Novo Nordisk's CagriSema Shows Superior, But Lower-than-expected Weight Loss In Obesity; Stock Drops

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(RTTNews) - Novo Nordisk A/S (NVO) announced Friday that its experimental obesity drug CagriSema demonstrated superior weight loss in adults with obesity or overweight in the REDEFINE 1 phase 3 trial. Meanwhile, the Danish drugmaker's shares were plunging around 19 percent in the pre-market activity on the NYSE after reports indicated that the achieved weight loss was lower than expected by the company.

In a statement, Novo Nordisk said CagriSema helped overweight patients cut their weight by 22.7 percent in the late-stage trial, which is below the 25 percent it reportedly had expected.

Martin Holst Lange, executive vice president for Development at Novo Nordisk, said, "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 percent of patients reached the highest CagriSema dose. With the insights obtained from the REDEFINE 1 trial, we plan to further explore the additional weight loss potential of CagriSema."

REDEFINE 1 is a 68-week efficacy and safety trial investigating subcutaneous CagriSema (a fixed dose combination of cagrilintide 2.4 mg and semaglutide 2.4 mg) compared to the individual components cagrilintide 2.4 mg, semaglutide 2.4 mg 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 106.9 kg.

Novo Nordisk said 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 percent of patients treated with CagriSema were on the highest dose, compared to 82.5 percent with cagrilintide 2.4 mg and 70.2 percent with semaglutide 2.4 mg.

People treated with CagriSema achieved a superior weight loss of 22.7 percent after 68 weeks, compared to a reduction of 11.8 percent with cagrilintide 2.4 mg, 16.1 percent with semaglutide 2.4 mg and 2.3 percent with placebo alone.

In addition, 40.4 percent of patients who received CagriSema reached a weight loss of 25 percent or more after 68 weeks. This is compared to 6.0 percent with cagrilintide 2.4 mg, 16.2 percent with semaglutide 2.4 mg, and 0.9 percent with placebo.

In the trial, CagriSema, cagrilintide 2.4 mg and semaglutide 2.4 mg showed 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.

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.

In pre-market activity on the NYSE, Novo Nordisk shares were trading at $83.88, down 18.9 percent.

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