Headline results from Novo Nordisk’s REDEFINE 1 has shown that the trial achieved its primary endpoint by demonstrating a statistically significant and superior weight loss at week 68 with CagriSema versus placebo. After 68 weeks, 57.3% of patients treated with CagriSema were on the highest dose compared to 82.5% with cagrilintide 2.4mg and 70.2% with semaglutide 2.4mg and people treated with CagriSema achieved a superior weight loss of 22.7% after 68 weeks compared to a reduction of 11.8% with cagrilintide 2.4mg, 16.1% with semaglutide 2.4mg and 2.3% with placebo alone.
REDEFINE 1 is a 68-week efficacy and safety trial investigating subcutaneous CagriSema (a fixed dose combination of cagrilintide 2.4mg and semaglutide 2.4mg) compared to the individual components cagrilintide 2.4mg, semaglutide 2.4mg and placebo, all administered once-weekly. The trial included 3,417 randomised people with obesity or overweight with one or more comorbidities and a mean baseline body weight of 106.9kg.
In addition, 40.4% of patients who received CagriSema reached a weight loss of 25% or more after 68 weeks, compared to 6.0% with cagrilintide 2.4mg, 16.2% with semaglutide 2.4mg, and 0.9% with placebo.
When applying the treatment policy estimand, people treated with CagriSema achieved a superior weight loss of 20.4% compared to a reduction of 11.5% with cagrilintide 2.4mg, 14.9% with semaglutide 2.4mg and 3.0% with placebo.
In the trial, CagriSema, cagrilintide 2.4mg and semaglutide 2.4mg 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 diminished over time, consistent with the GLP-1 receptor agonist class.
“We are encouraged by the weight loss profile of CagriSema demonstrating superiority over both semaglutide and cagrilintide in monotherapy in the REDEFINE 1 trial. This was achieved even though only 57% of patients reached the highest CagriSema dose,” said Martin Holst Lange, executive vice president for Development at Novo Nordisk. “With the insights obtained from the REDEFINE 1 trial, we plan to further explore the additional weight loss potential of CagriSema.”
The results from the second pivotal phase 3 trial, REDEFINE 2, in adults with type 2 diabetes and either obesity or overweight are expected during the first half of 2025.
Despite the positives results, shares in the company plunged on after the publication of the results as they fell short of the 25 percent Novo Nordisk had expected for the drug. The World Obesity Federation predicts that by 2035, over half of the world's population will be overweight or obese and the global economic impact could then exceed $4 trillion a year.
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