obesity and related health challenges. As the company prepares to release further results from its REDEFINE programme, the future of obesity management appears brighter than ever.